Treatment: Famciclovir (Famvir-SmithKline Beecham)
Information from:Infectious Disease News

A large, multinational study showed that famciclovir (Famvir, SmithKline Beecham) was effective in treating chronic hepatitis B. Its safety profile was comparable to a placebo, according to a study presented at the American Association for the Study of Liver Diseases (AASLD).

Clinical Trial:
The study involved 333 patients with chronic HBV from 64 centers in 14 countries. Seventy-three percent of patients were men, 75% were Caucasian and 23% were Asian. All patients had markers (HBsAg and HBeAg) for active, chronic HBV infection for at least six months, showing signs of ongoing viral replication.

Patients were selected at random before receiving either 16 weeks of famciclovir (500 mg, 250 mg or 125 mg) or placebo three times a day. Forty-one percent of patients failed to respond to interferon therapy prior to this clinical trial. Most had high HBV DNA levels (median 3,600 picograms) and the median ALT was low (1.7 times upper limit of normal range).

"Famciclovir treatment resulted in a rapid, dose-dependent suppression of hepatitis B virus replication. In all famciclovir treatment groups, the effect on hepatitis B virus DNA levels was evident within one week of therapy (p<0.0001) and was maintained throughout the 16-week treatment," said Trepo.

"All doses of famciclovir significantly reduced patients' levels of ALT. More importantly, the normalization of liver enzymes was sustained eight months after the 16-week treatment period in 50% of patients in the famciclovir 500 mg group," Trepo explained.

By the end of the study, there was significantly more seroconversion in the 500 mg treatment group than in the placebo group.

Safety Profile:
Famciclovir was found to be comparable to placebo with no serious adverse events related to famciclovir treatment.