Background: Pegylated interferon alfa (PEG-IFN-α) 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-α2b 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/μl (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-α2b 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.
From the aService d'Hépato-Gastroentérologie and bLaboratoire de Virologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France; and cLiver Unit, University of Calgary, Calgary, Alberta, Canada.
See also pp. 1, 59, 67, 121, 131
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Received: 16 May 2003; revised: 3 June 2003; accepted: 24 June 2003.