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- Title
Pegylated Interferon Alfa-2b vs Standard Interferon Alfa-2b, Plus Ribavirin, for Chronic Hepatitis C in HIV-Infected Patients: A Randomized Controlled Trial.
- Authors
Carrat, Fabrice; Bani-Sadr, Firouzé; Pol, Stanislas; Rosenthal, Eric; Lunel-Fabiani, Françoise; Benzekri, Asmae; Morand, Patrice; Goujard, Cécile; Pialoux, Gilles; Piroth, Lionel; Salmon-Céron, Dominique; Degott, Claude; Cacoub, Patrice; Perronne, Christian
- Abstract
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...
- Subjects
HEPATITIS C treatment; HIV-positive persons; ANTIVIRAL agents; GLYCOPROTEINS; ANTINEOPLASTIC agents; INTERFERONS; NUCLEOSIDES; RIBAVIRIN; RNA; GENETIC polymorphisms; GENETIC research; LIVER diseases; PANCREATITIS; CLINICAL trials; HEALTH outcome assessment
- Publication
JAMA: Journal of the American Medical Association, 2004, Vol 292, Issue 23, p2839
- ISSN
0098-7484
- Publication type
Abstract
- DOI
10.1001/jama.292.23.2839