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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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  Data: 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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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 9/22/2001, Vol. 358 Issue 9286, p958-965. 8p. 1 Diagram, 5 Charts, 1 Graph.
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  Data: <searchLink fieldCode="DE" term="%22Hepatitis+C+treatment%22">Hepatitis C treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Antiviral+agents%22">Antiviral agents</searchLink><br /><searchLink fieldCode="DE" term="%22Ribavirin%22">Ribavirin</searchLink><br /><searchLink fieldCode="DE" term="%22Interferons%22">Interferons</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutic+use+of+proteins%22">Therapeutic use of proteins</searchLink><br /><searchLink fieldCode="DE" term="%22Combination+drug+therapy%22">Combination drug therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Comparative+studies%22">Comparative studies</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+administration%22">Drug administration</searchLink><br /><searchLink fieldCode="DE" term="%22Dose-effect+relationship+in+pharmacology%22">Dose-effect relationship in pharmacology</searchLink><br /><searchLink fieldCode="DE" term="%22Research+methodology%22">Research methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+cooperation%22">Medical cooperation</searchLink><br /><searchLink fieldCode="DE" term="%22Polyethylene+glycol%22">Polyethylene glycol</searchLink><br /><searchLink fieldCode="DE" term="%22Proteins%22">Proteins</searchLink><br /><searchLink fieldCode="DE" term="%22Recombinant+proteins%22">Recombinant proteins</searchLink><br /><searchLink fieldCode="DE" term="%22Research%22">Research</searchLink><br /><searchLink fieldCode="DE" term="%22RNA%22">RNA</searchLink><br /><searchLink fieldCode="DE" term="%22Logistic+regression+analysis%22">Logistic regression analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation+research%22">Evaluation research</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Chronic+hepatitis+C%22">Chronic hepatitis C</searchLink><br /><searchLink fieldCode="DE" term="%22Genotypes%22">Genotypes</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Findings: </bold>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.<bold>Interpretation: </bold>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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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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