Hisham Y Ali1. 1. Department of Microbiology & Immunology, College of Medicine, University of Mosul, PO Box 11313, Ninevah, Iraq. talaat.m@warkaa.net
Abstract
OBJECTIVE: The persistence of hepatitis B core immunoglobulin M (HBc IgM) antibody in hepatitis B surface antigen (HBsAg) carriers is a risk factor with hidden dangers and forecasts the existence of liver damage. A trial of lamivudine in such subset of carriers was carried out for the first time in this study. METHODS:A total of 62 HBsAg with hepatitis e antibody individuals (age range, 25-45 years) with persistent HBc IgM antibody were randomized to receive either 100 mg lamivudine (32/62) or placebo (30/62) daily for 6 months. The study was performed from June 2000 to October 2002. The carriers were regular attendees of the Virology Center in Mosul, North Iraq for follow up. Enzyme-linked immunosorbent assay technique was performed to detect the different hepatitis B virus markers. RESULTS: Among the lamivudine group, HBc IgM antibody seroclearance achievement rate was 81.3% and HBsAg seroconversion rate was 9.4% compared to 6.3% and 3.3% in the placebo group. Number of adverse clinical events were observed, but were of mild nature and tolerable by the participants who completed the study. CONCLUSION: The trial of lamivudine in this subset of HBsAg carriers proved to be safe and efficacious. More studies are needed prior to recommending the drug for routine use on selected HBV carriers.
RCT Entities:
OBJECTIVE: The persistence of hepatitis B core immunoglobulin M (HBc IgM) antibody in hepatitis B surface antigen (HBsAg) carriers is a risk factor with hidden dangers and forecasts the existence of liver damage. A trial of lamivudine in such subset of carriers was carried out for the first time in this study. METHODS: A total of 62 HBsAg with hepatitis e antibody individuals (age range, 25-45 years) with persistent HBc IgM antibody were randomized to receive either 100 mg lamivudine (32/62) or placebo (30/62) daily for 6 months. The study was performed from June 2000 to October 2002. The carriers were regular attendees of the Virology Center in Mosul, North Iraq for follow up. Enzyme-linked immunosorbent assay technique was performed to detect the different hepatitis B virus markers. RESULTS: Among the lamivudine group, HBc IgM antibody seroclearance achievement rate was 81.3% and HBsAg seroconversion rate was 9.4% compared to 6.3% and 3.3% in the placebo group. Number of adverse clinical events were observed, but were of mild nature and tolerable by the participants who completed the study. CONCLUSION: The trial of lamivudine in this subset of HBsAg carriers proved to be safe and efficacious. More studies are needed prior to recommending the drug for routine use on selected HBV carriers.