Most HIV patients need treatment for acute HCV

BOSTON – Fewer than 12% of HIV infected men will clear new hepatitis C infections on their own.

If they haven’t had a 2-log drop in their hepatitis C virus (HCV) RNA loads after a month, they aren’t going to clear the infection, and need direct-acting antiretrovirals (DAAs), according to an observational European study of 465 HIV patients with newly acquired HCV infections, almost all of them men who have sex with men (MSM).

The findings spoke to a hot topic at the Conference on Retroviruses & Opportunistic Infections (CROI): DAAs for acute HCV infection in patients with HIV. It’s a pressing problem; the incidence of sexually transmitted HCV among MSM with HIV is rising worldwide.

However, on both sides of the Atlantic, DAAs are indicated only for chronic HCV, which usually means infection for 6 months or more, because a third or so of patients will clear the infection on their own. The drugs are expensive, and reimbursements don’t generally kick in until after the waiting period.

That’s a problem with HIV coinfection, and not just because far fewer patients will rid themselves of the virus. HCV is most likely to be spread by sexual contact in the acute phase; allowing patients destined to become chronic carriers to linger without treatment means that the infection will probably spread to new partners, according to researchers at CROI,

Proactive measures could help. Swiss investigators reported a 50% drop in new HCV infections when HIV-positive MSM were screened for the infection then treated immediately with DAAs. Some at the meeting argued that HCV screening – and treatment – should be automatic for patients taking pre-exposure HIV prophylaxis, as well as for newly diagnosed HIV.

Several said that, on a population level, treatment in the acute phase would save money by preventing new infections. It’s also cheaper to treat in the acute phase because coinfected patients only need 8 weeks of DAA treatment rather than the usual 12-16 for chronic infection, according to another European study at the meeting.

“The idea of targeting acute HCV makes a lot of sense on all levels. If treatment” among patients with HIV “is two-thirds as long and more than two-thirds have persistent infection, there is no reason to hold” off just because of cost, said David Thomas, MD, director of the division of infectious diseases at Johns Hopkins University, Baltimore, who moderated the study presentations.

 

Eight weeks is enough

The efficacy of an 8-week treatment course was established in a study of 63 MSM in the Netherlands and Belgium. They were 47 years old, on average, and all but three were HIV positive; two-thirds had HCV genotype 1, and the rest had genotype 4, some with extremely high viral loads.

Subjects received grazoprevir/elbasvir (Zepatier) once daily for 8 weeks, beginning at a mean of 4.5 months after their estimated infection date, and all within 6 months. Twelve weeks after the end of therapy, 59 (94%) were negative for HCV RNA on blood tests. Three of the patients who were still positive for HCV had new infections; the remaining patient had relapsed, and was the only true treatment failure.

“We can say that 8 weeks of grazoprevir/elbasvir for acute HCV was safe, highly effective, and noninferior compared to studies with longer treatment. On an individual level, you can wait for spontaneous clearance, but on the population level, by treating all patients in the acute phase, you prevent spread of hepatitis C,” said lead investigator Anne Boerekamps, PhD, of Erasmus University Medical Center, Rotterdam, Netherlands.

 

The 2-log cutoff

“We are withholding effective treatment from people just because we’re concerned about the money,” said Christoph Boesecke, MD, of Bonn (Germany) University Hospital, who was the lead investigator in the study that found low spontaneous clearance rates with HIV coinfection.

Almost all the 465 subjects were on combination antiretroviral HIV therapy. Most had HCV genotype 1, but there were also type 3 and 4 cases. The investigators followed their subjects for at least a year after HCV infection. Just 55 (11.8%) cleared the infection on their own.

“Almost 90% of acutely infected patients face a chronic course. ... DAA drug labels, as well as clinical guidelines, need to be amended to allow usage of DAA during the acute phase of HCV infection in a high-risk population,” Dr. Boesecke and his team concluded.

Clearance was harbingered by a 2-log decline in HCV RNA by week 4. The 2-log drop cutoff is “the best predictor [we have] ... to identify patients” for early treatment. “There may be some patients you overtreat, but we have to keep in mind that we are not causing any harms with DAAs; maybe harms in terms of money, but not in terms of toxicity,” he said.

The message is beginning to get out. New European AIDS Clinical Society guidelines recommend DAA treatment for patients with HIV who don’t have a 2-log drop after a month.

 

‘Treatment as prevention’ works

The Swiss study added evidence to the frequent assertion at CROI that early treatment stops the spread of HCV.

The investigators screened 3,722 MSM from the Swiss HIV Cohort Study and found 178 (4.8%) men with replicating genotype 1 or 4 HCV infections. Of these cases, 31 were deemed incident and 147 chronic. Almost all the men agreed to treatment with standard-of-care DAAs, usually grazoprevir/elbasvir plus or minus ribavirin. Just about everyone had a sustained virologic response 12 weeks later.

The team rescreened the men after about a year, and found 28 infections; 16 were newly acquired, almost a 50% drop from baseline. The remaining 12 infections were chronic cases not treated earlier.

“Systemic screening followed by prompt DAA treatment can serve as a model to eliminate HCV in coinfected MSM,” said lead investigator Dominique Braun, MD, of the University of Zurich.

Dr. Boesecke is a consultant and/or speaker for AbbVie, Gilead Sciences, Janssen, Merck, and ViiV Healthcare. Dr. Thomas is a Merck consultant. Dr. Boerekamps and Dr. Braun’s studies were both funded by Merck, maker of elbasvir/grazoprevir.

aotto@frontlinemedcom.com

SOURCE: Anne Boerekamps. 2018 CROI, Abstract 128. Christoph Boesecke. 2018 CROI, Abstract 129. Dominique Braun. 2018 CROI, Abstract 81LB.






 

BOSTON – Fewer than 12% of HIV infected men will clear new hepatitis C infections on their own.

If they haven’t had a 2-log drop in their hepatitis C virus (HCV) RNA loads after a month, they aren’t going to clear the infection, and need direct-acting antiretrovirals (DAAs), according to an observational European study of 465 HIV patients with newly acquired HCV infections, almost all of them men who have sex with men (MSM).

The findings spoke to a hot topic at the Conference on Retroviruses & Opportunistic Infections (CROI): DAAs for acute HCV infection in patients with HIV. It’s a pressing problem; the incidence of sexually transmitted HCV among MSM with HIV is rising worldwide.

However, on both sides of the Atlantic, DAAs are indicated only for chronic HCV, which usually means infection for 6 months or more, because a third or so of patients will clear the infection on their own. The drugs are expensive, and reimbursements don’t generally kick in until after the waiting period.

That’s a problem with HIV coinfection, and not just because far fewer patients will rid themselves of the virus. HCV is most likely to be spread by sexual contact in the acute phase; allowing patients destined to become chronic carriers to linger without treatment means that the infection will probably spread to new partners, according to researchers at CROI,

Proactive measures could help. Swiss investigators reported a 50% drop in new HCV infections when HIV-positive MSM were screened for the infection then treated immediately with DAAs. Some at the meeting argued that HCV screening – and treatment – should be automatic for patients taking pre-exposure HIV prophylaxis, as well as for newly diagnosed HIV.

Several said that, on a population level, treatment in the acute phase would save money by preventing new infections. It’s also cheaper to treat in the acute phase because coinfected patients only need 8 weeks of DAA treatment rather than the usual 12-16 for chronic infection, according to another European study at the meeting.

“The idea of targeting acute HCV makes a lot of sense on all levels. If treatment” among patients with HIV “is two-thirds as long and more than two-thirds have persistent infection, there is no reason to hold” off just because of cost, said David Thomas, MD, director of the division of infectious diseases at Johns Hopkins University, Baltimore, who moderated the study presentations.

 

Eight weeks is enough

The efficacy of an 8-week treatment course was established in a study of 63 MSM in the Netherlands and Belgium. They were 47 years old, on average, and all but three were HIV positive; two-thirds had HCV genotype 1, and the rest had genotype 4, some with extremely high viral loads.

Subjects received grazoprevir/elbasvir (Zepatier) once daily for 8 weeks, beginning at a mean of 4.5 months after their estimated infection date, and all within 6 months. Twelve weeks after the end of therapy, 59 (94%) were negative for HCV RNA on blood tests. Three of the patients who were still positive for HCV had new infections; the remaining patient had relapsed, and was the only true treatment failure.

“We can say that 8 weeks of grazoprevir/elbasvir for acute HCV was safe, highly effective, and noninferior compared to studies with longer treatment. On an individual level, you can wait for spontaneous clearance, but on the population level, by treating all patients in the acute phase, you prevent spread of hepatitis C,” said lead investigator Anne Boerekamps, PhD, of Erasmus University Medical Center, Rotterdam, Netherlands.

 

The 2-log cutoff

“We are withholding effective treatment from people just because we’re concerned about the money,” said Christoph Boesecke, MD, of Bonn (Germany) University Hospital, who was the lead investigator in the study that found low spontaneous clearance rates with HIV coinfection.

Almost all the 465 subjects were on combination antiretroviral HIV therapy. Most had HCV genotype 1, but there were also type 3 and 4 cases. The investigators followed their subjects for at least a year after HCV infection. Just 55 (11.8%) cleared the infection on their own.

“Almost 90% of acutely infected patients face a chronic course. ... DAA drug labels, as well as clinical guidelines, need to be amended to allow usage of DAA during the acute phase of HCV infection in a high-risk population,” Dr. Boesecke and his team concluded.

Clearance was harbingered by a 2-log decline in HCV RNA by week 4. The 2-log drop cutoff is “the best predictor [we have] ... to identify patients” for early treatment. “There may be some patients you overtreat, but we have to keep in mind that we are not causing any harms with DAAs; maybe harms in terms of money, but not in terms of toxicity,” he said.

The message is beginning to get out. New European AIDS Clinical Society guidelines recommend DAA treatment for patients with HIV who don’t have a 2-log drop after a month.

 

‘Treatment as prevention’ works

The Swiss study added evidence to the frequent assertion at CROI that early treatment stops the spread of HCV.

The investigators screened 3,722 MSM from the Swiss HIV Cohort Study and found 178 (4.8%) men with replicating genotype 1 or 4 HCV infections. Of these cases, 31 were deemed incident and 147 chronic. Almost all the men agreed to treatment with standard-of-care DAAs, usually grazoprevir/elbasvir plus or minus ribavirin. Just about everyone had a sustained virologic response 12 weeks later.

The team rescreened the men after about a year, and found 28 infections; 16 were newly acquired, almost a 50% drop from baseline. The remaining 12 infections were chronic cases not treated earlier.

“Systemic screening followed by prompt DAA treatment can serve as a model to eliminate HCV in coinfected MSM,” said lead investigator Dominique Braun, MD, of the University of Zurich.

Dr. Boesecke is a consultant and/or speaker for AbbVie, Gilead Sciences, Janssen, Merck, and ViiV Healthcare. Dr. Thomas is a Merck consultant. Dr. Boerekamps and Dr. Braun’s studies were both funded by Merck, maker of elbasvir/grazoprevir.

aotto@frontlinemedcom.com

SOURCE: Anne Boerekamps. 2018 CROI, Abstract 128. Christoph Boesecke. 2018 CROI, Abstract 129. Dominique Braun. 2018 CROI, Abstract 81LB.






 

BOSTON – Fewer than 12% of HIV infected men will clear new hepatitis C infections on their own.

If they haven’t had a 2-log drop in their hepatitis C virus (HCV) RNA loads after a month, they aren’t going to clear the infection, and need direct-acting antiretrovirals (DAAs), according to an observational European study of 465 HIV patients with newly acquired HCV infections, almost all of them men who have sex with men (MSM).

The findings spoke to a hot topic at the Conference on Retroviruses & Opportunistic Infections (CROI): DAAs for acute HCV infection in patients with HIV. It’s a pressing problem; the incidence of sexually transmitted HCV among MSM with HIV is rising worldwide.

However, on both sides of the Atlantic, DAAs are indicated only for chronic HCV, which usually means infection for 6 months or more, because a third or so of patients will clear the infection on their own. The drugs are expensive, and reimbursements don’t generally kick in until after the waiting period.

That’s a problem with HIV coinfection, and not just because far fewer patients will rid themselves of the virus. HCV is most likely to be spread by sexual contact in the acute phase; allowing patients destined to become chronic carriers to linger without treatment means that the infection will probably spread to new partners, according to researchers at CROI,

Proactive measures could help. Swiss investigators reported a 50% drop in new HCV infections when HIV-positive MSM were screened for the infection then treated immediately with DAAs. Some at the meeting argued that HCV screening – and treatment – should be automatic for patients taking pre-exposure HIV prophylaxis, as well as for newly diagnosed HIV.

Several said that, on a population level, treatment in the acute phase would save money by preventing new infections. It’s also cheaper to treat in the acute phase because coinfected patients only need 8 weeks of DAA treatment rather than the usual 12-16 for chronic infection, according to another European study at the meeting.

“The idea of targeting acute HCV makes a lot of sense on all levels. If treatment” among patients with HIV “is two-thirds as long and more than two-thirds have persistent infection, there is no reason to hold” off just because of cost, said David Thomas, MD, director of the division of infectious diseases at Johns Hopkins University, Baltimore, who moderated the study presentations.

 

Eight weeks is enough

The efficacy of an 8-week treatment course was established in a study of 63 MSM in the Netherlands and Belgium. They were 47 years old, on average, and all but three were HIV positive; two-thirds had HCV genotype 1, and the rest had genotype 4, some with extremely high viral loads.

Subjects received grazoprevir/elbasvir (Zepatier) once daily for 8 weeks, beginning at a mean of 4.5 months after their estimated infection date, and all within 6 months. Twelve weeks after the end of therapy, 59 (94%) were negative for HCV RNA on blood tests. Three of the patients who were still positive for HCV had new infections; the remaining patient had relapsed, and was the only true treatment failure.

“We can say that 8 weeks of grazoprevir/elbasvir for acute HCV was safe, highly effective, and noninferior compared to studies with longer treatment. On an individual level, you can wait for spontaneous clearance, but on the population level, by treating all patients in the acute phase, you prevent spread of hepatitis C,” said lead investigator Anne Boerekamps, PhD, of Erasmus University Medical Center, Rotterdam, Netherlands.

 

The 2-log cutoff

“We are withholding effective treatment from people just because we’re concerned about the money,” said Christoph Boesecke, MD, of Bonn (Germany) University Hospital, who was the lead investigator in the study that found low spontaneous clearance rates with HIV coinfection.

Almost all the 465 subjects were on combination antiretroviral HIV therapy. Most had HCV genotype 1, but there were also type 3 and 4 cases. The investigators followed their subjects for at least a year after HCV infection. Just 55 (11.8%) cleared the infection on their own.

“Almost 90% of acutely infected patients face a chronic course. ... DAA drug labels, as well as clinical guidelines, need to be amended to allow usage of DAA during the acute phase of HCV infection in a high-risk population,” Dr. Boesecke and his team concluded.

Clearance was harbingered by a 2-log decline in HCV RNA by week 4. The 2-log drop cutoff is “the best predictor [we have] ... to identify patients” for early treatment. “There may be some patients you overtreat, but we have to keep in mind that we are not causing any harms with DAAs; maybe harms in terms of money, but not in terms of toxicity,” he said.

The message is beginning to get out. New European AIDS Clinical Society guidelines recommend DAA treatment for patients with HIV who don’t have a 2-log drop after a month.

 

‘Treatment as prevention’ works

The Swiss study added evidence to the frequent assertion at CROI that early treatment stops the spread of HCV.

The investigators screened 3,722 MSM from the Swiss HIV Cohort Study and found 178 (4.8%) men with replicating genotype 1 or 4 HCV infections. Of these cases, 31 were deemed incident and 147 chronic. Almost all the men agreed to treatment with standard-of-care DAAs, usually grazoprevir/elbasvir plus or minus ribavirin. Just about everyone had a sustained virologic response 12 weeks later.

The team rescreened the men after about a year, and found 28 infections; 16 were newly acquired, almost a 50% drop from baseline. The remaining 12 infections were chronic cases not treated earlier.

“Systemic screening followed by prompt DAA treatment can serve as a model to eliminate HCV in coinfected MSM,” said lead investigator Dominique Braun, MD, of the University of Zurich.

Dr. Boesecke is a consultant and/or speaker for AbbVie, Gilead Sciences, Janssen, Merck, and ViiV Healthcare. Dr. Thomas is a Merck consultant. Dr. Boerekamps and Dr. Braun’s studies were both funded by Merck, maker of elbasvir/grazoprevir.

aotto@frontlinemedcom.com

SOURCE: Anne Boerekamps. 2018 CROI, Abstract 128. Christoph Boesecke. 2018 CROI, Abstract 129. Dominique Braun. 2018 CROI, Abstract 81LB.