Comparison of high ribavirin induction versus standard ribavirin dosing, plus peginterferon-for the treatment of chronic hepatitis C in HIV-infected patients: The PERICO trial

Abstract

Background. Ribavirin (RBV) exposure seems to be critical to maximize treatment response in human immunodeficiency virus (HIV)-positive patients with chronic hepatitis C virus (HCV) infection. Methods .HIV/HCV-coinfected individuals naive to interferon were prospectively randomized to receive peginterferon-α-2a (180 μg/d) plus either RBV standard dosing (1000 or 1200 mg/d if <75 or ≥75 kg, respectively) or RBV induction (2000 mg/d) along with subcutaneous erythropoietin (450 IU/kg/wk), both during the first 4 weeks, followed by standard RBV dosing until completion of therapy. Early stopping rules at weeks 12 and 24 were applied in patients with suboptimal virological response. Results .A total of 357 patients received ≥1 dose of the study medication. No differences in main baseline characteristics were found when comparing treatment arms. Sustained virological response (SVR) was attained by 160 (45) patients, with no significant differences between RBV induction and standard treatment arms (SVR in 72 of 169 patients [43] vs 88 of 188 [47], respectively). At week 4, undetectable HCV RNA (29 vs 25) and mean RBV trough concentration (2.48 vs 2.14 g/mL) were comparable in both arms, whereas mean hemoglobin decay was less pronounced in the RBV induction plus erythropoietin arm than in the RBV standard dosing arm (-1.7 vs-2.3 mg/dL; P