SourceURL:http://www.gastrohep.com/news/news.asp?id=2043

Lamivudine and combination therapy for interferon nonresponders

Lamivudine treatment for 52 weeks is as effective in interferon
nonresponders as in treatment-naive patients, finds a research team from
the United States.

Lamivudine is effective in treatment-naive patients with chronic hepatitis
B. However, its role in interferon nonresponders has not been described.

In this study, researchers assessed lamivudine, with or without interferon,
in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B
who had failed interferon therapy.

Their findings are published in the June issue of the Journal of Hepatology.

The team randomized 238 patients to either lamivudine (100 mg), or placebo,
for 52 weeks, or to a 24-week regimen of lamivudine plus interferon.

They compared treatments at week 52, and followed-up patients over a
16-week post-treatment period.

Histologic response:
- lamivudine = 52%
- combination = 32%
- placebo = 25%

The team measured histology, HBeAg response, normalization of alanine
aminotransferase, reduction of hepatitis B virus (HBV) DNA, and safety.

The researchers found that histologic response was more common in patients
treated with lamivudine (52%), or the combination regimen (32%), than the
placebo (25%).

Furthermore, HBeAg loss was more common with lamivudine (33%), compared
with the combination treatment (21%) or the placebo (13%).

Virologic and alanine aminotransferase responses were also better with the
lamivudine therapy.

The team found that among 28 subjects with HBeAg loss/seroconversion, 71%
had durable responses 16 weeks post-treatment.

Dr Eugene Schiff's team concluded, "Lamivudine for 52 weeks is as effective
in interferon nonresponders as in previously reported treatment-naive
patients".

"However, a combination of lamivudine for 24 weeks and interferon for 16
weeks was not effective in this population".

J Hepatol 2003; 38(6): 818-26
21 May 2003