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Expert: Eliminating HCV ‘sounds ambitious, but I think it’s possible’
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
LAS VEGAS – Between 2010 and 2017, the proportion of newly diagnosed cases of acute hepatitis C virus infection rose threefold, driven largely by the concomitant opioid epidemic.
That makes efforts to screen, diagnose, and cure high-risk populations more important than ever, Stevan A. Gonzalez, MD, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
About 70% of HCV cases are related to injection drug use,” said Dr. Gonzalez, medical director of liver transplantation at the Baylor Simmons Transplant Institute at the Baylor Scott & White All Saints Medical Center in Fort Worth, Tex. “This is affecting whites as much as blacks and Hispanics, females as much as males, and in nonurban areas as much as in urban areas.”
Data from the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration indicate that during 2004-2014, the number of acute HCV cases among those aged 18-29 years increased 400%, and the use of injection opioids rose 600%.
At the same time, the number of HCV cases among those aged 30-39 years increased 325%, and the use of injection opioids rose 83%.
“We’re starting to see a pattern overlapping between HCV exposure and opioid injection,” Dr. Gonzalez said. Other high-risk populations include homeless and incarcerated individuals.
More than 70 million people worldwide have chronic HCV infection, Dr. Gonzalez noted, with possibly as many as 5 million cases in the United States. It remains the nation’s most common blood-borne infection.
Chronic disease develops in up to 85% of people who are exposed, infection is asymptomatic, and HCV remains one of the leading indications for liver transplantation and causes of liver cancer.
From a geographic standpoint, the prevalence of HCV in young adults is eclipsing that of Baby Boomers in several states in the Appalachian region and in Northeast, which have long been trouble spots for opioid use disorder (Gastroenterol. 2018 May;154[6]:1850-1).
Surprising exposure risk
The primary risk of transmission is through contaminated blood and the exposure through needles.
“It really doesn’t matter whether it’s a needle that has a small amount of dead space where a little bit of blood can remain or needles that have a larger amount of blood,” Dr. Gonzalez said.
“I’ve had patients who come to me and say, ‘I can’t believe I have HCV. It’s impossible. I always use my own needles. They’re always brand new; I’ve never shared with anybody,’” he continued.
“This is where education and awareness is so critical, because it’s not just the needles,” Dr. Gonzalez explained. “HCV can survive on inanimate objects. For example, on a tabletop surface or a water container, HCV can remain viable up to 3 weeks. In a syringe, 2 months. For that reason, HCV can also be transmitted through crack pipes and nasal drug use, where the prevalence can be up to 35%.”
The duration of a person’s HCV infection drives the transmission.
“That’s important to think about, because people who have chronic hepatitis C are infectious until they’re treated,” Dr. Gonzalez said. “If they don’t know that they have hepatitis C, they continue to transmit the virus to others.”
One study found that half of people living with HCV are unaware of their infection (PLoS One. 2014 Jul 2;9[7]:e101554). According to Dr. Gonzalez, forthcoming guidelines from the U.S. Preventive Services Task Force are expected to recommend a one-time screening for HCV infection in all adults aged 18-79 years, a Grade B recommendation. “That’s a big deal,” he said. (The draft recommendations are available here.)
HCV infection disproportionately affects individuals in correctional institutions. In fact, an estimated one in three inmates in the United States has chronic HCV.
“This is sort of a forgotten population with a lot of substance use and mental illness,” Dr. Gonzalez said. “Injection drug use in that setting is the most common risk factor: It’s about 60% in terms of the risk of transmission within correctional settings. HCV-associated liver disease has now surpassed HIV as a cause of death within correctional settings.”
Weighing treatment options
The most common oral regimens for chronic HCV include sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir. They achieve cure in 93%-100% of cases.
“HCV can be cured; it can be eradicated from the body long term,” Dr. Gonzalez said. “The choice of regimen, treatment duration, and use of ribavirin depends on the presence/absence of cirrhosis, prior treatment experience, and the genotype.”
All six forms of the HCV genotype can be treated with oral medication, he added, and methadone, bupropion, and naloxone are safe to use during therapy.
Reinfection following HCV treatment occurs infrequently. Dr. Gonzalez cited a randomized, controlled trial presented as an abstract at the 2018 annual meeting of the American Association for the Study of Liver Diseases. That study’s researchers found that – among 199 patients on opioid-replacement therapy who were receiving direct-acting antiviral therapy, in whom greater than 50% were actively using drugs – the rate of reinfection at 3 years was 1.8 reinfections/100 person-years.
“That’s lower than people expect,” Dr. Gonzalez said.
How to boost screening
Electronic health record systems can be used as an important tool to increase HCV screening in health care settings.
In 2017, researchers published an analysis of three randomized trials carried out at three separate primary care settings to improve screening for HCV: repeated mailings, an EHR best practice alert (BPA), and patient solicitation (Hepatology 2017 Jan;65[1]:44-53). They evaluated HCV antibody testing, diagnosis, and costs for each of the interventions, compared with standard-of-care testing.
The investigators found that the BPA intervention had the lowest incremental cost per completed test – $24 with fixed start-up costs, including technical design and development of the BPA system; $3 without fixed start-up costs. The BPA intervention also had the lowest incremental cost per new case identified.
Other efforts to expand access to screening and treatment are underway.
In 2019, Louisiana health officials negotiated a one-time fee for unlimited access for 5 years to sofosbuvir/velpatasvir (Epclusa) to treat the estimated 30,000 patients on Louisiana Medicaid and in that state’s department of corrections who have HCV.
“The goal is 90% cure; the burden is on the state health department to screen, diagnose, and dispense medication,” Dr. Gonzalez said.
Also in 2019, the state of Washington used an open bidding process to negotiate access to glecaprevir/pibrentasvir (Mavyret) for the state’s Medicaid population who have HCV.
“Those states are setting the pace,” Dr. Gonzalez said. “They are showing examples of how we can start implementing a process to treat these vulnerable populations.”
Meanwhile, the World Health Organization set a goal of eliminating viral hepatitis as a major public health threat by 2030.
“That sounds ambitious, but I think it’s possible,” Dr. Gonzalez said. “It’s important to address these high-risk populations: the incarcerated, people who use drugs, and the homeless, because those are the groups that have a high prevalence of HCV – mainly through injection drug use.
“If we don’t address that population, and we only target the general population, we’re going to have a continual source of transmission,” Dr. Gonzalez warned. “In that case, we would never be able to achieve elimination.”
Dr. Gonzalez disclosed that he is a member of the speakers bureau for AbbVie and Salix.
REPORTING FROM NPA 2020
Antibiotic resistance rises among pneumococcus strains in kids
Antibiotic resistance in strains of Streptococcus pneumoniae has been rising since 2013 because of changing susceptibility profiles, based on data from 1,201 isolates collected from 448 children in primary care settings.
“New strains expressing capsular serotypes not included in the 13-valent pneumococcal conjugate vaccine are emerging to cause disease, and strains that acquire antibiotic resistance are increasing in frequency due to their survival of the fittest advantage,” wrote Ravinder Kaur, PhD, of Rochester (N.Y.) General Hospital Research Institute, and colleagues.
Similar Darwinian principles occurred after the introduction of PCV-7, the study authors added.
In a prospective cohort study published in Clinical Infectious Diseases, the researchers reviewed 1,201 isolates collected from the nasopharynx during healthy periods, and from the nasopharynx and middle ear fluid (MEF) during episodes of acute otitis media, in children aged 6-36 months who were seen in primary care settings.
The isolates were collected during 2006-2016 to reflect the pre- and post-PCV13 era. Children received PCV-7 from 2006 until April 2010, and received PCV-13 after April 2010.
Overall, the number of acute otitis media (AOM) cases caused by S. pneumoniae was not significantly different between the PCV-7 and PCV-13 eras, nor was the frequency of pneumococci identified in the nasopharynx during healthy visits and visits at the start of an AOM infection.
The researchers examined susceptibility using minimum inhibitory concentrations (MIC). During healthy visits, the MIC50 of isolated pneumococci was low (no greater than 0.06 mcg/mL) for all four beta-lactam drugs tested. And it didn’t change significantly over the study years.
In contrast, among the nasopharyngeal and MEF isolates during AOM, the MIC50 to penicillin, amoxicillin, ceftriaxone, and meropenem during 2013-2016 rose significantly, the investigators said.
A change in antibiotic susceptibility within a subtype also contributed to the development of PCV-13 resistance.
The study authors identified three serotypes that affected the changes in susceptibility in their study population. Serotypes 35B and 35F increased their beta-lactam resistance during 2013-2016, and serotype 11A had a higher MIC to quinolones and became more prevalent during 2013-2016. Those three serotypes accounted for most of the change in antibiotic susceptibility, the researchers said.
In addition, “the frequency of strains resistant to penicillin and amoxicillin decreased with the introduction of PCV-13, but rebounded to levels similar to those before PCV-13 introduction by 2015-2016,” the investigators noted.
The study findings were limited by several factors, including the homogeneous study population and potential lack of generalizability to other settings. In addition, the researchers did not study antibiotic consumption or antibiotic treatment failure, and they could not account for potential AOM cases that may have been treated in settings other than primary care.
However, the investigators said the results support the need for additional studies and attention to the development of the next generation of PCVs, the PCV-15 and PCV-20. Both include serotypes 22F and 33F, but neither includes 35B or 35F. The PCV-20 also includes 11A and 15B.
The study was supported in part by the National Institutes of Health and Sanofi Pasteur. Some isolates collected during the 2010-2013 time period were part of a study supported by Pfizer. The researchers had no relevant financial conflicts to disclose.
SOURCE: Kaur R et al. Clin Inf Dis. 2020 Feb 18. doi: 10.1093/cid/ciaa157.
Dr. Kaur and colleagues report their analysis of pneumococcal resistance among nasopharyngeal and middle ear isolates (90% nasopharyngeal and 10% middle ear) collected between 2008 and 2016. They demonstrate the dominant role that nonvaccine serotypes play in carriage and acute otitis media (AOM) in children, and by extension potentially the entire spectrum of pneumococcal disease in the 13-valent pneumococcal conjugate vaccine (PCV13) era. Nonsusceptibility to beta-lactams was reported for one-third of isolates with the increase in the most recent reported years (2013-2016).
What are the implications for treatment of pneumococcal infections? For AOM, amoxicillin minimum inhibitory concentrations (MIC) were all less than 4 mcg/mL, which is the pharmacodynamic breakpoint for high-dose (90 mg/kg per day) AOM regimens; these data support continued use of high-dose amoxicillin for children with AOM that requires antimicrobial treatment. Resistance to macrolides (erythromycin and likely azithromycin) occurred in approximately one-third of isolates; however, in contrast to beta-lactams (amoxicillin), higher macrolide doses do not overcome resistance. Thus macrolide use for AOM appears limited to those with beta-lactam allergy and no better alternative drug, i.e., expect failure in one-third of AOM patients if macrolides are used. For ceftriaxone, no 2013-2016 isolate had a MIC over 0.5 mcg/mL, implying that ceftriaxone remains appropriate first-line therapy for serious pneumococcal disease and effective for pneumococcal AOM when oral drugs have failed or are not an option because of repeated emesis. Interestingly, trimethoprim/sulfamethoxazole (T/S) had lower resistance rates against the nonvaccine “bad boy” serogroup 35 (8%-15%), compared with cephalosporins (32%-57%). Perhaps we are back to the future and T/S will again have a role against pneumococcal AOM. Of note, no isolate was resistant to levofloxacin or linezolid. Linezolid or macrolide use alone must be considered with the caveat that nontypeable Haemophilus influenzae now likely surpasses pneumococcus as an AOM pathogen, and neither drug class is active against nontypeable H. influenzae.
What are the implications for prevention? This is one of many studies in the post-PCV era reporting serotype replacement with nonvaccine serotypes. But most prior studies reported reduced overall disease burden; in other words, the absolute number of pneumococcal infections was reduced, but residual AOM nonvaccine types dominated as the etiology. The current study, however, suggests that the overall number of AOM episodes may not be less because increases in AOM caused by nonvaccine serotypes may be offsetting declines in AOM caused by vaccine serotypes. This concept contrasts to multiple large epidemiologic studies demonstrating a decline in overall incidence of AOM office visits/episodes and several Israeli studies reporting a decline in pneumococcal AOM in children who warrant tympanocentesis. These new data are food for thought, but antibiotic resistance can vary regionally, so confirmation based on data from other regions seems warranted.
Next-generation vaccines will need to consider which serotypes are prevalent in pneumococcal disease, including AOM, as we continue into the PCV13 era. However, serotypes causing invasive pneumococcal disease and pneumonia would be higher priorities than AOM. Indeed, several candidate PCV vaccines are currently in clinical trials adding up to seven serotypes, including most of the newly emerging invasive disease serotypes. One downside to the newer PCVs is lack of serogroup 35, a prominent culprit in AOM resistance in the current report.
Stephen I. Pelton, MD, is professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. Christopher J. Harrison, MD, is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital–Kansas City, Mo. Dr. Pelton has received honorarium from Merck Vaccines, Pfizer, and Sanofi for participation in advisory board meeting on pneumococcal vaccine and/or membership on the Data and Safety Monitoring Board. Boston Medical Center has received investigator-initiated research grants from Merck Vaccines and Pfizer.
Children’s Mercy Hospital – Kansas City Boston Medical Center has received funding from GlaxoSmithKline, Merck, and Pfizer for research vaccine studies, and from Pfizer and Merck for investigator-initiated research grants for in vitro pneumococcal investigations on which Dr. Harrison is an investigator.
Dr. Kaur and colleagues report their analysis of pneumococcal resistance among nasopharyngeal and middle ear isolates (90% nasopharyngeal and 10% middle ear) collected between 2008 and 2016. They demonstrate the dominant role that nonvaccine serotypes play in carriage and acute otitis media (AOM) in children, and by extension potentially the entire spectrum of pneumococcal disease in the 13-valent pneumococcal conjugate vaccine (PCV13) era. Nonsusceptibility to beta-lactams was reported for one-third of isolates with the increase in the most recent reported years (2013-2016).
What are the implications for treatment of pneumococcal infections? For AOM, amoxicillin minimum inhibitory concentrations (MIC) were all less than 4 mcg/mL, which is the pharmacodynamic breakpoint for high-dose (90 mg/kg per day) AOM regimens; these data support continued use of high-dose amoxicillin for children with AOM that requires antimicrobial treatment. Resistance to macrolides (erythromycin and likely azithromycin) occurred in approximately one-third of isolates; however, in contrast to beta-lactams (amoxicillin), higher macrolide doses do not overcome resistance. Thus macrolide use for AOM appears limited to those with beta-lactam allergy and no better alternative drug, i.e., expect failure in one-third of AOM patients if macrolides are used. For ceftriaxone, no 2013-2016 isolate had a MIC over 0.5 mcg/mL, implying that ceftriaxone remains appropriate first-line therapy for serious pneumococcal disease and effective for pneumococcal AOM when oral drugs have failed or are not an option because of repeated emesis. Interestingly, trimethoprim/sulfamethoxazole (T/S) had lower resistance rates against the nonvaccine “bad boy” serogroup 35 (8%-15%), compared with cephalosporins (32%-57%). Perhaps we are back to the future and T/S will again have a role against pneumococcal AOM. Of note, no isolate was resistant to levofloxacin or linezolid. Linezolid or macrolide use alone must be considered with the caveat that nontypeable Haemophilus influenzae now likely surpasses pneumococcus as an AOM pathogen, and neither drug class is active against nontypeable H. influenzae.
What are the implications for prevention? This is one of many studies in the post-PCV era reporting serotype replacement with nonvaccine serotypes. But most prior studies reported reduced overall disease burden; in other words, the absolute number of pneumococcal infections was reduced, but residual AOM nonvaccine types dominated as the etiology. The current study, however, suggests that the overall number of AOM episodes may not be less because increases in AOM caused by nonvaccine serotypes may be offsetting declines in AOM caused by vaccine serotypes. This concept contrasts to multiple large epidemiologic studies demonstrating a decline in overall incidence of AOM office visits/episodes and several Israeli studies reporting a decline in pneumococcal AOM in children who warrant tympanocentesis. These new data are food for thought, but antibiotic resistance can vary regionally, so confirmation based on data from other regions seems warranted.
Next-generation vaccines will need to consider which serotypes are prevalent in pneumococcal disease, including AOM, as we continue into the PCV13 era. However, serotypes causing invasive pneumococcal disease and pneumonia would be higher priorities than AOM. Indeed, several candidate PCV vaccines are currently in clinical trials adding up to seven serotypes, including most of the newly emerging invasive disease serotypes. One downside to the newer PCVs is lack of serogroup 35, a prominent culprit in AOM resistance in the current report.
Stephen I. Pelton, MD, is professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. Christopher J. Harrison, MD, is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital–Kansas City, Mo. Dr. Pelton has received honorarium from Merck Vaccines, Pfizer, and Sanofi for participation in advisory board meeting on pneumococcal vaccine and/or membership on the Data and Safety Monitoring Board. Boston Medical Center has received investigator-initiated research grants from Merck Vaccines and Pfizer.
Children’s Mercy Hospital – Kansas City Boston Medical Center has received funding from GlaxoSmithKline, Merck, and Pfizer for research vaccine studies, and from Pfizer and Merck for investigator-initiated research grants for in vitro pneumococcal investigations on which Dr. Harrison is an investigator.
Dr. Kaur and colleagues report their analysis of pneumococcal resistance among nasopharyngeal and middle ear isolates (90% nasopharyngeal and 10% middle ear) collected between 2008 and 2016. They demonstrate the dominant role that nonvaccine serotypes play in carriage and acute otitis media (AOM) in children, and by extension potentially the entire spectrum of pneumococcal disease in the 13-valent pneumococcal conjugate vaccine (PCV13) era. Nonsusceptibility to beta-lactams was reported for one-third of isolates with the increase in the most recent reported years (2013-2016).
What are the implications for treatment of pneumococcal infections? For AOM, amoxicillin minimum inhibitory concentrations (MIC) were all less than 4 mcg/mL, which is the pharmacodynamic breakpoint for high-dose (90 mg/kg per day) AOM regimens; these data support continued use of high-dose amoxicillin for children with AOM that requires antimicrobial treatment. Resistance to macrolides (erythromycin and likely azithromycin) occurred in approximately one-third of isolates; however, in contrast to beta-lactams (amoxicillin), higher macrolide doses do not overcome resistance. Thus macrolide use for AOM appears limited to those with beta-lactam allergy and no better alternative drug, i.e., expect failure in one-third of AOM patients if macrolides are used. For ceftriaxone, no 2013-2016 isolate had a MIC over 0.5 mcg/mL, implying that ceftriaxone remains appropriate first-line therapy for serious pneumococcal disease and effective for pneumococcal AOM when oral drugs have failed or are not an option because of repeated emesis. Interestingly, trimethoprim/sulfamethoxazole (T/S) had lower resistance rates against the nonvaccine “bad boy” serogroup 35 (8%-15%), compared with cephalosporins (32%-57%). Perhaps we are back to the future and T/S will again have a role against pneumococcal AOM. Of note, no isolate was resistant to levofloxacin or linezolid. Linezolid or macrolide use alone must be considered with the caveat that nontypeable Haemophilus influenzae now likely surpasses pneumococcus as an AOM pathogen, and neither drug class is active against nontypeable H. influenzae.
What are the implications for prevention? This is one of many studies in the post-PCV era reporting serotype replacement with nonvaccine serotypes. But most prior studies reported reduced overall disease burden; in other words, the absolute number of pneumococcal infections was reduced, but residual AOM nonvaccine types dominated as the etiology. The current study, however, suggests that the overall number of AOM episodes may not be less because increases in AOM caused by nonvaccine serotypes may be offsetting declines in AOM caused by vaccine serotypes. This concept contrasts to multiple large epidemiologic studies demonstrating a decline in overall incidence of AOM office visits/episodes and several Israeli studies reporting a decline in pneumococcal AOM in children who warrant tympanocentesis. These new data are food for thought, but antibiotic resistance can vary regionally, so confirmation based on data from other regions seems warranted.
Next-generation vaccines will need to consider which serotypes are prevalent in pneumococcal disease, including AOM, as we continue into the PCV13 era. However, serotypes causing invasive pneumococcal disease and pneumonia would be higher priorities than AOM. Indeed, several candidate PCV vaccines are currently in clinical trials adding up to seven serotypes, including most of the newly emerging invasive disease serotypes. One downside to the newer PCVs is lack of serogroup 35, a prominent culprit in AOM resistance in the current report.
Stephen I. Pelton, MD, is professor of pediatrics and epidemiology at Boston University and senior attending physician at Boston Medical Center. Christopher J. Harrison, MD, is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital–Kansas City, Mo. Dr. Pelton has received honorarium from Merck Vaccines, Pfizer, and Sanofi for participation in advisory board meeting on pneumococcal vaccine and/or membership on the Data and Safety Monitoring Board. Boston Medical Center has received investigator-initiated research grants from Merck Vaccines and Pfizer.
Children’s Mercy Hospital – Kansas City Boston Medical Center has received funding from GlaxoSmithKline, Merck, and Pfizer for research vaccine studies, and from Pfizer and Merck for investigator-initiated research grants for in vitro pneumococcal investigations on which Dr. Harrison is an investigator.
Antibiotic resistance in strains of Streptococcus pneumoniae has been rising since 2013 because of changing susceptibility profiles, based on data from 1,201 isolates collected from 448 children in primary care settings.
“New strains expressing capsular serotypes not included in the 13-valent pneumococcal conjugate vaccine are emerging to cause disease, and strains that acquire antibiotic resistance are increasing in frequency due to their survival of the fittest advantage,” wrote Ravinder Kaur, PhD, of Rochester (N.Y.) General Hospital Research Institute, and colleagues.
Similar Darwinian principles occurred after the introduction of PCV-7, the study authors added.
In a prospective cohort study published in Clinical Infectious Diseases, the researchers reviewed 1,201 isolates collected from the nasopharynx during healthy periods, and from the nasopharynx and middle ear fluid (MEF) during episodes of acute otitis media, in children aged 6-36 months who were seen in primary care settings.
The isolates were collected during 2006-2016 to reflect the pre- and post-PCV13 era. Children received PCV-7 from 2006 until April 2010, and received PCV-13 after April 2010.
Overall, the number of acute otitis media (AOM) cases caused by S. pneumoniae was not significantly different between the PCV-7 and PCV-13 eras, nor was the frequency of pneumococci identified in the nasopharynx during healthy visits and visits at the start of an AOM infection.
The researchers examined susceptibility using minimum inhibitory concentrations (MIC). During healthy visits, the MIC50 of isolated pneumococci was low (no greater than 0.06 mcg/mL) for all four beta-lactam drugs tested. And it didn’t change significantly over the study years.
In contrast, among the nasopharyngeal and MEF isolates during AOM, the MIC50 to penicillin, amoxicillin, ceftriaxone, and meropenem during 2013-2016 rose significantly, the investigators said.
A change in antibiotic susceptibility within a subtype also contributed to the development of PCV-13 resistance.
The study authors identified three serotypes that affected the changes in susceptibility in their study population. Serotypes 35B and 35F increased their beta-lactam resistance during 2013-2016, and serotype 11A had a higher MIC to quinolones and became more prevalent during 2013-2016. Those three serotypes accounted for most of the change in antibiotic susceptibility, the researchers said.
In addition, “the frequency of strains resistant to penicillin and amoxicillin decreased with the introduction of PCV-13, but rebounded to levels similar to those before PCV-13 introduction by 2015-2016,” the investigators noted.
The study findings were limited by several factors, including the homogeneous study population and potential lack of generalizability to other settings. In addition, the researchers did not study antibiotic consumption or antibiotic treatment failure, and they could not account for potential AOM cases that may have been treated in settings other than primary care.
However, the investigators said the results support the need for additional studies and attention to the development of the next generation of PCVs, the PCV-15 and PCV-20. Both include serotypes 22F and 33F, but neither includes 35B or 35F. The PCV-20 also includes 11A and 15B.
The study was supported in part by the National Institutes of Health and Sanofi Pasteur. Some isolates collected during the 2010-2013 time period were part of a study supported by Pfizer. The researchers had no relevant financial conflicts to disclose.
SOURCE: Kaur R et al. Clin Inf Dis. 2020 Feb 18. doi: 10.1093/cid/ciaa157.
Antibiotic resistance in strains of Streptococcus pneumoniae has been rising since 2013 because of changing susceptibility profiles, based on data from 1,201 isolates collected from 448 children in primary care settings.
“New strains expressing capsular serotypes not included in the 13-valent pneumococcal conjugate vaccine are emerging to cause disease, and strains that acquire antibiotic resistance are increasing in frequency due to their survival of the fittest advantage,” wrote Ravinder Kaur, PhD, of Rochester (N.Y.) General Hospital Research Institute, and colleagues.
Similar Darwinian principles occurred after the introduction of PCV-7, the study authors added.
In a prospective cohort study published in Clinical Infectious Diseases, the researchers reviewed 1,201 isolates collected from the nasopharynx during healthy periods, and from the nasopharynx and middle ear fluid (MEF) during episodes of acute otitis media, in children aged 6-36 months who were seen in primary care settings.
The isolates were collected during 2006-2016 to reflect the pre- and post-PCV13 era. Children received PCV-7 from 2006 until April 2010, and received PCV-13 after April 2010.
Overall, the number of acute otitis media (AOM) cases caused by S. pneumoniae was not significantly different between the PCV-7 and PCV-13 eras, nor was the frequency of pneumococci identified in the nasopharynx during healthy visits and visits at the start of an AOM infection.
The researchers examined susceptibility using minimum inhibitory concentrations (MIC). During healthy visits, the MIC50 of isolated pneumococci was low (no greater than 0.06 mcg/mL) for all four beta-lactam drugs tested. And it didn’t change significantly over the study years.
In contrast, among the nasopharyngeal and MEF isolates during AOM, the MIC50 to penicillin, amoxicillin, ceftriaxone, and meropenem during 2013-2016 rose significantly, the investigators said.
A change in antibiotic susceptibility within a subtype also contributed to the development of PCV-13 resistance.
The study authors identified three serotypes that affected the changes in susceptibility in their study population. Serotypes 35B and 35F increased their beta-lactam resistance during 2013-2016, and serotype 11A had a higher MIC to quinolones and became more prevalent during 2013-2016. Those three serotypes accounted for most of the change in antibiotic susceptibility, the researchers said.
In addition, “the frequency of strains resistant to penicillin and amoxicillin decreased with the introduction of PCV-13, but rebounded to levels similar to those before PCV-13 introduction by 2015-2016,” the investigators noted.
The study findings were limited by several factors, including the homogeneous study population and potential lack of generalizability to other settings. In addition, the researchers did not study antibiotic consumption or antibiotic treatment failure, and they could not account for potential AOM cases that may have been treated in settings other than primary care.
However, the investigators said the results support the need for additional studies and attention to the development of the next generation of PCVs, the PCV-15 and PCV-20. Both include serotypes 22F and 33F, but neither includes 35B or 35F. The PCV-20 also includes 11A and 15B.
The study was supported in part by the National Institutes of Health and Sanofi Pasteur. Some isolates collected during the 2010-2013 time period were part of a study supported by Pfizer. The researchers had no relevant financial conflicts to disclose.
SOURCE: Kaur R et al. Clin Inf Dis. 2020 Feb 18. doi: 10.1093/cid/ciaa157.
FROM CLINICAL INFECTIOUS DISEASES
U.S. reports first death from COVID-19, possible outbreak at long-term care facility
The first death in the United States from the novel coronavirus (COVID-19) was a Washington state man in his 50s who had underlying health conditions, state health officials announced on Feb 29. At the same time, officials there are investigating a possible COVID-19 outbreak at a long-term care facility.
Washington state officials reported two other presumptive positive cases of COVID-19, both of whom are associated with LifeCare of Kirkland, Washington. One is a woman in her 70s who is a resident at the facility and the other is a woman in her 40s who is a health care worker at the facility.
Additionally, many residents and staff members at the facility have reported respiratory symptoms, according to Jeff Duchin, MD, health officer for public health in Seattle and King County. Among the more than 100 residents at the facility, 27 have respiratory symptoms; while among the 180 staff members, 25 have reported symptoms.
Overall, these reports bring the total number of U.S. COVID-19 cases detected by the public health system to 22, though that number is expected to climb as these investigations continue.
The general risk to the American public is still low, including residents in long-term care facilities, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during the Feb. 29 press briefing. Older people are are higher risk, however, and long-term care facilities should emphasize handwashing and the early identification of individuals with symptoms.
Dr. Duchin added that health care workers who are sick should stay home and that visitors should be screened for symptoms, the same advice offered to limit the spread of influenza at long-term care facilities.
The CDC briefing comes after President Trump held his own press conference at the White House where he identified the person who had died as being a woman in her 50s who was medically at risk.
During that press conference, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said that the current pattern of disease with COVID-19 suggests that 75%-80% of patients will have mild illness and recover, while 15%-20% will require advanced medical care.
For the most part, the more serious cases will occur in those who are elderly or have underlying medical conditions. There is “no indication” that individuals who recover from the virus are becoming re-infected, Dr. Fauci said.
The administration also announced a series of actions aimed at slowing the spread of the virus and responding to it. On March 2, President Trump will meet with leaders in the pharmaceutical industry at the White House to discuss vaccine development. The administration is also working to ensure an adequate supply of face masks. Vice President Mike Pence said there are currently more than 40 million masks available, but that the administration has received promises of 35 million more masks per month from manufacturers. Access to masks will be prioritized for high-risk health care workers, Vice President Pence said. “The average American does not need to go out and buy a mask,” he added.
Additionally, Vice President Pence announced new travel restrictions with Iran that would bar entry to the United States for any foreign national who visited Iran in the last 14 days. The federal government is also advising Americans not to travel to the regions in Italy and South Korea that have been most affected by COVID-19. The government is also working with officials in Italy and South Korea to conduct medical screening of anyone coming into the United States from those countries.
The first death in the United States from the novel coronavirus (COVID-19) was a Washington state man in his 50s who had underlying health conditions, state health officials announced on Feb 29. At the same time, officials there are investigating a possible COVID-19 outbreak at a long-term care facility.
Washington state officials reported two other presumptive positive cases of COVID-19, both of whom are associated with LifeCare of Kirkland, Washington. One is a woman in her 70s who is a resident at the facility and the other is a woman in her 40s who is a health care worker at the facility.
Additionally, many residents and staff members at the facility have reported respiratory symptoms, according to Jeff Duchin, MD, health officer for public health in Seattle and King County. Among the more than 100 residents at the facility, 27 have respiratory symptoms; while among the 180 staff members, 25 have reported symptoms.
Overall, these reports bring the total number of U.S. COVID-19 cases detected by the public health system to 22, though that number is expected to climb as these investigations continue.
The general risk to the American public is still low, including residents in long-term care facilities, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during the Feb. 29 press briefing. Older people are are higher risk, however, and long-term care facilities should emphasize handwashing and the early identification of individuals with symptoms.
Dr. Duchin added that health care workers who are sick should stay home and that visitors should be screened for symptoms, the same advice offered to limit the spread of influenza at long-term care facilities.
The CDC briefing comes after President Trump held his own press conference at the White House where he identified the person who had died as being a woman in her 50s who was medically at risk.
During that press conference, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said that the current pattern of disease with COVID-19 suggests that 75%-80% of patients will have mild illness and recover, while 15%-20% will require advanced medical care.
For the most part, the more serious cases will occur in those who are elderly or have underlying medical conditions. There is “no indication” that individuals who recover from the virus are becoming re-infected, Dr. Fauci said.
The administration also announced a series of actions aimed at slowing the spread of the virus and responding to it. On March 2, President Trump will meet with leaders in the pharmaceutical industry at the White House to discuss vaccine development. The administration is also working to ensure an adequate supply of face masks. Vice President Mike Pence said there are currently more than 40 million masks available, but that the administration has received promises of 35 million more masks per month from manufacturers. Access to masks will be prioritized for high-risk health care workers, Vice President Pence said. “The average American does not need to go out and buy a mask,” he added.
Additionally, Vice President Pence announced new travel restrictions with Iran that would bar entry to the United States for any foreign national who visited Iran in the last 14 days. The federal government is also advising Americans not to travel to the regions in Italy and South Korea that have been most affected by COVID-19. The government is also working with officials in Italy and South Korea to conduct medical screening of anyone coming into the United States from those countries.
The first death in the United States from the novel coronavirus (COVID-19) was a Washington state man in his 50s who had underlying health conditions, state health officials announced on Feb 29. At the same time, officials there are investigating a possible COVID-19 outbreak at a long-term care facility.
Washington state officials reported two other presumptive positive cases of COVID-19, both of whom are associated with LifeCare of Kirkland, Washington. One is a woman in her 70s who is a resident at the facility and the other is a woman in her 40s who is a health care worker at the facility.
Additionally, many residents and staff members at the facility have reported respiratory symptoms, according to Jeff Duchin, MD, health officer for public health in Seattle and King County. Among the more than 100 residents at the facility, 27 have respiratory symptoms; while among the 180 staff members, 25 have reported symptoms.
Overall, these reports bring the total number of U.S. COVID-19 cases detected by the public health system to 22, though that number is expected to climb as these investigations continue.
The general risk to the American public is still low, including residents in long-term care facilities, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, said during the Feb. 29 press briefing. Older people are are higher risk, however, and long-term care facilities should emphasize handwashing and the early identification of individuals with symptoms.
Dr. Duchin added that health care workers who are sick should stay home and that visitors should be screened for symptoms, the same advice offered to limit the spread of influenza at long-term care facilities.
The CDC briefing comes after President Trump held his own press conference at the White House where he identified the person who had died as being a woman in her 50s who was medically at risk.
During that press conference, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said that the current pattern of disease with COVID-19 suggests that 75%-80% of patients will have mild illness and recover, while 15%-20% will require advanced medical care.
For the most part, the more serious cases will occur in those who are elderly or have underlying medical conditions. There is “no indication” that individuals who recover from the virus are becoming re-infected, Dr. Fauci said.
The administration also announced a series of actions aimed at slowing the spread of the virus and responding to it. On March 2, President Trump will meet with leaders in the pharmaceutical industry at the White House to discuss vaccine development. The administration is also working to ensure an adequate supply of face masks. Vice President Mike Pence said there are currently more than 40 million masks available, but that the administration has received promises of 35 million more masks per month from manufacturers. Access to masks will be prioritized for high-risk health care workers, Vice President Pence said. “The average American does not need to go out and buy a mask,” he added.
Additionally, Vice President Pence announced new travel restrictions with Iran that would bar entry to the United States for any foreign national who visited Iran in the last 14 days. The federal government is also advising Americans not to travel to the regions in Italy and South Korea that have been most affected by COVID-19. The government is also working with officials in Italy and South Korea to conduct medical screening of anyone coming into the United States from those countries.
CDC revises COVID-19 test kits, broadens ‘person under investigation’ definition
In a telebriefing on the COVID-19 outbreak, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at .
The definition has been revised “to meet the needs of this rapidly evolving situation,” she said. The new PUI definition includes travel to more geographic areas to reflect this past week’s marked uptick in coronavirus activity in Italy and Iran. In addition to these countries and China, recent travel to Japan or South Korea also constitutes an epidemiologic risk factor which, in conjunction with clinical features, warrant an individual being classified as a PUI. These five countries each now have widespread person-to-person transmission of the virus.
Dr. Messonnier left open the possibility that the PUI definition would continue to evolve if such transmission within communities becomes more common. Asked whether the small number of U.S. cases thus might be an artifact of low test volumes, she said, “We aggressively controlled our borders to slow the spread. This was an intentional U.S. strategy. The CDC has always had the capacity to test rapidly from the time the sequence was available. ...We have been testing aggressively.”
The original PUI definition, she explained, emphasized individuals with fever, cough, or trouble breathing who had traveled recently from areas with COVID-19 activity, in particular China’s Hubei province. “We have been most focused on symptomatic people who are closely linked to, or who had, travel history, but our criteria also allow for clinical discretion,” she said. “There is no substitute for an astute clinician on the front lines of patient care.”
The first COVID-19 case from person-to-person spread was reported on Feb. 27. “At this time, we don’t know how or where this person became infected,” said Dr. Messonnier, although investigations are still underway. She responded to a question about whether the CDC delayed allowing COVID-19 testing for the patient for several days, as was reported in some media accounts. “According to CDC records, the first call we got was Feb. 23,” when public health officials in California reported a severely ill person with no travel abroad and no known contacts with individuals that would trigger suspicions for coronavirus. The CDC recommended COVID-19 testing on that day, she said.
Dr. Messonnier declined to answer questions about a whistleblower report alleging improper training and inadequate protective measures for Department of Health & Human Services workers at the quarantine center at Travis Air Force Base, Calif.
Dr. Messonnier said that the CDC has been working closely with the Food and Drug Administration to address problems with the COVID-19 test kits that were unusable because of a large number of indeterminate results. The two agencies together have determined that of the three reactions that were initially deemed necessary for a definitive COVID-19 diagnosis, just two are sufficient, so new kits that omit the problematic chemical are being manufactured and distributed.
These new kits are rapidly being made available; the goal, said Dr. Messonnier, is to have to state and local public health departments equipped with test kits by about March 7.
As local tests become available, the most updated information will be coming from state and local public health departments, she stressed, adding that the CDC would continue to update case counts on Monday, Wednesday, and Friday of each week. Procedures are being developed for the management of patients presumed to have COVID-19, where local health departments see positive tests but the mandatory CDC confirmatory test hasn’t been completed.
While new cases emerge across Europe and Asia, China’s earlier COVID-19 explosion seems to be slowing. “It’s really good news that the case counts in China are decreasing,” both for the well-being of that country’s citizens, and as a sign of the disease’s potential global effects, said Dr. Messonnier. She added that epidemiologists and mathematical modelers are parsing case fatality rates as well.
She advised health care providers and public health officials to keep abreast of changes in CDC guidance by checking frequently at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
In a telebriefing on the COVID-19 outbreak, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at .
The definition has been revised “to meet the needs of this rapidly evolving situation,” she said. The new PUI definition includes travel to more geographic areas to reflect this past week’s marked uptick in coronavirus activity in Italy and Iran. In addition to these countries and China, recent travel to Japan or South Korea also constitutes an epidemiologic risk factor which, in conjunction with clinical features, warrant an individual being classified as a PUI. These five countries each now have widespread person-to-person transmission of the virus.
Dr. Messonnier left open the possibility that the PUI definition would continue to evolve if such transmission within communities becomes more common. Asked whether the small number of U.S. cases thus might be an artifact of low test volumes, she said, “We aggressively controlled our borders to slow the spread. This was an intentional U.S. strategy. The CDC has always had the capacity to test rapidly from the time the sequence was available. ...We have been testing aggressively.”
The original PUI definition, she explained, emphasized individuals with fever, cough, or trouble breathing who had traveled recently from areas with COVID-19 activity, in particular China’s Hubei province. “We have been most focused on symptomatic people who are closely linked to, or who had, travel history, but our criteria also allow for clinical discretion,” she said. “There is no substitute for an astute clinician on the front lines of patient care.”
The first COVID-19 case from person-to-person spread was reported on Feb. 27. “At this time, we don’t know how or where this person became infected,” said Dr. Messonnier, although investigations are still underway. She responded to a question about whether the CDC delayed allowing COVID-19 testing for the patient for several days, as was reported in some media accounts. “According to CDC records, the first call we got was Feb. 23,” when public health officials in California reported a severely ill person with no travel abroad and no known contacts with individuals that would trigger suspicions for coronavirus. The CDC recommended COVID-19 testing on that day, she said.
Dr. Messonnier declined to answer questions about a whistleblower report alleging improper training and inadequate protective measures for Department of Health & Human Services workers at the quarantine center at Travis Air Force Base, Calif.
Dr. Messonnier said that the CDC has been working closely with the Food and Drug Administration to address problems with the COVID-19 test kits that were unusable because of a large number of indeterminate results. The two agencies together have determined that of the three reactions that were initially deemed necessary for a definitive COVID-19 diagnosis, just two are sufficient, so new kits that omit the problematic chemical are being manufactured and distributed.
These new kits are rapidly being made available; the goal, said Dr. Messonnier, is to have to state and local public health departments equipped with test kits by about March 7.
As local tests become available, the most updated information will be coming from state and local public health departments, she stressed, adding that the CDC would continue to update case counts on Monday, Wednesday, and Friday of each week. Procedures are being developed for the management of patients presumed to have COVID-19, where local health departments see positive tests but the mandatory CDC confirmatory test hasn’t been completed.
While new cases emerge across Europe and Asia, China’s earlier COVID-19 explosion seems to be slowing. “It’s really good news that the case counts in China are decreasing,” both for the well-being of that country’s citizens, and as a sign of the disease’s potential global effects, said Dr. Messonnier. She added that epidemiologists and mathematical modelers are parsing case fatality rates as well.
She advised health care providers and public health officials to keep abreast of changes in CDC guidance by checking frequently at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
In a telebriefing on the COVID-19 outbreak, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at .
The definition has been revised “to meet the needs of this rapidly evolving situation,” she said. The new PUI definition includes travel to more geographic areas to reflect this past week’s marked uptick in coronavirus activity in Italy and Iran. In addition to these countries and China, recent travel to Japan or South Korea also constitutes an epidemiologic risk factor which, in conjunction with clinical features, warrant an individual being classified as a PUI. These five countries each now have widespread person-to-person transmission of the virus.
Dr. Messonnier left open the possibility that the PUI definition would continue to evolve if such transmission within communities becomes more common. Asked whether the small number of U.S. cases thus might be an artifact of low test volumes, she said, “We aggressively controlled our borders to slow the spread. This was an intentional U.S. strategy. The CDC has always had the capacity to test rapidly from the time the sequence was available. ...We have been testing aggressively.”
The original PUI definition, she explained, emphasized individuals with fever, cough, or trouble breathing who had traveled recently from areas with COVID-19 activity, in particular China’s Hubei province. “We have been most focused on symptomatic people who are closely linked to, or who had, travel history, but our criteria also allow for clinical discretion,” she said. “There is no substitute for an astute clinician on the front lines of patient care.”
The first COVID-19 case from person-to-person spread was reported on Feb. 27. “At this time, we don’t know how or where this person became infected,” said Dr. Messonnier, although investigations are still underway. She responded to a question about whether the CDC delayed allowing COVID-19 testing for the patient for several days, as was reported in some media accounts. “According to CDC records, the first call we got was Feb. 23,” when public health officials in California reported a severely ill person with no travel abroad and no known contacts with individuals that would trigger suspicions for coronavirus. The CDC recommended COVID-19 testing on that day, she said.
Dr. Messonnier declined to answer questions about a whistleblower report alleging improper training and inadequate protective measures for Department of Health & Human Services workers at the quarantine center at Travis Air Force Base, Calif.
Dr. Messonnier said that the CDC has been working closely with the Food and Drug Administration to address problems with the COVID-19 test kits that were unusable because of a large number of indeterminate results. The two agencies together have determined that of the three reactions that were initially deemed necessary for a definitive COVID-19 diagnosis, just two are sufficient, so new kits that omit the problematic chemical are being manufactured and distributed.
These new kits are rapidly being made available; the goal, said Dr. Messonnier, is to have to state and local public health departments equipped with test kits by about March 7.
As local tests become available, the most updated information will be coming from state and local public health departments, she stressed, adding that the CDC would continue to update case counts on Monday, Wednesday, and Friday of each week. Procedures are being developed for the management of patients presumed to have COVID-19, where local health departments see positive tests but the mandatory CDC confirmatory test hasn’t been completed.
While new cases emerge across Europe and Asia, China’s earlier COVID-19 explosion seems to be slowing. “It’s really good news that the case counts in China are decreasing,” both for the well-being of that country’s citizens, and as a sign of the disease’s potential global effects, said Dr. Messonnier. She added that epidemiologists and mathematical modelers are parsing case fatality rates as well.
She advised health care providers and public health officials to keep abreast of changes in CDC guidance by checking frequently at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
REPORTING FROM A CDC BRIEFING
Children bearing the brunt of declining flu activity
National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.
Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.
Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.
ILI-related deaths among children, however, are not dropping. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.
Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”
National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.
Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.
Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.
ILI-related deaths among children, however, are not dropping. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.
Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”
National flu activity decreased for the second consecutive week, but pediatric mortality is heading in the opposite direction, according to the Centers for Disease Control and Prevention.
Influenza-like illness (ILI) represented 5.5% of all visits to outpatient health care providers during the week ending Feb. 22, compared with 6.1% the previous week, the CDC’s influenza division reported Feb. 28. The ILI visit rate had reached 6.6% in early February after dropping to 5.0% in mid-January, following a rise to a season-high 7.1% in the last week of December.
Another measure of ILI activity, the percentage of laboratory specimens testing positive, also declined for the second week in a row. The rate was 26.4% for the week ending Feb. 22, which is down from the season high of 30.3% reached 2 weeks before, the influenza division said.
ILI-related deaths among children, however, are not dropping. The total for 2019-2020 is now up to 125, and that “number is higher for the same time period than in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.
Hospitalization rates, which have been fairly typical in the general population, also are elevated for young adults and school-aged children, the agency said, and “rates among children 0-4 years old are now the highest CDC has on record at this point in the season, surpassing rates reported during the second wave of the 2009 H1N1 pandemic.”
What hospitalists need to know about COVID-19
This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA website.)
An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.
As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.
On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.
As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.
What are the clinical features of COVID-19?
Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.
Who is at risk for COVID-19?
Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.
Who is at risk for severe disease from COVID-19?
Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.
How is COVID-19 spread?
Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.
When is someone infectious?
Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.
Can someone who has been quarantined for COVID-19 spread the illness to others?
For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.
Can a person test negative and later test positive for COVID-19?
Yes. In the early stages of infection, it is possible the virus will not be detected.
Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?
Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.
What should you do if you suspect a patient for COVID-19?
Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.
CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
What type of isolation is needed for COVID-19?
Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.
How should health care personnel protect themselves when evaluating a patient who may have COVID-19?
Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).
What face mask do health care workers wear for respiratory protection?
A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.
If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
What should you tell the patient if COVID-19 is suspected or confirmed?
Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.
Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?
No.
How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?
At this time, diagnostic testing for COVID-19 can be conducted only at CDC.
The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.
Testing for other respiratory pathogens should not delay specimen shipping to CDC. If a PUI tests positive for another respiratory pathogen, after clinical evaluation and consultation with public health authorities, they may no longer be considered a PUI.
Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?
No.
How is COVID-19 treated?
Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
What is considered ‘close contact’ for health care exposures?
Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.
What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?
Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.
Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?
None available.
COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?
A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.
What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?
Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?
Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).
When can patients with confirmed COVID-19 be discharged from the hospital?
Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.
Considerations to discontinue transmission-based precautions include all of the following:
- Resolution of fever, without the use of antipyretic medication.
- Improvement in illness signs and symptoms.
- Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.
Should people be concerned about pets or other animals and COVID-19?
To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.
Should patients avoid contact with pets or other animals if they are sick with COVID-19?
Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.
Does CDC recommend the use of face masks in the community to prevent COVID-19?
CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.
Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?
No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.
Can people who recover from COVID-19 be infected again?
Unknown. The immune response to COVID-19 is not yet understood.
What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?
The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.
According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.
The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.
Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.
Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.
Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.
This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA website.)
An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.
As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.
On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.
As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.
What are the clinical features of COVID-19?
Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.
Who is at risk for COVID-19?
Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.
Who is at risk for severe disease from COVID-19?
Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.
How is COVID-19 spread?
Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.
When is someone infectious?
Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.
Can someone who has been quarantined for COVID-19 spread the illness to others?
For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.
Can a person test negative and later test positive for COVID-19?
Yes. In the early stages of infection, it is possible the virus will not be detected.
Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?
Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.
What should you do if you suspect a patient for COVID-19?
Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.
CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
What type of isolation is needed for COVID-19?
Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.
How should health care personnel protect themselves when evaluating a patient who may have COVID-19?
Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).
What face mask do health care workers wear for respiratory protection?
A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.
If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
What should you tell the patient if COVID-19 is suspected or confirmed?
Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.
Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?
No.
How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?
At this time, diagnostic testing for COVID-19 can be conducted only at CDC.
The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.
Testing for other respiratory pathogens should not delay specimen shipping to CDC. If a PUI tests positive for another respiratory pathogen, after clinical evaluation and consultation with public health authorities, they may no longer be considered a PUI.
Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?
No.
How is COVID-19 treated?
Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
What is considered ‘close contact’ for health care exposures?
Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.
What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?
Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.
Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?
None available.
COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?
A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.
What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?
Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?
Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).
When can patients with confirmed COVID-19 be discharged from the hospital?
Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.
Considerations to discontinue transmission-based precautions include all of the following:
- Resolution of fever, without the use of antipyretic medication.
- Improvement in illness signs and symptoms.
- Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.
Should people be concerned about pets or other animals and COVID-19?
To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.
Should patients avoid contact with pets or other animals if they are sick with COVID-19?
Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.
Does CDC recommend the use of face masks in the community to prevent COVID-19?
CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.
Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?
No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.
Can people who recover from COVID-19 be infected again?
Unknown. The immune response to COVID-19 is not yet understood.
What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?
The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.
According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.
The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.
Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.
Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.
Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.
This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA website.)
An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.
As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.
On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.
As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.
What are the clinical features of COVID-19?
Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.
Who is at risk for COVID-19?
Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.
Who is at risk for severe disease from COVID-19?
Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.
How is COVID-19 spread?
Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.
When is someone infectious?
Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.
Can someone who has been quarantined for COVID-19 spread the illness to others?
For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.
Can a person test negative and later test positive for COVID-19?
Yes. In the early stages of infection, it is possible the virus will not be detected.
Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?
Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.
What should you do if you suspect a patient for COVID-19?
Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.
CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
What type of isolation is needed for COVID-19?
Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.
How should health care personnel protect themselves when evaluating a patient who may have COVID-19?
Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).
What face mask do health care workers wear for respiratory protection?
A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.
If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
What should you tell the patient if COVID-19 is suspected or confirmed?
Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.
Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?
No.
How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?
At this time, diagnostic testing for COVID-19 can be conducted only at CDC.
The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.
Testing for other respiratory pathogens should not delay specimen shipping to CDC. If a PUI tests positive for another respiratory pathogen, after clinical evaluation and consultation with public health authorities, they may no longer be considered a PUI.
Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?
No.
How is COVID-19 treated?
Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
What is considered ‘close contact’ for health care exposures?
Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.
What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?
Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.
Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?
None available.
COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?
A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.
What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?
Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?
Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).
When can patients with confirmed COVID-19 be discharged from the hospital?
Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.
Considerations to discontinue transmission-based precautions include all of the following:
- Resolution of fever, without the use of antipyretic medication.
- Improvement in illness signs and symptoms.
- Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.
Should people be concerned about pets or other animals and COVID-19?
To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.
Should patients avoid contact with pets or other animals if they are sick with COVID-19?
Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.
Does CDC recommend the use of face masks in the community to prevent COVID-19?
CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.
Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?
No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.
Can people who recover from COVID-19 be infected again?
Unknown. The immune response to COVID-19 is not yet understood.
What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?
The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.
According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.
The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.
Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.
Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.
Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.
Increased risk of infection seen in patients with MS
womensWEST PALM BEACH, FLA. – Patients with multiple sclerosis (MS) are at increased risk for most types of infection, with the highest risk associated with renal tract infections, according to an analysis of Department of Defense data.
Susan Jick, DSc, director of the Boston Collaborative Drug Surveillance Program and professor of epidemiology and biostatistics at Boston University, and colleagues sought to understand the rates at which infections occur because they are known to be a common cause of comorbidity and death in patients with MS.
At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Jick and associates presented rates of infection in patients with MS after MS diagnosis, compared with a matched population of patients without MS. The MS cohort included patients who had MS diagnosed and treated between January 2004 and August 2017. Patients had medical history available for at least 1 year before MS diagnosis and at least one prescription for an MS disease-modifying treatment.
Patients without MS were matched to patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. For each patient, the researchers identified the first diagnosed infection of each type after cohort entry. They followed patients until loss of eligibility, death, or end of data collection.
In all, the study included 8,695 patients with MS and 86,934 matched patients without MS. The median age at cohort entry was 41 years, and 71% were female. Median duration of follow-up after study entry was about 6 years. Patients with MS were more likely to have an infection in the year before cohort entry, compared with non-MS patients (43.9% vs. 36.3%).
After cohort entry, the incidence rate of any infection was higher among patients with MS, compared with non-MS patients (4,805 vs. 2,731 per 10,000 person-years; IR ratio, 1.76). In addition, the IR of hospitalized infection was higher among MS patients (125 vs. 51.3 per 10,000 person-years; IRR, 2.43). The IR also was increased for several other types of infections, including renal, skin, fungal, pneumonia or influenza, and other infections (such as rickettsial and spirochetal diseases, helminthiases, and nonsyphilitic and nongonococcal venereal diseases). Eye or ear, respiratory or throat, and viral IRRs “were marginally elevated,” the investigators wrote.
In both cohorts, females had a higher risk of infection than males did. The rate of renal tract infection was more than fourfold higher among females, compared with males, in both cohorts. Relative to non-MS patients, however, men with MS had a higher IRR for renal tract infection than women with MS did (2.47 vs. 1.90).
“The risk for any opportunistic infection was slightly increased among MS patients,” the researchers wrote (520 vs. 338 per 10,000 person-years; IRR, 1.54). This was particularly true for candidiasis (252 vs. 166 per 10,000 person-years; IRR, 1.52) and herpes virus infection (221 vs. 150 per 10,000 person-years; IRR, 1.47). “There were few cases of tuberculosis, hepatitis B infection, or hepatitis C infection,” they noted.
The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four authors are employees of Bristol-Myers Squibb, and one author works for a company that does business with Celgene.
SOURCE: Jick S et al. ACTRIMS Forum 2020, Abstract P086.
womensWEST PALM BEACH, FLA. – Patients with multiple sclerosis (MS) are at increased risk for most types of infection, with the highest risk associated with renal tract infections, according to an analysis of Department of Defense data.
Susan Jick, DSc, director of the Boston Collaborative Drug Surveillance Program and professor of epidemiology and biostatistics at Boston University, and colleagues sought to understand the rates at which infections occur because they are known to be a common cause of comorbidity and death in patients with MS.
At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Jick and associates presented rates of infection in patients with MS after MS diagnosis, compared with a matched population of patients without MS. The MS cohort included patients who had MS diagnosed and treated between January 2004 and August 2017. Patients had medical history available for at least 1 year before MS diagnosis and at least one prescription for an MS disease-modifying treatment.
Patients without MS were matched to patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. For each patient, the researchers identified the first diagnosed infection of each type after cohort entry. They followed patients until loss of eligibility, death, or end of data collection.
In all, the study included 8,695 patients with MS and 86,934 matched patients without MS. The median age at cohort entry was 41 years, and 71% were female. Median duration of follow-up after study entry was about 6 years. Patients with MS were more likely to have an infection in the year before cohort entry, compared with non-MS patients (43.9% vs. 36.3%).
After cohort entry, the incidence rate of any infection was higher among patients with MS, compared with non-MS patients (4,805 vs. 2,731 per 10,000 person-years; IR ratio, 1.76). In addition, the IR of hospitalized infection was higher among MS patients (125 vs. 51.3 per 10,000 person-years; IRR, 2.43). The IR also was increased for several other types of infections, including renal, skin, fungal, pneumonia or influenza, and other infections (such as rickettsial and spirochetal diseases, helminthiases, and nonsyphilitic and nongonococcal venereal diseases). Eye or ear, respiratory or throat, and viral IRRs “were marginally elevated,” the investigators wrote.
In both cohorts, females had a higher risk of infection than males did. The rate of renal tract infection was more than fourfold higher among females, compared with males, in both cohorts. Relative to non-MS patients, however, men with MS had a higher IRR for renal tract infection than women with MS did (2.47 vs. 1.90).
“The risk for any opportunistic infection was slightly increased among MS patients,” the researchers wrote (520 vs. 338 per 10,000 person-years; IRR, 1.54). This was particularly true for candidiasis (252 vs. 166 per 10,000 person-years; IRR, 1.52) and herpes virus infection (221 vs. 150 per 10,000 person-years; IRR, 1.47). “There were few cases of tuberculosis, hepatitis B infection, or hepatitis C infection,” they noted.
The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four authors are employees of Bristol-Myers Squibb, and one author works for a company that does business with Celgene.
SOURCE: Jick S et al. ACTRIMS Forum 2020, Abstract P086.
womensWEST PALM BEACH, FLA. – Patients with multiple sclerosis (MS) are at increased risk for most types of infection, with the highest risk associated with renal tract infections, according to an analysis of Department of Defense data.
Susan Jick, DSc, director of the Boston Collaborative Drug Surveillance Program and professor of epidemiology and biostatistics at Boston University, and colleagues sought to understand the rates at which infections occur because they are known to be a common cause of comorbidity and death in patients with MS.
At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Jick and associates presented rates of infection in patients with MS after MS diagnosis, compared with a matched population of patients without MS. The MS cohort included patients who had MS diagnosed and treated between January 2004 and August 2017. Patients had medical history available for at least 1 year before MS diagnosis and at least one prescription for an MS disease-modifying treatment.
Patients without MS were matched to patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. For each patient, the researchers identified the first diagnosed infection of each type after cohort entry. They followed patients until loss of eligibility, death, or end of data collection.
In all, the study included 8,695 patients with MS and 86,934 matched patients without MS. The median age at cohort entry was 41 years, and 71% were female. Median duration of follow-up after study entry was about 6 years. Patients with MS were more likely to have an infection in the year before cohort entry, compared with non-MS patients (43.9% vs. 36.3%).
After cohort entry, the incidence rate of any infection was higher among patients with MS, compared with non-MS patients (4,805 vs. 2,731 per 10,000 person-years; IR ratio, 1.76). In addition, the IR of hospitalized infection was higher among MS patients (125 vs. 51.3 per 10,000 person-years; IRR, 2.43). The IR also was increased for several other types of infections, including renal, skin, fungal, pneumonia or influenza, and other infections (such as rickettsial and spirochetal diseases, helminthiases, and nonsyphilitic and nongonococcal venereal diseases). Eye or ear, respiratory or throat, and viral IRRs “were marginally elevated,” the investigators wrote.
In both cohorts, females had a higher risk of infection than males did. The rate of renal tract infection was more than fourfold higher among females, compared with males, in both cohorts. Relative to non-MS patients, however, men with MS had a higher IRR for renal tract infection than women with MS did (2.47 vs. 1.90).
“The risk for any opportunistic infection was slightly increased among MS patients,” the researchers wrote (520 vs. 338 per 10,000 person-years; IRR, 1.54). This was particularly true for candidiasis (252 vs. 166 per 10,000 person-years; IRR, 1.52) and herpes virus infection (221 vs. 150 per 10,000 person-years; IRR, 1.47). “There were few cases of tuberculosis, hepatitis B infection, or hepatitis C infection,” they noted.
The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four authors are employees of Bristol-Myers Squibb, and one author works for a company that does business with Celgene.
SOURCE: Jick S et al. ACTRIMS Forum 2020, Abstract P086.
REPORTING FROM ACTRIMS FORUM 2020
Labor & Delivery: An overlooked entry point for the spread of viral infection
OB hospitalists have a key role to play
A novel coronavirus originating in Wuhan, China, has killed more than 2,800 people and infected more than 81,000 individuals globally. Public health officials around the world and in the United States are working together to contain the outbreak.
There are 57 confirmed cases in the United States, including 18 people evacuated from the Diamond Princess, a cruise ship docked in Yokohama, Japan.1 But the focus on coronavirus, even in early months of the epidemic, serves as an opportunity to revisit the spread of viral disease in hospital settings.
Multiple points of viral entry
In truth, most hospitals are well prepared for the coronavirus, starting with the same place they prepare for most infectious disease epidemics – the emergency department. Patients who seek treatment for early onset symptoms may start with their primary care physicians, but increasing numbers of patients with respiratory concerns and/or infection-related symptoms will first seek medical attention in an emergency care setting.2
Many experts have acknowledged the ED as a viral point of entry, including the American College of Emergency Physicians (ACEP), which produced an excellent guide for management of influenza that details prevention, diagnoses, and treatment protocols in an ED setting.3
But another important, and often forgotten, point of entry in a hospital setting is the obstetrical (OB) Labor & Delivery (L&D) department. Although triage for most patients begins in the main ED, in almost every hospital in the United States, women who present with pregnancy-related issues are sent directly to and triaged in L&D, where – when the proper protocols are not in place – they may transmit viral infection to others.
Pregnancy imparts higher risk
“High risk” is often associated with older, immune-compromised adults. But pregnant women who may appear “healthy” are actually in a state that a 2015 study calls “immunosuppressed” whereby the “… pregnant woman actually undergoes an immunological transformation, where the immune system is necessary to promote and support the pregnancy and growing fetus.”4 Pregnant women, or women with newborns or babies, are at higher risk when exposed to viral infection, with a higher mortality risk than the general population.5 In the best cases, women who contract viral infections are treated carefully and recover fully. In the worst cases, they end up on ventilators and can even die as a result.
Although we are still learning about the Wuhan coronavirus, we already know it is a respiratory illness with a lot of the same characteristics as the influenza virus, and that it is transmitted through droplets (such as a sneeze) or via bodily secretions. Given the extreme vulnerability and physician exposure of women giving birth – in which not one, but two lives are involved – viruses like coronavirus can pose extreme risk. What’s more, public health researchers are still learning about potential transmission of coronavirus from mothers to babies. In the international cases of infant exposure to coronavirus, the newborn showed symptoms within 36 hours of being born, but it is unclear if exposure happened in utero or was vertical transmission after birth.6
Role of OB hospitalists in identifying risk and treating viral infection
Regardless of the type of virus, OB hospitalists are key to screening for viral exposure and care for women, fetuses, and newborns. Given their 24/7 presence and experience with women in L&D, they must champion protocols and precautions that align with those in an ED.
For coronavirus, if a woman presents in L&D with a cough, difficulty breathing, or signs of pneumonia, clinicians should be accustomed to asking about travel to China within the last 14 days and whether the patient has been around someone who has recently traveled to China. If the answer to either question is yes, the woman needs to be immediately placed in a single patient room at negative pressure relative to the surrounding areas, with a minimum of six air changes per hour.
Diagnostic testing should immediately follow. The U.S. Food and Drug Administration just issued Emergency Use Authorization (EUA) for the first commercially-available coronavirus diagnostic test, allowing the use of the test at any lab across the country qualified by the Centers for Disease Control and Prevention.7
If exposure is suspected, containment is paramount until definitive results of diagnostic testing are received. The CDC recommends “Standard Precautions,” which assume that every person is potentially infected or colonized with a pathogen that could be transmitted in the health care setting. These precautions include hand hygiene and personal protective equipment (PPE) to ensure health care workers are not exposed.8
In short, protocols in L&D should mirror those of the ED. But in L&D, clinicians and staff haven’t necessarily been trained to look for or ask for these conditions. Hospitalists can educate their peers and colleagues and advocate for changes at the administrative level.
Biggest current threat: The flu
The coronavirus may eventually present a threat in the United States, but as yet, it is a largely unrealized one. From the perspective of an obstetrician, more immediately concerning is the risk of other viral infections. Although viruses like Ebola and Zika capture headlines, influenza remains the most serious threat to pregnant women in the United States.
According to an article by my colleague, Dr. Mark Simon, “pregnant women and their unborn babies are especially vulnerable to influenza and are more likely to develop serious complications from it … pregnant women who develop the flu are more likely to give birth to children with birth defects of the brain and spine.”9
As of Feb. 1, 2020, the CDC estimates there have been at least 22 million flu illnesses, 210,000 hospitalizations, and 12,000 deaths from flu in the 2019-2020 flu season.10 But the CDC data also suggest that only 54% of pregnant women were vaccinated for influenza in 2019 before or during their pregnancy.11 Hospitalists should ensure that patients diagnosed with flu are quickly and safely treated with antivirals at all stages of their pregnancy to keep them and their babies safe, as well as keep others safe from infection.
Hospitalists can also advocate for across-the-board protocols for the spread of viral illness. The same protocols that protect us from the flu will also protect against coronavirus and viruses that will emerge in the future. Foremost, pregnant women, regardless of trimester, need to receive a flu shot. Women who are pregnant and receive a flu shot can pass on immunity in vitro, and nursing mothers can deliver immunizing agents in their breast milk to their newborn.
Given that hospitalists serve in roles as patient-facing physicians, we should be doing more to protect the public from viral spread, whether coronavirus, influenza, or whatever new viruses the future may hold.
Dr. Dimino is a board-certified ob.gyn. and a Houston-based OB hospitalist with Ob Hospitalist Group. She serves as a faculty member of the TexasAIM Plus Obstetric Hemorrhage Learning Collaborative and currently serves on the Texas Medical Association Council of Science and Public Health.
References
1. The New York Times. Tracking the Coronavirus Map: Tracking the Spread of the Outbreak. Accessed Feb 24, 2020.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Accessed Feb 10, 2020.
3. Influenza Emergency Department Best Practices. ACEP Public Health & Injury Prevention Committee, Epidemic Expert Panel, https://www.acep.org/globalassets/uploads/uploaded-files/acep/by-medical-focus/influenza-emergency-department-best-practices.pdf.
4. Silasi M, Cardenas I, Kwon JY, Racicot K, Aldo P, Mor G. Viral infections during pregnancy. Am J Reprod Immunol. 2015;73(3):199-213.
5. Kwon JY, Romero R, Mor G. New insights into the relationship between viral infection and pregnancy complications. Am J Reprod Immunol. 2014;71:387-390.
6. BBC. Coronavirus: Newborn becomes youngest person diagnosed with virus. Accessed Feb 10, 2020.
7. FDA press release. FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic. Feb 4, 2020.
8. CDC. Interim Infection Prevention and Control Recommendations for Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) or Persons Under Investigation for 2019-nCoV in Healthcare Settings. Accessed Feb 10, 2020.
9. STAT First Opinion. Two-thirds of pregnant women aren’t getting the flu vaccine. That needs to change. Jan 18, 2018.
10. CDC. Weekly U.S. Influenza Surveillance Report, Key Updates for Week 5, ending February 1, 2020.
11. CDC. Vaccinating Pregnant Women Protects Moms and Babies. Accessed Feb 10, 2020.
OB hospitalists have a key role to play
OB hospitalists have a key role to play
A novel coronavirus originating in Wuhan, China, has killed more than 2,800 people and infected more than 81,000 individuals globally. Public health officials around the world and in the United States are working together to contain the outbreak.
There are 57 confirmed cases in the United States, including 18 people evacuated from the Diamond Princess, a cruise ship docked in Yokohama, Japan.1 But the focus on coronavirus, even in early months of the epidemic, serves as an opportunity to revisit the spread of viral disease in hospital settings.
Multiple points of viral entry
In truth, most hospitals are well prepared for the coronavirus, starting with the same place they prepare for most infectious disease epidemics – the emergency department. Patients who seek treatment for early onset symptoms may start with their primary care physicians, but increasing numbers of patients with respiratory concerns and/or infection-related symptoms will first seek medical attention in an emergency care setting.2
Many experts have acknowledged the ED as a viral point of entry, including the American College of Emergency Physicians (ACEP), which produced an excellent guide for management of influenza that details prevention, diagnoses, and treatment protocols in an ED setting.3
But another important, and often forgotten, point of entry in a hospital setting is the obstetrical (OB) Labor & Delivery (L&D) department. Although triage for most patients begins in the main ED, in almost every hospital in the United States, women who present with pregnancy-related issues are sent directly to and triaged in L&D, where – when the proper protocols are not in place – they may transmit viral infection to others.
Pregnancy imparts higher risk
“High risk” is often associated with older, immune-compromised adults. But pregnant women who may appear “healthy” are actually in a state that a 2015 study calls “immunosuppressed” whereby the “… pregnant woman actually undergoes an immunological transformation, where the immune system is necessary to promote and support the pregnancy and growing fetus.”4 Pregnant women, or women with newborns or babies, are at higher risk when exposed to viral infection, with a higher mortality risk than the general population.5 In the best cases, women who contract viral infections are treated carefully and recover fully. In the worst cases, they end up on ventilators and can even die as a result.
Although we are still learning about the Wuhan coronavirus, we already know it is a respiratory illness with a lot of the same characteristics as the influenza virus, and that it is transmitted through droplets (such as a sneeze) or via bodily secretions. Given the extreme vulnerability and physician exposure of women giving birth – in which not one, but two lives are involved – viruses like coronavirus can pose extreme risk. What’s more, public health researchers are still learning about potential transmission of coronavirus from mothers to babies. In the international cases of infant exposure to coronavirus, the newborn showed symptoms within 36 hours of being born, but it is unclear if exposure happened in utero or was vertical transmission after birth.6
Role of OB hospitalists in identifying risk and treating viral infection
Regardless of the type of virus, OB hospitalists are key to screening for viral exposure and care for women, fetuses, and newborns. Given their 24/7 presence and experience with women in L&D, they must champion protocols and precautions that align with those in an ED.
For coronavirus, if a woman presents in L&D with a cough, difficulty breathing, or signs of pneumonia, clinicians should be accustomed to asking about travel to China within the last 14 days and whether the patient has been around someone who has recently traveled to China. If the answer to either question is yes, the woman needs to be immediately placed in a single patient room at negative pressure relative to the surrounding areas, with a minimum of six air changes per hour.
Diagnostic testing should immediately follow. The U.S. Food and Drug Administration just issued Emergency Use Authorization (EUA) for the first commercially-available coronavirus diagnostic test, allowing the use of the test at any lab across the country qualified by the Centers for Disease Control and Prevention.7
If exposure is suspected, containment is paramount until definitive results of diagnostic testing are received. The CDC recommends “Standard Precautions,” which assume that every person is potentially infected or colonized with a pathogen that could be transmitted in the health care setting. These precautions include hand hygiene and personal protective equipment (PPE) to ensure health care workers are not exposed.8
In short, protocols in L&D should mirror those of the ED. But in L&D, clinicians and staff haven’t necessarily been trained to look for or ask for these conditions. Hospitalists can educate their peers and colleagues and advocate for changes at the administrative level.
Biggest current threat: The flu
The coronavirus may eventually present a threat in the United States, but as yet, it is a largely unrealized one. From the perspective of an obstetrician, more immediately concerning is the risk of other viral infections. Although viruses like Ebola and Zika capture headlines, influenza remains the most serious threat to pregnant women in the United States.
According to an article by my colleague, Dr. Mark Simon, “pregnant women and their unborn babies are especially vulnerable to influenza and are more likely to develop serious complications from it … pregnant women who develop the flu are more likely to give birth to children with birth defects of the brain and spine.”9
As of Feb. 1, 2020, the CDC estimates there have been at least 22 million flu illnesses, 210,000 hospitalizations, and 12,000 deaths from flu in the 2019-2020 flu season.10 But the CDC data also suggest that only 54% of pregnant women were vaccinated for influenza in 2019 before or during their pregnancy.11 Hospitalists should ensure that patients diagnosed with flu are quickly and safely treated with antivirals at all stages of their pregnancy to keep them and their babies safe, as well as keep others safe from infection.
Hospitalists can also advocate for across-the-board protocols for the spread of viral illness. The same protocols that protect us from the flu will also protect against coronavirus and viruses that will emerge in the future. Foremost, pregnant women, regardless of trimester, need to receive a flu shot. Women who are pregnant and receive a flu shot can pass on immunity in vitro, and nursing mothers can deliver immunizing agents in their breast milk to their newborn.
Given that hospitalists serve in roles as patient-facing physicians, we should be doing more to protect the public from viral spread, whether coronavirus, influenza, or whatever new viruses the future may hold.
Dr. Dimino is a board-certified ob.gyn. and a Houston-based OB hospitalist with Ob Hospitalist Group. She serves as a faculty member of the TexasAIM Plus Obstetric Hemorrhage Learning Collaborative and currently serves on the Texas Medical Association Council of Science and Public Health.
References
1. The New York Times. Tracking the Coronavirus Map: Tracking the Spread of the Outbreak. Accessed Feb 24, 2020.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Accessed Feb 10, 2020.
3. Influenza Emergency Department Best Practices. ACEP Public Health & Injury Prevention Committee, Epidemic Expert Panel, https://www.acep.org/globalassets/uploads/uploaded-files/acep/by-medical-focus/influenza-emergency-department-best-practices.pdf.
4. Silasi M, Cardenas I, Kwon JY, Racicot K, Aldo P, Mor G. Viral infections during pregnancy. Am J Reprod Immunol. 2015;73(3):199-213.
5. Kwon JY, Romero R, Mor G. New insights into the relationship between viral infection and pregnancy complications. Am J Reprod Immunol. 2014;71:387-390.
6. BBC. Coronavirus: Newborn becomes youngest person diagnosed with virus. Accessed Feb 10, 2020.
7. FDA press release. FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic. Feb 4, 2020.
8. CDC. Interim Infection Prevention and Control Recommendations for Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) or Persons Under Investigation for 2019-nCoV in Healthcare Settings. Accessed Feb 10, 2020.
9. STAT First Opinion. Two-thirds of pregnant women aren’t getting the flu vaccine. That needs to change. Jan 18, 2018.
10. CDC. Weekly U.S. Influenza Surveillance Report, Key Updates for Week 5, ending February 1, 2020.
11. CDC. Vaccinating Pregnant Women Protects Moms and Babies. Accessed Feb 10, 2020.
A novel coronavirus originating in Wuhan, China, has killed more than 2,800 people and infected more than 81,000 individuals globally. Public health officials around the world and in the United States are working together to contain the outbreak.
There are 57 confirmed cases in the United States, including 18 people evacuated from the Diamond Princess, a cruise ship docked in Yokohama, Japan.1 But the focus on coronavirus, even in early months of the epidemic, serves as an opportunity to revisit the spread of viral disease in hospital settings.
Multiple points of viral entry
In truth, most hospitals are well prepared for the coronavirus, starting with the same place they prepare for most infectious disease epidemics – the emergency department. Patients who seek treatment for early onset symptoms may start with their primary care physicians, but increasing numbers of patients with respiratory concerns and/or infection-related symptoms will first seek medical attention in an emergency care setting.2
Many experts have acknowledged the ED as a viral point of entry, including the American College of Emergency Physicians (ACEP), which produced an excellent guide for management of influenza that details prevention, diagnoses, and treatment protocols in an ED setting.3
But another important, and often forgotten, point of entry in a hospital setting is the obstetrical (OB) Labor & Delivery (L&D) department. Although triage for most patients begins in the main ED, in almost every hospital in the United States, women who present with pregnancy-related issues are sent directly to and triaged in L&D, where – when the proper protocols are not in place – they may transmit viral infection to others.
Pregnancy imparts higher risk
“High risk” is often associated with older, immune-compromised adults. But pregnant women who may appear “healthy” are actually in a state that a 2015 study calls “immunosuppressed” whereby the “… pregnant woman actually undergoes an immunological transformation, where the immune system is necessary to promote and support the pregnancy and growing fetus.”4 Pregnant women, or women with newborns or babies, are at higher risk when exposed to viral infection, with a higher mortality risk than the general population.5 In the best cases, women who contract viral infections are treated carefully and recover fully. In the worst cases, they end up on ventilators and can even die as a result.
Although we are still learning about the Wuhan coronavirus, we already know it is a respiratory illness with a lot of the same characteristics as the influenza virus, and that it is transmitted through droplets (such as a sneeze) or via bodily secretions. Given the extreme vulnerability and physician exposure of women giving birth – in which not one, but two lives are involved – viruses like coronavirus can pose extreme risk. What’s more, public health researchers are still learning about potential transmission of coronavirus from mothers to babies. In the international cases of infant exposure to coronavirus, the newborn showed symptoms within 36 hours of being born, but it is unclear if exposure happened in utero or was vertical transmission after birth.6
Role of OB hospitalists in identifying risk and treating viral infection
Regardless of the type of virus, OB hospitalists are key to screening for viral exposure and care for women, fetuses, and newborns. Given their 24/7 presence and experience with women in L&D, they must champion protocols and precautions that align with those in an ED.
For coronavirus, if a woman presents in L&D with a cough, difficulty breathing, or signs of pneumonia, clinicians should be accustomed to asking about travel to China within the last 14 days and whether the patient has been around someone who has recently traveled to China. If the answer to either question is yes, the woman needs to be immediately placed in a single patient room at negative pressure relative to the surrounding areas, with a minimum of six air changes per hour.
Diagnostic testing should immediately follow. The U.S. Food and Drug Administration just issued Emergency Use Authorization (EUA) for the first commercially-available coronavirus diagnostic test, allowing the use of the test at any lab across the country qualified by the Centers for Disease Control and Prevention.7
If exposure is suspected, containment is paramount until definitive results of diagnostic testing are received. The CDC recommends “Standard Precautions,” which assume that every person is potentially infected or colonized with a pathogen that could be transmitted in the health care setting. These precautions include hand hygiene and personal protective equipment (PPE) to ensure health care workers are not exposed.8
In short, protocols in L&D should mirror those of the ED. But in L&D, clinicians and staff haven’t necessarily been trained to look for or ask for these conditions. Hospitalists can educate their peers and colleagues and advocate for changes at the administrative level.
Biggest current threat: The flu
The coronavirus may eventually present a threat in the United States, but as yet, it is a largely unrealized one. From the perspective of an obstetrician, more immediately concerning is the risk of other viral infections. Although viruses like Ebola and Zika capture headlines, influenza remains the most serious threat to pregnant women in the United States.
According to an article by my colleague, Dr. Mark Simon, “pregnant women and their unborn babies are especially vulnerable to influenza and are more likely to develop serious complications from it … pregnant women who develop the flu are more likely to give birth to children with birth defects of the brain and spine.”9
As of Feb. 1, 2020, the CDC estimates there have been at least 22 million flu illnesses, 210,000 hospitalizations, and 12,000 deaths from flu in the 2019-2020 flu season.10 But the CDC data also suggest that only 54% of pregnant women were vaccinated for influenza in 2019 before or during their pregnancy.11 Hospitalists should ensure that patients diagnosed with flu are quickly and safely treated with antivirals at all stages of their pregnancy to keep them and their babies safe, as well as keep others safe from infection.
Hospitalists can also advocate for across-the-board protocols for the spread of viral illness. The same protocols that protect us from the flu will also protect against coronavirus and viruses that will emerge in the future. Foremost, pregnant women, regardless of trimester, need to receive a flu shot. Women who are pregnant and receive a flu shot can pass on immunity in vitro, and nursing mothers can deliver immunizing agents in their breast milk to their newborn.
Given that hospitalists serve in roles as patient-facing physicians, we should be doing more to protect the public from viral spread, whether coronavirus, influenza, or whatever new viruses the future may hold.
Dr. Dimino is a board-certified ob.gyn. and a Houston-based OB hospitalist with Ob Hospitalist Group. She serves as a faculty member of the TexasAIM Plus Obstetric Hemorrhage Learning Collaborative and currently serves on the Texas Medical Association Council of Science and Public Health.
References
1. The New York Times. Tracking the Coronavirus Map: Tracking the Spread of the Outbreak. Accessed Feb 24, 2020.
2. Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Accessed Feb 10, 2020.
3. Influenza Emergency Department Best Practices. ACEP Public Health & Injury Prevention Committee, Epidemic Expert Panel, https://www.acep.org/globalassets/uploads/uploaded-files/acep/by-medical-focus/influenza-emergency-department-best-practices.pdf.
4. Silasi M, Cardenas I, Kwon JY, Racicot K, Aldo P, Mor G. Viral infections during pregnancy. Am J Reprod Immunol. 2015;73(3):199-213.
5. Kwon JY, Romero R, Mor G. New insights into the relationship between viral infection and pregnancy complications. Am J Reprod Immunol. 2014;71:387-390.
6. BBC. Coronavirus: Newborn becomes youngest person diagnosed with virus. Accessed Feb 10, 2020.
7. FDA press release. FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic. Feb 4, 2020.
8. CDC. Interim Infection Prevention and Control Recommendations for Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) or Persons Under Investigation for 2019-nCoV in Healthcare Settings. Accessed Feb 10, 2020.
9. STAT First Opinion. Two-thirds of pregnant women aren’t getting the flu vaccine. That needs to change. Jan 18, 2018.
10. CDC. Weekly U.S. Influenza Surveillance Report, Key Updates for Week 5, ending February 1, 2020.
11. CDC. Vaccinating Pregnant Women Protects Moms and Babies. Accessed Feb 10, 2020.
ACIP: Flu vaccines for older adults show similar safety profiles
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.
To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.
Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).
Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.
In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.
The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”
Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.
Dr. Schmader had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.
To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.
Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).
Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.
In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.
The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”
Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.
Dr. Schmader had no financial conflicts to disclose.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.
To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.
Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).
Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.
In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.
The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”
Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.
Dr. Schmader had no financial conflicts to disclose.
FROM AN ACIP MEETING
ACIP advocates pre-exposure Ebola vaccination for high-risk groups
Vaccination against the Ebola virus is recommended for first responders, health care personnel, and laboratory workers deemed at high risk of exposure, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).
The committee voted unanimously to recommended pre-exposure vaccination with the rVSVdeltaG-ZEBOV-GP vaccine for adults aged 18 years and older who are at potential risk of exposure to the Ebola species Zaire ebolavirus because they fall into any of the following three categories:
- They are responding to an outbreak of Ebola virus disease.
- They are working as health care personnel at a federally designated Ebola Treatment Center in the United States.
- The are working in laboratories or are other staff members at biosafety-level 4 facilities in the United States.
Mary Choi, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) presented data on the safety and effectiveness of the vaccine and the work group considerations in recommending vaccination in the three target populations.
In clinical trials, the most commonly reported adverse events associated with the vaccine were arthritis and arthralgia, Dr. Choi said, but the duration of those cases was limited to months and did not persist long term.
Pre-exposure vaccination for health care personnel, laboratory workers, and support staff would provide an additional layer of protection, she explained, in addition to existing safeguards such as personal protective equipment and engineering controls at the facility. The work group’s research showed that most of the target population believed that the desirable effects of that protection outweigh potentially undesirable effects, Dr. Choi noted.
Some committee members expressed concerns about vaccination of pregnant women. But the recommendations are presented as “population based, not shared decision making,” said Sharon E. Frey, MD, of Saint Louis University in St. Louis, Missouri.
Several members noted that pregnant women should not be automatically included or excluded from vaccination if they fall into a high-risk population. And the committee agreed that additional guidance in the policy note will help assess risk and that organizations will determine the risk for their employees and whether to offer the vaccine.
The FDA approved the currently available U.S. vaccine for Ebola in 2019. Merck manufactures that vaccine.
The ACIP members had no relevant financial conflicts to disclose.
Vaccination against the Ebola virus is recommended for first responders, health care personnel, and laboratory workers deemed at high risk of exposure, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).
The committee voted unanimously to recommended pre-exposure vaccination with the rVSVdeltaG-ZEBOV-GP vaccine for adults aged 18 years and older who are at potential risk of exposure to the Ebola species Zaire ebolavirus because they fall into any of the following three categories:
- They are responding to an outbreak of Ebola virus disease.
- They are working as health care personnel at a federally designated Ebola Treatment Center in the United States.
- The are working in laboratories or are other staff members at biosafety-level 4 facilities in the United States.
Mary Choi, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) presented data on the safety and effectiveness of the vaccine and the work group considerations in recommending vaccination in the three target populations.
In clinical trials, the most commonly reported adverse events associated with the vaccine were arthritis and arthralgia, Dr. Choi said, but the duration of those cases was limited to months and did not persist long term.
Pre-exposure vaccination for health care personnel, laboratory workers, and support staff would provide an additional layer of protection, she explained, in addition to existing safeguards such as personal protective equipment and engineering controls at the facility. The work group’s research showed that most of the target population believed that the desirable effects of that protection outweigh potentially undesirable effects, Dr. Choi noted.
Some committee members expressed concerns about vaccination of pregnant women. But the recommendations are presented as “population based, not shared decision making,” said Sharon E. Frey, MD, of Saint Louis University in St. Louis, Missouri.
Several members noted that pregnant women should not be automatically included or excluded from vaccination if they fall into a high-risk population. And the committee agreed that additional guidance in the policy note will help assess risk and that organizations will determine the risk for their employees and whether to offer the vaccine.
The FDA approved the currently available U.S. vaccine for Ebola in 2019. Merck manufactures that vaccine.
The ACIP members had no relevant financial conflicts to disclose.
Vaccination against the Ebola virus is recommended for first responders, health care personnel, and laboratory workers deemed at high risk of exposure, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).
The committee voted unanimously to recommended pre-exposure vaccination with the rVSVdeltaG-ZEBOV-GP vaccine for adults aged 18 years and older who are at potential risk of exposure to the Ebola species Zaire ebolavirus because they fall into any of the following three categories:
- They are responding to an outbreak of Ebola virus disease.
- They are working as health care personnel at a federally designated Ebola Treatment Center in the United States.
- The are working in laboratories or are other staff members at biosafety-level 4 facilities in the United States.
Mary Choi, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) presented data on the safety and effectiveness of the vaccine and the work group considerations in recommending vaccination in the three target populations.
In clinical trials, the most commonly reported adverse events associated with the vaccine were arthritis and arthralgia, Dr. Choi said, but the duration of those cases was limited to months and did not persist long term.
Pre-exposure vaccination for health care personnel, laboratory workers, and support staff would provide an additional layer of protection, she explained, in addition to existing safeguards such as personal protective equipment and engineering controls at the facility. The work group’s research showed that most of the target population believed that the desirable effects of that protection outweigh potentially undesirable effects, Dr. Choi noted.
Some committee members expressed concerns about vaccination of pregnant women. But the recommendations are presented as “population based, not shared decision making,” said Sharon E. Frey, MD, of Saint Louis University in St. Louis, Missouri.
Several members noted that pregnant women should not be automatically included or excluded from vaccination if they fall into a high-risk population. And the committee agreed that additional guidance in the policy note will help assess risk and that organizations will determine the risk for their employees and whether to offer the vaccine.
The FDA approved the currently available U.S. vaccine for Ebola in 2019. Merck manufactures that vaccine.
The ACIP members had no relevant financial conflicts to disclose.