telbivudine plus adefovir versus lamivudine plus adefovir for lamivudine-resistant chronic hepatitis b: tesla randomized trial

Background: in countries with unavailable tenofovir, a combination of lamivudine (lmv) and adefovir (adv) is recommended for the treatment of lmv-resistant chronic hepatitis b (chb). considering that telbivudine (l-dt) was demonstrated to be superior to lmv in previous studies, l-dt and adv combination therapy is expected to show better antiviral efficacy than the combination of lmv and adv in patients with lmv-resistant chb. methods: this was a prospective randomized multicenter study. the primary endpoint was hepatitis b virus (hbv) dna reduction after 52 weeks of treatment. the secondary endpoints were hbv dna undetectability, hepatitis b e antigen seroconversion, the incidence of virological and biochemical breakthroughs, and safety during the study period. results: a total of 43 lmv-resistant chb patients were enrolled. twenty-one were treated with lmv + adv and 22 with l-dt + adv. after 52 weeks of antiviral treatment, the hbv dna reduction showed no significant intergroup difference (-4.541.23 log iu/ml in the lmv + adv group, -4.24  1.46 log iu/ml in the l-dt + adv group, p = 0.475). there were no significant intergroup differences in hbv dna undetectability rates, mean hbv dna level, or hepatitis b e antigen seroconversion rate at 13, 26, 39, and 52 weeks of treatment. in terms of safety, the mean creatine phosphokinase level was significantly higher in the l-dt + adv group. conclusions: in the treatment of lmv-resistant chb, the combination of l-dt and adv did not show any clinical benefit compared to the combination of lmv and adv.