Real-world efficacy of long-term entecavir and tenofovir in patients with chronic hepatitis B.

Background and Aim: Entecavir (ETV) and tenofovir (TDF) are potent antiviral therapies for chronic hepatitis B (CHB). Data remain limited on the long-term (> 48 weeks) efficacy and safety of ETV and TDF in patients with CHB managed in a tertiary care setting, particularly treatmentexperienced and cirrhotic patients. We evaluated the long-term safety and efficacy of ETV and TDF in a large heterogeneous cohort of initial and treatment-experienced patients with CHB. Method(s): We conducted a multicenter retrospective cohort study of patients with CHB aged >= 18 years who received either ETV or TDF for >= 6 months. Patients were treated at seven tertiary health care networks across Melbourne, Australia, between January 2007 and January 2017. The primary end-points were undetectable hepatitis B virus (HBV)-DNA suppression (viral load [VL] of < 15 IU/mL) and alanine aminotransferase (ALT) normalization (American Association for the Study of Liver Diseases criteria). The rate of HBeAg and HBsAg loss/seroconversion, adverse events (AEs), and clinical outcomes, such as hepatocellular carcinoma and hepatic decompensation, were also evaluated. Result(s): Of the 1093 patients in the cohort, 68.89% were male, and the mean age was 48.28 +/- 13.18 years. At baseline, 28.73% were cirrhotic, and 30.28% were treatment-experienced. Baseline mean HBV-DNA VL was 4.63 +/- 2.14 log10 IU/mL. A total of 779 patients (71.27%) received ETV and 314 (28.73%) received TDF, with median treatment durations of 37 (IQR, 20-56) and 24.5 (IQR, 15-31) months, respectively. In the ETV group, 34% were HBeAg seropositive, and in the TDF group, 42.52% were. The Kaplan-Meier curve estimated probability of complete HBV-DNA suppression on ETV or TDF was 42.82% at 10 months, 69.57% at 20 months, and 83.31% at 30 months. Multivariate Cox regression analysis of the entire cohort identified baseline cirrhosis (hazard ratio [HR], 0.54; 95% CI, 0.32-0.91; P = 0.02) as an independent negative predictor for HBV-DNA s