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

Myers, Robert Pa,c; Benhamou, Yvesa; Bochet, Mariea; Thibault, Vincentb; Mehri, Delphinea; Poynard, Thierrya

Clinical Science: Concise Communication

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

Correspondence and reprint requests to Dr Robert P. Myers, G126, 3350 Hospital Drive NW, Calgary, AB, Canada T2N 4N1.

Tel: +1 403 210 9363; fax: +1 403 210 9368; e-mail: rpmyers@ucalgary.ca

Received: 16 May 2003; revised: 3 June 2003; accepted: 24 June 2003.

© 2004 Lippincott Williams & Wilkins, Inc.