Document Type
Article
Original Publication Date
2009
Journal/Book/Conference Title
The New England Journal of Medicine
Volume
361
DOI of Original Publication
10.1056/NEJMoa0808010
Date of Submission
January 2015
Abstract
Background
Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared.
Methods
At 118 sites, patients who had HCV genotype 1 infection and who had not previously been treated were randomly assigned to undergo 48 weeks of treatment with one of three regimens: peginterferon alfa-2b at a standard dose of 1.5 μg per kilogram of body weight per week or a low dose of 1.0 μg per kilogram per week, plus ribavirin at a dose of 800 to 1400 mg per day, or peginterferon alfa-2a at a dose of 180 μg per week plus ribavirin at a dose of 1000 to 1200 mg per day. We compared the rate of sustained virologic response and the safety and adverse-event profiles between the peginterferon alfa-2b regimens and between the standard-dose peginterferon alfa- 2b regimen and the peginterferon alfa-2a regimen.
Results
Among 3070 patients, rates of sustained virologic response were similar among the regimens: 39.8% with standard-dose peginterferon alfa-2b, 38.0% with low-dose peginterferon alfa-2b, and 40.9% with peginterferon alfa-2a (P=0.20 for standarddose vs. low-dose peginterferon alfa-2b; P=0.57 for standard-dose peginterferon alfa-2b vs. peginterferon alfa-2a). Estimated differences in response rates were 1.8% (95% confidence interval [CI], −2.3 to 6.0) between standard-dose and low-dose peginterferon alfa-2b and −1.1% (95% CI, −5.3 to 3.0) between standard-dose peginterferon alfa-2b and peginterferon alfa-2a. Relapse rates were 23.5% (95% CI, 19.9 to 27.2) for standard-dose peginterferon alfa-2b, 20.0% (95% CI, 16.4 to 23.6) for lowdose peginterferon alfa-2b, and 31.5% (95% CI, 27.9 to 35.2) for peginterferon alfa- 2a. The safety profile was similar among the three groups; serious adverse events were observed in 8.6 to 11.7% of patients. Among the patients with undetectable HCV RNA levels at treatment weeks 4 and 12, a sustained virologic response was achieved in 86.2% and 78.7%, respectively.
Conclusions
In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon– ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials. gov number, NCT00081770.)
Rights
From The New England Journal of Medicine, McHutchison, J. G., Lawitz, E. J., Shiffman, M.L. et al., Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection, Vol. 361, Page 580, Copyright © 2009 Massachusetts Medical Society.
Is Part Of
VCU Internal Medicine Publications
Supplementary Appendix
Comments
Originally Published at http://dx.doi.org/10.1056/NEJMoa0808010
This article was updated at NEJM.org. The correction was published as follows:
Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection (Original Article, N Engl J Med 2009:361;580 593) . In the first sentence of the Study Design subsection in Methods (page 581), the two levels of stratification according to hepatitis C virus (HCV) RNA levels given parenthetically should have been expressed as IU per milliliter, not as IU per cubic millimeter. In the first sentence of the Efficacy Assessments subsection in Methods (page 582), the lower limit of quantitation should have been 27 IU per milliliter, not 27 IU per cubic millimeter. In the Efficacy subsection of Results, the two mentions of HCV RNA levels (pages 583 and 584) should have been expressed as IU per milliliter rather than as IU per cubic millimeter. In the footnotes under Table 1 (page 585), the footnote designated by a double dagger should have expressed HCV RNA as IU per milliliter rather than as IU per cubic millimeter. In the footnotes under Table 2 (page 587), the footnote designated by an asterisk should have expressed HCV RNA as IU per milliliter rather than as IU per cubic millimeter. In the footnotes under Table 3 (page 589), the footnote designated by an asterisk should have expressed the lower limit of detection as 27 IU per milliliter, not 27 IU per cubic millimeter. We regret the errors. The article has been corrected at NEJM.org.