Other members of the Famciclovir Hepatitis B Study Group are listed in the Acknowledgment section.
A randomized, placebo-controlled study to evaluate the efficacy of 12-month famciclovir treatment in patients with chronic hepatitis B e antigen–positive hepatitis B
Article first published online: 30 DEC 2003
Copyright © 2000 American Association for the Study of Liver Diseases
Volume 32, Issue 2, pages 413–417, August 2000
How to Cite
de Man, R. A., Marcellin, P., Habal, F., Desmond, P., Wright, T., Rose, T., Jurewicz, R. and Young, C. (2000), A randomized, placebo-controlled study to evaluate the efficacy of 12-month famciclovir treatment in patients with chronic hepatitis B e antigen–positive hepatitis B. Hepatology, 32: 413–417. doi: 10.1053/jhep.2000.9407
- Issue published online: 30 DEC 2003
- Article first published online: 30 DEC 2003
- Manuscript Accepted: 25 MAY 2000
- Manuscript Received: 19 JAN 2000
- SmithKline Beecham Pharmaceuticals
We conducted a randomized, placebo-controlled clinical study evaluating famciclovir (500 mg 3 times daily and 1.5 g once daily) for 1 year (6 months post-treatment follow-up) in patients with chronic hepatitis B e antigen (HBeAg)-positive hepatitis B virus (HBV) infection. The study was conducted in 80 centers in North America, Europe, and Australia/New Zealand. A total of 417 patients with histologically documented chronic hepatitis B (histologic activity index [HAI] 9.5-11.0) received famciclovir (500 mg 3 times daily or 1.5 g once daily) or placebo. Famciclovir 500 mg 3 times daily significantly reduced HBV DNA and median HAI scores versus placebo. By week 8, median HBV DNA decreased from 1,645 to 283 MEq/mL (famciclovir 500 mg 3 times daily) and from 1,147 to 304 MEq/mL (famciclovir 1.5 g once daily), while increasing for placebo (1,617 to 1,685 MEq/mL). Median change in HBV DNA at the end of therapy was −76% (famciclovir 500 mg 3 times daily; P < .01) and −60% (famciclovir 1.5 g once daily; P = .25) versus −37% for placebo. Median change in HAI was −1.5 points (famciclovir 500 mg 3 times daily; P = .02) and −1.0 point (famciclovir 1.5 g once daily; P = .35) and zero for placebo. Fifty percent of patients receiving famciclovir 500 mg 3 times daily (P = .07) and 43% receiving 1.5 g once daily (P = .41) experienced ≥2 points improvement in HAI versus 37% for placebo. Nine percent of patients treated with famciclovir 500 mg 3 times daily underwent anti-HBeAg seroconversion with undetectable HBV DNA at end of follow-up versus 3% in the placebo group (P = .05). Famciclovir was well tolerated; the incidence of post-treatment alanine transaminase (ALT) elevations was comparable with placebo. In conclusion, famciclovir 500 mg 3 times daily gave modest suppression of viral replication, but translated into significant histologic improvement in median HAI score at 1 year.