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Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial.

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Title: Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial.
Authors: Manns, Michael P, McHutchison, John G, Gordon, Stuart C, Rustgi, Vinod K, Shiffman, Mitchell, Reindollar, Robert, Goodman, Zachary D, Koury, Kenneth, Mei-Hsiu Ling, Albrecht, Janice K, Manns, M P (AUTHOR), McHutchison, J G (AUTHOR), Gordon, S C (AUTHOR), Rustgi, V K (AUTHOR), Shiffman, M (AUTHOR), Reindollar, R (AUTHOR), Goodman, Z D (AUTHOR), Koury, K (AUTHOR), Ling, M (AUTHOR), Albrecht, J K (AUTHOR)
Source: Lancet. 9/22/2001, Vol. 358 Issue 9286, p958-965. 8p. 1 Diagram, 5 Charts, 1 Graph.
Subjects: Hepatitis C treatment, Clinical trials, Antiviral agents, Ribavirin, Interferons, Therapeutic use of proteins, Combination drug therapy, Comparative studies, Drug administration, Dose-effect relationship in pharmacology, Research methodology, Medical cooperation, Polyethylene glycol, Proteins, Recombinant proteins, Research, RNA, Logistic regression analysis, Evaluation research, Randomized controlled trials, Treatment effectiveness, Chronic hepatitis C, Genotypes
Abstract: Background: A sustained virological response (SVR) rate of 41% has been achieved with interferon alfa-2b plus ribavirin therapy of chronic hepatitis C. In this randomised trial, peginterferon alfa-2b plus ribavirin was compared with interferon alfa-2b plus ribavirin.Methods: 1530 patients with chronic hepatitis C were assigned interferon alfa-2b (3 MU subcutaneously three times per week) plus ribavirin 1000-1200 mg/day orally, peginterferon alfa-2b 1.5 microg/kg each week plus 800 mg/day ribavirin, or peginterferon alfa-2b 1.5 microg/kg per week for 4 weeks then 0.5 microg/kg per week plus ribavirin 1000-1200 mg/day for 48 weeks. The primary endpoint was the SVR rate (undetectable hepatitis C virus [HCV] RNA in serum at 24-week follow-up). Analyses were based on patients who received at least one dose of study medication.Findings: The SVR rate was significantly higher (p=0.01 for both comparisons) in the higher-dose peginterferon group (274/511 [54%]) than in the lower-dose peginterferon (244/514 [47%]) or interferon (235/505 [47%]) groups. Among patients with HCV genotype 1 infection, the corresponding SVR rates were 42% (145/348), 34% (118/349), and 33% (114/343). The rate for patients with genotype 2 and 3 infections was about 80% for all treatment groups. Secondary analyses identified bodyweight as an important predictor of SVR, prompting comparison of the interferon regimens after adjusting ribavirin for bodyweight (mg/kg). Side-effect profiles were similar between the treatment groups.Interpretation: In patients with chronic hepatitis C, the most effective therapy is the combination of peginterferon alfa-2b 1.5 microg/kg per week plus ribavirin. The benefit is mostly achieved in patients with HCV genotype 1 infections. [ABSTRACT FROM AUTHOR]
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Database: Psychology and Behavioral Sciences Collection
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