Randomized, prospective, efficacy and pharmacoeconomic trial of short course combination antiviral of lamivudine and adefovir versus entecavir monotherapy in HBeAg-positive chronic hepatitis B

The aim of this study was to compare the safety, efficacy, and pharmacoeconomics of the diminishing type antiviral combination of lamivudine and adefovir group (LA group) and entecavir monotherapy group (E group) in HBeAg-positive chronic hepatitis B. One hundred (100) patients were randomized equally to LA group, and E group in a multi-center randomized clinical trial. In the LA group, the earliest time for lamivudine discontinuation was 12 weeks and adefovir monotherapy continued until 96 weeks. Group E received entecavir monotherapy for 96 weeks. At 12 weeks, the hepatitis B virus (HBV)DNA suppression and ALT normalization rates in LA group were both comparable to E group. At weeks 24 and 48 of treatment, the difference in virological response (VR) and HBeAg seroconversion between LA group and E group was not significant, while similar results were observed for the biochemical response (BR). At 96 weeks, HBeAg seroconversion of LA group were higher than that of the E group, but the difference was still not statistically significant, while BR and VR in LA and E group were similar. At the same time, no virological breakthrough or drug resistance occurred in either of the two treatment groups by week 96 of the study. Both treatment strategies were well tolerated, with a low incidence of adverse reaction. The costs of all items related to LA group were lower than those related to E group (RMB i?¥14,480.13 vs. RMB i?¥28,818.47; t=164.78, p<0.001). This study demonstrates that diminishing type antiviral combination of lamivudine and adefovir is economical, safe, and effective in HBeAg-positive chronic hepatitis B.   Key words: Chronic hepatitis B, HBeAg-positive, lamivudine, adefovir dipivoxil, combination treatment, entecavir, monotherapy, pharmacoeconomic.