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

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-naı¨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 log10 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.