Clinical

Long-term peginterferon shows promise against hepatitis B in pilot study

Last Updated: 2007-12-21 12:44:24 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Sixty weeks of treatment with pegylated interferon alfa-2a appears to produce a higher rate of sustained virologic response in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B than that usually achieved with the standard treatment duration of 48 weeks. The study is reported in the December issue of the American Journal of Gastroenterology.

There is a high rate of relapse when conventional interferon or peginterferon are given for 48 weeks, but higher rates of lasting response have been seen when conventional interferon is given for 2 years, note Dr. Robert Perrillo at Baylor University Medical Center in Dallas Texas, and colleagues.

The researchers therefore undertook a pilot study with 13 patients to evaluate the virologic effectiveness of a 60-week course of treatment with peginterferon. They also explored the effectiveness of combination therapy using lamivudine.

The primary end point was sustained virologic response, which was defined as hepatitis B virus DNA less than 20,000 copies/mL and a decrease from baseline in HBV DNA of at least 2 log copies/mL.

Seven of the 13 patients were randomized to receive peginterferon alfa-2a only for 60 weeks, and the other six received the same course of peginterferon, plus lamivudine from weeks 13 through 60. All 13 patients were followed for at least 24 weeks post-treatment.

By the end of treatment, only one patient in each group had not achieved a sustained virologic response. As of the end of the follow-up period (week 84), 5 of 7 (71%) treated with peginterferon monotherapy and 3 of 6 (50%) treated with the combination therapy met the criteria for a sustained virologic response.

The overall 62% sustained virologic response rate in this study compares with a response rate of 42% seen in a recent similar trial of a 48-week regimen, Dr. Perrillo and colleagues point out.

They call for larger randomized, controlled trials to study the effectiveness of peginterferon against HBeAg-negative chronic hepatitis B, with post-treatment follow-up of up to 5 years.

Am J Gastroenterol 2007;102:2718-2723