96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir dipivoxil monotherapy in the treatment of chronic hepatitis B

Abstract

Background/Aims: In order to prevent the occurrence of drug-resistant mutants associated with treatment for chronic hepatitis B virus (HBV) infection, combination therapy is being developed. To determine the efficacy of adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy in chronic HBV infection. Methods: Thirty treatment-nai{dotless}̈ve, HBeAg-positive patients were randomized to combination ADV plus FTC (n = 14) or ADV plus placebo monotherapy (n = 16) for 96 weeks. HBV DNA was measured by polymerase chain reaction. Treatment was stopped in those with HBeAg seroconversion. Results: The median decrease in HBV DNA at week 96 was higher in the combination group (-5.30 vs. -3.98 log 10 copies/ml, p = 0.05). More patients in the combination group had normalization of alanine aminotransaminase and HBV DNA < 300 copies/ml at week 96 when compared with the monotherapy group [11 of the 14 patients (78.6%) vs. 6 of the 16 patients (37.5%), p = 0.03]. However, HBeAg seroconversion at week 96 was similar in the 2 groups [2/14 (14.3%) vs. 4/16 (25.0%), p = NS]. No ADV or FTC resistance was detected at week 96. In those with HBeAg seroconversion, 50.0% had post-treatment relapse. Conclusions: Combination ADV plus FTC resulted in more potent suppression of HBV DNA over 96 weeks of therapy. © 2008 European Association for the Study of the Liver.