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A Randomized-Controlled Study investigating Viral Suppression and Serological Response following PreS1/PreS2/S Vaccine Therapy Combined with Lamivudine in HBeAg-positive Chronic Hepatitis B Patients.

Author(s): Hoa PT, Huy NT, Thu LT, Nga CN, Nakao K, Eguchi K, Chi NH, Hoang BH, Hirayama K

Affiliation(s): Department of Infectious Diseases, University of Medicine & Pharmacy at Ho Chi Minh City, Vietnam; The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Department of Immunogenetics, Institute of Tropical Medicine (NEKKEN), Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan; University of Medicine at Can Tho City, Vietnam; Department of Internal Medicine, Nagasaki University School of Medicine, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan; Department of Internal Medicine, University of Medicine & Pharmacy at Ho Chi Minh City, Vietnam; Center for International Collaborative Research, Nagasaki University, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan; Global COE program, Nagasaki University, Japan.

Publication date & source: 2009-09-21, Antimicrob Agents Chemother., [Epub ahead of print]

The aim of the current study was to evaluate viral suppression following combined S/preS1/preS2 vaccine and lamivudine treatment in patients with chronic hepatitis B. We established a randomized, controlled clinical trial to compare the response between three different treatment groups including vaccine monotherapy, lamivudine monotherapy and combination treatment. Viral response was evaluated via HBV-DNA suppression using different levels of classification. Seroconversion was evaluated via HBeAg loss, HBeAg sero-conversion and HBsAg loss and anti-HBs response. We found that the group receiving combination treatment demonstrated a significant increase in viral suppression compared to the lamivudine or vaccine monotherapy groups, although the HBeAg sero-conversion was not different. This enhanced suppression effect in the combination group was reversed after discontinuation of vaccine treatment, suggesting that booster doses are required for a sustained viral response. Anti-HBs were detected in 55/120 vaccine recipients but only three patients demonstrated HBsAg loss, indicating that the vaccine-induced anti-HBs was unable to completely neutralize HBsAg in the serum. At the study endpoint, anti-HBs responders showed significantly increased HBeAg sero-conversion, suppression of HBV-DNA levels, and a lower median HBV-DNA reduction compared to the anti-HBs non-responders. Our results suggest that the combined treatment of vaccine and lamivudine was significantly more effective than lamivudine monotherapy in the short term, and was especially successful for viral suppression and enhanced anti-HBs antibody response.

Page last updated: 2009-10-20

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