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Safety and efficacy of an induction dose of pegylated interferon alpha-2a on early hepatitis C virus kinetics in HIV/HCV co-infected patients: the CORAL-1 multicentre pilot study

Authors


  • Partial results from this study were presented as oral late breaker in the 45th ICAAC, 2005 Washington DC (LB H-416b)

Dr Cristina Tural, Hospital Germans Trias i Pujol, C/Carretera del Canyet s/n, 08916 Badalona, Barcelona, Spain. E-mail: ctural.germanstrias@gencat.net

Abstract

summary.  To evaluate the safety and efficacy of an induction dose of pegylated interferon alpha 2a (IFN-α2a) on the 12-week hepatitis C virus (HCV) kinetics in human immunodeficiency virus (HIV) patients co-infected with HCV. One hundred sixteen HIV/HCV co-infected patients from nine hospitals in Spain were randomized to receive 270 μg/week of pegylated IFN-α2a for 4 weeks followed by 180 μg/week for 8 weeks or 180 μg/week for 12 weeks. Ribavirin was given at a daily dose of 1000 or 1200 mg. The main outcome measure was the percentage of patients achieving an HCV-RNA below 50 IU/mL or a decrease of 2 or more log10 at week 12 (early virologic response, EVR). HCV-RNA was measured at baseline, weekly, for the first 4 weeks and monthly thereafter. We observed no difference in the percentage of patients achieving an EVR between arms (on-treatment, 74% in both arms; intention-to-treat, 70% in the induction arm and 67% in the control arm), nor were there differences in the percentage achieving an undetectable HCV qualitative polymerase chain reaction at any time points or in the decrease in HCV-RNA from baseline. No differences were found between arms in the percentage of dropouts (8% in the whole study population). Our study failed to find a benefit of an induction dose of 270 μg/week of pegylated IFN-α2a for 4 weeks on the EVR in co-infected patients who are treatment naive. Despite the lack of benefit with this regimen, induction therapy with this schedule was safe and well tolerated in co-infected patients.

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