Document Type

Article

Original Publication Date

2000

Journal/Book/Conference Title

The New England Journal of Medicine

Volume

343

DOI of Original Publication

10.1056/NEJM200012073432302

Comments

Originally Published at http://dx.doi.org/10.1056/NEJM200012073432302

Date of Submission

January 2015

Abstract

Background

Chronic hepatitis C virus (HCV) infection in patients with cirrhosis is difficult to treat. In patients with chronic hepatitis C but without cirrhosis, once-weekly administration of interferon modified by the attachment of a 40-kd branched-chain polyethylene glycol moiety (peginterferon alfa-2a) is more efficacious than a regimen of unmodified interferon. We examined the efficacy and safety of peginterferon alfa-2a in patients with HCV-related cirrhosis or bridging fibrosis.

Methods

We randomly assigned 271 patients with cirrhosis or bridging fibrosis to receive subcutaneous treatment with 3 million units of interferon alfa-2a three times weekly (88 patients), 90 µg of peginterferon alfa-2a once weekly (96), or 180 µg of peginterferon alfa-2a once weekly (87). Treatment lasted 48 weeks and was followed by a 24-week follow-up period. We assessed efficacy by measuring HCV RNA and alanine aminotransferase and by evaluating liverbiopsy specimens. A histologic response was defined as a decrease of at least 2 points on the 22-point Histological Activity Index.

Results

In an intention-to-treat analysis, HCV RNA was undetectable at week 72 in 8 percent, 15 percent, and 30 percent of the patients treated with interferon alfa-2a and with 90 µg and 180 µg of peginterferon alfa-2a, respectively (P=0.001 for the comparison between 180 µg of peginterferon alfa-2a and interferon alfa-2a). At week 72, alanine aminotransferase concentrations had normalized in 15 percent, 20 percent, and 34 percent of patients, respectively (P=0.004 for the comparison between 180 µg of peginterferon alfa-2a and interferon alfa-2a). In the subgroup of 184 patients with paired liver-biopsy specimens, the rates of histologic response at week 72 were 31 percent, 44 percent, and 54 percent, respectively (P=0.02 for the comparison between 180 µg of peginterferon alfa-2a and interferon alfa-2a). All three treatments were similarly tolerated.

Conclusions

In patients with chronic hepatitis C and cirrhosis or bridging fibrosis, 180 µg of peginterferon alfa-2a administered once weekly is significantly more effective than 3 million units of standard interferon alfa-2a administered three times weekly. (N Engl J Med 2000;343:1673-80.)

Rights

From The New England Journal of Medicine, Heathcote, E. J., Shiffman, M. L., Cooksley, W. G. E. et al., PEGINTERFERON ALFA-2a IN PATIENTS WITH CHRONIC HEPATITIS C AND CIRRHOSIS, Vol. 343, Page 1673, Copyright © 2000 Massachusetts Medical Society. Reprinted with permission.

Is Part Of

VCU Medical Center Publications

Share

COinS