Lamivudine Safe in Long-Term Hepatitis B Therapy

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Lamivudine Safe in Long-Term Hepatitis B Therapy

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NEW YORK (Reuters Health) Dec 26 - 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. 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.