ACTG A5294: A Prospective, Phase III Open-Label Study of Response-Guided Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in HCV/HIV Coinfected Subjects

Investigator: Anne Luetkemeyer, MD
Sponsor: Merck and Co., Inc.

Location(s): United States


Hepatitis C virus (HCV) infection is a leading cause of death and illness in people with HIV-1. Currently, the standard treatment for people with HIV-1 and HCV coinfection includes two drugs—pegylated-interferon alfa 2b (PEG-IFN) and ribavirin (RBV). The purpose of this study is to evaluate the effectiveness of giving boceprevir (BOC) together with standard treatment in treating HCV infection in people with HIV-1 and HCV coinfection.

For HIV-1-infected individuals, HCV infection is a leading cause of morbidity and mortality, and the prevalence of HCV infection is higher among those infected with HIV-1. The current standard-of-care (SOC) therapy for HCV infection is treatment with both PEG-IFN and RBV. This therapy is 40%-45% effective in patients with HCV infection but is significantly less effective in patients with both HCV and HIV-1. This study will evaluate the effectiveness of adding BOC, a novel HCV protease inhibitor, to SOC therapy in treating HCV infection (genotype 1) in HCV/HIV-1-coinfected adults.

Participants will be assigned to one of two groups based on previous HCV treatment. Group A will include HCV treatment-naive participants who have never received treatment with PEG-IFN or experimental agents used to treat HCV, with or without RBV. Group B will include HCV treatment-experienced participants who have received any treatment with standard interferon or with PEG-IFN with or without RBV, provided the last dose of treatment was 90 days or more before study entry. All participants should be on stable antiretroviral therapy (ART) for at least 8 weeks prior to study entry using a dual nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone plus one of the following: efavirenz (EFV), raltegravir (RAL), lopinavir (LPV)/ritonavir (RTV) 400/100 mg twice daily, atazanavir (ATV)/RTV, darunavir (DRV)/RTV 600/100 mg twice daily OR not have received any ART for at least 4 weeks immediately prior to entry. Participation in this study will last approximately 72 weeks.