Peginterferon alfa-2a Plus Ribavirin for HIV-HCV Genotype 1 Coinfected Patients: A Randomized International Trial

• DOI: 10.1310/hct1303-142
• Publication Date: 2012-06-08T18:37:06Z
• Authors: Maribel Rodriguez...; Jihad Slim; Laveeza Bhatti; Richard Sterling; Mark Sulkowski; Tarek Hassanein; Rosário Serrão; Ricard Sola; Anne Bertasso; Sharon Passe, and; Saray Stancic
• Keywords: Adult; Male; 0303 health sciences; Genotype; Coinfection; Interferon-alpha; HIV Infections; Hepacivirus; Middle Aged; Antiviral Agents; Hepatitis C; Recombinant Proteins; CD4 Lymphocyte Count; Polyethylene Glycols; 3. Good health; 03 medical and health sciences; Double-Blind Method; Ribavirin; Humans; Drug Therapy, Combination; Female

The safety and efficacy of weight-based ribavirin (RBV) dosing regimens in patients with HIV-HCV coinfection has not been demonstrated in randomized clinical trials.This randomized, double-blind, international, parallel-group study in specialist outpatient clinics in the United States, Spain, and Portugal compares the efficacy and safety of 2 RBV dose regimens (800 mg/day and 1000/1200 mg/day) combined with peginterferon alfa-2a (40KD) in patients with HIV-HCV (genotype 1) coinfection.Patients with HIV-HCV coinfection, quantifiable HCV RNA in serum, HCV genotype-1 infection, compensated liver disease, and stable HIV disease (CD4+ count ≥100 cells/µL) with or without ongoing antiretroviral therapy were randomized to 48 weeks' treatment with RBV at standard dose (800 mg/day) or weight-based dose (1000 mg/day for patients weighing <75 kg; 1200 mg/day for patients weighing ≥75 kg) in combination with peginterferon alfa-2a (40KD) 180 µg once a week. Planned enrollment was 400 patients with ≥100 non-Latino African Americans. The primary endpoint was sustained virological response (SVR) (undetectable HCV RNA [<20 IU/mL] at the end of a 24-week untreated follow-up period [week 72]).SVR rates were 19% (26/135) and 22% (60/275) in patients randomized to RBV 800 mg/day and 1000/1200 mg/day, respectively (odds ratio, 1.15; 95% CI, 0.68-1.93; P = .6119). In the 1000/1200 mg/day RBV dose group, the incidence of hemoglobin reductions <100 g/L and anaemia reported as an adverse event were higher versus the standard 800 mg/day RBV dose group.Compared with the standard RBV dose (800 mg/day), weight-based RBV dosing (1000/1200 mg/day) did not significantly increase SVR rates, but did increase the incidence of anemia in HIV-HCV (genotype 1) coinfected patients.