Authors' objectives: This report aims to summarise the available evidence on the use of Hepagene vaccine in the treatment of chronic hepatitis B.

Authors' recommendations: An exploratory phase placebo-controlled study on Hepagene vaccine has given indications of its efficacy in the treatment of chronic Hepatitis B. The study was conducted in Asians in Pacific Rim countries with a final study population of 86 patients from 108 who were recruited. Patients were randomised to receive four doses of Hepagene or of placebo at monthly intervals. They were followed up for nine months after treatment and then all patients received a second course of eight Hepagene doses at monthly intervals in an open study. After four doses, 19.6% of patients were free of replicating virus (placebo group 7.7%); in those with raised baseline aminotransferase (ALT) activity the response was 38.1% compared with 18.2% on placebo. These differences did not reach statistical significance. After the second, open treatment course, 7 of 18 patients (38.9%) with raised ALT were free of replicating virus. Evidence of efficacy was not clearly shown in patients who received Hepagene for the first time in the second, open phase of the study. Hepagene was well tolerated and no adverse effects of clinical concern were observed.

Authors' methods: Overview

Project Status: Completed

Year Published: 2000

URL for published report: https://www.ihe.ca/advanced-search?type=1020

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Institute of Health Economics

Contact Address: 1200, 10405 Jasper Avenue, Edmonton, Alberta, Canada, T5J 3N4. Tel: +1 780 448 4881; Fax: +1 780 448 0018;

Contact Name: djuzwishin@ihe.ca

Contact Email: djuzwishin@ihe.ca

Copyright: Alberta Heritage Foundation for Medical Research (AHFMR)