1University of Paris Diderot, Paris 7 and Department of Infectious Diseases, Saint-Louis Hospital, Paris, France. Electronic address: firstname.lastname@example.org.
2Barts Health National Health Service Trust, London, UK.
3Infectious Diseases Unit, Alfred Hospital, Melbourne, VIC, Australia.
4HIV Unit, Internal Medicine Service, Hospital Universitario La Paz (IdiPAZ), Madrid, Spain.
5Chelsea and Westminster Hospital, St Stephens Centre, London, UK.
6Infectious Diseases Unit at Medical Department, Hospital of the Johann Wolfgang Goethe-University, Frankfurt, Germany.
7Gilead Sciences, Foster City, CA, USA.
8Division of Infectious Diseases, AO Ospedale Niguarda Ca' Granda, Milan, Italy.
9Department of General Internal Medicine I, University Hospital of Bonn, Bonn, Germany.
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.
Between Feb 7, 2013, and July 29, 2013, we enrolled 275 eligible patients, of whom 262 (95%) completed treatment; 274 patients were included in the final analysis. Overall rates of sustained virological response 12 weeks after treatment were 85% (95% CI 77-91) in patients with genotype-1 HCV, 88% (69-98) in patients with genotype-2 HCV, 89% (81-94) in patients with genotype-3 HCV, and 84% (66-95) in patients with genotype-4 HCV. Response rates in treatment-naive patients with HCV genotypes 2 or 3 (89% [95% CI 67-99] and 91% [81-97], respectively) were similar to those in treatment-experienced patients infected with those genotypes (83% [36-100] and 86% [73-94], respectively). There was no emergence of sofosbuvir-resistance mutations in patients with HCV viral relapse. Six (2%) patients discontinued treatment because of adverse events. The most common adverse events were fatigue, insomnia, asthenia, and headache. Four (1%) patients had serious adverse events regarded as related to study treatment. Additionally, four (1%) patients receiving antiretroviral treatment had a transient HIV viral breakthrough; however, none required changes in antiretroviral regimen.
Sofosbuvir and ribavirin provided high rates of sustained virological response after 12 weeks of treatment in treatment-naive and treatment-experienced patients co-infected with HIV and HCV genotypes 1-4. The characteristics of this interferon-free combination regimen make sofosbuvir plus ribavirin a useful treatment option for this patient population.