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Hep Talk by Larry Buhl

For MSMs: treatment hope for HCV—and a warning

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There’s more evidence of the effectiveness of new antiretroviral drugs in treating the hepatitis C virus (HCV). This time it’s a study, presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013) in March in Atlanta, that showed adding telaprevir (Incivek) to pegylated interferon and ribavirin shortens the duration of therapy and improves the likelihood of a cure for HIV-positive men with acute sexually transmitted hepatitis C.

Daniel Fierer from Mt. Sinai Medical Center in New York City performed an open-label pilot study to see if adding the direct-acting HCV protease inhibitor telaprevir to interferon-based therapy could increase response to treatment for acute HCV infection and shorten the duration of therapy.

Fierer included eligible patients consecutively enrolled at a single clinical practice between July 2011 and September 2012. Patients were sexually active HIV-positive men who have sex with men, who were recently found to have newly elevated ALT (alanine aminotransferase) and tested positive for HCV genetic material or antibodies. Within six months of their first noted ALT elevation, participants were started on a twelve-week triple combination regimen of 750 mg (or 1125 mg if using efavirenz) thrice-daily oral telaprevir, 180 mcg once-weekly injected pegylated interferon 2a (Pegasys), and twice-daily weight-based oral ribavirin.

Of the forty participants initially enrolled, half were never treated; seven had HCV genotypes other than one (the only one for which telaprevir is indicated), five did not have insurance that would cover telaprevir for this unapproved purpose, and one had unmanageable interactions with his ART regimen. In addition, five people spontaneously cleared HCV before starting therapy and two refused treatment. Eighty-five percent of the twenty treated participants were white and the median age was forty-four years; eighteen had the more difficult-to-treat HCV subtype 1a.

The good news: Sixty-five percent had IL28B CC gene pattern associated with good interferon response. Summarizing these results, Fierer said that starting pegylated interferon/ribavirin treatment during acute rather than chronic HCV infection doubles the sustained response rate in half the time, and adding telaprevir is “twice as good” and cuts treatment time in half again. He suggested that triple therapy should be a new standard for treatment of acute genotype 1 HCV in HIV-infected patients.

But he added a few caveats, when talking with A&U magazine: “First, this was not a randomized, controlled study. Second, it was a small sample. And third, even with these favorable results, there were about a third not cured. I was hoping to cure more patients with this regimen.”

A warning for MSMs
Beyond the study caveats, there was an implication about Fierer’s presentation that was more provocative: the group Fierer studied. Since the mid-2000s Fierer’s team has been following HIV-positive gay and bisexual men with sexually transmitted hepatitis C, some of whom have experienced rapid liver disease progression. He’s been following these men, he says, because of his concern that men who have sex with men are generally unaware of the risks of HCV. And they should be aware, he says.

“There is a new risk group for hep C now, and that’s HIV-positive men who have sex with men. If they are having sex with other HIV-infected men, they are also putting themselves at risk for hep C. The CDC is not identifying these men as a risk group, but the fact is hepatitis can be transmitted sexually. It’s not as easy to get as HIV, but it can and does happen.”

Fierer added that, included in his study results should be a prevention message. “Condoms are still needed, so wrap it up, guys.”

Larry Buhl is a radio news reporter, screenwriter, and novelist living in Los Angeles. His young adult novel, The Genius of Little Things, debuted in January 2013. His comic mystery novel, We’re Here to Help, will be available later in 2013.

Read this article in the May 2013 digital issue by clicking here.