Infectious Diseases

The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.

The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.

Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.

For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.

“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.

Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.

All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*

HPV

The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.

“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”

“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.

Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.

Influenza, hepatitis A and B

For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.

Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.

For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.

Meningitis B

Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.

Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.

Td/Tdap, varicella

The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.

Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.

Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”

In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.

Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.

As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.

The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.

The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine. 

The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.

The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.

Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.

For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.

“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.

Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.

All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*

HPV

The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.

“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”

“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.

Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.

Influenza, hepatitis A and B

For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.

Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.

For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.

Meningitis B

Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.

Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.

Td/Tdap, varicella

The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.

Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.

Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”

In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.

Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.

As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.

The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.

The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine. 

The Centers for Disease Control and Prevention has released an updated schedule for adult vaccines. The update includes changes regarding the administration of several vaccines, including those for influenza, human papillomavirus (HPV), hepatitis A and B, and meningitis B, as well as the pneumococcal 13-valent conjugate (PCV13) vaccine.

The schedule, revised annually by the Advisory Committee on Immunization Practices (ACIP) of the CDC, was simultaneously published online February 3, 2020, in the Annals of Internal Medicine and on the CDC website.

Perhaps the change most likely to raise questions is that concerning the PCV13 vaccine. “Owing to a decline in prevalence of the types covered by the PCV13 vaccine, this is no longer routinely recommended for all persons age 65 and older,” senior author Mark Freedman, DVM, MPH, of the immunization services division at the National Center for Immunization and Respiratory Disease, said in an interview.

For purposes of shared clinical decision, however, it should be discussed with previously unvaccinated seniors who do not have risk factors, such as an immunocompromising condition, a cerebrospinal fluid leak, or a cochlear implant.

“But the circumstances for use of the vaccine are not always clear even based on the detailed list of considerations provided, because it’s impossible to think of every conceivable combination of risk factors,” Mr. Freedman added.

Possible beneficiaries of this vaccine are vulnerable elderly people living in nursing homes and long-term care facilities and those living in or traveling to settings in which the rate of pediatric PCV13 uptake is low or zero.

All adults in this age group should continue to receive a single dose of the pneumococcal 23-valent polysaccharide vaccine.*

HPV

The advisory committee now recommends catch-up immunization for women and men through age 26 years (the previous cutoff for men was 21). And in another new recommendation, the ACIP advises considering vaccination for some patients aged 27-45 years who have not been adequately vaccinated.

“Most people ages 27-45 do not need vaccination, but some may benefit,” Mr. Freedman said. “For example, somebody who’s been in a prior long-term monogamous relationship and suddenly finds himself with a new sexual partner.”

“That makes very good sense for older people who haven’t been vaccinated and might continue to be exposed to HPV,” Daniel M. Musher, MD, a professor of medicine at Baylor College of Medicine and an infectious diseases physician at the Michael E. DeBakey Veterans Affairs Medical Center, both in Houston, said in an interview.

Here again, the ACIP advises taking a shared decision-making approach, with clinicians discussing the merits of vaccination in this and other scenarios with patients according to the talking points outlined in the HPV section.

Influenza, hepatitis A and B

For the 2019-2020 influenza season, routine influenza vaccination is recommended for all persons aged 6 months or older who have no contraindications. Where more than one appropriate option is available, the ACIP does not recommend any product over another.

Routine hepatitis A vaccination is recommended for all persons aged 1 year or older who have HIV infection regardless of their level of immune suppression.

For hepatitis B, a new addition to the list of vulnerable patients who may possibly benefit from vaccination is pregnant women at risk for infection or an adverse infection-related pregnancy outcome. Whereas older formulations are safe, the ACIP does not recommend the HepB-CpG (Heplisav-B) vaccine during pregnancy, owing to the fact that safety data are lacking.

Meningitis B

Individuals aged 10 years or older who have complement deficiency, who use a complement inhibitor, who have asplenia, or who are microbiologists should receive a meningitis B booster dose 1 year following completion of a primary series. After that, they should receive booster doses every 2-3 years for as long they are at elevated risk.

Vaccination should be discussed with individuals aged 16-23 years even if they are not at increased risk for meningococcal disease. Persons aged 10 years or older whom public health authorities deem to be at increased risk during an outbreak should have a one-time booster dose if at least 1 year has elapsed since completion of a meningitis B primary series.

Td/Tdap, varicella

The ACIP now recommends that either the Td or Tdap vaccine be given in cases in which currently just the Td vaccine is recommended; that is, for the 10-year booster shot as well as for tetanus prophylaxis in wound management and the catch-up immunization schedule, including that for pregnant women.

Vaccination against varicella should be considered for HIV-infected individuals who are without evidence of varicella immunity and whose CD4 counts are at least 200 cells/mL.

Dr. Musher, who was not involved in drafting the recommendations, takes issue generally with the addition of shared clinical decision making on vaccination. “Shared decision making is a problem for anyone practicing medicine. It places a terrible burden [on] the doctors to discuss these options with patients at great length. Most patients want the doctor to make the decision.”

In his view, this approach makes little sense in the case of the PCV13 vaccine because the strains it covers have disappeared from the population through the widespread vaccination of children. “But discussions are important for some vaccines, such as the herpes zoster vaccine, since patients can have a terrible reaction to the first dose and refuse to have the second,” he said.

Some of these new recommendations were released in 2019 after ACIP members met to vote on them in February, June, and October.

As in previous years, the schedule has been streamlined for easier reference. Physicians are reminded to closely read the details in the vaccine notes, as these specify who needs what vaccine, when, and at what dose.

The ACIP develops its recommendations after reviewing vaccine-related data, including the data regarding the epidemiology and burden of the vaccine-preventable disease, vaccine effectiveness and safety, the quality of evidence, implementability, and the economics of immunization policy.

The authors have received grants and expense payments from public and not-for-profit institutions. One coauthor has received fees from ACI Clinical for data and safety monitoring in an immunization trial. Dr. Musher has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Correction, 3/31/20: An earlier version of this article misstated the recommendation for administration of the pneumococcal 23-valent polysaccharide vaccine. All adults in this age group should continue to receive a single dose of this vaccine. 

An additional 5 cases of 2019 novel coronavirus (2109-nCoV) have been confirmed in the United States, bringing the total number of confirmed cases to 11, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a Centers for Disease Control and Prevention press briefing.

Four of the new cases are in California, and one in Massachusetts. Although four of the new cases have recent travel history to Wuhan, China, the epicenter of the 2019-nCoV outbreak, the fifth is a close household contact of one of the other California patients, said Dr. Messonnier. This last case is the second instance of person-to-person spread of 2019-nCoV in the United States.

“We expect to find additional cases of the novel coronavirus in the United States,” she said. “We expect to see more cases of person-to-person spread among close contacts. And we continue to expect this will happen given the explosive nature of this outbreak in China.”

As of the morning of Feb. 3, 167 persons under investigation, or PUIs, for possible 2019-nCoV have tested negative for the virus, and an additional 82 PUIs have testing pending – this latter figure includes some tests that are still in transit to the CDC, said Dr. Messonnier.

During the briefing, Dr. Messonnier emphasized both the aggressive nature of the U.S. public health response and the rationale for quick and assertive action. “The goal of our public health response is to protect and contain,” she said. “Strong measures now may blunt the impact of this virus on the United States.”

She cited the intensity of transmission in Hubei Province, the expansion of transmission to other provinces in China, the expansion of cases outside of China, and sporadic ongoing deaths from 2019-nCoV as drivers of the aggressive U.S. public health response.

A presidential proclamation is currently in place that bars U.S. entry to foreign nationals who have visited mainland China within the past 14 days; the ban does not apply to travelers from Hong Kong and Macao. Immediate family members of U.S. citizens and individuals who have U.S. permanent resident status are exempted from the entry ban and will be allowed entry into the United States.

However, explained Dr. Messonnier, those who have traveled to China recently and are permitted entry will be subject to screening. All passengers with such recent travel will be directed to one of 11 U.S. airports set up to perform additional screening.

As of Feb 3, the list of airports includes:

• San Francisco International Airport in California.
• Los Angeles International Airport in California.
• Hartsfield-Jackson Atlanta International Airport in Georgia.
• Daniel K. Inouye International Airport in Hawaii.
• O’Hare International Airport in Illinois.
• Detroit Metropolitan Airport in Michigan.
• Newark Liberty International Airport in New Jersey.
• John F. Kennedy International Airport in New York.
• Dallas/Fort Worth International Airport in Texas.
• Washington Dulles International Airport in Virginia.
• Seattle-Tacoma International Airport in Washington.

Travelers who have been to Hubei Province in the previous 14 days will have an additional health assessment at which they will be screened for fever, cough, or difficulty breathing. Any American citizens or exempt individuals who are symptomatic would then be transferred for further medical evaluation. Asymptomatic travelers in this category will be subject to a mandatory 14-day quarantine near their point of entry, rather than continuing on to their final destinations.

Dr. Messonnier emphasized that the mandatory 14-day quarantine is specifically for Americans or exempt individuals returning from Hubei Province, adding that the CDC is presently working with individual states to determine the exact venues for quarantine.

American citizens and exempt individuals returning from other parts of mainland China will be routed to one of the 11 airports and will also receive additional health screening. Symptomatic individuals in this travel category would be referred for further evaluation before being able to complete their itinerary.

Asymptomatic American citizens and exempt individuals who are returning from mainland China – but not Hubei Province – will be allowed to travel on to their final destinations, but will be asked to stay home as much as possible and to monitor their health during the 14 days after their return.

The U.S. Department of State is bringing back more Americans from Wuhan province this week, and these individuals will also be kept under federal quarantine for 14 days.

“There are likely to be confirmed infections among returning travelers,” said Dr. Messonnier. “It is important to note that this strategy is not meant to catch every single traveler returning from China with novel coronavirus; given the nature of this virus and how it’s spreading, that would be impossible, but working together we can catch the majority of them.

“The goal here is to slow the entry of this virus into the United States,” she said, adding that the nation’s health care and public health systems stand on high alert to detect the virus in community settings. In response to questioning from the press, Dr. Messonnier defended the stringent quarantine measures, noting that they are in line with those taken by some other nations, and with the aggressive action being taken by the Chinese government itself. “These actions are science based and aimed at protecting the health of all Americans,” she said.

The real-time reverse transcription polymerase chain reaction (rRT-PCR) assay that the CDC has developed detects 2019-nCoV in both respiratory and serum specimens. Dr. Messonnier reported that the CDC is today filing an emergency use authorization (EUA) application to the U.S. Food and Drug Administration to expedite access to the assay for public health laboratories across the country. “This will greatly enhance our capacity to test for this virus,” she said, noting that EUA approval may come as soon as the end of this week.

Although the CDC is poised to send an expert team to China, it’s still awaiting favorable results from the international negotiations currently underway. “This is a horrible situation in China,” said Dr. Messonnier. “Our presence on the ground in China would be a help to China. ... Science should trump everything else; that’s what we’re hoping – that the scientific expertise of the global community can be brought to bear on the incredibly complicated, difficult situation that our colleagues in China are dealing with.”

[email protected]

An additional 5 cases of 2019 novel coronavirus (2109-nCoV) have been confirmed in the United States, bringing the total number of confirmed cases to 11, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a Centers for Disease Control and Prevention press briefing.

Four of the new cases are in California, and one in Massachusetts. Although four of the new cases have recent travel history to Wuhan, China, the epicenter of the 2019-nCoV outbreak, the fifth is a close household contact of one of the other California patients, said Dr. Messonnier. This last case is the second instance of person-to-person spread of 2019-nCoV in the United States.

“We expect to find additional cases of the novel coronavirus in the United States,” she said. “We expect to see more cases of person-to-person spread among close contacts. And we continue to expect this will happen given the explosive nature of this outbreak in China.”

As of the morning of Feb. 3, 167 persons under investigation, or PUIs, for possible 2019-nCoV have tested negative for the virus, and an additional 82 PUIs have testing pending – this latter figure includes some tests that are still in transit to the CDC, said Dr. Messonnier.

During the briefing, Dr. Messonnier emphasized both the aggressive nature of the U.S. public health response and the rationale for quick and assertive action. “The goal of our public health response is to protect and contain,” she said. “Strong measures now may blunt the impact of this virus on the United States.”

She cited the intensity of transmission in Hubei Province, the expansion of transmission to other provinces in China, the expansion of cases outside of China, and sporadic ongoing deaths from 2019-nCoV as drivers of the aggressive U.S. public health response.

A presidential proclamation is currently in place that bars U.S. entry to foreign nationals who have visited mainland China within the past 14 days; the ban does not apply to travelers from Hong Kong and Macao. Immediate family members of U.S. citizens and individuals who have U.S. permanent resident status are exempted from the entry ban and will be allowed entry into the United States.

However, explained Dr. Messonnier, those who have traveled to China recently and are permitted entry will be subject to screening. All passengers with such recent travel will be directed to one of 11 U.S. airports set up to perform additional screening.

As of Feb 3, the list of airports includes:

• San Francisco International Airport in California.
• Los Angeles International Airport in California.
• Hartsfield-Jackson Atlanta International Airport in Georgia.
• Daniel K. Inouye International Airport in Hawaii.
• O’Hare International Airport in Illinois.
• Detroit Metropolitan Airport in Michigan.
• Newark Liberty International Airport in New Jersey.
• John F. Kennedy International Airport in New York.
• Dallas/Fort Worth International Airport in Texas.
• Washington Dulles International Airport in Virginia.
• Seattle-Tacoma International Airport in Washington.

Travelers who have been to Hubei Province in the previous 14 days will have an additional health assessment at which they will be screened for fever, cough, or difficulty breathing. Any American citizens or exempt individuals who are symptomatic would then be transferred for further medical evaluation. Asymptomatic travelers in this category will be subject to a mandatory 14-day quarantine near their point of entry, rather than continuing on to their final destinations.

Dr. Messonnier emphasized that the mandatory 14-day quarantine is specifically for Americans or exempt individuals returning from Hubei Province, adding that the CDC is presently working with individual states to determine the exact venues for quarantine.

American citizens and exempt individuals returning from other parts of mainland China will be routed to one of the 11 airports and will also receive additional health screening. Symptomatic individuals in this travel category would be referred for further evaluation before being able to complete their itinerary.

Asymptomatic American citizens and exempt individuals who are returning from mainland China – but not Hubei Province – will be allowed to travel on to their final destinations, but will be asked to stay home as much as possible and to monitor their health during the 14 days after their return.

The U.S. Department of State is bringing back more Americans from Wuhan province this week, and these individuals will also be kept under federal quarantine for 14 days.

“There are likely to be confirmed infections among returning travelers,” said Dr. Messonnier. “It is important to note that this strategy is not meant to catch every single traveler returning from China with novel coronavirus; given the nature of this virus and how it’s spreading, that would be impossible, but working together we can catch the majority of them.

“The goal here is to slow the entry of this virus into the United States,” she said, adding that the nation’s health care and public health systems stand on high alert to detect the virus in community settings. In response to questioning from the press, Dr. Messonnier defended the stringent quarantine measures, noting that they are in line with those taken by some other nations, and with the aggressive action being taken by the Chinese government itself. “These actions are science based and aimed at protecting the health of all Americans,” she said.

The real-time reverse transcription polymerase chain reaction (rRT-PCR) assay that the CDC has developed detects 2019-nCoV in both respiratory and serum specimens. Dr. Messonnier reported that the CDC is today filing an emergency use authorization (EUA) application to the U.S. Food and Drug Administration to expedite access to the assay for public health laboratories across the country. “This will greatly enhance our capacity to test for this virus,” she said, noting that EUA approval may come as soon as the end of this week.

Although the CDC is poised to send an expert team to China, it’s still awaiting favorable results from the international negotiations currently underway. “This is a horrible situation in China,” said Dr. Messonnier. “Our presence on the ground in China would be a help to China. ... Science should trump everything else; that’s what we’re hoping – that the scientific expertise of the global community can be brought to bear on the incredibly complicated, difficult situation that our colleagues in China are dealing with.”

[email protected]

An additional 5 cases of 2019 novel coronavirus (2109-nCoV) have been confirmed in the United States, bringing the total number of confirmed cases to 11, Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a Centers for Disease Control and Prevention press briefing.

Four of the new cases are in California, and one in Massachusetts. Although four of the new cases have recent travel history to Wuhan, China, the epicenter of the 2019-nCoV outbreak, the fifth is a close household contact of one of the other California patients, said Dr. Messonnier. This last case is the second instance of person-to-person spread of 2019-nCoV in the United States.

“We expect to find additional cases of the novel coronavirus in the United States,” she said. “We expect to see more cases of person-to-person spread among close contacts. And we continue to expect this will happen given the explosive nature of this outbreak in China.”

As of the morning of Feb. 3, 167 persons under investigation, or PUIs, for possible 2019-nCoV have tested negative for the virus, and an additional 82 PUIs have testing pending – this latter figure includes some tests that are still in transit to the CDC, said Dr. Messonnier.

During the briefing, Dr. Messonnier emphasized both the aggressive nature of the U.S. public health response and the rationale for quick and assertive action. “The goal of our public health response is to protect and contain,” she said. “Strong measures now may blunt the impact of this virus on the United States.”

She cited the intensity of transmission in Hubei Province, the expansion of transmission to other provinces in China, the expansion of cases outside of China, and sporadic ongoing deaths from 2019-nCoV as drivers of the aggressive U.S. public health response.

A presidential proclamation is currently in place that bars U.S. entry to foreign nationals who have visited mainland China within the past 14 days; the ban does not apply to travelers from Hong Kong and Macao. Immediate family members of U.S. citizens and individuals who have U.S. permanent resident status are exempted from the entry ban and will be allowed entry into the United States.

However, explained Dr. Messonnier, those who have traveled to China recently and are permitted entry will be subject to screening. All passengers with such recent travel will be directed to one of 11 U.S. airports set up to perform additional screening.

As of Feb 3, the list of airports includes:

• San Francisco International Airport in California.
• Los Angeles International Airport in California.
• Hartsfield-Jackson Atlanta International Airport in Georgia.
• Daniel K. Inouye International Airport in Hawaii.
• O’Hare International Airport in Illinois.
• Detroit Metropolitan Airport in Michigan.
• Newark Liberty International Airport in New Jersey.
• John F. Kennedy International Airport in New York.
• Dallas/Fort Worth International Airport in Texas.
• Washington Dulles International Airport in Virginia.
• Seattle-Tacoma International Airport in Washington.

Travelers who have been to Hubei Province in the previous 14 days will have an additional health assessment at which they will be screened for fever, cough, or difficulty breathing. Any American citizens or exempt individuals who are symptomatic would then be transferred for further medical evaluation. Asymptomatic travelers in this category will be subject to a mandatory 14-day quarantine near their point of entry, rather than continuing on to their final destinations.

Dr. Messonnier emphasized that the mandatory 14-day quarantine is specifically for Americans or exempt individuals returning from Hubei Province, adding that the CDC is presently working with individual states to determine the exact venues for quarantine.

American citizens and exempt individuals returning from other parts of mainland China will be routed to one of the 11 airports and will also receive additional health screening. Symptomatic individuals in this travel category would be referred for further evaluation before being able to complete their itinerary.

Asymptomatic American citizens and exempt individuals who are returning from mainland China – but not Hubei Province – will be allowed to travel on to their final destinations, but will be asked to stay home as much as possible and to monitor their health during the 14 days after their return.

The U.S. Department of State is bringing back more Americans from Wuhan province this week, and these individuals will also be kept under federal quarantine for 14 days.

“There are likely to be confirmed infections among returning travelers,” said Dr. Messonnier. “It is important to note that this strategy is not meant to catch every single traveler returning from China with novel coronavirus; given the nature of this virus and how it’s spreading, that would be impossible, but working together we can catch the majority of them.

“The goal here is to slow the entry of this virus into the United States,” she said, adding that the nation’s health care and public health systems stand on high alert to detect the virus in community settings. In response to questioning from the press, Dr. Messonnier defended the stringent quarantine measures, noting that they are in line with those taken by some other nations, and with the aggressive action being taken by the Chinese government itself. “These actions are science based and aimed at protecting the health of all Americans,” she said.

The real-time reverse transcription polymerase chain reaction (rRT-PCR) assay that the CDC has developed detects 2019-nCoV in both respiratory and serum specimens. Dr. Messonnier reported that the CDC is today filing an emergency use authorization (EUA) application to the U.S. Food and Drug Administration to expedite access to the assay for public health laboratories across the country. “This will greatly enhance our capacity to test for this virus,” she said, noting that EUA approval may come as soon as the end of this week.

Although the CDC is poised to send an expert team to China, it’s still awaiting favorable results from the international negotiations currently underway. “This is a horrible situation in China,” said Dr. Messonnier. “Our presence on the ground in China would be a help to China. ... Science should trump everything else; that’s what we’re hoping – that the scientific expertise of the global community can be brought to bear on the incredibly complicated, difficult situation that our colleagues in China are dealing with.”

[email protected]

After 2 weeks of declines at the beginning of the year, flu activity has now increased for 2 consecutive weeks, according to the U.S. Centers for Disease Control and Prevention.

Nationally, an estimated 5.7% of all outpatients visiting health care providers had influenza-like illness (ILI) for the week ending Jan. 25, which was up from 5.1% the previous week but still lower than the current seasonal high of 7.1% recorded during the week of Dec. 22-28, the CDC’s influenza division reported.

Another key indicator of influenza activity, the percentage of respiratory specimens testing positive, also remains high as it rose from 25.7% the week before to 27.7% for the week ending Jan. 25, the influenza division said. That is the highest rate of the 2019-2020 season so far, surpassing the 26.8% reached during Dec. 22-28.

Another new seasonal high involves the number of states, 33 plus Puerto Rico, at the highest level of ILI activity on the CDC’s 1-10 scale for the latest reporting week, topping the 32 jurisdictions from the last full week of December. Another eight states and the District of Columbia were in the “high” range with activity levels of 8 and 9, and no state with available data was lower than level 6, the CDC data show.

Going along with the recent 2-week increase in activity is a large increase in the number of ILI-related pediatric deaths, which rose from 39 on Jan. 11 to the current count of 68, the CDC said. At the same point last year, there had been 36 pediatric deaths.

Other indicators of ILI severity, however, “are not high at this point in the season,” the influenza division noted. “Overall, hospitalization rates remain similar to what has been seen at this time during recent seasons, but rates among children and young adults are higher at this time than in recent seasons.” Overall pneumonia and influenza mortality is also low, the CDC added.

[email protected]

After 2 weeks of declines at the beginning of the year, flu activity has now increased for 2 consecutive weeks, according to the U.S. Centers for Disease Control and Prevention.

Nationally, an estimated 5.7% of all outpatients visiting health care providers had influenza-like illness (ILI) for the week ending Jan. 25, which was up from 5.1% the previous week but still lower than the current seasonal high of 7.1% recorded during the week of Dec. 22-28, the CDC’s influenza division reported.

Another key indicator of influenza activity, the percentage of respiratory specimens testing positive, also remains high as it rose from 25.7% the week before to 27.7% for the week ending Jan. 25, the influenza division said. That is the highest rate of the 2019-2020 season so far, surpassing the 26.8% reached during Dec. 22-28.

Another new seasonal high involves the number of states, 33 plus Puerto Rico, at the highest level of ILI activity on the CDC’s 1-10 scale for the latest reporting week, topping the 32 jurisdictions from the last full week of December. Another eight states and the District of Columbia were in the “high” range with activity levels of 8 and 9, and no state with available data was lower than level 6, the CDC data show.

Going along with the recent 2-week increase in activity is a large increase in the number of ILI-related pediatric deaths, which rose from 39 on Jan. 11 to the current count of 68, the CDC said. At the same point last year, there had been 36 pediatric deaths.

Other indicators of ILI severity, however, “are not high at this point in the season,” the influenza division noted. “Overall, hospitalization rates remain similar to what has been seen at this time during recent seasons, but rates among children and young adults are higher at this time than in recent seasons.” Overall pneumonia and influenza mortality is also low, the CDC added.

[email protected]

After 2 weeks of declines at the beginning of the year, flu activity has now increased for 2 consecutive weeks, according to the U.S. Centers for Disease Control and Prevention.

Nationally, an estimated 5.7% of all outpatients visiting health care providers had influenza-like illness (ILI) for the week ending Jan. 25, which was up from 5.1% the previous week but still lower than the current seasonal high of 7.1% recorded during the week of Dec. 22-28, the CDC’s influenza division reported.

Another key indicator of influenza activity, the percentage of respiratory specimens testing positive, also remains high as it rose from 25.7% the week before to 27.7% for the week ending Jan. 25, the influenza division said. That is the highest rate of the 2019-2020 season so far, surpassing the 26.8% reached during Dec. 22-28.

Another new seasonal high involves the number of states, 33 plus Puerto Rico, at the highest level of ILI activity on the CDC’s 1-10 scale for the latest reporting week, topping the 32 jurisdictions from the last full week of December. Another eight states and the District of Columbia were in the “high” range with activity levels of 8 and 9, and no state with available data was lower than level 6, the CDC data show.

Going along with the recent 2-week increase in activity is a large increase in the number of ILI-related pediatric deaths, which rose from 39 on Jan. 11 to the current count of 68, the CDC said. At the same point last year, there had been 36 pediatric deaths.

Other indicators of ILI severity, however, “are not high at this point in the season,” the influenza division noted. “Overall, hospitalization rates remain similar to what has been seen at this time during recent seasons, but rates among children and young adults are higher at this time than in recent seasons.” Overall pneumonia and influenza mortality is also low, the CDC added.

[email protected]

Study Overview

Objective. To evaluate the effect of changing from tenofovir disoproxil fumarate (TDF) –containing antiretroviral therapy (ART) to tenofovir alafenamide (TAF) –containing ART in patients ages 60 years and older living with HIV.

Design. Prospective, open-label, multicenter, randomized controlled trial.

Setting and participants. The study was completed across 36 European centers over 48 weeks. Patients were enrolled from December 12, 2015, to March 21, 2018, and were eligible to participate if they were diagnosed with HIV-1; virologically suppressed to < 50 copies/mL; on a TDF-containing ART regimen; and ≥ 60 years of age.

Intervention. Participants (n = 167) were randomly assigned in a 2:1 ratio to ART with TAF (10 mg), elvitegravir (EVG; 150 mg), cobicistat (COB; 150 mg), and emtricitabine (FTC; 200 mg) or to continued therapy with a TDF-containing ART regimen (300 mg TDF).

Main outcome measures. Primary outcome measures were the change in spine and hip bone mineral density from baseline at week 48. Secondary outcome measures included bone mineral density changes from baseline at week 24, HIV viral suppression and change in CD4 count at weeks 24 and 48, and the assessment of safety and tolerability of each ART regimen until week 48.

Main results. At 48 weeks, patients (n = 111) in the TAF+EVG+COB+FTC group had a mean 2.24% (SD, 3.27) increase in spine bone mineral density, while those in the TDF-containing group (n = 56) had a mean 0.10% decrease (SD, 3.39), a difference of 2.43% (95% confidence interval [CI], 1.34-3.52; P < 0.0001). In addition, at 48 weeks patients in the TAF+EVG+COB+FTC group had a mean 1.33% increase (SD, 2.20) in hip bone mineral density, as compared with a mean 0.73% decrease (SD, 3.21) in the TDF-containing group, a difference of 2.04% (95% CI, 1.17-2.90; P < 0.0001).

Similar results were seen in spine and hip bone mineral density in the TAF+EVG+COB+FTC group at week 24, with increases of 1.75% (P = 0.00080) and 1.35% (P = 0.00040), respectively. Both treatment groups maintained high virologic suppression. The TAF+EVG+COB+FTC group maintained 94.5% virologic suppression at week 24 and 93.6% at week 48, as compared with virologic suppression of 100% and 94.5% at weeks 24 and 48, respectively, in the TDF-containing group. However, the TAF+EVG+COB+FTC group had an increase in CD4 count from baseline (56 cells/µL), with no real change in the TDF-containing group (–1 cell/µL). Patients in the TAF+EVG+COB+FTC group had a mean 27.8 mg/g decrease in urine albumin-to-creatinine ratio (UACR) versus a 7.7 mg/g decrease in the TDF-containing group (P = 0.0042). In addition, patients in the TAF+EVG+COB+FTC group had a mean 49.8 mg/g decrease in urine protein-to-creatinine ratio (UPCR) versus a 3.8 mg/g decrease in the TDF-containing group (P = 0.0042).

Conclusion. Patients 60 years of age or older living with virologically suppressed HIV may benefit from improved bone mineral density by switching from a TDF-containing ART regimen to a TAF-containing regimen after 48 weeks, which, in turn, may help to reduce the risk for osteoporosis. Patients who were switched to a TAF-containing regimen also had favorable improvements in UACR and UPCR, which could indicate better renal function.

Commentary

The Centers for Disease Control and Prevention estimated that in 2018 nearly half of those living with HIV in the United States were older than 50 years.¹ Today, the life expectancy of patients living with HIV on ART in developed countries is similar to that of patients not living with HIV. A meta-analysis published in 2017 estimated that patients diagnosed with HIV at age 20 beginning ART have a life expectancy of 63 years, and another study estimated that life expectancy in such patients is 89.1% of that of the general population in Canada.^2,3 Overall, most people living with HIV infection are aging and at risk for medical conditions similar to persons without HIV disease. However, rates of osteoporosis in elderly patients with HIV are estimated to be 3 times greater than rates in persons without HIV.⁴ As a result, it is becoming increasingly important to find ways to decrease the risk of osteoporosis in these patients.

ART typically includes a nucleoside reverse transcriptase inhibitor (NRTI) combination and a third agent, such as an integrase strand inhibitor. Tenofovir is a commonly used backbone NRTI that comes in 2 forms, TDF (tenofovir disoproxil fumarate) and TAF (tenofovir alafenamide). Both are prodrugs that are converted to tenofovir diphosphate. TDF specifically is associated with an increased risk of bone loss and nephrotoxicity. The loss in bone mineral density is most similar to the bone loss seen with oral glucocorticoids.⁵ TDF has been shown to increase plasma levels of RANKL and tumor necrosis factor-α, leading to increased bone resorption.⁶ The long-term effects of TDF- versus TAF-containing ART on bone mineral density have, to our knowledge, not been compared previously in a randomized control study. The significance of demonstrating an increase in bone mineral density in the prevention of osteoporotic bone fracture in people living with HIV is less clear. A long-term cohort study completed in Japan looking at patients on TDF showed an increased risk of bone fractures in both older postmenopausal women and younger men.⁷ However, a retrospective cohort study looking at 1981 patients with HIV found no association between bone fractures and TDF.⁸

This randomized controlled trial used appropriate methods to measure the reported primary and secondary endpoints; however, it would be of benefit to continue following these patients to measure their true long-term risk of osteoporosis-related complications. In terms of the study’s secondary endpoints, it is notable that the patients maintained HIV viral suppression after the switch and CD4 counts remained stable (with a slight increase observed in the TAF-containing ART cohort).

In regard to the patient’s renal function, patients in the TAF group had significantly improved UACR and UPCR, which likely reflects improved glomerular filtration. Improved renal function is also increasingly important for patients with HIV, as up to 48.5% have some form of chronic kidney disease.⁹

This study shows that making the switch from TDF- to TAF-containing ART can lead to improved bone mineral density. We can extrapolate that switching may lead to a decreased risk of osteoporosis and osteoporosis-related complications, such as bone fracture, but this needs to be investigated in more detail. As demonstrated in this study, switching from a TDF- to a TAF-containing regimen can also lead to improved renal function while maintaining HIV viral suppression and CD4 counts.

Unfortunately, the regimen selected with TAF in this study (elvitegravir, cobicistat, and emtricitabine) includes cobicistat, which is no longer recommended as initial therapy due to its risk of drug-drug interactions, and elvitegravir, which has a lower barrier to resistance than other integrase strand inhibitors.^10,11 The United States Department of Health and Human Services guidelines and the International Antiviral Society-USA Panel suggest using several other TAF-containing regimens for beginning or even switching therapy in older patients.^10,11

When choosing between either a TAF- or a TDF-containing regimen to treat HIV infection in older patients, increasing evidence shows that using a TAF-containing ART regimen may be more beneficial for people living and aging with virologically suppressed HIV infection.

–Sean P. Bliven, and Norman L. Beatty, MD, University of Florida College of Medicine, Division of Infectious Diseases and Global Medicine, Gainesville, FL

Study Overview

Objective. To evaluate the effect of changing from tenofovir disoproxil fumarate (TDF) –containing antiretroviral therapy (ART) to tenofovir alafenamide (TAF) –containing ART in patients ages 60 years and older living with HIV.

Design. Prospective, open-label, multicenter, randomized controlled trial.

Setting and participants. The study was completed across 36 European centers over 48 weeks. Patients were enrolled from December 12, 2015, to March 21, 2018, and were eligible to participate if they were diagnosed with HIV-1; virologically suppressed to < 50 copies/mL; on a TDF-containing ART regimen; and ≥ 60 years of age.

Intervention. Participants (n = 167) were randomly assigned in a 2:1 ratio to ART with TAF (10 mg), elvitegravir (EVG; 150 mg), cobicistat (COB; 150 mg), and emtricitabine (FTC; 200 mg) or to continued therapy with a TDF-containing ART regimen (300 mg TDF).

Main outcome measures. Primary outcome measures were the change in spine and hip bone mineral density from baseline at week 48. Secondary outcome measures included bone mineral density changes from baseline at week 24, HIV viral suppression and change in CD4 count at weeks 24 and 48, and the assessment of safety and tolerability of each ART regimen until week 48.

Main results. At 48 weeks, patients (n = 111) in the TAF+EVG+COB+FTC group had a mean 2.24% (SD, 3.27) increase in spine bone mineral density, while those in the TDF-containing group (n = 56) had a mean 0.10% decrease (SD, 3.39), a difference of 2.43% (95% confidence interval [CI], 1.34-3.52; P < 0.0001). In addition, at 48 weeks patients in the TAF+EVG+COB+FTC group had a mean 1.33% increase (SD, 2.20) in hip bone mineral density, as compared with a mean 0.73% decrease (SD, 3.21) in the TDF-containing group, a difference of 2.04% (95% CI, 1.17-2.90; P < 0.0001).

Similar results were seen in spine and hip bone mineral density in the TAF+EVG+COB+FTC group at week 24, with increases of 1.75% (P = 0.00080) and 1.35% (P = 0.00040), respectively. Both treatment groups maintained high virologic suppression. The TAF+EVG+COB+FTC group maintained 94.5% virologic suppression at week 24 and 93.6% at week 48, as compared with virologic suppression of 100% and 94.5% at weeks 24 and 48, respectively, in the TDF-containing group. However, the TAF+EVG+COB+FTC group had an increase in CD4 count from baseline (56 cells/µL), with no real change in the TDF-containing group (–1 cell/µL). Patients in the TAF+EVG+COB+FTC group had a mean 27.8 mg/g decrease in urine albumin-to-creatinine ratio (UACR) versus a 7.7 mg/g decrease in the TDF-containing group (P = 0.0042). In addition, patients in the TAF+EVG+COB+FTC group had a mean 49.8 mg/g decrease in urine protein-to-creatinine ratio (UPCR) versus a 3.8 mg/g decrease in the TDF-containing group (P = 0.0042).

Conclusion. Patients 60 years of age or older living with virologically suppressed HIV may benefit from improved bone mineral density by switching from a TDF-containing ART regimen to a TAF-containing regimen after 48 weeks, which, in turn, may help to reduce the risk for osteoporosis. Patients who were switched to a TAF-containing regimen also had favorable improvements in UACR and UPCR, which could indicate better renal function.

Commentary

The Centers for Disease Control and Prevention estimated that in 2018 nearly half of those living with HIV in the United States were older than 50 years.¹ Today, the life expectancy of patients living with HIV on ART in developed countries is similar to that of patients not living with HIV. A meta-analysis published in 2017 estimated that patients diagnosed with HIV at age 20 beginning ART have a life expectancy of 63 years, and another study estimated that life expectancy in such patients is 89.1% of that of the general population in Canada.^2,3 Overall, most people living with HIV infection are aging and at risk for medical conditions similar to persons without HIV disease. However, rates of osteoporosis in elderly patients with HIV are estimated to be 3 times greater than rates in persons without HIV.⁴ As a result, it is becoming increasingly important to find ways to decrease the risk of osteoporosis in these patients.

ART typically includes a nucleoside reverse transcriptase inhibitor (NRTI) combination and a third agent, such as an integrase strand inhibitor. Tenofovir is a commonly used backbone NRTI that comes in 2 forms, TDF (tenofovir disoproxil fumarate) and TAF (tenofovir alafenamide). Both are prodrugs that are converted to tenofovir diphosphate. TDF specifically is associated with an increased risk of bone loss and nephrotoxicity. The loss in bone mineral density is most similar to the bone loss seen with oral glucocorticoids.⁵ TDF has been shown to increase plasma levels of RANKL and tumor necrosis factor-α, leading to increased bone resorption.⁶ The long-term effects of TDF- versus TAF-containing ART on bone mineral density have, to our knowledge, not been compared previously in a randomized control study. The significance of demonstrating an increase in bone mineral density in the prevention of osteoporotic bone fracture in people living with HIV is less clear. A long-term cohort study completed in Japan looking at patients on TDF showed an increased risk of bone fractures in both older postmenopausal women and younger men.⁷ However, a retrospective cohort study looking at 1981 patients with HIV found no association between bone fractures and TDF.⁸

This randomized controlled trial used appropriate methods to measure the reported primary and secondary endpoints; however, it would be of benefit to continue following these patients to measure their true long-term risk of osteoporosis-related complications. In terms of the study’s secondary endpoints, it is notable that the patients maintained HIV viral suppression after the switch and CD4 counts remained stable (with a slight increase observed in the TAF-containing ART cohort).

In regard to the patient’s renal function, patients in the TAF group had significantly improved UACR and UPCR, which likely reflects improved glomerular filtration. Improved renal function is also increasingly important for patients with HIV, as up to 48.5% have some form of chronic kidney disease.⁹

This study shows that making the switch from TDF- to TAF-containing ART can lead to improved bone mineral density. We can extrapolate that switching may lead to a decreased risk of osteoporosis and osteoporosis-related complications, such as bone fracture, but this needs to be investigated in more detail. As demonstrated in this study, switching from a TDF- to a TAF-containing regimen can also lead to improved renal function while maintaining HIV viral suppression and CD4 counts.

Unfortunately, the regimen selected with TAF in this study (elvitegravir, cobicistat, and emtricitabine) includes cobicistat, which is no longer recommended as initial therapy due to its risk of drug-drug interactions, and elvitegravir, which has a lower barrier to resistance than other integrase strand inhibitors.^10,11 The United States Department of Health and Human Services guidelines and the International Antiviral Society-USA Panel suggest using several other TAF-containing regimens for beginning or even switching therapy in older patients.^10,11

When choosing between either a TAF- or a TDF-containing regimen to treat HIV infection in older patients, increasing evidence shows that using a TAF-containing ART regimen may be more beneficial for people living and aging with virologically suppressed HIV infection.

–Sean P. Bliven, and Norman L. Beatty, MD, University of Florida College of Medicine, Division of Infectious Diseases and Global Medicine, Gainesville, FL

Study Overview

Objective. To evaluate the effect of changing from tenofovir disoproxil fumarate (TDF) –containing antiretroviral therapy (ART) to tenofovir alafenamide (TAF) –containing ART in patients ages 60 years and older living with HIV.

Design. Prospective, open-label, multicenter, randomized controlled trial.

Setting and participants. The study was completed across 36 European centers over 48 weeks. Patients were enrolled from December 12, 2015, to March 21, 2018, and were eligible to participate if they were diagnosed with HIV-1; virologically suppressed to < 50 copies/mL; on a TDF-containing ART regimen; and ≥ 60 years of age.

Intervention. Participants (n = 167) were randomly assigned in a 2:1 ratio to ART with TAF (10 mg), elvitegravir (EVG; 150 mg), cobicistat (COB; 150 mg), and emtricitabine (FTC; 200 mg) or to continued therapy with a TDF-containing ART regimen (300 mg TDF).

Main outcome measures. Primary outcome measures were the change in spine and hip bone mineral density from baseline at week 48. Secondary outcome measures included bone mineral density changes from baseline at week 24, HIV viral suppression and change in CD4 count at weeks 24 and 48, and the assessment of safety and tolerability of each ART regimen until week 48.

Main results. At 48 weeks, patients (n = 111) in the TAF+EVG+COB+FTC group had a mean 2.24% (SD, 3.27) increase in spine bone mineral density, while those in the TDF-containing group (n = 56) had a mean 0.10% decrease (SD, 3.39), a difference of 2.43% (95% confidence interval [CI], 1.34-3.52; P < 0.0001). In addition, at 48 weeks patients in the TAF+EVG+COB+FTC group had a mean 1.33% increase (SD, 2.20) in hip bone mineral density, as compared with a mean 0.73% decrease (SD, 3.21) in the TDF-containing group, a difference of 2.04% (95% CI, 1.17-2.90; P < 0.0001).

Similar results were seen in spine and hip bone mineral density in the TAF+EVG+COB+FTC group at week 24, with increases of 1.75% (P = 0.00080) and 1.35% (P = 0.00040), respectively. Both treatment groups maintained high virologic suppression. The TAF+EVG+COB+FTC group maintained 94.5% virologic suppression at week 24 and 93.6% at week 48, as compared with virologic suppression of 100% and 94.5% at weeks 24 and 48, respectively, in the TDF-containing group. However, the TAF+EVG+COB+FTC group had an increase in CD4 count from baseline (56 cells/µL), with no real change in the TDF-containing group (–1 cell/µL). Patients in the TAF+EVG+COB+FTC group had a mean 27.8 mg/g decrease in urine albumin-to-creatinine ratio (UACR) versus a 7.7 mg/g decrease in the TDF-containing group (P = 0.0042). In addition, patients in the TAF+EVG+COB+FTC group had a mean 49.8 mg/g decrease in urine protein-to-creatinine ratio (UPCR) versus a 3.8 mg/g decrease in the TDF-containing group (P = 0.0042).

Conclusion. Patients 60 years of age or older living with virologically suppressed HIV may benefit from improved bone mineral density by switching from a TDF-containing ART regimen to a TAF-containing regimen after 48 weeks, which, in turn, may help to reduce the risk for osteoporosis. Patients who were switched to a TAF-containing regimen also had favorable improvements in UACR and UPCR, which could indicate better renal function.

Commentary

The Centers for Disease Control and Prevention estimated that in 2018 nearly half of those living with HIV in the United States were older than 50 years.¹ Today, the life expectancy of patients living with HIV on ART in developed countries is similar to that of patients not living with HIV. A meta-analysis published in 2017 estimated that patients diagnosed with HIV at age 20 beginning ART have a life expectancy of 63 years, and another study estimated that life expectancy in such patients is 89.1% of that of the general population in Canada.^2,3 Overall, most people living with HIV infection are aging and at risk for medical conditions similar to persons without HIV disease. However, rates of osteoporosis in elderly patients with HIV are estimated to be 3 times greater than rates in persons without HIV.⁴ As a result, it is becoming increasingly important to find ways to decrease the risk of osteoporosis in these patients.

ART typically includes a nucleoside reverse transcriptase inhibitor (NRTI) combination and a third agent, such as an integrase strand inhibitor. Tenofovir is a commonly used backbone NRTI that comes in 2 forms, TDF (tenofovir disoproxil fumarate) and TAF (tenofovir alafenamide). Both are prodrugs that are converted to tenofovir diphosphate. TDF specifically is associated with an increased risk of bone loss and nephrotoxicity. The loss in bone mineral density is most similar to the bone loss seen with oral glucocorticoids.⁵ TDF has been shown to increase plasma levels of RANKL and tumor necrosis factor-α, leading to increased bone resorption.⁶ The long-term effects of TDF- versus TAF-containing ART on bone mineral density have, to our knowledge, not been compared previously in a randomized control study. The significance of demonstrating an increase in bone mineral density in the prevention of osteoporotic bone fracture in people living with HIV is less clear. A long-term cohort study completed in Japan looking at patients on TDF showed an increased risk of bone fractures in both older postmenopausal women and younger men.⁷ However, a retrospective cohort study looking at 1981 patients with HIV found no association between bone fractures and TDF.⁸

This randomized controlled trial used appropriate methods to measure the reported primary and secondary endpoints; however, it would be of benefit to continue following these patients to measure their true long-term risk of osteoporosis-related complications. In terms of the study’s secondary endpoints, it is notable that the patients maintained HIV viral suppression after the switch and CD4 counts remained stable (with a slight increase observed in the TAF-containing ART cohort).

In regard to the patient’s renal function, patients in the TAF group had significantly improved UACR and UPCR, which likely reflects improved glomerular filtration. Improved renal function is also increasingly important for patients with HIV, as up to 48.5% have some form of chronic kidney disease.⁹

This study shows that making the switch from TDF- to TAF-containing ART can lead to improved bone mineral density. We can extrapolate that switching may lead to a decreased risk of osteoporosis and osteoporosis-related complications, such as bone fracture, but this needs to be investigated in more detail. As demonstrated in this study, switching from a TDF- to a TAF-containing regimen can also lead to improved renal function while maintaining HIV viral suppression and CD4 counts.

Unfortunately, the regimen selected with TAF in this study (elvitegravir, cobicistat, and emtricitabine) includes cobicistat, which is no longer recommended as initial therapy due to its risk of drug-drug interactions, and elvitegravir, which has a lower barrier to resistance than other integrase strand inhibitors.^10,11 The United States Department of Health and Human Services guidelines and the International Antiviral Society-USA Panel suggest using several other TAF-containing regimens for beginning or even switching therapy in older patients.^10,11

When choosing between either a TAF- or a TDF-containing regimen to treat HIV infection in older patients, increasing evidence shows that using a TAF-containing ART regimen may be more beneficial for people living and aging with virologically suppressed HIV infection.

–Sean P. Bliven, and Norman L. Beatty, MD, University of Florida College of Medicine, Division of Infectious Diseases and Global Medicine, Gainesville, FL

The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.

"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*

The government also began a quarantine of travelers. The 195 passengers who arrived at March Air Reserve Base in Ontario, Calif., from Wuhan, China on Jan. 29 are under federal quarantine amid growing concerns about the 2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.

“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”

These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”

The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”

[email protected]

* This story was updated on 01/31/2020. 

The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.

"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*

The government also began a quarantine of travelers. The 195 passengers who arrived at March Air Reserve Base in Ontario, Calif., from Wuhan, China on Jan. 29 are under federal quarantine amid growing concerns about the 2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.

“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”

These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”

The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”

[email protected]

* This story was updated on 01/31/2020. 

The federal government declared a formal public health emergency on Jan. 31 to aid in the response to the 2019 Novel Coronavirus (2019-nCoV). The declaration, issued by Health and Human Services Secretary Alex. M. Azar II gives state, tribal, and local health departments additional flexibility to request assistance from the federal government in responding to the coronavirus.

"While this virus poses a serious public health threat, the risk to the American public remains low at this time, and we are working to keep this risk low."*

The government also began a quarantine of travelers. The 195 passengers who arrived at March Air Reserve Base in Ontario, Calif., from Wuhan, China on Jan. 29 are under federal quarantine amid growing concerns about the 2019-nCoV—the first such action taken by the Centers for Disease Control and Prevention in more than 50 years.

“This decision is based on the current scientific facts,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during a press briefing Jan. 31. “While we understand the action seems drastic, our goal today, tomorrow, and always continues to be the safety of the American public. We would rather be remembered for over-reacting than under-reacting.”

These actions come on the heels of the World Health Organization’s Jan. 30 declaration of 2019-nCoV as a public health emergency of international concern, and from a recent spike in cases reported by Chinese health officials. “Every day this week China has reported additional cases,” Dr. Messonnier said. “Today’s numbers are a 26% increase since yesterday. Over the course of the last week, there have been nearly 7,000 new cases reported. This tells us the virus is continuing to spread rapidly in China. The reported deaths have continued to rise as well. In addition, locations outside China have continued to report cases. There have been an increasing number of reports of person-to-person spread, and now, most recently, a report in the New England Journal of Medicine of asymptomatic spread.”

The quarantine of passengers will last 14 days from when the plane left Wuhan, China. Martin Cetron, MD, who directs the CDC’s Division of Global Migration and Quarantine, said that the quarantine order “offers the greatest level of protection for the American public in preventing introduction and spread. That is our primary concern. Prior epidemics suggest that when people are properly informed, they’re usually very compliant with this request to restrict their movement. This allows someone who would become symptomatic to be rapidly identified. Offering early, rapid diagnosis of their illness could alleviate a lot of anxiety and uncertainty. In addition, this is a protective effect on family members. No individual wants to be the source of introducing or exposing a family member or a loved one to their virus. Additionally, this is part of their civic responsibility to protect their communities.”

[email protected]

* This story was updated on 01/31/2020. 

The Diagnosis: Herpes Zoster Opthalmicus 

Due to the potential concern of vision loss, the patient was directed to a local emergency department for immediate ophthalmologic evaluation. He was diagnosed with herpes zoster ophthalmicus (HZO) and treated with oral acyclovir and prednisone. The rash and periorbital swelling resolved within 2 weeks of treatment, and he remained asymptomatic at follow-up 3 months later.  

Herpes zoster ophthalmicus presents with an erythematous and vesicular rash in the distribution of cranial nerve V1. The herpetiform grouping of lesions on the forehead is diagnostic of HZO. Varicella-zoster virus (VZV) infection presents in 2 distinct forms. Primary infection (commonly known as chickenpox) presents clinically as a vesicular rash usually located on the face, arms, and trunk. Although the initial presentation usually occurs in childhood and is self-limited, the virus becomes latent in the dorsal root ganglia of sensory neurons. Varicella-zoster virus may become reactivated later in life and is termed herpes zoster (commonly known as shingles). It most often presents as a painful vesicular rash that may later form pustules.  

Zoster outbreaks typically do not cross the midline but may in disseminated disease. Patients may experience a prodrome in the form of pain or less commonly pruritus or paresthesia along the dermatome between 1 and 10 days before the rash appears. Triggers for herpes zoster include illness, medications, malnutrition, surgery, or the natural decline in immune function due to aging. Trauma is another important precipitating event for VZV reactivation; one case-control study showed that zoster patients were 3.4 times more likely than controls to have had trauma the week prior.¹ Patients with cranial zoster are more than 25 times more likely to have experienced trauma in the preceding week. Local trauma may predispose these patients to VZV reactivation by stimulating local sensory nerves or by disrupting local cutaneous immunity.² 

Herpes zoster ophthalmicus occurs when zoster presents in the ophthalmic division of the fifth cranial nerve. It is a serious, vision-threatening condition with a presentation that can include conjunctivitis, scleritis, keratitis, optic neuritis, exophthalmos, lid retraction, ptosis, and extraocular muscle palsies. Treatment includes antiviral medication (eg, acyclovir, valacyclovir, famciclovir) and prompt ophthalmologic consultation due to potential vision-threatening complications, such as acute retinal necrosis. Acute pain control may be necessary with nonsteroidal anti-inflammatory drugs, opioids, steroids, tricyclic antidepressants, or anticonvulsants.³ Wet-to-dry dressings with sterile saline or Burow solution and/or calamine lotion can provide symptomatic relief of itching.  

Periorbital and preseptal cellulitis typically present with more erythema of the skin surrounding the eye and without the accompanying rash. Periorbital cellulitis is the more serious infection and may be clinically distinguished by the presence of pain with extraocular muscle movement. Contact dermatitis and pemphigus vulgaris are possibilities, but both were less likely than HZO in this case presentation given the distribution of the rash and the patient history. Contact dermatitis typically presents with no prodrome with a main concern of pruritus. Pemphigus vulgaris nearly always includes involvement of the oral mucous membranes. 

The Diagnosis: Herpes Zoster Opthalmicus 

Due to the potential concern of vision loss, the patient was directed to a local emergency department for immediate ophthalmologic evaluation. He was diagnosed with herpes zoster ophthalmicus (HZO) and treated with oral acyclovir and prednisone. The rash and periorbital swelling resolved within 2 weeks of treatment, and he remained asymptomatic at follow-up 3 months later.  

Herpes zoster ophthalmicus presents with an erythematous and vesicular rash in the distribution of cranial nerve V1. The herpetiform grouping of lesions on the forehead is diagnostic of HZO. Varicella-zoster virus (VZV) infection presents in 2 distinct forms. Primary infection (commonly known as chickenpox) presents clinically as a vesicular rash usually located on the face, arms, and trunk. Although the initial presentation usually occurs in childhood and is self-limited, the virus becomes latent in the dorsal root ganglia of sensory neurons. Varicella-zoster virus may become reactivated later in life and is termed herpes zoster (commonly known as shingles). It most often presents as a painful vesicular rash that may later form pustules.  

Zoster outbreaks typically do not cross the midline but may in disseminated disease. Patients may experience a prodrome in the form of pain or less commonly pruritus or paresthesia along the dermatome between 1 and 10 days before the rash appears. Triggers for herpes zoster include illness, medications, malnutrition, surgery, or the natural decline in immune function due to aging. Trauma is another important precipitating event for VZV reactivation; one case-control study showed that zoster patients were 3.4 times more likely than controls to have had trauma the week prior.¹ Patients with cranial zoster are more than 25 times more likely to have experienced trauma in the preceding week. Local trauma may predispose these patients to VZV reactivation by stimulating local sensory nerves or by disrupting local cutaneous immunity.² 

Herpes zoster ophthalmicus occurs when zoster presents in the ophthalmic division of the fifth cranial nerve. It is a serious, vision-threatening condition with a presentation that can include conjunctivitis, scleritis, keratitis, optic neuritis, exophthalmos, lid retraction, ptosis, and extraocular muscle palsies. Treatment includes antiviral medication (eg, acyclovir, valacyclovir, famciclovir) and prompt ophthalmologic consultation due to potential vision-threatening complications, such as acute retinal necrosis. Acute pain control may be necessary with nonsteroidal anti-inflammatory drugs, opioids, steroids, tricyclic antidepressants, or anticonvulsants.³ Wet-to-dry dressings with sterile saline or Burow solution and/or calamine lotion can provide symptomatic relief of itching.  

Periorbital and preseptal cellulitis typically present with more erythema of the skin surrounding the eye and without the accompanying rash. Periorbital cellulitis is the more serious infection and may be clinically distinguished by the presence of pain with extraocular muscle movement. Contact dermatitis and pemphigus vulgaris are possibilities, but both were less likely than HZO in this case presentation given the distribution of the rash and the patient history. Contact dermatitis typically presents with no prodrome with a main concern of pruritus. Pemphigus vulgaris nearly always includes involvement of the oral mucous membranes. 

The Diagnosis: Herpes Zoster Opthalmicus 

Due to the potential concern of vision loss, the patient was directed to a local emergency department for immediate ophthalmologic evaluation. He was diagnosed with herpes zoster ophthalmicus (HZO) and treated with oral acyclovir and prednisone. The rash and periorbital swelling resolved within 2 weeks of treatment, and he remained asymptomatic at follow-up 3 months later.  

Herpes zoster ophthalmicus presents with an erythematous and vesicular rash in the distribution of cranial nerve V1. The herpetiform grouping of lesions on the forehead is diagnostic of HZO. Varicella-zoster virus (VZV) infection presents in 2 distinct forms. Primary infection (commonly known as chickenpox) presents clinically as a vesicular rash usually located on the face, arms, and trunk. Although the initial presentation usually occurs in childhood and is self-limited, the virus becomes latent in the dorsal root ganglia of sensory neurons. Varicella-zoster virus may become reactivated later in life and is termed herpes zoster (commonly known as shingles). It most often presents as a painful vesicular rash that may later form pustules.  

Zoster outbreaks typically do not cross the midline but may in disseminated disease. Patients may experience a prodrome in the form of pain or less commonly pruritus or paresthesia along the dermatome between 1 and 10 days before the rash appears. Triggers for herpes zoster include illness, medications, malnutrition, surgery, or the natural decline in immune function due to aging. Trauma is another important precipitating event for VZV reactivation; one case-control study showed that zoster patients were 3.4 times more likely than controls to have had trauma the week prior.¹ Patients with cranial zoster are more than 25 times more likely to have experienced trauma in the preceding week. Local trauma may predispose these patients to VZV reactivation by stimulating local sensory nerves or by disrupting local cutaneous immunity.² 

Herpes zoster ophthalmicus occurs when zoster presents in the ophthalmic division of the fifth cranial nerve. It is a serious, vision-threatening condition with a presentation that can include conjunctivitis, scleritis, keratitis, optic neuritis, exophthalmos, lid retraction, ptosis, and extraocular muscle palsies. Treatment includes antiviral medication (eg, acyclovir, valacyclovir, famciclovir) and prompt ophthalmologic consultation due to potential vision-threatening complications, such as acute retinal necrosis. Acute pain control may be necessary with nonsteroidal anti-inflammatory drugs, opioids, steroids, tricyclic antidepressants, or anticonvulsants.³ Wet-to-dry dressings with sterile saline or Burow solution and/or calamine lotion can provide symptomatic relief of itching.  

Periorbital and preseptal cellulitis typically present with more erythema of the skin surrounding the eye and without the accompanying rash. Periorbital cellulitis is the more serious infection and may be clinically distinguished by the presence of pain with extraocular muscle movement. Contact dermatitis and pemphigus vulgaris are possibilities, but both were less likely than HZO in this case presentation given the distribution of the rash and the patient history. Contact dermatitis typically presents with no prodrome with a main concern of pruritus. Pemphigus vulgaris nearly always includes involvement of the oral mucous membranes. 

Amid the rising spread of the 2019 Novel Coronavirus (2019-nCoV), the World Health Organization (WHO) has declared the virus outbreak a public health emergency of international concern (PHEIC).

WHO.int

The declaration was made during a press briefing on Jan. 30 after a week of growing concern and pressure on WHO to designate the virus at a higher emergency level. WHO’s Emergency Committee made the nearly unanimous decision after considering the increasing number of coronavirus cases in China, the rising infections outside of China, and the questionable measures some countries are taking regarding travel, said committee chair Didier Houssin, MD, said during the press conference.

As of Jan. 30, there were 8,236 confirmed cases of the coronavirus in China and 171 deaths, with another 112 cases identified outside of China in 21 other countries.

“Declaring a Public Health Emergency of International Concern is likely to facilitate [WHO’s] leadership role for public health measures, holding countries to account concerning additional measures they may take regarding travel, trade, quarantine or screening, research efforts, global coordination and anticipation of economic impact [and] support to vulnerable states,” Dr. Houssin said during the press conference. “Declaring a PHEIC should certainly not be seen as manifestation of distrust in the Chinese authorities and people which are doing tremendous efforts on the frontlines of this outbreak, with transparency, and let us hope, with success.”
 

What happens next?

Once a PHEIC is declared, WHO launches a series of steps, including the release of temporary recommendations for the affected country on health measures to implement and guidance for other countries on preventing and reducing the international spread of the disease, WHO spokesman Tarik Jasarevic said in an interview.

“The purpose of declaring a PHEIC is to advise the world on what measures need to be taken to enhance global health security by preventing international transmission of an infectious hazard,” he said.

Following the Jan. 30 press conference, WHO released temporary guidance for China and for other countries regarding identifying, managing, containing, and preventing the virus. China is advised to continue updating the population about the outbreak, continue enhancing its public health measures for containment and surveillance of cases, and to continue collaboration with WHO and other partners to investigate the epidemiology and evolution of the outbreak and share data on all human cases.

Other countries should be prepared for containment, including the active surveillance, early detection, isolation, case management, and prevention of virus transmission and to share full data with WHO, according to the recommendations.

Under the International Health Regulations (IHR), countries are required to share information and data with WHO. Additionally, WHO leaders advised the global community to support low- and middle-income countries with their response to the coronavirus and to facilitate diagnostics, potential vaccines, and therapeutics in these areas.

The IHR requires that countries implementing health measures that go beyond what WHO recommends must send to WHO the public health rationale and justification within 48 hours of their implementation for WHO review, Mr. Jasarevic noted.

“WHO is obliged to share the information about measures and the justification received with other countries involved,” he said.
 

PHEIC travel and resource impact

Declaration of a PHEIC means WHO will now oversee any travel restrictions made by other countries in response to 2019-nCoV. The agency recommends that countries conduct a risk and cost-benefit analysis before enacting travel restrictions and other countries are required to inform WHO about any travel measures taken.

“Countries will be asked to provide public health justification for any travel or trade measures that are not scientifically based, such as refusal of entry of suspect cases or unaffected persons to affected areas,” Mr. Jasarevic said in an interview.

As far as resources, the PHEIC mechanism is not a fundraising mechanism, but some donors might consider a PHEIC declaration as a trigger for releasing additional funding to respond to the health threat, he said.

Allison T. Chamberlain, PhD, acting director for the Emory Center for Public Health Preparedness and Research at the Emory Rollins School of Public Health in Atlanta, said national governments and nongovernmental aid organizations are among the most affected by a PHEIC because they are looked at to provide assistance to the most heavily affected areas and to bolster public health preparedness within their own borders.

“In terms of resources that are deployed, a Public Health Emergency of International Concern raises levels of international support and commitment to stopping the emergency,” Dr. Chamberlain said in an interview. “By doing so, it gives countries the needed flexibility to release financial resources of their own accord to support things like response teams that might go into heavily affected areas to assist, for instance.”

WHO Director-General Dr. Tedros Adhanom Ghebreyesus stressed that cooperation among countries is key during the PHEIC.

“We can only stop it together,” he said during the press conference. “This is the time for facts, not fear. This is the time for science, not rumors. This is the time for solidarity, not stigma.”

This is the sixth PHEIC declared by WHO in the last 10 years. Such declarations were made for the 2009 H1NI influenza pandemic, the 2014 polio resurgence, the 2014 Ebola outbreak in West Africa, the 2016 Zika virus, and the 2019 Kivu Ebola outbreak in the Democratic Republic of Congo.

[email protected]

Amid the rising spread of the 2019 Novel Coronavirus (2019-nCoV), the World Health Organization (WHO) has declared the virus outbreak a public health emergency of international concern (PHEIC).

WHO.int

The declaration was made during a press briefing on Jan. 30 after a week of growing concern and pressure on WHO to designate the virus at a higher emergency level. WHO’s Emergency Committee made the nearly unanimous decision after considering the increasing number of coronavirus cases in China, the rising infections outside of China, and the questionable measures some countries are taking regarding travel, said committee chair Didier Houssin, MD, said during the press conference.

As of Jan. 30, there were 8,236 confirmed cases of the coronavirus in China and 171 deaths, with another 112 cases identified outside of China in 21 other countries.

“Declaring a Public Health Emergency of International Concern is likely to facilitate [WHO’s] leadership role for public health measures, holding countries to account concerning additional measures they may take regarding travel, trade, quarantine or screening, research efforts, global coordination and anticipation of economic impact [and] support to vulnerable states,” Dr. Houssin said during the press conference. “Declaring a PHEIC should certainly not be seen as manifestation of distrust in the Chinese authorities and people which are doing tremendous efforts on the frontlines of this outbreak, with transparency, and let us hope, with success.”
 

What happens next?

Once a PHEIC is declared, WHO launches a series of steps, including the release of temporary recommendations for the affected country on health measures to implement and guidance for other countries on preventing and reducing the international spread of the disease, WHO spokesman Tarik Jasarevic said in an interview.

“The purpose of declaring a PHEIC is to advise the world on what measures need to be taken to enhance global health security by preventing international transmission of an infectious hazard,” he said.

Following the Jan. 30 press conference, WHO released temporary guidance for China and for other countries regarding identifying, managing, containing, and preventing the virus. China is advised to continue updating the population about the outbreak, continue enhancing its public health measures for containment and surveillance of cases, and to continue collaboration with WHO and other partners to investigate the epidemiology and evolution of the outbreak and share data on all human cases.

Other countries should be prepared for containment, including the active surveillance, early detection, isolation, case management, and prevention of virus transmission and to share full data with WHO, according to the recommendations.

Under the International Health Regulations (IHR), countries are required to share information and data with WHO. Additionally, WHO leaders advised the global community to support low- and middle-income countries with their response to the coronavirus and to facilitate diagnostics, potential vaccines, and therapeutics in these areas.

The IHR requires that countries implementing health measures that go beyond what WHO recommends must send to WHO the public health rationale and justification within 48 hours of their implementation for WHO review, Mr. Jasarevic noted.

“WHO is obliged to share the information about measures and the justification received with other countries involved,” he said.
 

PHEIC travel and resource impact

Declaration of a PHEIC means WHO will now oversee any travel restrictions made by other countries in response to 2019-nCoV. The agency recommends that countries conduct a risk and cost-benefit analysis before enacting travel restrictions and other countries are required to inform WHO about any travel measures taken.

“Countries will be asked to provide public health justification for any travel or trade measures that are not scientifically based, such as refusal of entry of suspect cases or unaffected persons to affected areas,” Mr. Jasarevic said in an interview.

As far as resources, the PHEIC mechanism is not a fundraising mechanism, but some donors might consider a PHEIC declaration as a trigger for releasing additional funding to respond to the health threat, he said.

Allison T. Chamberlain, PhD, acting director for the Emory Center for Public Health Preparedness and Research at the Emory Rollins School of Public Health in Atlanta, said national governments and nongovernmental aid organizations are among the most affected by a PHEIC because they are looked at to provide assistance to the most heavily affected areas and to bolster public health preparedness within their own borders.

“In terms of resources that are deployed, a Public Health Emergency of International Concern raises levels of international support and commitment to stopping the emergency,” Dr. Chamberlain said in an interview. “By doing so, it gives countries the needed flexibility to release financial resources of their own accord to support things like response teams that might go into heavily affected areas to assist, for instance.”

WHO Director-General Dr. Tedros Adhanom Ghebreyesus stressed that cooperation among countries is key during the PHEIC.

“We can only stop it together,” he said during the press conference. “This is the time for facts, not fear. This is the time for science, not rumors. This is the time for solidarity, not stigma.”

This is the sixth PHEIC declared by WHO in the last 10 years. Such declarations were made for the 2009 H1NI influenza pandemic, the 2014 polio resurgence, the 2014 Ebola outbreak in West Africa, the 2016 Zika virus, and the 2019 Kivu Ebola outbreak in the Democratic Republic of Congo.

[email protected]

Amid the rising spread of the 2019 Novel Coronavirus (2019-nCoV), the World Health Organization (WHO) has declared the virus outbreak a public health emergency of international concern (PHEIC).

WHO.int

The declaration was made during a press briefing on Jan. 30 after a week of growing concern and pressure on WHO to designate the virus at a higher emergency level. WHO’s Emergency Committee made the nearly unanimous decision after considering the increasing number of coronavirus cases in China, the rising infections outside of China, and the questionable measures some countries are taking regarding travel, said committee chair Didier Houssin, MD, said during the press conference.

As of Jan. 30, there were 8,236 confirmed cases of the coronavirus in China and 171 deaths, with another 112 cases identified outside of China in 21 other countries.

“Declaring a Public Health Emergency of International Concern is likely to facilitate [WHO’s] leadership role for public health measures, holding countries to account concerning additional measures they may take regarding travel, trade, quarantine or screening, research efforts, global coordination and anticipation of economic impact [and] support to vulnerable states,” Dr. Houssin said during the press conference. “Declaring a PHEIC should certainly not be seen as manifestation of distrust in the Chinese authorities and people which are doing tremendous efforts on the frontlines of this outbreak, with transparency, and let us hope, with success.”
 

What happens next?

Once a PHEIC is declared, WHO launches a series of steps, including the release of temporary recommendations for the affected country on health measures to implement and guidance for other countries on preventing and reducing the international spread of the disease, WHO spokesman Tarik Jasarevic said in an interview.

“The purpose of declaring a PHEIC is to advise the world on what measures need to be taken to enhance global health security by preventing international transmission of an infectious hazard,” he said.

Following the Jan. 30 press conference, WHO released temporary guidance for China and for other countries regarding identifying, managing, containing, and preventing the virus. China is advised to continue updating the population about the outbreak, continue enhancing its public health measures for containment and surveillance of cases, and to continue collaboration with WHO and other partners to investigate the epidemiology and evolution of the outbreak and share data on all human cases.

Other countries should be prepared for containment, including the active surveillance, early detection, isolation, case management, and prevention of virus transmission and to share full data with WHO, according to the recommendations.

Under the International Health Regulations (IHR), countries are required to share information and data with WHO. Additionally, WHO leaders advised the global community to support low- and middle-income countries with their response to the coronavirus and to facilitate diagnostics, potential vaccines, and therapeutics in these areas.

The IHR requires that countries implementing health measures that go beyond what WHO recommends must send to WHO the public health rationale and justification within 48 hours of their implementation for WHO review, Mr. Jasarevic noted.

“WHO is obliged to share the information about measures and the justification received with other countries involved,” he said.
 

PHEIC travel and resource impact

Declaration of a PHEIC means WHO will now oversee any travel restrictions made by other countries in response to 2019-nCoV. The agency recommends that countries conduct a risk and cost-benefit analysis before enacting travel restrictions and other countries are required to inform WHO about any travel measures taken.

“Countries will be asked to provide public health justification for any travel or trade measures that are not scientifically based, such as refusal of entry of suspect cases or unaffected persons to affected areas,” Mr. Jasarevic said in an interview.

As far as resources, the PHEIC mechanism is not a fundraising mechanism, but some donors might consider a PHEIC declaration as a trigger for releasing additional funding to respond to the health threat, he said.

Allison T. Chamberlain, PhD, acting director for the Emory Center for Public Health Preparedness and Research at the Emory Rollins School of Public Health in Atlanta, said national governments and nongovernmental aid organizations are among the most affected by a PHEIC because they are looked at to provide assistance to the most heavily affected areas and to bolster public health preparedness within their own borders.

“In terms of resources that are deployed, a Public Health Emergency of International Concern raises levels of international support and commitment to stopping the emergency,” Dr. Chamberlain said in an interview. “By doing so, it gives countries the needed flexibility to release financial resources of their own accord to support things like response teams that might go into heavily affected areas to assist, for instance.”

WHO Director-General Dr. Tedros Adhanom Ghebreyesus stressed that cooperation among countries is key during the PHEIC.

“We can only stop it together,” he said during the press conference. “This is the time for facts, not fear. This is the time for science, not rumors. This is the time for solidarity, not stigma.”

This is the sixth PHEIC declared by WHO in the last 10 years. Such declarations were made for the 2009 H1NI influenza pandemic, the 2014 polio resurgence, the 2014 Ebola outbreak in West Africa, the 2016 Zika virus, and the 2019 Kivu Ebola outbreak in the Democratic Republic of Congo.

[email protected]

The 2019 Novel Coronavirus (2019-nCoV) outbreak has unfolded so rapidly that many clinicians are scrambling to stay on top of it. Here are the answers to some frequently asked questions about how to prepare your clinic to respond to this outbreak.

Keep in mind that the outbreak is moving rapidly. Though scientific and epidemiologic knowledge has increased at unprecedented speed, there is much we don’t know, and some of what we think we know will change. Follow the links for the most up-to-date information.

What should our clinic do first?

Plan ahead with the following:

• Develop a plan for office staff to take travel histories from anyone with a respiratory illness and provide training for those who need it. Travel history at present should include asking about travel to China in the past 14 days, specifically Wuhan city or Hubei province.
• Review up-to-date infection control practices with all office staff and provide training for those who need it.
• Take an inventory of supplies of personal protective equipment (PPE), such as gowns, gloves, masks, eye protection, and N95 respirators or powered air-purifying respirators (PAPRs), and order items that are missing or low in stock.
• Fit-test users of N95 masks for maximal effectiveness.
• Plan where a potential patient would be isolated while obtaining expert advice.
• Know whom to contact at the state or local health department if you have a patient with the appropriate travel history.

The Centers for Disease Control and Prevention has prepared a toolkit to help frontline health care professionals prepare for this virus. Providers need to stay up to date on the latest recommendations, as the situation is changing rapidly.

When should I suspect 2019-nCoV illness, and what should I do?

Take the following steps to assess the concern and respond:

• If a patient with respiratory illness has traveled to China in the past 14 days, immediately put a mask on the patient and move the individual to a private room. Use a negative-pressure room if available.
• Put on appropriate PPE (including gloves, gown, eye protection, and mask) for contact, droplet, and airborne precautions. CDC recommends an N95 respirator mask if available, although we don’t know yet if there is true airborne spread.
• Obtain an accurate travel history, including dates and cities. (Tip: Get the correct spelling, as the English spelling of cities in China can cause confusion.)
• If the patient meets the current CDC definition of “person under investigation” or PUI, or if you need guidance on how to proceed, notify infection control (if you are in a facility that has it) and call your state or local health department immediately.
• Contact public health authorities who can help decide whether the patient should be admitted to airborne isolation or monitored at home with appropriate precautions.

What is the definition of a PUI?

The current definition of a PUI is a person who has fever and symptoms of a respiratory infection (cough, shortness of breath) AND who has EITHER been in Wuhan city or Hubei province in the past 14 days OR had close contact with a person either under investigation for 2019-nCoV infection or with confirmed infection. The definition of a PUI will change over time, so check this link.

How can I test for 2019-nCoV?

As of Jan. 30, 2020, testing is by polymerase chain reaction (PCR) and is available in the United States only through the CDC in Atlanta. Testing should soon be available in state health department laboratories. If public health authorities decide that your patient should be tested, they will instruct you on which samples to obtain.

The full sequence of 2019-nCoV has been shared, so some reference laboratories may develop and validate tests, ideally with assistance from CDC. If testing becomes available, make certain that it is a reputable lab that has carefully validated the test.

Should I test for other viruses?

Because the symptoms of 2019-nCoV infection overlap with those of influenza and other respiratory viruses, PCR testing for other viruses should be considered if it will change management (i.e., change the decision to provide influenza antivirals). Use appropriate PPE while collecting specimens, including eye protection. If 2019-nCoV is a consideration, you may want to send the specimen to a hospital lab for testing, where the sample will be processed under a biosafety hood, rather than doing point-of-care testing in the office.

How dangerous is 2019-nCoV?

The current estimated mortality rate is 2%-3%. That is probably an overestimate, as those with severe disease and those who die are more likely to be tested and reported early in an epidemic.

Our current knowledge is based on preliminary reports from hospitalized patients and will probably change. From the speed of spread and a single family cluster, it seems likely that there are milder cases and perhaps asymptomatic infection.

What else do I need to know about coronaviruses?

Coronaviruses are a large and diverse group of viruses, many of which are animal viruses. Before the discovery of the 2019-nCoV, six coronaviruses were known to infect humans. Four of these (HKU1, NL63, OC43, and 229E) predominantly caused mild to moderate upper respiratory illness, and they are thought to be responsible for 10%-30% of colds. They occasionally cause viral pneumonia and can be detected by some commercial multiplex panels.

Two other coronaviruses have caused outbreaks of severe respiratory illness in people: SARS, which emerged in Southern China in 2002, and MERS in the Middle East, in 2012. Unlike SARS, sporadic cases of MERS continue to occur.

The current outbreak is caused by 2019-nCoV, a previously unknown beta coronavirus. It is most closely related (~96%) to a bat virus and shares about 80% sequence homology with SARS CoV.

Andrew T. Pavia, MD, is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious disease in the department of pediatrics at the University of Utah, Salt Lake City. He is also director of hospital epidemiology and associate director of antimicrobial stewardship at Primary Children’s Hospital, Salt Lake City. Dr. Pavia has disclosed that he has served as a consultant for Genentech, Merck, and Seqirus and that he has served as associate editor for The Sanford Guide.

This article first appeared on Medscape.com.

The 2019 Novel Coronavirus (2019-nCoV) outbreak has unfolded so rapidly that many clinicians are scrambling to stay on top of it. Here are the answers to some frequently asked questions about how to prepare your clinic to respond to this outbreak.

Keep in mind that the outbreak is moving rapidly. Though scientific and epidemiologic knowledge has increased at unprecedented speed, there is much we don’t know, and some of what we think we know will change. Follow the links for the most up-to-date information.

What should our clinic do first?

Plan ahead with the following:

• Develop a plan for office staff to take travel histories from anyone with a respiratory illness and provide training for those who need it. Travel history at present should include asking about travel to China in the past 14 days, specifically Wuhan city or Hubei province.
• Review up-to-date infection control practices with all office staff and provide training for those who need it.
• Take an inventory of supplies of personal protective equipment (PPE), such as gowns, gloves, masks, eye protection, and N95 respirators or powered air-purifying respirators (PAPRs), and order items that are missing or low in stock.
• Fit-test users of N95 masks for maximal effectiveness.
• Plan where a potential patient would be isolated while obtaining expert advice.
• Know whom to contact at the state or local health department if you have a patient with the appropriate travel history.

The Centers for Disease Control and Prevention has prepared a toolkit to help frontline health care professionals prepare for this virus. Providers need to stay up to date on the latest recommendations, as the situation is changing rapidly.

When should I suspect 2019-nCoV illness, and what should I do?

Take the following steps to assess the concern and respond:

• If a patient with respiratory illness has traveled to China in the past 14 days, immediately put a mask on the patient and move the individual to a private room. Use a negative-pressure room if available.
• Put on appropriate PPE (including gloves, gown, eye protection, and mask) for contact, droplet, and airborne precautions. CDC recommends an N95 respirator mask if available, although we don’t know yet if there is true airborne spread.
• Obtain an accurate travel history, including dates and cities. (Tip: Get the correct spelling, as the English spelling of cities in China can cause confusion.)
• If the patient meets the current CDC definition of “person under investigation” or PUI, or if you need guidance on how to proceed, notify infection control (if you are in a facility that has it) and call your state or local health department immediately.
• Contact public health authorities who can help decide whether the patient should be admitted to airborne isolation or monitored at home with appropriate precautions.

What is the definition of a PUI?

The current definition of a PUI is a person who has fever and symptoms of a respiratory infection (cough, shortness of breath) AND who has EITHER been in Wuhan city or Hubei province in the past 14 days OR had close contact with a person either under investigation for 2019-nCoV infection or with confirmed infection. The definition of a PUI will change over time, so check this link.

How can I test for 2019-nCoV?

As of Jan. 30, 2020, testing is by polymerase chain reaction (PCR) and is available in the United States only through the CDC in Atlanta. Testing should soon be available in state health department laboratories. If public health authorities decide that your patient should be tested, they will instruct you on which samples to obtain.

The full sequence of 2019-nCoV has been shared, so some reference laboratories may develop and validate tests, ideally with assistance from CDC. If testing becomes available, make certain that it is a reputable lab that has carefully validated the test.

Should I test for other viruses?

Because the symptoms of 2019-nCoV infection overlap with those of influenza and other respiratory viruses, PCR testing for other viruses should be considered if it will change management (i.e., change the decision to provide influenza antivirals). Use appropriate PPE while collecting specimens, including eye protection. If 2019-nCoV is a consideration, you may want to send the specimen to a hospital lab for testing, where the sample will be processed under a biosafety hood, rather than doing point-of-care testing in the office.

How dangerous is 2019-nCoV?

The current estimated mortality rate is 2%-3%. That is probably an overestimate, as those with severe disease and those who die are more likely to be tested and reported early in an epidemic.

Our current knowledge is based on preliminary reports from hospitalized patients and will probably change. From the speed of spread and a single family cluster, it seems likely that there are milder cases and perhaps asymptomatic infection.

What else do I need to know about coronaviruses?

Coronaviruses are a large and diverse group of viruses, many of which are animal viruses. Before the discovery of the 2019-nCoV, six coronaviruses were known to infect humans. Four of these (HKU1, NL63, OC43, and 229E) predominantly caused mild to moderate upper respiratory illness, and they are thought to be responsible for 10%-30% of colds. They occasionally cause viral pneumonia and can be detected by some commercial multiplex panels.

Two other coronaviruses have caused outbreaks of severe respiratory illness in people: SARS, which emerged in Southern China in 2002, and MERS in the Middle East, in 2012. Unlike SARS, sporadic cases of MERS continue to occur.

The current outbreak is caused by 2019-nCoV, a previously unknown beta coronavirus. It is most closely related (~96%) to a bat virus and shares about 80% sequence homology with SARS CoV.

Andrew T. Pavia, MD, is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious disease in the department of pediatrics at the University of Utah, Salt Lake City. He is also director of hospital epidemiology and associate director of antimicrobial stewardship at Primary Children’s Hospital, Salt Lake City. Dr. Pavia has disclosed that he has served as a consultant for Genentech, Merck, and Seqirus and that he has served as associate editor for The Sanford Guide.

This article first appeared on Medscape.com.

The 2019 Novel Coronavirus (2019-nCoV) outbreak has unfolded so rapidly that many clinicians are scrambling to stay on top of it. Here are the answers to some frequently asked questions about how to prepare your clinic to respond to this outbreak.

Keep in mind that the outbreak is moving rapidly. Though scientific and epidemiologic knowledge has increased at unprecedented speed, there is much we don’t know, and some of what we think we know will change. Follow the links for the most up-to-date information.

What should our clinic do first?

Plan ahead with the following:

• Develop a plan for office staff to take travel histories from anyone with a respiratory illness and provide training for those who need it. Travel history at present should include asking about travel to China in the past 14 days, specifically Wuhan city or Hubei province.
• Review up-to-date infection control practices with all office staff and provide training for those who need it.
• Take an inventory of supplies of personal protective equipment (PPE), such as gowns, gloves, masks, eye protection, and N95 respirators or powered air-purifying respirators (PAPRs), and order items that are missing or low in stock.
• Fit-test users of N95 masks for maximal effectiveness.
• Plan where a potential patient would be isolated while obtaining expert advice.
• Know whom to contact at the state or local health department if you have a patient with the appropriate travel history.

The Centers for Disease Control and Prevention has prepared a toolkit to help frontline health care professionals prepare for this virus. Providers need to stay up to date on the latest recommendations, as the situation is changing rapidly.

When should I suspect 2019-nCoV illness, and what should I do?

Take the following steps to assess the concern and respond:

• If a patient with respiratory illness has traveled to China in the past 14 days, immediately put a mask on the patient and move the individual to a private room. Use a negative-pressure room if available.
• Put on appropriate PPE (including gloves, gown, eye protection, and mask) for contact, droplet, and airborne precautions. CDC recommends an N95 respirator mask if available, although we don’t know yet if there is true airborne spread.
• Obtain an accurate travel history, including dates and cities. (Tip: Get the correct spelling, as the English spelling of cities in China can cause confusion.)
• If the patient meets the current CDC definition of “person under investigation” or PUI, or if you need guidance on how to proceed, notify infection control (if you are in a facility that has it) and call your state or local health department immediately.
• Contact public health authorities who can help decide whether the patient should be admitted to airborne isolation or monitored at home with appropriate precautions.

What is the definition of a PUI?

The current definition of a PUI is a person who has fever and symptoms of a respiratory infection (cough, shortness of breath) AND who has EITHER been in Wuhan city or Hubei province in the past 14 days OR had close contact with a person either under investigation for 2019-nCoV infection or with confirmed infection. The definition of a PUI will change over time, so check this link.

How can I test for 2019-nCoV?

As of Jan. 30, 2020, testing is by polymerase chain reaction (PCR) and is available in the United States only through the CDC in Atlanta. Testing should soon be available in state health department laboratories. If public health authorities decide that your patient should be tested, they will instruct you on which samples to obtain.

The full sequence of 2019-nCoV has been shared, so some reference laboratories may develop and validate tests, ideally with assistance from CDC. If testing becomes available, make certain that it is a reputable lab that has carefully validated the test.

Should I test for other viruses?

Because the symptoms of 2019-nCoV infection overlap with those of influenza and other respiratory viruses, PCR testing for other viruses should be considered if it will change management (i.e., change the decision to provide influenza antivirals). Use appropriate PPE while collecting specimens, including eye protection. If 2019-nCoV is a consideration, you may want to send the specimen to a hospital lab for testing, where the sample will be processed under a biosafety hood, rather than doing point-of-care testing in the office.

How dangerous is 2019-nCoV?

The current estimated mortality rate is 2%-3%. That is probably an overestimate, as those with severe disease and those who die are more likely to be tested and reported early in an epidemic.

Our current knowledge is based on preliminary reports from hospitalized patients and will probably change. From the speed of spread and a single family cluster, it seems likely that there are milder cases and perhaps asymptomatic infection.

What else do I need to know about coronaviruses?

Coronaviruses are a large and diverse group of viruses, many of which are animal viruses. Before the discovery of the 2019-nCoV, six coronaviruses were known to infect humans. Four of these (HKU1, NL63, OC43, and 229E) predominantly caused mild to moderate upper respiratory illness, and they are thought to be responsible for 10%-30% of colds. They occasionally cause viral pneumonia and can be detected by some commercial multiplex panels.

Two other coronaviruses have caused outbreaks of severe respiratory illness in people: SARS, which emerged in Southern China in 2002, and MERS in the Middle East, in 2012. Unlike SARS, sporadic cases of MERS continue to occur.

The current outbreak is caused by 2019-nCoV, a previously unknown beta coronavirus. It is most closely related (~96%) to a bat virus and shares about 80% sequence homology with SARS CoV.

Andrew T. Pavia, MD, is the George and Esther Gross Presidential Professor and chief of the division of pediatric infectious disease in the department of pediatrics at the University of Utah, Salt Lake City. He is also director of hospital epidemiology and associate director of antimicrobial stewardship at Primary Children’s Hospital, Salt Lake City. Dr. Pavia has disclosed that he has served as a consultant for Genentech, Merck, and Seqirus and that he has served as associate editor for The Sanford Guide.

This article first appeared on Medscape.com.

A Chicago woman in her 60s who tested positive for the 2019 Novel Coronavirus (2019-nCoV) after returning from Wuhan, China, earlier this month has infected her husband, becoming the first known instance of person-to-person transmission of the 2019-nCoV in the United States.

James Gathany/Centers for Disease Control and Prevention

“Limited person-to-person spread of this new virus outside of China has already been seen in nine close contacts, where travelers were infected and transmitted the virus to someone else,” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during a press briefing on Jan. 30, 2020. “However, the full picture of how easy and how sustainable this virus can spread is unclear. Today’s news underscores the important risk-dependent exposure. The vast majority of Americans have not had recent travel to China, where sustained human-to-human transmission is occurring. Individuals who are close personal contacts of cases, though, could have a risk.”

The affected man, also in his 60s, is the spouse of the first confirmed travel-associated case of 2019-nCoV to be reported in the state of Illinois, according to Ngozi O. Ezike, MD, director of the Illinois Department of Public Health. The man had no history of recent travel to China. “This person-to-person spread was between two very close contacts: a wife and husband,” said Dr. Ezike, who added that 21 individuals in the state are under investigation for 2019-nCoV. “The virus is not spreading widely across the community. At this time, we are not recommending that people in the general public take additional precautions such as canceling activities or avoiding going out. While there is concern with this second case, public health officials are actively monitoring close contacts, including health care workers, and we believe that people in Illinois are at low risk.”

Jennifer Layden, MD, state epidemiologist at the Illinois Department of Public Health, said that the infected Chicago woman returned from Wuhan, China on Jan. 13, 2020. She is hospitalized in stable condition “and continues to do well,” Dr. Layden said. “Public health officials have been actively and closely monitoring individuals who had contacts with her, including her husband, who had close contact for symptoms. He recently began reporting symptoms and was immediately admitted to the hospital and placed in an isolation room, where he is in stable condition. We are actively monitoring individuals such as health care workers, household contacts, and others who were in contact with either of the confirmed cases in the goal to contain and reduce the risk of additional transmission.”

Nancy Messonnier, MD, director, National Center for Immunization and Respiratory Diseases, expects that more cases of 2019-nCoV will transpire in the United States.

“More cases means the potential for more person-to-person spread,” Dr. Messonnier said. “We’re trying to strike a balance in our response right now. We want to be aggressive, but we want our actions to be evidence-based and appropriate for the current circumstance. For example, CDC does not currently recommend use of face masks for the general public. The virus is not spreading in the general community.”

[email protected]

A Chicago woman in her 60s who tested positive for the 2019 Novel Coronavirus (2019-nCoV) after returning from Wuhan, China, earlier this month has infected her husband, becoming the first known instance of person-to-person transmission of the 2019-nCoV in the United States.

James Gathany/Centers for Disease Control and Prevention

“Limited person-to-person spread of this new virus outside of China has already been seen in nine close contacts, where travelers were infected and transmitted the virus to someone else,” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during a press briefing on Jan. 30, 2020. “However, the full picture of how easy and how sustainable this virus can spread is unclear. Today’s news underscores the important risk-dependent exposure. The vast majority of Americans have not had recent travel to China, where sustained human-to-human transmission is occurring. Individuals who are close personal contacts of cases, though, could have a risk.”

The affected man, also in his 60s, is the spouse of the first confirmed travel-associated case of 2019-nCoV to be reported in the state of Illinois, according to Ngozi O. Ezike, MD, director of the Illinois Department of Public Health. The man had no history of recent travel to China. “This person-to-person spread was between two very close contacts: a wife and husband,” said Dr. Ezike, who added that 21 individuals in the state are under investigation for 2019-nCoV. “The virus is not spreading widely across the community. At this time, we are not recommending that people in the general public take additional precautions such as canceling activities or avoiding going out. While there is concern with this second case, public health officials are actively monitoring close contacts, including health care workers, and we believe that people in Illinois are at low risk.”

Jennifer Layden, MD, state epidemiologist at the Illinois Department of Public Health, said that the infected Chicago woman returned from Wuhan, China on Jan. 13, 2020. She is hospitalized in stable condition “and continues to do well,” Dr. Layden said. “Public health officials have been actively and closely monitoring individuals who had contacts with her, including her husband, who had close contact for symptoms. He recently began reporting symptoms and was immediately admitted to the hospital and placed in an isolation room, where he is in stable condition. We are actively monitoring individuals such as health care workers, household contacts, and others who were in contact with either of the confirmed cases in the goal to contain and reduce the risk of additional transmission.”

Nancy Messonnier, MD, director, National Center for Immunization and Respiratory Diseases, expects that more cases of 2019-nCoV will transpire in the United States.

“More cases means the potential for more person-to-person spread,” Dr. Messonnier said. “We’re trying to strike a balance in our response right now. We want to be aggressive, but we want our actions to be evidence-based and appropriate for the current circumstance. For example, CDC does not currently recommend use of face masks for the general public. The virus is not spreading in the general community.”

[email protected]

A Chicago woman in her 60s who tested positive for the 2019 Novel Coronavirus (2019-nCoV) after returning from Wuhan, China, earlier this month has infected her husband, becoming the first known instance of person-to-person transmission of the 2019-nCoV in the United States.

James Gathany/Centers for Disease Control and Prevention

“Limited person-to-person spread of this new virus outside of China has already been seen in nine close contacts, where travelers were infected and transmitted the virus to someone else,” Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, said during a press briefing on Jan. 30, 2020. “However, the full picture of how easy and how sustainable this virus can spread is unclear. Today’s news underscores the important risk-dependent exposure. The vast majority of Americans have not had recent travel to China, where sustained human-to-human transmission is occurring. Individuals who are close personal contacts of cases, though, could have a risk.”

The affected man, also in his 60s, is the spouse of the first confirmed travel-associated case of 2019-nCoV to be reported in the state of Illinois, according to Ngozi O. Ezike, MD, director of the Illinois Department of Public Health. The man had no history of recent travel to China. “This person-to-person spread was between two very close contacts: a wife and husband,” said Dr. Ezike, who added that 21 individuals in the state are under investigation for 2019-nCoV. “The virus is not spreading widely across the community. At this time, we are not recommending that people in the general public take additional precautions such as canceling activities or avoiding going out. While there is concern with this second case, public health officials are actively monitoring close contacts, including health care workers, and we believe that people in Illinois are at low risk.”

Jennifer Layden, MD, state epidemiologist at the Illinois Department of Public Health, said that the infected Chicago woman returned from Wuhan, China on Jan. 13, 2020. She is hospitalized in stable condition “and continues to do well,” Dr. Layden said. “Public health officials have been actively and closely monitoring individuals who had contacts with her, including her husband, who had close contact for symptoms. He recently began reporting symptoms and was immediately admitted to the hospital and placed in an isolation room, where he is in stable condition. We are actively monitoring individuals such as health care workers, household contacts, and others who were in contact with either of the confirmed cases in the goal to contain and reduce the risk of additional transmission.”

Nancy Messonnier, MD, director, National Center for Immunization and Respiratory Diseases, expects that more cases of 2019-nCoV will transpire in the United States.

“More cases means the potential for more person-to-person spread,” Dr. Messonnier said. “We’re trying to strike a balance in our response right now. We want to be aggressive, but we want our actions to be evidence-based and appropriate for the current circumstance. For example, CDC does not currently recommend use of face masks for the general public. The virus is not spreading in the general community.”

[email protected]

The presence of occult hepatitis C virus infection is determined by finding HCV RNA in the liver and peripheral blood mononuclear cells, with no HCV RNA in the serum. Researchers have shown that the presence of occult HCV infection (OCI) was correlated with unfavorable polymorphisms near interferon lambda-3/4 (IFNL3/4), which has been associated with spontaneous HCV clearance.

This study was conducted to assess the frequency of OCI in 450 hemophilia patients in Iran with negative HCV markers, and to evaluate the association of three IFNL3 single nucleotide polymorphisms (rs8099917, rs12979860, and rs12980275) and the IFNL4 ss469415590 SNP with OCI positivity.

The estimated OCI rate was 10.2%. Among the 46 OCI patients, 56.5%, 23.9%, and 19.6% were infected with HCV-1b, HCV-1a, and HCV-3a, respectively. The researchers found that, compared with patients without OCI, unfavorable IFNL3 rs12979860, IFNL3 rs8099917, IFNL3 rs12980275, and IFNL4 ss469415590 genotypes were more frequently found in OCI patients. Multivariate analysis showed that ALT, cholesterol, triglyceride, as well as the aforementioned unfavorable interferon SNP geneotypes were associated with OCI positivity.

“10.2% of anti-HCV seronegative Iranian patients with hemophilia had OCI in our study; therefore, risk of this infection should be taken into consideration. We also showed that patients with unfavorable IFNL3 SNPs and IFNL4 ss469415590 genotypes were exposed to a higher risk of OCI, compared to hemophilia patients with other genotypes,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Nafari AH et al. Infect Genet Evol. 2019 Dec 13. doi: 10.1016/j.meegid.2019.104144.

The presence of occult hepatitis C virus infection is determined by finding HCV RNA in the liver and peripheral blood mononuclear cells, with no HCV RNA in the serum. Researchers have shown that the presence of occult HCV infection (OCI) was correlated with unfavorable polymorphisms near interferon lambda-3/4 (IFNL3/4), which has been associated with spontaneous HCV clearance.

This study was conducted to assess the frequency of OCI in 450 hemophilia patients in Iran with negative HCV markers, and to evaluate the association of three IFNL3 single nucleotide polymorphisms (rs8099917, rs12979860, and rs12980275) and the IFNL4 ss469415590 SNP with OCI positivity.

The estimated OCI rate was 10.2%. Among the 46 OCI patients, 56.5%, 23.9%, and 19.6% were infected with HCV-1b, HCV-1a, and HCV-3a, respectively. The researchers found that, compared with patients without OCI, unfavorable IFNL3 rs12979860, IFNL3 rs8099917, IFNL3 rs12980275, and IFNL4 ss469415590 genotypes were more frequently found in OCI patients. Multivariate analysis showed that ALT, cholesterol, triglyceride, as well as the aforementioned unfavorable interferon SNP geneotypes were associated with OCI positivity.

“10.2% of anti-HCV seronegative Iranian patients with hemophilia had OCI in our study; therefore, risk of this infection should be taken into consideration. We also showed that patients with unfavorable IFNL3 SNPs and IFNL4 ss469415590 genotypes were exposed to a higher risk of OCI, compared to hemophilia patients with other genotypes,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Nafari AH et al. Infect Genet Evol. 2019 Dec 13. doi: 10.1016/j.meegid.2019.104144.

The presence of occult hepatitis C virus infection is determined by finding HCV RNA in the liver and peripheral blood mononuclear cells, with no HCV RNA in the serum. Researchers have shown that the presence of occult HCV infection (OCI) was correlated with unfavorable polymorphisms near interferon lambda-3/4 (IFNL3/4), which has been associated with spontaneous HCV clearance.

This study was conducted to assess the frequency of OCI in 450 hemophilia patients in Iran with negative HCV markers, and to evaluate the association of three IFNL3 single nucleotide polymorphisms (rs8099917, rs12979860, and rs12980275) and the IFNL4 ss469415590 SNP with OCI positivity.

The estimated OCI rate was 10.2%. Among the 46 OCI patients, 56.5%, 23.9%, and 19.6% were infected with HCV-1b, HCV-1a, and HCV-3a, respectively. The researchers found that, compared with patients without OCI, unfavorable IFNL3 rs12979860, IFNL3 rs8099917, IFNL3 rs12980275, and IFNL4 ss469415590 genotypes were more frequently found in OCI patients. Multivariate analysis showed that ALT, cholesterol, triglyceride, as well as the aforementioned unfavorable interferon SNP geneotypes were associated with OCI positivity.

“10.2% of anti-HCV seronegative Iranian patients with hemophilia had OCI in our study; therefore, risk of this infection should be taken into consideration. We also showed that patients with unfavorable IFNL3 SNPs and IFNL4 ss469415590 genotypes were exposed to a higher risk of OCI, compared to hemophilia patients with other genotypes,” the researchers concluded.

The authors reported that they had no disclosures.

[email protected]

SOURCE: Nafari AH et al. Infect Genet Evol. 2019 Dec 13. doi: 10.1016/j.meegid.2019.104144.