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- Title
Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose.
- Authors
Hadziyannis SJ; Sette H Jr.; Morgan TR; Balan V; Diago M; Marcellin P; Ramadori G; Bodenheimer H Jr.; Bernstein D; Rizzetto M; Zeuzem S; Pockros PJ; Lin A; Ackrill AM; PEGASYS International Study Group; Hadziyannis, Stephanos J; Sette, Hoel Jr; Morgan, Timothy R; Balan, Vijayan; Diago, Moises
- Abstract
<bold>Background: </bold>Treatment with pegylated interferon (peginterferon) and ribavirin for 48 weeks is more effective than conventional interferon and ribavirin in patients with chronic hepatitis C.<bold>Objective: </bold>To assess the efficacy and safety of 24 or 48 weeks of treatment with peginterferon-alpha2a plus a low or standard dose of ribavirin.<bold>Design: </bold>Randomized, double-blind trial.<bold>Setting: </bold>99 international centers.<bold>Patients: </bold>1311 patients with chronic hepatitis C.<bold>Intervention: </bold>Peginterferon-alpha2a, 180 microg/wk, for 24 or 48 weeks plus a low-dose (800 mg/d) or standard weight-based dose (1000 or 1200 mg/d) of ribavirin.<bold>Measurement: </bold>Sustained virologic response: undetectable HCV RNA concentration at the end of treatment and during 12 to 24 weeks of follow-up.<bold>Results: </bold>Overall and in patients infected with HCV genotype 1, 48 weeks of treatment was statistically superior to 24 weeks and standard-dose ribavirin was statistically superior to low-dose ribavirin. In patients with HCV genotype 1, absolute differences in sustained virologic response rates between 48 and 24 weeks of treatment were 11.2% (95% CI, 3.6% to 18.9%) and 11.9% (CI, 4.7% to 18.9%), respectively, between standard- and low-dose ribavirin. Sustained virologic response rates for peginterferon-alpha2a and standard-dose ribavirin for 48 weeks were 63% (CI, 59% to 68%) overall and 52% (CI, 46% to 58%) in patients with HCV genotype 1. In patients with HCV genotypes 2 or 3, the sustained virologic response rates in the 4 treatment groups were not statistically significantly different.<bold>Conclusion: </bold>Treatment with peginterferon-alpha2a and ribavirin may be individualized by genotype. Patients with HCV genotype 1 require treatment for 48 weeks and a standard dose of ribavirin; those with HCV genotypes 2 or 3 seem to be adequately treated with a low dose of ribavirin for 24 weeks.
- Publication
Annals of Internal Medicine, 2004, Vol 140, Issue 5, p346
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-140-5-200403020-00010