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Sofosbuvir and ribavirin for Hepatitis C in patients with HIV coinfection

This week's publication of the Journal of the American Medical Association determines the rates of HCV eradication, and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.

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Treatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.

Dr Mark Sulkowski and colleagues determined the rates of HCV eradication, and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.

The research team performed an open-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV.

Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less, and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL.

In treatment-na´ve patients, 88% of genotype 2 achieved sustained virological response at 12 weeks after cessation of therapy
Journal of the American Medical Association

Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants.

Treatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks.

The team's primary study outcome was the proportion of patients with sustained virological response 12 weeks after cessation of HCV therapy.

The research team found that among treatment-naive participants, 76% with genotype 1, 88% with genotype 2, and 67% with genotype 3 achieved sustained virological response at 12 weeks after cessation of therapy.

Among treatment-experienced participants, 92% of genotype 2 achieved sustained virological response at 12 weeks after cessation of therapy.

The team observed that the most common adverse events were fatigue, insomnia, headache, and nausea.

The research team noted that 3% of patients discontinued HCV treatment due to adverse events.

No adverse effect on HIV disease or its treatment was observed.

Dr Sulkowski's team concludes, "In this open-label, nonrandomized, uncontrolled study, patients with HIV who were coinfected with HCV genotype 1, 2, or 3 who received the oral, interferon-free combination of sofosbuvir and ribavirin for 12 or 24 weeks had high rates of sustained virological response at 12 weeks after cessation of therapy."

"Further studies of this oral regimen in diverse populations of coinfected patients are warranted.

JAMA 2014;312(4): 353-361
23 July 2014

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