Famciclovir in chronic hepatitis B: results of a dose-finding study.

Abstract

BACKGROUND/AIMS:

Famciclovir, an orally available nucleoside analogue with potent in vitro activity against HBV, is being investigated for treatment of chronic hepatitis B.

METHODS:

A dose-finding study was conducted in patients with hepatitis B e antigen present in serum. Patients received famciclovir 125 mg, 250 mg, 500 mg three times daily (tid) or placebo for 16 weeks, followed by 8 months post-treatment observation, and 16 weeks open-label treatment. More than 90% of patients had previously received alpha-interferon or had baseline characteristics indicating a high likelihood of poor response to alpha-interferon.

RESULTS:

Famciclovir induced rapid, dose-dependent suppression of viral replication and reduction in alanine aminotransferase (ALT), with greatest efficacy in the 500-mg tid treatment group. HBV DNA reduction was maintained throughout the treatment period. ALT also steadily declined during the treatment period. Approximately 40% of patients with pretreatment ALT>upper limit of normal (ULN) receiving famciclovir 500 mg tid, experienced sustained normalization of ALT at the end of the 8-month follow-up. Anti-HBe seroconversion occurred more frequently in patients receiving famciclovir 500 mg tid compared with placebo (p=0.04). Famciclovir was generally well tolerated; the incidence of adverse events was comparable to placebo. Exacerbation of liver disease or serious ALT flares were not observed.

CONCLUSION:

Famciclovir 500 mg three times daily may offer an alternative to alpha-interferon for treatment for chronic hepatitis B. Anti-HBe seroconversion in the famciclovir 500-mg tid group suggests that 16 weeks treatment has the potential for HBV clearance. Further studies with a longer treatment duration are warranted.

• Authors: C Trépo, P Jezek, G Atkinson, R Boon, C Young
• Journal: Journal of hepatology (J Hepatol) Vol. 32 Issue 6 Pg. 1011-8 (Jun 2000) ISSN: 0168-8278 [Print] Netherlands
• PMID: 10898322 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis Antibodies
• Hepatitis B e Antigens
• 2-Aminopurine
• Alanine Transaminase
• Famciclovir

Topics

• 2-Aminopurine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Adult
• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage, adverse effects, therapeutic use)
• DNA, Viral (analysis)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Famciclovir
• Female
• Hepacivirus (drug effects, genetics, immunology, physiology)
• Hepatitis Antibodies (analysis)
• Hepatitis B e Antigens (immunology)
• Hepatitis B, Chronic (blood, drug therapy, virology)
• Humans
• Male
• Middle Aged
• Treatment Outcome
• Virus Replication (drug effects)