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

Comments

Originally Published at http://dx.doi.org/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

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