A new study showed that Pegasys was more effective compared to lamivudine in the most difficult-to-treat form of Hepatitis B disease and the addition of lamivudine to Pegasys does not provide additional efficacy.

This Phase III study, conducted in 13 countries, is the largest multinational study of pegylated interferon in patients with 'variant' hepatitis B virus and it is the first large-scale head-to-head study to compare Roche's pegylated interferon against lamivudine. Lamivudine is the most commonly used therapy for infections with the hepatitis B virus.

“With Pegasys, we have for the first time a hepatitis B therapy which can produce a high sustained treatment response, and this is extremely encouraging to physicians looking for treatment solutions,” said professor Patrick Marcellin, Hepatologist from the Hospital Beaujon, Clichy, France and the lead investigator for the study. “What is also important is that with Pegasys we have a defined treatment period, which is what most patients would want.”

“These are highly encouraging results for physicians and patients in the fight against this serious liver infection,” said William M. Burns, head of the pharmaceutical division at Roche. “Based on these extremely positive results, we plan to file Pegasys in hepatitis B with health authorities next year.”

The 537 patients enrolled in the study, all of whom had HBeAg negative HBV and raised blood levels of ALT, a specific liver enzyme serving as a marker for liver inflammation, were treated for 48 weeks with either Pegasys 180 mg once weekly plus placebo, lamivudine 100 mg once daily or a combination of the two. They were then observed for a further 24 weeks with no treatment. The treatment was considered effective if ALT levels fell to normal and viral DNA levels, a measure for the concentration of virus in the bloodstream, were reduced below 20,000 copies/ml at the end of the follow-up period.

At the end of the follow-up period, the study found for the two primary endpoints that — 42.9 per cent of patients treated with Pegasys monotherapy reduced their hepatitis B viral DNA to less than 20,000 copies per/ml compared to only 29.3 per cent of those treated with lamivudine. This result is statistically highly significant. The combination of Pegasys and lamivudine yielded a reduction in hepatitis B viral DNA in 44.1 per cent of patients, demonstrating that the addition of lamivudine to Pegasys does not improve the treatment outcome.

In addition Pegasys had a better impact on ALT than lamivudine: 59.3 per cent of patients treated with Pegasys had their elevated ALT levels return to normal; compared to only 44.2 per cent of lamivudine-treated patients. The combination of Pegasys and lamivudine (59.8 per cent) was not statistically different to Pegasys alone.