Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: A randomized international trial

Maribel Rodriguez-Torres, Jihad Slim, Laveeza Bhatti, Richard Sterling, Mark Sulkowski, Tarek Hassanein, Rosário Serrão, Ricard Sola, Anne Bertasso, Sharon Passe, Saray Stancic

Research output: Contribution to journalArticle

Abstract

Background: 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. Objective: 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. Methods: Patients with HIV-HCV coinfec-tion, 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]). Results: 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)142-152
Number of pages11
JournalHIV Clinical Trials
Volume13
Issue number3
DOIs
StatePublished - Jan 1 2012

Keywords

  • HCV
  • HIV
  • HIV-HCV co-infection
  • peginterferon alfa-2a
  • randomized controlled trial
  • ribavirin

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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    Rodriguez-Torres, M., Slim, J., Bhatti, L., Sterling, R., Sulkowski, M., Hassanein, T., Serrão, R., Sola, R., Bertasso, A., Passe, S., & Stancic, S. (2012). Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: A randomized international trial. HIV Clinical Trials, 13(3), 142-152. https://doi.org/10.1310/hct1303-142