Reuters Health Information (2004-10-06): Lamivudine slows progression of chronic hepatitis B with advanced fibrosis
Lamivudine slows progression of chronic hepatitis B with advanced fibrosis
Last Updated: 2004-10-06 17:00:24 -0400 (Reuters Health)
NEW YORK (Reuters Health) - By reducing the occurrence
of hepatic decompensation and the risk of liver cancer, lamivudine
therapy delays the progression of chronic hepatitis B with advanced
fibrosis or cirrhosis, new research indicates.
The findings, which appear in The New England Journal of Medicine
for October 7, are based on a study of 651 patients who were randomized
to receive lamivudine or placebo for up to 5 years. The study was
terminated after a median period of 32.4 months after a clear
difference in treatment efficacy was observed.
The main endpoint was the time to disease progression, which was
defined as hepatic decompensation, hepatocellular carcinoma,
spontaneous bacterial peritonitis, bleeding gastroesophageal varices,
or liver disease-related death.
Treatment with lamivudine helped prevent hepatic decompensation and
hepatocellular carcinoma, lead author Dr. Yun-Fan Liaw, from Chang Gung
Memorial Hospital and University in Taipei and colleagues note.
Worsening of the Child-Pugh score was noted in 8.8% of control
patients compared with just 3.4% of lamivudine-treated patients, the
authors state (p = 0.02). Hepatocellular carcinoma occurred in 7.4% and
3.9% of patients in the control and lamivudine groups, respectively (p
Nearly half of the patients treated with lamivudine developed
genotypic resistance YMDD mutations, the researchers note. The presence
of such mutations was associated with a worsening of the Child-Pugh
The incidence and type of adverse events in each group were similar.
Serious adverse events occurred in 12% of the treatment group and 18%
of the placebo group.
The results suggest that lamivudine is effective in reducing liver
complications in patients with chronic hepatitis B and advanced
fibrosis or cirrhosis. "The magnitude of protection conferred by
lamivudine is substantial, with a reduction of approximately 50% in
disease progression during a median period of 32 months of treatment."
In a related editorial, Dr. Jack R. Wands, from Brown Medical School
in Providence, Rhode Island, comments that "the use of potent antiviral
agents such as lamivudine represents a major advance in the treatment
of chronic HBV infection and slow the progression of severe liver
disease to cirrhosis and hepatocellular carcinoma."
N Engl J Med 2004;1521-1531,1567-1570.