Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-infected Patients

Summary

Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.

Timeline

Start

2002-04

Primary completion

—

Completion

2004-06

Publications

• Background Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38. doi: 10.1186/1471-2288-6-38.
• Results Seydi M, Morlat P, Bonnet F, Rambeloarisoa J, Bernard N, Lacoste D, Bonarek M, Trimoulet P, Ramanampamonjy R, Lafon ME, Drame M, Beylot J. [Efficacy and safety of pegylated-interferon plus ribavirin in HIV-infected patients co-infected with hepatitis C virus in clinical practice: a 32 cases observational follow-up]. Rev Med Interne. 2005 Apr;26(4):280-7. doi: 10.1016/j.revmed.2004.11.022. French.

Drugs

Indications