Clinical

Lamivudine safe in long-term hepatitis B therapy

Last Updated: 2003-12-26 7:45:24 -0400 (Reuters Health)

By David Douglas

NEW YORK (Reuters Health) - Lamivudine treatment for up to six years has an excellent safety profile in patients with chronic hepatitis Be antigen (HBeAg)-positive compensated liver disease, researchers report. However, documented lamivudine resistance mutations, which can affect up to two-thirds of patients by the fifth year of treatment, can be a marker for significantly more hepatitis flares.

Dr. Anna S. F. Lok of the University of Michigan Medical Center, Ann Arbor, and colleagues conducted an analysis of safety data from multinational trials involving 998 patients with chronic HBeAg-positive compensated liver disease who underwent lamivudine treatment for a median of 4 years.

The study, published in the December issue of Gastroenterology, found that hepatitis flares were seen in 10% of treated patients in the first year and as many as 21% in the following 4 years. Furthermore, documented lamivudine resistance mutations rose from 23% in the first year to 65% in the fifth year. These patients also experienced significantly more flares than did other patients.

Overall, 4 patients died, 2 from liver-related causes, and 53 lamivudine-treated patients (5%) experienced a total of 60 liver-disease related serious adverse events.

However, Dr. Lok told Reuters Health that "liver failure is extremely uncommon during the first three years after the emergence of lamivudine resistance, in this patient population, so some patients may be maintained on lamivudine and adefovir added at a later stage, provided the patients are closely monitored."

Despite the apparent safety of lamivudine, Dr. Lok also pointed out that "the findings in this study may not apply to other patients, such as those with HBeAg-negative compensated liver disease, patients with cirrhosis, and immunosuppressed patients."

Gastroenterology 2003;125:1714-1722.