Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naive patients with chronic hepatitis B: a multicenter real-life study

Objective: To compare responses to tenofovir (TDF) and entecavir (ETV) therapy. Methods: This was a multicenter retrospective study including treatment-naive patients with chronic hepatitis B (CHB) who received TDF or ETV. The primary end-points were undetectable HBV-DNA at 48 weeks and serological and biochemical responses. Results: Out of 195 CHB patients, 90 (46%) received TDF and 105 (54%) received ETV; 72% were male, their mean age was 43 +/- 12 years, and the mean duration of treatment was 30.2 +/- 15.7 months. Hepatitis B e antigen (HBeAg) seropositivity was 32% in the TDF group and 34% in the ETV group. HBeAg seroconversion rates in HBeAg-positive patients were 24% in the TDF group and 39% in the ETV group; the difference was not significant (p = 0.2). The mean time to alanine aminotransferase (ALT) normalization and rates of ALT normalization at 3, 6, 12, 18, and 24 months were similar in the two groups (p > 0.05). The mean time to undetectable HBV-DNA levels in the TDF and ETV groups was 11.5 +/- 8.9 and 12.9 +/- 10.8 months, respectively (p = 0.32). A significantly greater decline in HBV-DNA levels at 12 and 18 months was observed in the TDF group (p = 0.02 and p = 0.03, respectively). Seven (7%) patients on ETV therapy had virological breakthrough (p = 0.01). Only one patient in each group had hepatitis B surface antigen (HBsAg) clearance. None of the patients developed decompensation or hepatocellular carcinoma during treatment. Conclusions: The two drugs appear to have similar efficacy in CHB patients. However, 7% of patients on ETV therapy had virological breakthrough, while none of the patients on TDF therapy did. (C) 2014 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license.