Real-world single-center experience with entecavir and tenofovir disoproxil fumarate in treatment-naïve and experienced patients with chronic hepatitis B.

Background/Aim: The goal of antiviral therapy for chronic hepatitis B (CHB) is to improve survival of the patients by achieving a complete virological response (CVR). This study aimed to evaluate long-term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) in nucleos(t)ide analog (NA)-naïve and NA-experienced Korean patients with CHB and to determine the incidence of cirrhosis-related complications in these patients.

Patients and Methods: We retrospectively reviewed medical records of all patients treated with ETV or TDF from July 2007 to January 2017. We examined CVR and analyzed the predictive factors influencing the rate of CVR and evaluated the incidences of cirrhosis-related complications.

Results: The proportion of patients who achieved CVR was 94.2% in the ETV group and 91.1% in the TDF group (P = 0.358). Among patients who achieved CVR, the mean time to CVR was 13.5 ± 14.3 months in the ETV group and 11.5 ± 10.6 months in the TDF group (P = 0.169). Positive predictive factors for CVR included the current treatment with TDF, a low hepatitis B virus DNA level, negative hepatitis B e-antigen status, and high alanine aminotransferase level in baseline laboratory test. The annual incidence rate of HCC was 127 per 10,000 patient-years (1.27% per year) in ETV group, and 85 per 10,000 patient-years (0.85% per year) in TDF group (P = 0.526).

Conclusion: Both ETV and TDF therapy resulted in a high CVR, and the annual incidence rates of HCC and other cirrhosis-related complications were not significantly different between the two treatment groups.