BEHoLD Trial: Entecavir + Lamivudine for Hep B

behold trial enecavir hep B
2006 BEHOLD TRIAL A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B multicenter, double-blind, double-dummy, randomized controlled trial M Objective: To compare the efficacy and safety of 48 weeks of therapy with entecavir with 48 weeks of therapy with lamivudine in patients with HBeAg-positive chronic hepatitis B who had not previously received a nucleoside analogue. 715 Patients 722 72 67 Inclusion criteria: Patients aged ≥16 years with HBeAg-positive chronic hepatitis B, compensated liver function, detectable HBsAg for ≥24 weeks before screening. B VS Entecavir group (n=354) Lamivudine group (n=355) PRIMARY OUTCOME Histological improvement after 48 weeks % Diff 9.9; 95% CI, 2.6 to 17.2; P=0.009 SECONDARY OUTCOMES Undetectable Sr.HBV DNA levels according to PCR assay % Diff 30.3; 95% CI, 23.3 to 37.3; P<0.001 29 62 36 36 68 Normalization of alanine aminotransferase levels % 60 Diff 8.4; 95% CI, 1.3 to 15.4; P=0.02 8 Serious adverse events % P=0.78 8 Conclusion: Among patients with HBeAg-positive chronic hepatitis B, the rates of histologic, virologic, and biochemical improvement are significantly higher with entecavir than with lamivudine. The safety profile of the two agents is similar, and there is no evidence of viral resistance to entecavir. TT Chang et al. NEJM 2006; 354:1001-1010 | Summary by Dr.Shreyash Bhoyar, MBBS M Visualmed