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DAAs reduce mortality, cancer risk in HCV study
Direct-acting antivirals significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C, according to results of the first prospective, longitudinal study to evaluate the effect of the drugs on complications related to the infection.
Compared with no treatment, DAA therapy cut risk of hepatocellular carcinoma by about one-third and all-cause mortality by about half in the study, which included about 10,000 adult patients with chronic hepatitis C virus (HCV) infection treated at 1 of 32 hepatology centers in France (NCT01953458).
There were no signs of increased risk of hepatocellular carcinoma during treatment with DAAs, providing more evidence refuting earlier, single-center reports that had suggested an increased incidence early after treatment. These findings also counterbalance a recent Cochrane review that could not confirm or reject a potential benefit of drugs on long-term morbidity and mortality.
Results of the study, published in the Lancet, are based on analysis of 9,895 patients, including 7,344 who started DAA treatment and 2,551 who remained untreated at a median follow-up of more than 31 months. The median patient age was 56 years, and 53% were men.
Treatment with DAAs reduced risk of hepatocellular carcinoma when compared with no DAA treatment, with a hazard ratio of 0.66 (95% confidence interval, 0.46-0.93), and reduced risk of all-cause mortality, with an HR of 0.48 (95% CI, 0.33-0.70), investigators reported in a multivariable analysis that adjusted for variables including age, sex, fibrosis score, HCV genotype, alcohol use, and more.
“These inverse associations persisted in the subgroup of patients who achieved a sustained virological response, whereas those who did not achieve a sustained virological response were a higher risk for hepatocellular carcinoma,” said the investigators, led by Fabrice Carrat, PhD, of Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris.
Sustained virologic response was observed in 94% of patients who had known response status and sufficient follow-up, investigators said.
In patients with cirrhosis at baseline, DAA treatment had a similarly strong association with reduced hepatocellular carcinoma and mortality, with a sustained virologic response rate of 92% in those for whom sufficient data was available, they said.
There was no evidence for an increased risk of hepatocellular carcinoma on treatment, with an adjusted HR of 0.74 (95% CI, 0.49-1.13; P = 0.17), they added.
“Our results support urgent treatment of patients with advanced liver disease and extension of the follow-up of treated patients with less severe disease to assess the long-term clinical effect of direct-acting antiviral treatment,” Dr. Carrat and colleagues said in a commentary on their results.
However, the long-term effect of DAAs on liver decompensation has yet to be clarified, they added, noting that their study excluded patients with decompensated cirrhosis or a history of hepatocellular carcinoma.
Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to Gilead, AbbVie, Bristol-Myers Squibb, MSD, and Janssen, among others.
SOURCE: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/S0140-6736(18)32111-1
This study provides “substantive evidence” that curing hepatitis C virus with all-oral direct-acting antiviral regimens provides clinical benefits, according to Raymond T. Chung, MD, and his coauthors of a related editorial.
Investigators in this study provide the best evidence so far in support of guidelines that advise direct-acting antiviral (DAA) treatment for all patients with chronic hepatitis C virus (HCV) infection, the editorial’s authors stated.
Results of the French study provide a strong counterpoint to the findings of a recent Cochrane review of DAA trials that could not confirm or reject whether DAAs had effects on long-term morbidity and mortality related to HCV, added Dr. Chung and his coauthors. “Finally, they provide credence to the achievability of the goals set out by the World Health Organization (WHO), not only to eliminate HCV but also to substantially reduce its complications.”
The WHO targets were established in light of earlier evidence that sustained virologic responses are linked to reductions in hepatocellular carcinoma, liver transplantation, and mortality, they said.
“In view of the high sustained virological response and excellent tolerability achieved with DAAs, it seemed highly plausible to envision reductions in chronic HCV infection–related complications with these drugs,” they said in reference to the study by Carrat and colleagues.
This editorial appearing in the Lancet was authored by Jacinta A. Holmes, Stephanie M. Rutledge, and Raymond T. Chung of the Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston. Dr. Chung provided disclosures related to AbbVie, Gilead, Merck, Bristol-Myers Squibb, Roche, Janssen, and Boehringer Ingelheim.
This study provides “substantive evidence” that curing hepatitis C virus with all-oral direct-acting antiviral regimens provides clinical benefits, according to Raymond T. Chung, MD, and his coauthors of a related editorial.
Investigators in this study provide the best evidence so far in support of guidelines that advise direct-acting antiviral (DAA) treatment for all patients with chronic hepatitis C virus (HCV) infection, the editorial’s authors stated.
Results of the French study provide a strong counterpoint to the findings of a recent Cochrane review of DAA trials that could not confirm or reject whether DAAs had effects on long-term morbidity and mortality related to HCV, added Dr. Chung and his coauthors. “Finally, they provide credence to the achievability of the goals set out by the World Health Organization (WHO), not only to eliminate HCV but also to substantially reduce its complications.”
The WHO targets were established in light of earlier evidence that sustained virologic responses are linked to reductions in hepatocellular carcinoma, liver transplantation, and mortality, they said.
“In view of the high sustained virological response and excellent tolerability achieved with DAAs, it seemed highly plausible to envision reductions in chronic HCV infection–related complications with these drugs,” they said in reference to the study by Carrat and colleagues.
This editorial appearing in the Lancet was authored by Jacinta A. Holmes, Stephanie M. Rutledge, and Raymond T. Chung of the Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston. Dr. Chung provided disclosures related to AbbVie, Gilead, Merck, Bristol-Myers Squibb, Roche, Janssen, and Boehringer Ingelheim.
This study provides “substantive evidence” that curing hepatitis C virus with all-oral direct-acting antiviral regimens provides clinical benefits, according to Raymond T. Chung, MD, and his coauthors of a related editorial.
Investigators in this study provide the best evidence so far in support of guidelines that advise direct-acting antiviral (DAA) treatment for all patients with chronic hepatitis C virus (HCV) infection, the editorial’s authors stated.
Results of the French study provide a strong counterpoint to the findings of a recent Cochrane review of DAA trials that could not confirm or reject whether DAAs had effects on long-term morbidity and mortality related to HCV, added Dr. Chung and his coauthors. “Finally, they provide credence to the achievability of the goals set out by the World Health Organization (WHO), not only to eliminate HCV but also to substantially reduce its complications.”
The WHO targets were established in light of earlier evidence that sustained virologic responses are linked to reductions in hepatocellular carcinoma, liver transplantation, and mortality, they said.
“In view of the high sustained virological response and excellent tolerability achieved with DAAs, it seemed highly plausible to envision reductions in chronic HCV infection–related complications with these drugs,” they said in reference to the study by Carrat and colleagues.
This editorial appearing in the Lancet was authored by Jacinta A. Holmes, Stephanie M. Rutledge, and Raymond T. Chung of the Liver Center, Gastrointestinal Division, Massachusetts General Hospital, Boston. Dr. Chung provided disclosures related to AbbVie, Gilead, Merck, Bristol-Myers Squibb, Roche, Janssen, and Boehringer Ingelheim.
Direct-acting antivirals significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C, according to results of the first prospective, longitudinal study to evaluate the effect of the drugs on complications related to the infection.
Compared with no treatment, DAA therapy cut risk of hepatocellular carcinoma by about one-third and all-cause mortality by about half in the study, which included about 10,000 adult patients with chronic hepatitis C virus (HCV) infection treated at 1 of 32 hepatology centers in France (NCT01953458).
There were no signs of increased risk of hepatocellular carcinoma during treatment with DAAs, providing more evidence refuting earlier, single-center reports that had suggested an increased incidence early after treatment. These findings also counterbalance a recent Cochrane review that could not confirm or reject a potential benefit of drugs on long-term morbidity and mortality.
Results of the study, published in the Lancet, are based on analysis of 9,895 patients, including 7,344 who started DAA treatment and 2,551 who remained untreated at a median follow-up of more than 31 months. The median patient age was 56 years, and 53% were men.
Treatment with DAAs reduced risk of hepatocellular carcinoma when compared with no DAA treatment, with a hazard ratio of 0.66 (95% confidence interval, 0.46-0.93), and reduced risk of all-cause mortality, with an HR of 0.48 (95% CI, 0.33-0.70), investigators reported in a multivariable analysis that adjusted for variables including age, sex, fibrosis score, HCV genotype, alcohol use, and more.
“These inverse associations persisted in the subgroup of patients who achieved a sustained virological response, whereas those who did not achieve a sustained virological response were a higher risk for hepatocellular carcinoma,” said the investigators, led by Fabrice Carrat, PhD, of Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris.
Sustained virologic response was observed in 94% of patients who had known response status and sufficient follow-up, investigators said.
In patients with cirrhosis at baseline, DAA treatment had a similarly strong association with reduced hepatocellular carcinoma and mortality, with a sustained virologic response rate of 92% in those for whom sufficient data was available, they said.
There was no evidence for an increased risk of hepatocellular carcinoma on treatment, with an adjusted HR of 0.74 (95% CI, 0.49-1.13; P = 0.17), they added.
“Our results support urgent treatment of patients with advanced liver disease and extension of the follow-up of treated patients with less severe disease to assess the long-term clinical effect of direct-acting antiviral treatment,” Dr. Carrat and colleagues said in a commentary on their results.
However, the long-term effect of DAAs on liver decompensation has yet to be clarified, they added, noting that their study excluded patients with decompensated cirrhosis or a history of hepatocellular carcinoma.
Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to Gilead, AbbVie, Bristol-Myers Squibb, MSD, and Janssen, among others.
SOURCE: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/S0140-6736(18)32111-1
Direct-acting antivirals significantly decrease risk of hepatocellular carcinoma and mortality in persons with hepatitis C, according to results of the first prospective, longitudinal study to evaluate the effect of the drugs on complications related to the infection.
Compared with no treatment, DAA therapy cut risk of hepatocellular carcinoma by about one-third and all-cause mortality by about half in the study, which included about 10,000 adult patients with chronic hepatitis C virus (HCV) infection treated at 1 of 32 hepatology centers in France (NCT01953458).
There were no signs of increased risk of hepatocellular carcinoma during treatment with DAAs, providing more evidence refuting earlier, single-center reports that had suggested an increased incidence early after treatment. These findings also counterbalance a recent Cochrane review that could not confirm or reject a potential benefit of drugs on long-term morbidity and mortality.
Results of the study, published in the Lancet, are based on analysis of 9,895 patients, including 7,344 who started DAA treatment and 2,551 who remained untreated at a median follow-up of more than 31 months. The median patient age was 56 years, and 53% were men.
Treatment with DAAs reduced risk of hepatocellular carcinoma when compared with no DAA treatment, with a hazard ratio of 0.66 (95% confidence interval, 0.46-0.93), and reduced risk of all-cause mortality, with an HR of 0.48 (95% CI, 0.33-0.70), investigators reported in a multivariable analysis that adjusted for variables including age, sex, fibrosis score, HCV genotype, alcohol use, and more.
“These inverse associations persisted in the subgroup of patients who achieved a sustained virological response, whereas those who did not achieve a sustained virological response were a higher risk for hepatocellular carcinoma,” said the investigators, led by Fabrice Carrat, PhD, of Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris.
Sustained virologic response was observed in 94% of patients who had known response status and sufficient follow-up, investigators said.
In patients with cirrhosis at baseline, DAA treatment had a similarly strong association with reduced hepatocellular carcinoma and mortality, with a sustained virologic response rate of 92% in those for whom sufficient data was available, they said.
There was no evidence for an increased risk of hepatocellular carcinoma on treatment, with an adjusted HR of 0.74 (95% CI, 0.49-1.13; P = 0.17), they added.
“Our results support urgent treatment of patients with advanced liver disease and extension of the follow-up of treated patients with less severe disease to assess the long-term clinical effect of direct-acting antiviral treatment,” Dr. Carrat and colleagues said in a commentary on their results.
However, the long-term effect of DAAs on liver decompensation has yet to be clarified, they added, noting that their study excluded patients with decompensated cirrhosis or a history of hepatocellular carcinoma.
Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to Gilead, AbbVie, Bristol-Myers Squibb, MSD, and Janssen, among others.
SOURCE: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/S0140-6736(18)32111-1
FROM THE LANCET
Key clinical point:
Major finding: DAAs reduced risk of hepatocellular carcinoma (HR, 0.66; 95% confidence interval, 0.46-0.93) and all-cause mortality (HR, 0.48; 95% CI, 0.33-0.70).
Study details: A prospective study including about 10,000 adults with chronic HCV infection enrolled at 1 of 32 centers in France.
Disclosures: Funding for the study came from INSERM, Agence Nationale de la Recherche, DGS (Direction Générale de la Santé), MSD, Janssen, Gilead, AbbVie, Bristol-Myers Squibb, and Roche. Dr. Carrat reported personal fees from Imaxio not related to the present study. Coauthors provided additional disclosures related to the study pharma sponsors among others.
Source: Carrat F et al. Lancet. 2019 Feb 11. doi: 10.1016/20S0140-6736(18)32111-1.
United States now over 100 measles cases for the year
according to the Centers for Disease Control and Prevention.
Just over half of the cases in 2019 have occurred in Clark County, Wash., which has reported 53 cases. That outbreak led Gov. Jay Inslee to declare a public health emergency for the entire state on Jan. 25.
The cases in Washington represent one of the five outbreaks – the CDC defines an outbreak as three or more cases – that have occurred so far this year, with three reported in New York State (Rockland County, Monroe County, and New York City) and one in Texas, which has been spread out over five counties, the CDC reported Feb. 11.
“These outbreaks are linked to travelers who brought measles back from other countries such as Israel and Ukraine, where large measles outbreaks are occurring,” the CDC noted. The other states with confirmed cases are California, Colorado, Connecticut, Georgia, Illinois, New Jersey, and Oregon.
In a video released Feb. 1, Surgeon General Jerome Adams stressed the importance of getting vaccinated and noted that an infected person can transmit the measles virus up to 4 days before he or she develops symptoms.
according to the Centers for Disease Control and Prevention.
Just over half of the cases in 2019 have occurred in Clark County, Wash., which has reported 53 cases. That outbreak led Gov. Jay Inslee to declare a public health emergency for the entire state on Jan. 25.
The cases in Washington represent one of the five outbreaks – the CDC defines an outbreak as three or more cases – that have occurred so far this year, with three reported in New York State (Rockland County, Monroe County, and New York City) and one in Texas, which has been spread out over five counties, the CDC reported Feb. 11.
“These outbreaks are linked to travelers who brought measles back from other countries such as Israel and Ukraine, where large measles outbreaks are occurring,” the CDC noted. The other states with confirmed cases are California, Colorado, Connecticut, Georgia, Illinois, New Jersey, and Oregon.
In a video released Feb. 1, Surgeon General Jerome Adams stressed the importance of getting vaccinated and noted that an infected person can transmit the measles virus up to 4 days before he or she develops symptoms.
according to the Centers for Disease Control and Prevention.
Just over half of the cases in 2019 have occurred in Clark County, Wash., which has reported 53 cases. That outbreak led Gov. Jay Inslee to declare a public health emergency for the entire state on Jan. 25.
The cases in Washington represent one of the five outbreaks – the CDC defines an outbreak as three or more cases – that have occurred so far this year, with three reported in New York State (Rockland County, Monroe County, and New York City) and one in Texas, which has been spread out over five counties, the CDC reported Feb. 11.
“These outbreaks are linked to travelers who brought measles back from other countries such as Israel and Ukraine, where large measles outbreaks are occurring,” the CDC noted. The other states with confirmed cases are California, Colorado, Connecticut, Georgia, Illinois, New Jersey, and Oregon.
In a video released Feb. 1, Surgeon General Jerome Adams stressed the importance of getting vaccinated and noted that an infected person can transmit the measles virus up to 4 days before he or she develops symptoms.
Flu activity hits seasonal high
Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.
Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.
Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.
There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.
Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.
Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.
Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.
There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.
Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.
Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.
Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.
There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.
Marijuana smoking is an independent risk factor for lung disease in HIV+
Long-term marijuana smoking was associated with lung disease in HIV-infected (HIV+) but not HIV uninfected (HIV–) men who have sex with men (MSM), according to the results of a large, prospective cohort study.
“There were no significant interactions between marijuana and tobacco smoking in any multivariable model tested for HIV+ participants, indicating independent effects of these factors,” wrote David R. Lorenz, PhD, of the Dana-Farber Cancer Institute, Boston, and his colleagues.
These findings are especially important given that the proportion of HIV+ individuals who frequently smoke marijuana is higher than in the general population in the United States, and has increased in recent years, according to the report, published online in EClinicalMedicine.
The study examined 2,704 MSM who met eligibility criteria (1,352 HIV+ and 1,352 HIV− individuals), with a median age of 44 years at baseline and a median follow-up of 10.5 years. A total of 27% of HIV+ participants reported daily or weekly marijuana smoking for 1 year or more during follow-up, compared with 18% of the HIV− participants.
HIV+ participants who smoked marijuana were more likely to report one or more pulmonary diagnoses, versus nonsmoking HIV+ individuals during follow-up (41.0% vs. 30.0% infectious, and 24.8% vs. 19.0% noninfectious), according to the authors. In contrast, there was no association between marijuana smoking and either an infectious or noninfectious pulmonary diagnosis among HIV− participants (24.2% vs. 20.9%, and 14.8% vs. 17.7%, respectively).
For HIV+ individuals, each 10 days/month increase in marijuana smoking in the prior 2-year period was found to be associated with a 6% increased risk of infectious pulmonary diagnosis (hazard risk 1.06 [95% confidence interval 1.00-1.11]; P = .041). Overall, they found that from the 53,000 person-visits in the study, marijuana smoking was associated with increased risk of both infectious and noninfectious pulmonary diagnoses among the 1,352 HIV-infected participants independent of CD4 count, antiretroviral therapy (ART) adherence, and demographic factors as well.
In particular, viral suppression did not seem to interfere with this association between marijuana smoking and infectious pulmonary diagnoses, as it remained significant in models restricted to those person-visits with suppressed HIV viral load (HR 1.41 [1.03-1.91], P = .029).
The authors suggested that HIV-specific factors such as lung immune cell depletion and dysfunction, persistent immune cell activation, systemic inflammation, respiratory microbiome alterations, and oxidative stress, or a combination of these effects, may interact with the alveolar macrophage dysfunction seen in both humans and mouse models exposed to marijuana smoke. Thus, “a potential additive risk of marijuana smoking and HIV disease may explain the increased prevalence of infectious pulmonary diagnoses in our adjusted analyses,” Dr. Lorenz and his colleagues stated.
“These findings suggest that marijuana smoking is a modifiable risk factor that healthcare providers should consider when seeking to prevent or treat lung disease in people infected with HIV, particularly those with other known risk factors including heavy tobacco smoking, and low CD4 T cell count or advanced HIV disease,” they concluded.
The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.
SOURCE: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.
Long-term marijuana smoking was associated with lung disease in HIV-infected (HIV+) but not HIV uninfected (HIV–) men who have sex with men (MSM), according to the results of a large, prospective cohort study.
“There were no significant interactions between marijuana and tobacco smoking in any multivariable model tested for HIV+ participants, indicating independent effects of these factors,” wrote David R. Lorenz, PhD, of the Dana-Farber Cancer Institute, Boston, and his colleagues.
These findings are especially important given that the proportion of HIV+ individuals who frequently smoke marijuana is higher than in the general population in the United States, and has increased in recent years, according to the report, published online in EClinicalMedicine.
The study examined 2,704 MSM who met eligibility criteria (1,352 HIV+ and 1,352 HIV− individuals), with a median age of 44 years at baseline and a median follow-up of 10.5 years. A total of 27% of HIV+ participants reported daily or weekly marijuana smoking for 1 year or more during follow-up, compared with 18% of the HIV− participants.
HIV+ participants who smoked marijuana were more likely to report one or more pulmonary diagnoses, versus nonsmoking HIV+ individuals during follow-up (41.0% vs. 30.0% infectious, and 24.8% vs. 19.0% noninfectious), according to the authors. In contrast, there was no association between marijuana smoking and either an infectious or noninfectious pulmonary diagnosis among HIV− participants (24.2% vs. 20.9%, and 14.8% vs. 17.7%, respectively).
For HIV+ individuals, each 10 days/month increase in marijuana smoking in the prior 2-year period was found to be associated with a 6% increased risk of infectious pulmonary diagnosis (hazard risk 1.06 [95% confidence interval 1.00-1.11]; P = .041). Overall, they found that from the 53,000 person-visits in the study, marijuana smoking was associated with increased risk of both infectious and noninfectious pulmonary diagnoses among the 1,352 HIV-infected participants independent of CD4 count, antiretroviral therapy (ART) adherence, and demographic factors as well.
In particular, viral suppression did not seem to interfere with this association between marijuana smoking and infectious pulmonary diagnoses, as it remained significant in models restricted to those person-visits with suppressed HIV viral load (HR 1.41 [1.03-1.91], P = .029).
The authors suggested that HIV-specific factors such as lung immune cell depletion and dysfunction, persistent immune cell activation, systemic inflammation, respiratory microbiome alterations, and oxidative stress, or a combination of these effects, may interact with the alveolar macrophage dysfunction seen in both humans and mouse models exposed to marijuana smoke. Thus, “a potential additive risk of marijuana smoking and HIV disease may explain the increased prevalence of infectious pulmonary diagnoses in our adjusted analyses,” Dr. Lorenz and his colleagues stated.
“These findings suggest that marijuana smoking is a modifiable risk factor that healthcare providers should consider when seeking to prevent or treat lung disease in people infected with HIV, particularly those with other known risk factors including heavy tobacco smoking, and low CD4 T cell count or advanced HIV disease,” they concluded.
The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.
SOURCE: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.
Long-term marijuana smoking was associated with lung disease in HIV-infected (HIV+) but not HIV uninfected (HIV–) men who have sex with men (MSM), according to the results of a large, prospective cohort study.
“There were no significant interactions between marijuana and tobacco smoking in any multivariable model tested for HIV+ participants, indicating independent effects of these factors,” wrote David R. Lorenz, PhD, of the Dana-Farber Cancer Institute, Boston, and his colleagues.
These findings are especially important given that the proportion of HIV+ individuals who frequently smoke marijuana is higher than in the general population in the United States, and has increased in recent years, according to the report, published online in EClinicalMedicine.
The study examined 2,704 MSM who met eligibility criteria (1,352 HIV+ and 1,352 HIV− individuals), with a median age of 44 years at baseline and a median follow-up of 10.5 years. A total of 27% of HIV+ participants reported daily or weekly marijuana smoking for 1 year or more during follow-up, compared with 18% of the HIV− participants.
HIV+ participants who smoked marijuana were more likely to report one or more pulmonary diagnoses, versus nonsmoking HIV+ individuals during follow-up (41.0% vs. 30.0% infectious, and 24.8% vs. 19.0% noninfectious), according to the authors. In contrast, there was no association between marijuana smoking and either an infectious or noninfectious pulmonary diagnosis among HIV− participants (24.2% vs. 20.9%, and 14.8% vs. 17.7%, respectively).
For HIV+ individuals, each 10 days/month increase in marijuana smoking in the prior 2-year period was found to be associated with a 6% increased risk of infectious pulmonary diagnosis (hazard risk 1.06 [95% confidence interval 1.00-1.11]; P = .041). Overall, they found that from the 53,000 person-visits in the study, marijuana smoking was associated with increased risk of both infectious and noninfectious pulmonary diagnoses among the 1,352 HIV-infected participants independent of CD4 count, antiretroviral therapy (ART) adherence, and demographic factors as well.
In particular, viral suppression did not seem to interfere with this association between marijuana smoking and infectious pulmonary diagnoses, as it remained significant in models restricted to those person-visits with suppressed HIV viral load (HR 1.41 [1.03-1.91], P = .029).
The authors suggested that HIV-specific factors such as lung immune cell depletion and dysfunction, persistent immune cell activation, systemic inflammation, respiratory microbiome alterations, and oxidative stress, or a combination of these effects, may interact with the alveolar macrophage dysfunction seen in both humans and mouse models exposed to marijuana smoke. Thus, “a potential additive risk of marijuana smoking and HIV disease may explain the increased prevalence of infectious pulmonary diagnoses in our adjusted analyses,” Dr. Lorenz and his colleagues stated.
“These findings suggest that marijuana smoking is a modifiable risk factor that healthcare providers should consider when seeking to prevent or treat lung disease in people infected with HIV, particularly those with other known risk factors including heavy tobacco smoking, and low CD4 T cell count or advanced HIV disease,” they concluded.
The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.
SOURCE: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.
FROM ECLINICALMEDICINE
Key clinical point: HIV+ but not HIV– marijuana smokers had an increased rate of pulmonary diagnoses.
Major finding: HIV+ marijuana smokers were more likely to report one or more infectious or noninfectious pulmonary diagnoses, compared with nonsmoking HIV+ individuals (41.0% vs. 30.0%, and 24.8% vs. 19.0%, respectively).
Study details: A prospective cohort study of 1,352 HIV+ vs. 1,352 HIV– men who have sex with men.
Disclosures: The National Institutes of Health funded the study. The authors reported that they had no relevant disclosures.
Source: Lorenz DR et al. EClinicalMedicine. 2019 Jan 24. doi: 10.1016/j.eclinm.2019.01.003.
Measles outbreak sends vaccine demand soaring, even among the hesitant
Demand for measles vaccine has surged in the Washington county in which the highly contagious virus is linked to more than 50 confirmed illnesses this year – including among people who had previously shunned the shots.
Orders for two types of measles vaccines in Clark County were up nearly 500% in January, compared with the same month last year, jumping from 530 doses to 3,150, according to state health department figures.
Area health clinics are scrambling to keep up with sudden demand, mostly among parents of children who had not been inoculated.
“During an outbreak is when you see an influx of patients who would otherwise be vaccine hesitant,” said Virginia Ramos, infection control nurse with Sea Mar Community Health Center, which runs six sites that offer vaccines in Clark County.
“We’re just happy that we’re prepared and that there is vaccine available.”
The Vancouver Clinic, which operates medical offices and urgent care centers in the area, reported that shots administered jumped from 263 in January 2018 to 1,444 last month, a nearly 450% increase.
That’s a huge rise in a county in which vaccination rates lag – only 76.5% of kindergartners had all the required immunizations for the 2017-2018 school year. Health officials have long worried about the potential for an outbreak in the region.
Statewide in Washington, orders for measles vaccine jumped about 30% in January, compared with the same month last year, climbing from 12,140 doses to 15,780 doses, figures showed. The vaccines include MMR, which protects against measles, mumps and rubella, and MMR-V, which also protects against the varicella-zoster virus, which causes chickenpox. The vaccine takes effect within 72 hours, health officials said.
The orders represent only state-supplied vaccines requested through the federal Vaccines for Children program, which provides free immunizations to children who otherwise couldn’t afford them.
But it’s a snapshot of the scare an outbreak can cause, said Alan Melnick, MD, the health officer and public health director for Clark County overseeing the response.
“I would rather it not take an outbreak for this to happen,” he said.
Since Jan. 1, 2019, 50 cases of measles have been confirmed in Clark County, with 11 more cases suspected, officials said. The Pacific Northwest outbreak includes one confirmed case in King County, where Seattle is located, and four in Multnomah County, which includes Portland, Ore.
On Feb. 6, officials sent letters to families of 5,000 children in Multnomah County telling them they’ll be excluded from school if they don’t have up-to-date immunizations or valid exemptions by Feb. 20.
Most of the infections have occurred in children, under age 18 years, who were unvaccinated. The outbreak includes 43 cases among those who were not immunized, 6 cases in which immunization has not been verified, and 1 case in which the person had received only a single dose of vaccine.
The Centers for Disease Control and Prevention recommends two doses of measles vaccine, one given at between 12 and 15 months of age and one between ages 4 and 6. Health officials say the shots are safe and effective, providing about 93% protection with one dose and 97% with two doses.
The Northwest cases are among three ongoing measles outbreaks in the United States that sickened 79 people in January, according to the CDC. Last year, 372 measles cases were confirmed nationwide, the most since an outbreak in 2014 sickened 667 people.
Washington and Oregon are among 17 states that allow nonmedical exemptions from vaccination requirements for school entry, according to the National Conference of State Legislatures.
Washington state Rep. Paul Harris (R-Vancouver) has introduced a measure that would remove personal belief exemptions for the MMR vaccine.
Research has confirmed that vaccines don’t cause autism, a common reason cited by parents who reject vaccinations. Others object to the timing and combinations of the vaccines and to being forced to inoculate their children.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Demand for measles vaccine has surged in the Washington county in which the highly contagious virus is linked to more than 50 confirmed illnesses this year – including among people who had previously shunned the shots.
Orders for two types of measles vaccines in Clark County were up nearly 500% in January, compared with the same month last year, jumping from 530 doses to 3,150, according to state health department figures.
Area health clinics are scrambling to keep up with sudden demand, mostly among parents of children who had not been inoculated.
“During an outbreak is when you see an influx of patients who would otherwise be vaccine hesitant,” said Virginia Ramos, infection control nurse with Sea Mar Community Health Center, which runs six sites that offer vaccines in Clark County.
“We’re just happy that we’re prepared and that there is vaccine available.”
The Vancouver Clinic, which operates medical offices and urgent care centers in the area, reported that shots administered jumped from 263 in January 2018 to 1,444 last month, a nearly 450% increase.
That’s a huge rise in a county in which vaccination rates lag – only 76.5% of kindergartners had all the required immunizations for the 2017-2018 school year. Health officials have long worried about the potential for an outbreak in the region.
Statewide in Washington, orders for measles vaccine jumped about 30% in January, compared with the same month last year, climbing from 12,140 doses to 15,780 doses, figures showed. The vaccines include MMR, which protects against measles, mumps and rubella, and MMR-V, which also protects against the varicella-zoster virus, which causes chickenpox. The vaccine takes effect within 72 hours, health officials said.
The orders represent only state-supplied vaccines requested through the federal Vaccines for Children program, which provides free immunizations to children who otherwise couldn’t afford them.
But it’s a snapshot of the scare an outbreak can cause, said Alan Melnick, MD, the health officer and public health director for Clark County overseeing the response.
“I would rather it not take an outbreak for this to happen,” he said.
Since Jan. 1, 2019, 50 cases of measles have been confirmed in Clark County, with 11 more cases suspected, officials said. The Pacific Northwest outbreak includes one confirmed case in King County, where Seattle is located, and four in Multnomah County, which includes Portland, Ore.
On Feb. 6, officials sent letters to families of 5,000 children in Multnomah County telling them they’ll be excluded from school if they don’t have up-to-date immunizations or valid exemptions by Feb. 20.
Most of the infections have occurred in children, under age 18 years, who were unvaccinated. The outbreak includes 43 cases among those who were not immunized, 6 cases in which immunization has not been verified, and 1 case in which the person had received only a single dose of vaccine.
The Centers for Disease Control and Prevention recommends two doses of measles vaccine, one given at between 12 and 15 months of age and one between ages 4 and 6. Health officials say the shots are safe and effective, providing about 93% protection with one dose and 97% with two doses.
The Northwest cases are among three ongoing measles outbreaks in the United States that sickened 79 people in January, according to the CDC. Last year, 372 measles cases were confirmed nationwide, the most since an outbreak in 2014 sickened 667 people.
Washington and Oregon are among 17 states that allow nonmedical exemptions from vaccination requirements for school entry, according to the National Conference of State Legislatures.
Washington state Rep. Paul Harris (R-Vancouver) has introduced a measure that would remove personal belief exemptions for the MMR vaccine.
Research has confirmed that vaccines don’t cause autism, a common reason cited by parents who reject vaccinations. Others object to the timing and combinations of the vaccines and to being forced to inoculate their children.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Demand for measles vaccine has surged in the Washington county in which the highly contagious virus is linked to more than 50 confirmed illnesses this year – including among people who had previously shunned the shots.
Orders for two types of measles vaccines in Clark County were up nearly 500% in January, compared with the same month last year, jumping from 530 doses to 3,150, according to state health department figures.
Area health clinics are scrambling to keep up with sudden demand, mostly among parents of children who had not been inoculated.
“During an outbreak is when you see an influx of patients who would otherwise be vaccine hesitant,” said Virginia Ramos, infection control nurse with Sea Mar Community Health Center, which runs six sites that offer vaccines in Clark County.
“We’re just happy that we’re prepared and that there is vaccine available.”
The Vancouver Clinic, which operates medical offices and urgent care centers in the area, reported that shots administered jumped from 263 in January 2018 to 1,444 last month, a nearly 450% increase.
That’s a huge rise in a county in which vaccination rates lag – only 76.5% of kindergartners had all the required immunizations for the 2017-2018 school year. Health officials have long worried about the potential for an outbreak in the region.
Statewide in Washington, orders for measles vaccine jumped about 30% in January, compared with the same month last year, climbing from 12,140 doses to 15,780 doses, figures showed. The vaccines include MMR, which protects against measles, mumps and rubella, and MMR-V, which also protects against the varicella-zoster virus, which causes chickenpox. The vaccine takes effect within 72 hours, health officials said.
The orders represent only state-supplied vaccines requested through the federal Vaccines for Children program, which provides free immunizations to children who otherwise couldn’t afford them.
But it’s a snapshot of the scare an outbreak can cause, said Alan Melnick, MD, the health officer and public health director for Clark County overseeing the response.
“I would rather it not take an outbreak for this to happen,” he said.
Since Jan. 1, 2019, 50 cases of measles have been confirmed in Clark County, with 11 more cases suspected, officials said. The Pacific Northwest outbreak includes one confirmed case in King County, where Seattle is located, and four in Multnomah County, which includes Portland, Ore.
On Feb. 6, officials sent letters to families of 5,000 children in Multnomah County telling them they’ll be excluded from school if they don’t have up-to-date immunizations or valid exemptions by Feb. 20.
Most of the infections have occurred in children, under age 18 years, who were unvaccinated. The outbreak includes 43 cases among those who were not immunized, 6 cases in which immunization has not been verified, and 1 case in which the person had received only a single dose of vaccine.
The Centers for Disease Control and Prevention recommends two doses of measles vaccine, one given at between 12 and 15 months of age and one between ages 4 and 6. Health officials say the shots are safe and effective, providing about 93% protection with one dose and 97% with two doses.
The Northwest cases are among three ongoing measles outbreaks in the United States that sickened 79 people in January, according to the CDC. Last year, 372 measles cases were confirmed nationwide, the most since an outbreak in 2014 sickened 667 people.
Washington and Oregon are among 17 states that allow nonmedical exemptions from vaccination requirements for school entry, according to the National Conference of State Legislatures.
Washington state Rep. Paul Harris (R-Vancouver) has introduced a measure that would remove personal belief exemptions for the MMR vaccine.
Research has confirmed that vaccines don’t cause autism, a common reason cited by parents who reject vaccinations. Others object to the timing and combinations of the vaccines and to being forced to inoculate their children.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
HHS effort aims to end new HIV cases within 10 years
WASHINGTON – Leaders from five federal agencies came together to announce the framework for a bold new national initiative that aims to eliminate new cases of HIV infection in the United States within 10 years. The announcement came the day after President Trump’s State of the Union address, which highlighted the new effort.
“HIV has cost America too much for too long,” said Adm. Brett Giroir, MD, assistant secretary for health at the Department of Health & Human Services, in a press briefing. In addition to the 700,000 U.S. lives the disease has claimed since 1981, “We are at high risk of another 400,000 becoming infected over the next decade,” with about 40,000 new infections still occurring every year, he said.
Dr. Giroir will lead a coordinated effort among HHS, the Centers for Disease Control, the National Institutes of Health, the Health Resources and Services Administration, and the Indian Health Service. The goals are to reduce new cases of HIV by 50% within 5 years, and by 90% within 10 years.
These 48 counties, together with Washington and San Juan, Puerto Rico, accounted for more than half of the new HIV diagnoses in 2016 and 2017, said Dr. Giroir.
“This is a laser-focused program targeting counties where infection is the highest,” said CDC Director Robert R. Redfield, MD. “We propose to deploy personnel, resources, and strategies” in these targeted areas to maximize not just diagnosis and treatment but also to reach those at risk for HIV to enroll them in preexposure prophylaxis (PrEP) regimens, he said.
In addition to the targeted counties, seven states in the rural South as well as Native American and Alaskan Native populations also will receive intensified education, diagnostic, and treatment services. The targeted states are Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina.
George Sigounas, PhD, administrator or the Health Resources and Services Administration, said that existing community health centers will be especially important in reaching rural underserved and marginalized populations. Currently, he said, HRSA supports 12,000 service delivery sites across the country that are already delivering care to 27 million individuals. “These sites will play a major expanded role in providing PrEP to those who are at the greatest risk of contracting HIV,” said Dr. Sigounas.
Among the currently existing resources that will be leveraged are services provided by the Ryan White HIV/AIDS program, which already provides HIV primary medical care and support services through a network of grants to states and local government and community organizations. About half of the people currently diagnosed with HIV in the United States receive services through this program now.
The NIH maintains a geographically distributed network of Centers for AIDS Research that also will be folded into the new initiative.
In his remarks, Anthony S. Fauci, MD, director of the NIH’s National Center for Allergy and Infectious Diseases, pointed out that, “Treatment and detection are wrapped together, because treated individuals can’t transmit HIV” if they are adherent to antiretroviral medication use and achieve an undetectable viral load, he said. “If you get everyone who’s infected on antiretrovirals and give those who need it PrEP, you can theoretically end the epidemic as we know it – and that is our goal.”
Dr. Fauci went on to say that implementation science will play a key role in achieving a targeted and coordinated approach. “We will work closely with our colleagues to make sure the implementation is done well. We have lessons learned; we will do better and better,” he said.
The nuts and bolts of the program include a four-pronged strategy to diagnose individuals as early as possible after infection, to initiate prompt, effective, and sustained treatment, to protect those at risk for HIV by proven means including PrEP, and to provide rapid response when new HIV clusters are identified. A reimagining of current and future personnel into an “HIV health force” will put teams on the ground in each jurisdiction to carry out the initiative.
Though the goal is to provide PrEP to every at-risk individual, Dr. Fauci said that current modeling shows that if PrEP reaches 50%-60% in the at-risk population, new infections can be reduced by 90%. He added, “PrEP works. The efficacy is well over 90%.”
Funding details were not released at the press briefing; Dr. Giroir said that figures will be released by the Office of Management and Budget as part of the 2020 budget cycle. He confirmed, however, that new funds will be allocated for the effort, rather than a mere reshuffling of existing fund and resources.
Several of the leaders acknowledged the problem of stigma and marginalization that many individuals living with or at risk for HIV face, since men who have sex with men, transgender people, sex workers, and those with opioid use disorder all fall into this category.
“Every American deserves to be treated with respect and dignity. We will vigorously enforce all laws on the books about discrimination,” said Rear Adm. Michael Weahkee, MD, principal deputy director of the Indian Health Service. This is especially important in Native American communities “where everybody knows everybody,” he said, and it’s vitally important to include individual and community education in the efforts.
Dr. Redfield concurred, adding that “Dr. Fauci and I have been engaged in HIV since 1981. We have witnessed firsthand the negative impact that stigma can have on our capacity to practice public health. The transgender population, in particular, needs to be reached out to. We need to be able to address in a comprehensive way how to destigmatize the HIV population.”
WASHINGTON – Leaders from five federal agencies came together to announce the framework for a bold new national initiative that aims to eliminate new cases of HIV infection in the United States within 10 years. The announcement came the day after President Trump’s State of the Union address, which highlighted the new effort.
“HIV has cost America too much for too long,” said Adm. Brett Giroir, MD, assistant secretary for health at the Department of Health & Human Services, in a press briefing. In addition to the 700,000 U.S. lives the disease has claimed since 1981, “We are at high risk of another 400,000 becoming infected over the next decade,” with about 40,000 new infections still occurring every year, he said.
Dr. Giroir will lead a coordinated effort among HHS, the Centers for Disease Control, the National Institutes of Health, the Health Resources and Services Administration, and the Indian Health Service. The goals are to reduce new cases of HIV by 50% within 5 years, and by 90% within 10 years.
These 48 counties, together with Washington and San Juan, Puerto Rico, accounted for more than half of the new HIV diagnoses in 2016 and 2017, said Dr. Giroir.
“This is a laser-focused program targeting counties where infection is the highest,” said CDC Director Robert R. Redfield, MD. “We propose to deploy personnel, resources, and strategies” in these targeted areas to maximize not just diagnosis and treatment but also to reach those at risk for HIV to enroll them in preexposure prophylaxis (PrEP) regimens, he said.
In addition to the targeted counties, seven states in the rural South as well as Native American and Alaskan Native populations also will receive intensified education, diagnostic, and treatment services. The targeted states are Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina.
George Sigounas, PhD, administrator or the Health Resources and Services Administration, said that existing community health centers will be especially important in reaching rural underserved and marginalized populations. Currently, he said, HRSA supports 12,000 service delivery sites across the country that are already delivering care to 27 million individuals. “These sites will play a major expanded role in providing PrEP to those who are at the greatest risk of contracting HIV,” said Dr. Sigounas.
Among the currently existing resources that will be leveraged are services provided by the Ryan White HIV/AIDS program, which already provides HIV primary medical care and support services through a network of grants to states and local government and community organizations. About half of the people currently diagnosed with HIV in the United States receive services through this program now.
The NIH maintains a geographically distributed network of Centers for AIDS Research that also will be folded into the new initiative.
In his remarks, Anthony S. Fauci, MD, director of the NIH’s National Center for Allergy and Infectious Diseases, pointed out that, “Treatment and detection are wrapped together, because treated individuals can’t transmit HIV” if they are adherent to antiretroviral medication use and achieve an undetectable viral load, he said. “If you get everyone who’s infected on antiretrovirals and give those who need it PrEP, you can theoretically end the epidemic as we know it – and that is our goal.”
Dr. Fauci went on to say that implementation science will play a key role in achieving a targeted and coordinated approach. “We will work closely with our colleagues to make sure the implementation is done well. We have lessons learned; we will do better and better,” he said.
The nuts and bolts of the program include a four-pronged strategy to diagnose individuals as early as possible after infection, to initiate prompt, effective, and sustained treatment, to protect those at risk for HIV by proven means including PrEP, and to provide rapid response when new HIV clusters are identified. A reimagining of current and future personnel into an “HIV health force” will put teams on the ground in each jurisdiction to carry out the initiative.
Though the goal is to provide PrEP to every at-risk individual, Dr. Fauci said that current modeling shows that if PrEP reaches 50%-60% in the at-risk population, new infections can be reduced by 90%. He added, “PrEP works. The efficacy is well over 90%.”
Funding details were not released at the press briefing; Dr. Giroir said that figures will be released by the Office of Management and Budget as part of the 2020 budget cycle. He confirmed, however, that new funds will be allocated for the effort, rather than a mere reshuffling of existing fund and resources.
Several of the leaders acknowledged the problem of stigma and marginalization that many individuals living with or at risk for HIV face, since men who have sex with men, transgender people, sex workers, and those with opioid use disorder all fall into this category.
“Every American deserves to be treated with respect and dignity. We will vigorously enforce all laws on the books about discrimination,” said Rear Adm. Michael Weahkee, MD, principal deputy director of the Indian Health Service. This is especially important in Native American communities “where everybody knows everybody,” he said, and it’s vitally important to include individual and community education in the efforts.
Dr. Redfield concurred, adding that “Dr. Fauci and I have been engaged in HIV since 1981. We have witnessed firsthand the negative impact that stigma can have on our capacity to practice public health. The transgender population, in particular, needs to be reached out to. We need to be able to address in a comprehensive way how to destigmatize the HIV population.”
WASHINGTON – Leaders from five federal agencies came together to announce the framework for a bold new national initiative that aims to eliminate new cases of HIV infection in the United States within 10 years. The announcement came the day after President Trump’s State of the Union address, which highlighted the new effort.
“HIV has cost America too much for too long,” said Adm. Brett Giroir, MD, assistant secretary for health at the Department of Health & Human Services, in a press briefing. In addition to the 700,000 U.S. lives the disease has claimed since 1981, “We are at high risk of another 400,000 becoming infected over the next decade,” with about 40,000 new infections still occurring every year, he said.
Dr. Giroir will lead a coordinated effort among HHS, the Centers for Disease Control, the National Institutes of Health, the Health Resources and Services Administration, and the Indian Health Service. The goals are to reduce new cases of HIV by 50% within 5 years, and by 90% within 10 years.
These 48 counties, together with Washington and San Juan, Puerto Rico, accounted for more than half of the new HIV diagnoses in 2016 and 2017, said Dr. Giroir.
“This is a laser-focused program targeting counties where infection is the highest,” said CDC Director Robert R. Redfield, MD. “We propose to deploy personnel, resources, and strategies” in these targeted areas to maximize not just diagnosis and treatment but also to reach those at risk for HIV to enroll them in preexposure prophylaxis (PrEP) regimens, he said.
In addition to the targeted counties, seven states in the rural South as well as Native American and Alaskan Native populations also will receive intensified education, diagnostic, and treatment services. The targeted states are Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina.
George Sigounas, PhD, administrator or the Health Resources and Services Administration, said that existing community health centers will be especially important in reaching rural underserved and marginalized populations. Currently, he said, HRSA supports 12,000 service delivery sites across the country that are already delivering care to 27 million individuals. “These sites will play a major expanded role in providing PrEP to those who are at the greatest risk of contracting HIV,” said Dr. Sigounas.
Among the currently existing resources that will be leveraged are services provided by the Ryan White HIV/AIDS program, which already provides HIV primary medical care and support services through a network of grants to states and local government and community organizations. About half of the people currently diagnosed with HIV in the United States receive services through this program now.
The NIH maintains a geographically distributed network of Centers for AIDS Research that also will be folded into the new initiative.
In his remarks, Anthony S. Fauci, MD, director of the NIH’s National Center for Allergy and Infectious Diseases, pointed out that, “Treatment and detection are wrapped together, because treated individuals can’t transmit HIV” if they are adherent to antiretroviral medication use and achieve an undetectable viral load, he said. “If you get everyone who’s infected on antiretrovirals and give those who need it PrEP, you can theoretically end the epidemic as we know it – and that is our goal.”
Dr. Fauci went on to say that implementation science will play a key role in achieving a targeted and coordinated approach. “We will work closely with our colleagues to make sure the implementation is done well. We have lessons learned; we will do better and better,” he said.
The nuts and bolts of the program include a four-pronged strategy to diagnose individuals as early as possible after infection, to initiate prompt, effective, and sustained treatment, to protect those at risk for HIV by proven means including PrEP, and to provide rapid response when new HIV clusters are identified. A reimagining of current and future personnel into an “HIV health force” will put teams on the ground in each jurisdiction to carry out the initiative.
Though the goal is to provide PrEP to every at-risk individual, Dr. Fauci said that current modeling shows that if PrEP reaches 50%-60% in the at-risk population, new infections can be reduced by 90%. He added, “PrEP works. The efficacy is well over 90%.”
Funding details were not released at the press briefing; Dr. Giroir said that figures will be released by the Office of Management and Budget as part of the 2020 budget cycle. He confirmed, however, that new funds will be allocated for the effort, rather than a mere reshuffling of existing fund and resources.
Several of the leaders acknowledged the problem of stigma and marginalization that many individuals living with or at risk for HIV face, since men who have sex with men, transgender people, sex workers, and those with opioid use disorder all fall into this category.
“Every American deserves to be treated with respect and dignity. We will vigorously enforce all laws on the books about discrimination,” said Rear Adm. Michael Weahkee, MD, principal deputy director of the Indian Health Service. This is especially important in Native American communities “where everybody knows everybody,” he said, and it’s vitally important to include individual and community education in the efforts.
Dr. Redfield concurred, adding that “Dr. Fauci and I have been engaged in HIV since 1981. We have witnessed firsthand the negative impact that stigma can have on our capacity to practice public health. The transgender population, in particular, needs to be reached out to. We need to be able to address in a comprehensive way how to destigmatize the HIV population.”
FROM A HEALTH AND HUMAN SERVICES BRIEFING
President Trump calls for end to HIV/AIDS, pediatric cancer
HIV/AIDS, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights of President Donald Trump’s second State of the Union address Feb. 5.
Mr. Trump promised to push for funds to end HIV/AIDS and childhood cancer within in 10 years. “In recent years, we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach,” he said to assembled members of Congress and leaders of the executive and judicial branches of government. “My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years.”
Following the speech, Alex Azar, secretary of the Department of Health and Human Services, offered more details in a blog post on the agency’s website.
Funding for the initiative, dubbed “Ending the HIV Epidemic: A Plan for America,” will have three components.
The first involves increasing investments in “geographic hotspots” though existing programs like the Ryan White HIV/AIDS Program and a new community health center–based program to provide antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) to those at the highest risk of contracting the disease.
Second is the use of data to track where the disease is spreading most rapidly to help target prevention, care, and treatment at the local level. The third will provide funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment efforts.
A fact sheet on this initiative called for a 75% reduction in new cases of HIV infection in 5 years and at least a 90% reduction within 10 years.
President Trump called for similar efforts to address pediatric cancer.
“Tonight I am also asking you to join me in another fight that all American can get behind – the fight against childhood cancer,” he said, adding that his budget request will come with a line item of $500 million over 10 years to fund research. “Many childhood cancers have not seen new therapies in decades.”
President Trump also asked Congress to legislate a prohibition of late-term abortion.
“There could be no greater contrast to the beautiful image of a mother holding her infant child than the chilling displays our nation saw in recent days,” he said. “Lawmakers in New York cheered with delight upon the passage of legislation that would allow a baby to be ripped from the mother’s womb moments from birth. These are living, feeling beautiful babies who will never get the chance to share their love and their dreams with the world. ... Let us work together to build a culture that cherishes innocent life.”
He also touched on the recurring themes regarding lowering the cost of health care and prescription drugs, as well as protecting those with preexisting conditions, something he called a major priority.
“It’s unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong. This is unfair and together we will stop it, and we will stop it fast,” he said.
He did not offer any specific policy recommendation on how to address prescription drug costs, other than a comment on the need for greater price transparency.
“I am asking Congress to pass legislation that finally takes on the problem of global freeloading and delivers fairness and price transparency for American patients,” he said.
“We should also require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs way down.”
SOURCE: Trump D. State of the Union Address, Feb. 5, 2019.
HIV/AIDS, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights of President Donald Trump’s second State of the Union address Feb. 5.
Mr. Trump promised to push for funds to end HIV/AIDS and childhood cancer within in 10 years. “In recent years, we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach,” he said to assembled members of Congress and leaders of the executive and judicial branches of government. “My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years.”
Following the speech, Alex Azar, secretary of the Department of Health and Human Services, offered more details in a blog post on the agency’s website.
Funding for the initiative, dubbed “Ending the HIV Epidemic: A Plan for America,” will have three components.
The first involves increasing investments in “geographic hotspots” though existing programs like the Ryan White HIV/AIDS Program and a new community health center–based program to provide antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) to those at the highest risk of contracting the disease.
Second is the use of data to track where the disease is spreading most rapidly to help target prevention, care, and treatment at the local level. The third will provide funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment efforts.
A fact sheet on this initiative called for a 75% reduction in new cases of HIV infection in 5 years and at least a 90% reduction within 10 years.
President Trump called for similar efforts to address pediatric cancer.
“Tonight I am also asking you to join me in another fight that all American can get behind – the fight against childhood cancer,” he said, adding that his budget request will come with a line item of $500 million over 10 years to fund research. “Many childhood cancers have not seen new therapies in decades.”
President Trump also asked Congress to legislate a prohibition of late-term abortion.
“There could be no greater contrast to the beautiful image of a mother holding her infant child than the chilling displays our nation saw in recent days,” he said. “Lawmakers in New York cheered with delight upon the passage of legislation that would allow a baby to be ripped from the mother’s womb moments from birth. These are living, feeling beautiful babies who will never get the chance to share their love and their dreams with the world. ... Let us work together to build a culture that cherishes innocent life.”
He also touched on the recurring themes regarding lowering the cost of health care and prescription drugs, as well as protecting those with preexisting conditions, something he called a major priority.
“It’s unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong. This is unfair and together we will stop it, and we will stop it fast,” he said.
He did not offer any specific policy recommendation on how to address prescription drug costs, other than a comment on the need for greater price transparency.
“I am asking Congress to pass legislation that finally takes on the problem of global freeloading and delivers fairness and price transparency for American patients,” he said.
“We should also require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs way down.”
SOURCE: Trump D. State of the Union Address, Feb. 5, 2019.
HIV/AIDS, pediatric cancer research, abortion, prescription drug prices, and preexisting conditions were among the health care highlights of President Donald Trump’s second State of the Union address Feb. 5.
Mr. Trump promised to push for funds to end HIV/AIDS and childhood cancer within in 10 years. “In recent years, we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach,” he said to assembled members of Congress and leaders of the executive and judicial branches of government. “My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years.”
Following the speech, Alex Azar, secretary of the Department of Health and Human Services, offered more details in a blog post on the agency’s website.
Funding for the initiative, dubbed “Ending the HIV Epidemic: A Plan for America,” will have three components.
The first involves increasing investments in “geographic hotspots” though existing programs like the Ryan White HIV/AIDS Program and a new community health center–based program to provide antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) to those at the highest risk of contracting the disease.
Second is the use of data to track where the disease is spreading most rapidly to help target prevention, care, and treatment at the local level. The third will provide funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment efforts.
A fact sheet on this initiative called for a 75% reduction in new cases of HIV infection in 5 years and at least a 90% reduction within 10 years.
President Trump called for similar efforts to address pediatric cancer.
“Tonight I am also asking you to join me in another fight that all American can get behind – the fight against childhood cancer,” he said, adding that his budget request will come with a line item of $500 million over 10 years to fund research. “Many childhood cancers have not seen new therapies in decades.”
President Trump also asked Congress to legislate a prohibition of late-term abortion.
“There could be no greater contrast to the beautiful image of a mother holding her infant child than the chilling displays our nation saw in recent days,” he said. “Lawmakers in New York cheered with delight upon the passage of legislation that would allow a baby to be ripped from the mother’s womb moments from birth. These are living, feeling beautiful babies who will never get the chance to share their love and their dreams with the world. ... Let us work together to build a culture that cherishes innocent life.”
He also touched on the recurring themes regarding lowering the cost of health care and prescription drugs, as well as protecting those with preexisting conditions, something he called a major priority.
“It’s unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong. This is unfair and together we will stop it, and we will stop it fast,” he said.
He did not offer any specific policy recommendation on how to address prescription drug costs, other than a comment on the need for greater price transparency.
“I am asking Congress to pass legislation that finally takes on the problem of global freeloading and delivers fairness and price transparency for American patients,” he said.
“We should also require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs way down.”
SOURCE: Trump D. State of the Union Address, Feb. 5, 2019.
Key clinical point: President Trump calls for an end to HIV/AIDS and pediatric cancer in 10 years.
Major finding: His budget will request $500 million for cancer research and as yet undisclosed amount for HIV/AIDS research.
Study details: More specific details on the proposals will likely come when the president makes his budget submission to Congress in the coming weeks.
Disclosures: There are no disclosures.
Source: Trump D. State of the Union Address, Feb. 5, 2019.
Rise in HCV infection rates linked to OxyContin reformulation
Public health experts have attributed the alarming rise in hepatitis C virus (HCV) infection rates in recent years to the opioid epidemic, and a new Rand study suggests that an effort to deter opioid abuse – namely the 2010 abuse-deterrent reformulation of OxyContin – is partly to blame.
Between 2004 and 2015, HCV infection rates in the United States nearly tripled, but a closer look showed that states with above-median rates of OxyContin misuse prior to the reformulation had a 222% increase in HCV rates, compared with a 75% increase in states with below-median OxyContin misuse, said David Powell, PhD, a senior economist at Rand in Arlington, Va., and his colleagues, Abby Alpert, PhD, and Rosalie L. Pacula, PhD. The report was published in Health Affairs.
The coauthors found that hepatitis C infection rates were not significantly different between the two groups of states before the reformulation (0.350 vs. 0.260). But after 2010, there were large and statistically significant differences in the rates (1.128 vs. 0.455; P less than 0.01), they wrote, noting that the above-median states experienced an additional 0.58 HCV infections per 100,000 population through 2015 relative to the below-median states).
HCV infection rates declined during the 1990s followed by a plateau beginning around 2003, then rose sharply beginning in 2010, coinciding with the introduction of the release of the abuse-deterrent formulation of OxyContin, which is one of the most commonly misused opioid analgesics, the investigators said, explaining that the reformulated version was harder to crush or dissolve, making it more difficult to inhale or inject.
“Prior studies have shown that, after OxyContin became more difficult to abuse, some nonmedical users of OxyContin switched to heroin (a pharmacologically similar opiate),” they noted.
This led to a decline of more than 40% in OxyContin misuse but also to a sharp increase in heroin overdoses after 2010.
The investigators assessed whether the related increase in heroin use might explain the increase in HCV infections, which can be transmitted through shared needle use.
Using a quasi-experimental difference-in-differences approach, they examined whether states with higher exposure to the reformulated OxyContin had faster growth of HCV infection rates after the reformulations, and as a falsification exercise, they also looked at whether the nonmedical use of pain relievers other than OxyContin predicted post-reformulation HCV infection rate increases.
HCV infection rates for each calendar year from 2004 to 2015 were assessed using confirmed case reports collected by the Centers for Disease Control and Prevention, and nonmedical OxyContin use was measured using self-reported data from the National Survey on Drug Use and Health, which is the largest U.S. survey on substance use disorder.
The two groups of states had similar demographic and economic conditions, except that the above-median misuse states had smaller populations and a larger proportion of white residents.
Of note, the patterns of HCV infection mirrored those of heroin overdoses. There was small relative increase in HCV infection rates in 2010 in the above-median OxyContin misuse states, and the gap between above- and below-median misuse states widened more rapidly from 2011 to 2013. “This striking inflection point in the trend of hepatitis C infections for high-misuse states after 2010 mimics the inflection in heroin overdoses that occurred as a result of the reformulation,” they said, noting that heroin morality per 100,000 population was nearly identical in the two groups of states in the pre-reformulation period (0.859 and 0.847).
The falsification exercise looking at nonmedical use of pain relievers other than OxyContin in the two groups of states showed that after 2010 groups’ rates of hepatitis C infections grew at virtually identical rates.
“Thus, the differential risk in hepatitis C infections was uniquely associated with OxyContin misuse, rather than prescription pain reliever misuse more generally,” they said. “This suggests that it was the OxyContin reformulation, not other policies broadly affecting opioids, that drove much of the differential growth.”
The investigators controlled for numerous other factors, including opioid policies that might have an impact on OxyContin and heroin use, prescription drug monitoring programs and pain clinic regulations, as well as the role of major pill-mill crackdowns in 2010 and 2011.
The findings represent a “substantial public health concern,” they said, explaining that, while “considerable policy attention is being given to managing the opioid epidemic ... a ‘silent epidemic’ of hepatitis C has emerged as a result of a transition in the mode of administration toward injection drug use.”
In 2017, the CDC reported on this link between the opioid epidemic and rising HCV infection rates, as well.
Dr. Powell and his colleagues wrote.
Their findings regarding the unintended consequences of the OxyContin reformulation suggest that caution is warranted with respect to future interventions that limit the supply of abusable prescription opioids, they said, adding that “such interventions must be paired with polices that alleviate the harms associated with switching to illicit drugs, such as improved access to substance use disorder treatment and increased efforts aimed at identifying and treating diseases associated with injection drug use.”
However, policy makers and medical professionals also must recognize that reducing opioid-related mortality and increasing access to drug treatment might not be sufficient to fully address all of the public health consequences associated with the opioid crisis. As additional reformulations of opioids are promoted and more policies seek to limit access to prescription opioids, “both the medical and the law enforcement communities must recognize the critical transition from prescription opioids to other drugs, particularly those that are injected, and be prepared to consider complementary strategies that can effectively reduce the additional harms from the particular mode of drug use,” they concluded.
The coauthors cited several limitations, including the possibility that true hepatitis C infection rates might have been underestimated in the study.
He and Dr. Pacula received funding from the National Institute on Drug Abuse. Dr. Powell also cited funding from the Rand Alumni Impact Award.
SOURCE: Powell D et al. Health Aff. 2019;38(2):287-94.
Increases have been seen not only in infectious diseases but also in cardiovascular diseases as intravenous opioid use has risen, Mark S. Gold, MD, said in an interview. “These emerging co-occurring diseases tend to lag behind drug deaths and other data,” he said.
The study by Powell et al. shows that drugs of abuse are dangerous, and that, with addictive use, we find consequences. “Each change appears to bring with it intended consequences we study, but over time, unintended consequences emerge,” he said. “It is important to remain vigilant.”
Dr. Gold is 17th Distinguished Alumni Professor at the University of Florida, Gainesville, and professor of psychiatry (adjunct) at Washington University in St. Louis.
Increases have been seen not only in infectious diseases but also in cardiovascular diseases as intravenous opioid use has risen, Mark S. Gold, MD, said in an interview. “These emerging co-occurring diseases tend to lag behind drug deaths and other data,” he said.
The study by Powell et al. shows that drugs of abuse are dangerous, and that, with addictive use, we find consequences. “Each change appears to bring with it intended consequences we study, but over time, unintended consequences emerge,” he said. “It is important to remain vigilant.”
Dr. Gold is 17th Distinguished Alumni Professor at the University of Florida, Gainesville, and professor of psychiatry (adjunct) at Washington University in St. Louis.
Increases have been seen not only in infectious diseases but also in cardiovascular diseases as intravenous opioid use has risen, Mark S. Gold, MD, said in an interview. “These emerging co-occurring diseases tend to lag behind drug deaths and other data,” he said.
The study by Powell et al. shows that drugs of abuse are dangerous, and that, with addictive use, we find consequences. “Each change appears to bring with it intended consequences we study, but over time, unintended consequences emerge,” he said. “It is important to remain vigilant.”
Dr. Gold is 17th Distinguished Alumni Professor at the University of Florida, Gainesville, and professor of psychiatry (adjunct) at Washington University in St. Louis.
Public health experts have attributed the alarming rise in hepatitis C virus (HCV) infection rates in recent years to the opioid epidemic, and a new Rand study suggests that an effort to deter opioid abuse – namely the 2010 abuse-deterrent reformulation of OxyContin – is partly to blame.
Between 2004 and 2015, HCV infection rates in the United States nearly tripled, but a closer look showed that states with above-median rates of OxyContin misuse prior to the reformulation had a 222% increase in HCV rates, compared with a 75% increase in states with below-median OxyContin misuse, said David Powell, PhD, a senior economist at Rand in Arlington, Va., and his colleagues, Abby Alpert, PhD, and Rosalie L. Pacula, PhD. The report was published in Health Affairs.
The coauthors found that hepatitis C infection rates were not significantly different between the two groups of states before the reformulation (0.350 vs. 0.260). But after 2010, there were large and statistically significant differences in the rates (1.128 vs. 0.455; P less than 0.01), they wrote, noting that the above-median states experienced an additional 0.58 HCV infections per 100,000 population through 2015 relative to the below-median states).
HCV infection rates declined during the 1990s followed by a plateau beginning around 2003, then rose sharply beginning in 2010, coinciding with the introduction of the release of the abuse-deterrent formulation of OxyContin, which is one of the most commonly misused opioid analgesics, the investigators said, explaining that the reformulated version was harder to crush or dissolve, making it more difficult to inhale or inject.
“Prior studies have shown that, after OxyContin became more difficult to abuse, some nonmedical users of OxyContin switched to heroin (a pharmacologically similar opiate),” they noted.
This led to a decline of more than 40% in OxyContin misuse but also to a sharp increase in heroin overdoses after 2010.
The investigators assessed whether the related increase in heroin use might explain the increase in HCV infections, which can be transmitted through shared needle use.
Using a quasi-experimental difference-in-differences approach, they examined whether states with higher exposure to the reformulated OxyContin had faster growth of HCV infection rates after the reformulations, and as a falsification exercise, they also looked at whether the nonmedical use of pain relievers other than OxyContin predicted post-reformulation HCV infection rate increases.
HCV infection rates for each calendar year from 2004 to 2015 were assessed using confirmed case reports collected by the Centers for Disease Control and Prevention, and nonmedical OxyContin use was measured using self-reported data from the National Survey on Drug Use and Health, which is the largest U.S. survey on substance use disorder.
The two groups of states had similar demographic and economic conditions, except that the above-median misuse states had smaller populations and a larger proportion of white residents.
Of note, the patterns of HCV infection mirrored those of heroin overdoses. There was small relative increase in HCV infection rates in 2010 in the above-median OxyContin misuse states, and the gap between above- and below-median misuse states widened more rapidly from 2011 to 2013. “This striking inflection point in the trend of hepatitis C infections for high-misuse states after 2010 mimics the inflection in heroin overdoses that occurred as a result of the reformulation,” they said, noting that heroin morality per 100,000 population was nearly identical in the two groups of states in the pre-reformulation period (0.859 and 0.847).
The falsification exercise looking at nonmedical use of pain relievers other than OxyContin in the two groups of states showed that after 2010 groups’ rates of hepatitis C infections grew at virtually identical rates.
“Thus, the differential risk in hepatitis C infections was uniquely associated with OxyContin misuse, rather than prescription pain reliever misuse more generally,” they said. “This suggests that it was the OxyContin reformulation, not other policies broadly affecting opioids, that drove much of the differential growth.”
The investigators controlled for numerous other factors, including opioid policies that might have an impact on OxyContin and heroin use, prescription drug monitoring programs and pain clinic regulations, as well as the role of major pill-mill crackdowns in 2010 and 2011.
The findings represent a “substantial public health concern,” they said, explaining that, while “considerable policy attention is being given to managing the opioid epidemic ... a ‘silent epidemic’ of hepatitis C has emerged as a result of a transition in the mode of administration toward injection drug use.”
In 2017, the CDC reported on this link between the opioid epidemic and rising HCV infection rates, as well.
Dr. Powell and his colleagues wrote.
Their findings regarding the unintended consequences of the OxyContin reformulation suggest that caution is warranted with respect to future interventions that limit the supply of abusable prescription opioids, they said, adding that “such interventions must be paired with polices that alleviate the harms associated with switching to illicit drugs, such as improved access to substance use disorder treatment and increased efforts aimed at identifying and treating diseases associated with injection drug use.”
However, policy makers and medical professionals also must recognize that reducing opioid-related mortality and increasing access to drug treatment might not be sufficient to fully address all of the public health consequences associated with the opioid crisis. As additional reformulations of opioids are promoted and more policies seek to limit access to prescription opioids, “both the medical and the law enforcement communities must recognize the critical transition from prescription opioids to other drugs, particularly those that are injected, and be prepared to consider complementary strategies that can effectively reduce the additional harms from the particular mode of drug use,” they concluded.
The coauthors cited several limitations, including the possibility that true hepatitis C infection rates might have been underestimated in the study.
He and Dr. Pacula received funding from the National Institute on Drug Abuse. Dr. Powell also cited funding from the Rand Alumni Impact Award.
SOURCE: Powell D et al. Health Aff. 2019;38(2):287-94.
Public health experts have attributed the alarming rise in hepatitis C virus (HCV) infection rates in recent years to the opioid epidemic, and a new Rand study suggests that an effort to deter opioid abuse – namely the 2010 abuse-deterrent reformulation of OxyContin – is partly to blame.
Between 2004 and 2015, HCV infection rates in the United States nearly tripled, but a closer look showed that states with above-median rates of OxyContin misuse prior to the reformulation had a 222% increase in HCV rates, compared with a 75% increase in states with below-median OxyContin misuse, said David Powell, PhD, a senior economist at Rand in Arlington, Va., and his colleagues, Abby Alpert, PhD, and Rosalie L. Pacula, PhD. The report was published in Health Affairs.
The coauthors found that hepatitis C infection rates were not significantly different between the two groups of states before the reformulation (0.350 vs. 0.260). But after 2010, there were large and statistically significant differences in the rates (1.128 vs. 0.455; P less than 0.01), they wrote, noting that the above-median states experienced an additional 0.58 HCV infections per 100,000 population through 2015 relative to the below-median states).
HCV infection rates declined during the 1990s followed by a plateau beginning around 2003, then rose sharply beginning in 2010, coinciding with the introduction of the release of the abuse-deterrent formulation of OxyContin, which is one of the most commonly misused opioid analgesics, the investigators said, explaining that the reformulated version was harder to crush or dissolve, making it more difficult to inhale or inject.
“Prior studies have shown that, after OxyContin became more difficult to abuse, some nonmedical users of OxyContin switched to heroin (a pharmacologically similar opiate),” they noted.
This led to a decline of more than 40% in OxyContin misuse but also to a sharp increase in heroin overdoses after 2010.
The investigators assessed whether the related increase in heroin use might explain the increase in HCV infections, which can be transmitted through shared needle use.
Using a quasi-experimental difference-in-differences approach, they examined whether states with higher exposure to the reformulated OxyContin had faster growth of HCV infection rates after the reformulations, and as a falsification exercise, they also looked at whether the nonmedical use of pain relievers other than OxyContin predicted post-reformulation HCV infection rate increases.
HCV infection rates for each calendar year from 2004 to 2015 were assessed using confirmed case reports collected by the Centers for Disease Control and Prevention, and nonmedical OxyContin use was measured using self-reported data from the National Survey on Drug Use and Health, which is the largest U.S. survey on substance use disorder.
The two groups of states had similar demographic and economic conditions, except that the above-median misuse states had smaller populations and a larger proportion of white residents.
Of note, the patterns of HCV infection mirrored those of heroin overdoses. There was small relative increase in HCV infection rates in 2010 in the above-median OxyContin misuse states, and the gap between above- and below-median misuse states widened more rapidly from 2011 to 2013. “This striking inflection point in the trend of hepatitis C infections for high-misuse states after 2010 mimics the inflection in heroin overdoses that occurred as a result of the reformulation,” they said, noting that heroin morality per 100,000 population was nearly identical in the two groups of states in the pre-reformulation period (0.859 and 0.847).
The falsification exercise looking at nonmedical use of pain relievers other than OxyContin in the two groups of states showed that after 2010 groups’ rates of hepatitis C infections grew at virtually identical rates.
“Thus, the differential risk in hepatitis C infections was uniquely associated with OxyContin misuse, rather than prescription pain reliever misuse more generally,” they said. “This suggests that it was the OxyContin reformulation, not other policies broadly affecting opioids, that drove much of the differential growth.”
The investigators controlled for numerous other factors, including opioid policies that might have an impact on OxyContin and heroin use, prescription drug monitoring programs and pain clinic regulations, as well as the role of major pill-mill crackdowns in 2010 and 2011.
The findings represent a “substantial public health concern,” they said, explaining that, while “considerable policy attention is being given to managing the opioid epidemic ... a ‘silent epidemic’ of hepatitis C has emerged as a result of a transition in the mode of administration toward injection drug use.”
In 2017, the CDC reported on this link between the opioid epidemic and rising HCV infection rates, as well.
Dr. Powell and his colleagues wrote.
Their findings regarding the unintended consequences of the OxyContin reformulation suggest that caution is warranted with respect to future interventions that limit the supply of abusable prescription opioids, they said, adding that “such interventions must be paired with polices that alleviate the harms associated with switching to illicit drugs, such as improved access to substance use disorder treatment and increased efforts aimed at identifying and treating diseases associated with injection drug use.”
However, policy makers and medical professionals also must recognize that reducing opioid-related mortality and increasing access to drug treatment might not be sufficient to fully address all of the public health consequences associated with the opioid crisis. As additional reformulations of opioids are promoted and more policies seek to limit access to prescription opioids, “both the medical and the law enforcement communities must recognize the critical transition from prescription opioids to other drugs, particularly those that are injected, and be prepared to consider complementary strategies that can effectively reduce the additional harms from the particular mode of drug use,” they concluded.
The coauthors cited several limitations, including the possibility that true hepatitis C infection rates might have been underestimated in the study.
He and Dr. Pacula received funding from the National Institute on Drug Abuse. Dr. Powell also cited funding from the Rand Alumni Impact Award.
SOURCE: Powell D et al. Health Aff. 2019;38(2):287-94.
FROM HEALTH AFFAIRS
Key clinical point: Physicians and others must be “prepared to consider complementary strategies that can effectively reduce the additional harms from the particular mode of drug use.”
Major finding: HCV rates increased 222% in states that had above-median OxyContin misuse rates, compared with an increase of 75% in states with below-median misuse.
Study details: A review of data from 2004 to 2015.
Disclosures: Dr. Powell and Dr. Pacula received funding from the National Institute on Drug Abuse. Dr. Powell also cited funding from the Rand Alumni Impact Award.
Source: Powell D et al. Health Aff. 2019;38(2):287-94.
No increase in severe community-acquired pneumonia after PCV13
Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.
This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.
The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.
Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.
“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.
“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”
This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.
“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.
Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”
Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.
Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.
SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.
Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.
This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.
The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.
Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.
“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.
“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”
This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.
“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.
Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”
Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.
Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.
SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.
Despite concern about the rise of nonvaccine serotypes following widespread PCV13 immunization, cases of community-acquired pneumonia (CAP) remain nearly as low as after initial implementation of the vaccine and severe cases have not risen at all.
This was the finding of a prospective time-series analysis study from eight French pediatric emergency departments between June 2009 and May 2017.
The 12,587 children with CAP enrolled in the study between June 2009 and May 2017 were all aged 15 years or younger and came from one of eight French pediatric EDs.
Pediatric pneumonia cases per 1,000 ED visits dropped 44% after PCV13 was implemented, a decrease from 6.3 to 3.5 cases of CAP per 1,000 pediatric visits from June 2011 to May 2014, with a slight but statistically significant increase to 3.8 cases of CAP per 1,000 pediatric visits from June 2014 to May 2017. However, there was no statistically significant increase in cases with pleural effusion, hospitalization, or high inflammatory biomarkers.
“These results contrast with the recent increase in frequency of invasive pneumococcal disease observed in several countries during the same period linked to serotype replacement beyond 5 years after PCV13 implementation,” reported Naïm Ouldali, MD, of the Association Clinique et Thérapeutique Infantile du Val-de-Marne in France, and associates. The report is in JAMA Pediatrics.
“This difference in the trends suggests different consequences of serotype replacement on pneumococcal CAP vs invasive pneumococcal disease,” they wrote. “The recent slight increase in the number of all CAP cases and virus involvement may reflect changes in the epidemiology of other pathogens and/or serotype replacement with less pathogenic serotypes.”
This latter point arose from discovering no dominant serotype during the study period. Of the 11 serotypes not covered by PCV13, none appeared in more than four cases.
“The implementation of PCV13 has led to the quasi-disappearance of the more invasive serotypes and increase in others in nasopharyngeal flora, which greatly reduces the frequency of the more severe forms of CAP, but could also play a role in the slight increase in frequency of the more benign forms,” the authors reported.
Among the study’s limitations was lack of a control group, precluding the ability to attribute findings to any changes in case reporting. And “participating physicians were encouraged to not change their practice, including test use, and no other potential interfering intervention.”
Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research and a Pfizer Investigator Initiated Research grant.
Dr Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received non-financial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer and/or Sanofi Pasteur.
SOURCE: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.
FROM JAMA PEDIATRICS
Key clinical point:
Major finding: Pediatric community-acquired pneumonia cases dropped from 6.3 to 3.5 cases per 1,000 visits from 2010 to 2014 and increased to 3.8 cases per 1,000 visits in May 2017.
Study details: The findings are based on a prospective time series analysis of 12,587 pediatric pneumonia cases (under 15 years old) in eight French emergency departments from June 2009 to May 2017.
Disclosures: Funding sources for this study included the Pediatric Infectious Diseases Group of the French Pediatrics Society, Association Clinique et Thérapeutique Infantile du Val-de-Marne, the Foundation for Medical Research, and a Pfizer Investigator Initiated Research grant. Dr. Ouldali has received grants from GlaxoSmithKline, and many of the authors have financial ties and/or have received nonfinancial support from AstraZeneca, Biocodex, GlaxoSmithKline, Merck, Novartis, Pfizer, and/or Sanofi Pasteur.
Source: Ouldali N et al. JAMA Pediatrics. 2019 Feb 4. doi: 10.1001/jamapediatrics.2018.5273.
Flu activity & measles outbreaks: Where we stand, steps we can take
Resources
Measles (Robeola). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/measles/index.html. Updated January 28, 2019. Accessed January 31, 2019.
Influenza (Flu). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/flu/index.htm. Updated January 25, 2019. Accessed January 31, 2019.
Resources
Measles (Robeola). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/measles/index.html. Updated January 28, 2019. Accessed January 31, 2019.
Influenza (Flu). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/flu/index.htm. Updated January 25, 2019. Accessed January 31, 2019.
Resources
Measles (Robeola). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/measles/index.html. Updated January 28, 2019. Accessed January 31, 2019.
Influenza (Flu). Centers for Disease Control and Prevention Web site. https://www.cdc.gov/flu/index.htm. Updated January 25, 2019. Accessed January 31, 2019.
