Pegasys provides a significantly greater proportion of patients with lasting remission compared to the current standard of care, lamivudine, in the treatment of chronic hepatitis B, according to a new study by Roche. The study was conducted in patients with 'e' antigen (HBeAg) positive hepatitis B - a subtype of the disease which affects the majority of hepatitis B patients worldwide.

Six months after completing therapy, 32 per cent of patients treated with Pegasys for 48 weeks achieved the primary endpoint of 'HBe' seroconversion compared with 19 per cent treated with lamivudine, a nucleoside analogue. 'HBe' seroconversion is a marker for long-term remission of the disease. It is characterized by the loss of HB 'e' antigen (a protein indicating replication of the virus) and the development of antibodies against the virus. Importantly, another marker of disease remission, 'HBs' seroconversion, was only observed with Pegasys therapy in this study. 'HBs' seroconversion is a very rare event which is as close to a cure as it is possible to get, release from Roche said.

Dr George Lau, gastroenterologist at the Queen Mary Hospital, Hong Kong; assistant dean in the Department of Medicine at the University of Hong Kong and lead investigator of the trial said, "There is now evidence from two trials in HBeAg-positive hepatitis B that Pegasys is more beneficial than conventional interferon1 or lamivudine, both of which are today considered the first-line treatments. In a disease that is next to impossible to eradicate, Pegasys has a very good ability to fight it."

"With the mounting evidence we have demonstrating the superiority of Pegasys to the most commonly used medications for chronic hepatitis B today, we feel confident that Pegasys will be adopted by physicians as a first-line treatment when it becomes available next year," said William M. Burns, Head of Pharmaceutical Division.

The study examined two primary and common endpoints of therapy that are indicators of a successful response to treatment: 'HBe' seroconversion and long-term reduction in viral load (HBV DNA levels).

The study showed at week 72 -significantly more patients treated with Pegasys achieved a reduction in HBV DNA levels to below 100,000 copies/ml compared to lamivudine alone (32% vs. 22% respectively). Again, the combination of Pegasys and lamivudine was not statistically different to Pegasys alone. The percentage of patients who normalised ALT (an enzyme that is marker of liver inflammation) levels was significantly higher with Pegasys (41%) versus lamivudine-treated patients (28%).
HBs seroconversion was reported in 16 patients treated with Pegasys (with or without lamivudine) and in none of the patients treated with lamivudine alone.

Roche filed Pegasys globally for a new indication to treat both HBeAg-positive and HBeAg-negative chronic hepatitis B in July. When approved, it will become the first pegylated interferon indicated for the treatment of chronic hepatitis B. The data for Pegasys in HBeAg-negative disease was published in the New England Journal of Medicine last month.

Roche is involved in the viral hepatitis disease area, having introduced Roferon-A for hepatitis B and C, followed by Pegasys in hepatitis C and a full development program in hepatitis B which has now been completed.