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