Pegylated interferon alfa-2b vs standard interferon alfa-2b, plus ribavirin, for chronic hepatitis C in HIV-infected patients: a randomized controlled trial.

摘要: ContextTreatment of chronic hepatitis C virus (HCV) infection in human immunodeficiency virus (HIV)–infected patients is a growing concern. Most data on the virologic efficacy and safety the combination peginterferon alfa-2b and ribavirin coinfected come from uncontrolled studies.ObjectiveTo study alfa-2b plus ribavirin vs standard interferon HIV-HCV patients.Design SettingsA multicenter, randomized, parallel-group, open-label trial. Patients were enrolled February 2000 to 2002 followed up for 72 weeks.PatientsFour hundred twelve with detectable serum HCV-RNA, abnormal liver histology, CD4 cell count at least 200 × 106/L, stable plasma HIV-RNA.InterventionTreatment 400 mg twice day, orally, either peginterferon alfa-2b (1.5 μg/kg subcutaneous injection once week) or interferon alfa-2b (3 million units 3 times 48 weeks.Main Outcome MeasuresSustained virologic response, defined by undetectable serum HCV-RNA at week 72.ResultsMore had sustained responses peginterferon group than group (27% vs 20%, P = .047). This difference between treatments was found in HCV genotype 1 4 (17% 6% for interferon, P = .006) but was not found 2, 3, 5 (44% peginterferon vs 43% P = .88). Together, decline HCV-RNA less 2 log10 baseline and 12 predicted 99% treatment failures. Histologic activity diminished fibrosis stabilized responders. The regimens showed similar tolerability although dose modifications for clinical biological events were more frequent peginterferon. Eleven cases pancreatitis symptomatic hyperlactatemia observed, all in patients receiving didanosine-containing antiretroviral regimens.ConclusionIn ribavirin, alfa-2b is effective HIV-infected patients.