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HCV Tx-as-Prevention Strategy Seems to Work in HIV+ MSM

— Two studies examined containing HCV in this population via treatment

Last Updated March 12, 2018
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BOSTON -- Two trials successfully examined a "treatment as prevention" strategy for hepatitis C in mostly HIV-infected men who have sex with men (MSM), and were reported by researchers here.

The first trial found that for hepatitis C virus (HCV)-infected MSM, a shorter 8-week course of grazoprevir/elbasvir, a direct-acting antiviral combination therapy for acute HCV infection was comparable to a 12-week treatment.

After 8 weeks of treatment, a sustained virologic response at 12 weeks (SVR12) was observed in 98% (95% CI 90-100%) of patients with HCV genotypes 1 and 4, reported Anne Boerekamps, MD, of Erasmus University Medical Center in Rotterdam, The Netherlands, and colleagues.

Action Points

  • Note that these studies were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • Note that two studies suggest that the treatment of hepatitis C virus (HCV) in HIV-infected men who have sex with men (MSM) is both highly effective and likely to reduce further transmission.
  • One study examined incident infections, and the other prevalent infections, but treatment efficacy was greater than 90% in both cases.

Due to the ongoing, potentially unexplained, epidemic of hepatitis C in HIV-positive MSM, and the lack of evidence for behavioral intervention, the "treatment as prevention" strategy in this population is very important, Boerekamps said at a press conference at the Conference on Retroviruses and Opportunistic Infections (CROI).

"A recent modeling study showed that if you can treat patients in the acute phase with a shorter duration of therapy, which is cheaper, it could be cost-saving if you do it in a group with high risk of transmitting the virus to others."

The team conducted a small multicenter trial in the Netherlands and Belgium for adults with HCV genotypes 1 and 4. Therapy was started less than 6 months after the estimated date of infection, with a primary endpoint of SVR1 in the intention-to-treat population.

Patients were MSM who acquired HCV through sex. Their mean age was 47, and 90% were Caucasian. A little less than two-thirds of patients were HCV genotype 1a, and the median time between estimated infection date and HCV treatment was 4.4 months. Over 90% of patients had HIV co-infection, with a median CD4 count of 604; viral load for nearly all patients was <50 copies/mL. Median HCV viral load at the entry of the study was 3.67E5 IU/ml.

A total of 80 patients initiated treatment, and data on 63 were available 12 weeks after therapy; 59 patients tested negative for HCV RNA, and four tested positive. Of these four, three were re-infected and only one had his infection relapse. The authors noted that all 13 patients with a baseline viral load >10E6 IU/ml reached an SVR12.

Re-infection was not defined as "failure" in the study, the researchers noted, but if it was, SVR12 would be 94% (exact 95% CI 85%-98%), and thus still non-inferior to an SVR12 rate in the prior C-EDGE trial.

A second late-breaking study, presented by Dominique Braun, MD, of the University of Zurich in Switzerland, found that a three-phase approach reduced HCV infections in HIV-infected MSM by 49%, and cut chronic HCV infections by nearly 93% from phase A through phase C.

The team examined a cohort of patients from the Swiss HIV Cohort Study. Phase A of the Swiss HCVree trial screened 3,722 HIV-infected MSM via HCV-polymerase chain reaction (PCR) testing. Of these, nearly 5% tested positive, with 147 chronic HCV infections and 30 incident infections -- defined as a negative HCV-PCR prior to Phase A screening and a positive HCV-PCR in Phase A; chronic infections tested positive prior to Phase A.

In Phase B, these 147 patients initiated treatment with 12 weeks of grazoprevir/elbasvir, unless they were contraindicated for the treatment. In total, 91% of these patients were treated, and the SVR12 was 99.5%.

The treatment intervention was combined with an intervention to reduce sexual risk behavior to lessen the possibility of infection, Braun noted at the press conference.

Phase C was a re-screening of all 3,722 patients, where only 28 patients then tested positive for HCV (0.8%), with 16 incident infections and 12 chronic infections. Of these, 22 of 28 of newly diagnosed MSM were treated with direct-acting antivirals during phase C for an SVR12 of 100%.

Braun said he believed the approach could serve as a model to reach World Health Organization targets in reducing the number of new hepatitis C infections.

However, David Thomas, MD, of Johns Hopkins University in Baltimore, who moderated the press conference but was not involved in the research, said while the idea of immediately treating hepatitis C in this population makes a lot of sense on all levels, there is "insufficient data at this point -- whether or not it's going to change guidelines remains to be seen."

Disclosures

Boerekamps disclosed no conflicts of interest, but noted the investigator-initiated study was conducted with financial support from Merck Sharp & Dohme.

Braun disclosed support from Merck Sharp & Dohme, and research grants to his institution for the Swiss HIV Cohort Study and the University of Zurich's Clinical Research Priority Program Viral Infectious Diseases Zurich Primary HIV Infection Study.

Primary Source

Conference on Retroviruses and Opportunistic Infections

Boerekamps A, et al "8 weeks of grazoprevir/elbasvir for acute HCV: A multicenter clinical trial (DAHHS 2)" CROI 2018; Abstract 128.

Secondary Source

Conference on Retroviruses and Opportunistic Infections

Braun DL, et al "A treatment as prevention trial to eliminate HCV in HIV+ MSM: the Swiss HCVree trial" CROI 2018; Abstract 81LB.