Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): A multicentre, open-label, non-randomised, phase 3 study

Jean Michel Molina, Chloe Orkin, David M. Iser, Francisco Xavier Zamora, Mark Nelson, Christoph Stephan, Benedetta Massetto, Anuj Gaggar, Liyun Ni, Evguenia Svarovskaia, Diana Brainard, G. Mani Subramanian, John G. McHutchison, Massimo Puoti, Jürgen K. Rockstroh

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Abstract

Background Although interferon-free regimens are approved for patients co-infected with HIV and genotype-2 or genotype-3 hepatitis C virus (HCV), interferon-based regimens are still an option for those co-infected with HIV and HCV genotypes 1 or 4. These regimens are limited by clinically significant toxic effects and drug interactions with antiretroviral therapy. We aimed to assess the efficacy and safety of an interferon-free, all-oral regimen of sofosbuvir plus ribavirin in patients with HIV and HCV co-infection. Methods We did this open-label, non-randomised, uncontrolled, phase 3 study at 45 sites in seven European countries and Australia. We enrolled patients (aged ≥18 years) co-infected with stable HIV and chronic HCV genotypes 1-4, including those with compensated cirrhosis. Once-daily sofosbuvir (400 mg) plus twice-daily ribavirin (1000 mg in patients with bodyweights

Original languageEnglish (US)
Pages (from-to)1098-1106
Number of pages9
JournalThe Lancet
Volume385
Issue number9973
DOIs
Publication statusPublished - Mar 21 2015
Externally publishedYes

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ASJC Scopus subject areas

  • Medicine(all)

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