Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naïve 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-naïve 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.