Document Type
Article
Original Publication Date
2007
Journal/Book/Conference Title
The New England Journal of Medicine
Volume
357
DOI of Original Publication
10.1056/NEJMoa066403
Date of Submission
January 2015
Abstract
Background
Patients infected with hepatitis C virus (HCV) genotype 2 or 3 have sustained virologic response rates of approximately 80% after receiving treatment with peginterferon and ribavirin for 24 weeks. We conducted a large, randomized, multinational, noninferiority trial to determine whether similar efficacy could be achieved with only 16 weeks of treatment with peginterferon alfa-2a and ribavirin.
Methods
We randomly assigned 1469 patients with HCV genotype 2 or 3 to receive 180 μg of peginterferon alfa-2a weekly, plus 800 mg of ribavirin daily, for either 16 or 24 weeks. A sustained virologic response was defined as an undetectable serum HCV RNA level (milliliter) 24 weeks after the end of treatment.
Results
The study failed to demonstrate that the 16-week regimen was noninferior to the 24-week regimen. The sustained virologic response rate was significantly lower in patients treated for 16 weeks than in patients treated for 24 weeks (62% vs. 70%; odds ratio for 16 weeks vs. 24 weeks, 0.67; 95% confidence interval, 0.54 to 0.84; P
Conclusions
Treatment with peginterferon and ribavirin for 16 weeks in patients infected with HCV genotype 2 or 3 results in a lower overall sustained virologic response rate than treatment with the standard 24-week regimen. (ClinicalTrials.gov number, NCT00077636.)
Rights
From The New England Journal of Medicine, Shiffman, M. L., Suter, F., Bacon, B. R. et al., Peginterferon Alfa-2a and Ribavirin for 16 or 24 Weeks in HCV Genotype 2 or 3, Vol. 357, Page 124, Copyright © 2007 Massachusetts Medical Society. Reprinted with permission.
Is Part Of
VCU Medical Center Publications
Comments
Originally Published at http://dx.doi.org/10.1056/NEJMoa066403