Pegylated interferon alpha 2b and ribavirin in HIV/hepatitis C virus-co-infected non-responders and relapsers to IFN-based therapy

Background: Pegylated interferon alfa (PEG-IFN-alpha) and ribavirin is the most effective available treatment for chronic hepatitis C virus (HCV) infection. Its role in HIV/HCV-co-infected patients who have failed IFN-based therapy is unclear. Objective: The aim of this study was to determine the safety and efficacy of this therapy in HIV/HCV-co-infected non-responders and relapsers. Design: An open-label cohort study of 32 non-responders and relapsers to IFN (with or without ribavirin). Patients were treated for 48 weeks with PEG-IFN-alpha2b and ribavirin. Main outcome measure: A sustained virological response (SVR) defined as a negative HCV-RNA level 24 weeks after the end of treatment. Results: The mean age of the patients was 40 years; 78% were men, 67% had genotype 1, and 36% had bridging fibrosis or cirrhosis. The majority had a CD4 cell count greater than 200 cells/mul (97%) and an undetectable HIV-RNA level (81%). Fifteen patients (47%) withdrew because of adverse events, predominantly neuropsychiatric. In an intention-to-treat analysis, a SVR was observed in five patients (16%); 9% with genotype 1 versus 29% with genotype 3 and 33% with genotype 4 (P=NS). Additional, but statistically non-significant, univariate predictors of response were lower serum HCV-RNA (P=0.07) and higher alanine aminotransferase levels (P=0.055) at baseline. No patient with bridging fibrosis or cirrhosis responded. Treatment had a minimal impact on HIV parameters. Conclusion: PEG-IFN-alpha2b and ribavirin is a potentially useful therapy in HIV/HCV co-infected patients who have failed standard IFN-based regimens. Strategies to improve adherence are vital so as to maximize long-term response rates. (C) 2004 Lippincott Williams Wilkins.