Famciclovir in chronic hepatitis B: results of a dose-finding study
| Autor: | Christian Trepo, Clarence L. Young, Gillian Frances Atkinson, Pavel Jezek, Ron Boon |
|---|---|
| Rok vydání: | 2000 |
| Předmět: |
Adult
Male medicine.medical_specialty Exacerbation Hepacivirus Virus Replication Placebo Antiviral Agents Gastroenterology Liver disease Hepatitis B Chronic Double-Blind Method Internal medicine medicine Humans Hepatitis Antibodies Hepatitis B e Antigens Seroconversion 2-Aminopurine Adverse effect Dose-Response Relationship Drug Hepatology Nucleoside analogue business.industry Famciclovir Alanine Transaminase Middle Aged Hepatitis B medicine.disease Treatment Outcome DNA Viral Immunology Female business medicine.drug |
| Zdroj: | Journal of Hepatology. 32:1011-1018 |
| ISSN: | 0168-8278 |
| DOI: | 10.1016/s0168-8278(00)80106-3 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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