乌鸦传媒

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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.

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 3.67^E5 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 >10^E6 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."