Results in chronic hepatitis B patients using tenofovir and entecavir for at least 10 years; HBV clearance rare, disease outcomes good: An observational cohort study

This study aims to investigate antiviral effectiveness, side effects, and disease outcomes in patients who have been using entecavir (ETV) and tenofovir disoproxil fumarate (TDF) for a long-term in chronic hepatitis B. Patients with chronic hepatitis B who had been using TDF or ETV for at least 10 years were included in this retrospective study. Co-infected patients, those receiving immunosuppressive therapy, and transplant patients were excluded. Of the study's total 173 patients (baseline mean age 43.4 ± 11.7 years), 110 (63.6%) were men. Thirty-three (19.1%) patients were cirrhotic, and hepatitis B e-antigen was negative in 131 (75.7%) patients at the baseline. Ninety-two (53.2%) patients used TDF and 81 (46.8%) used ETV for a mean of 156.76 ± 21.60 (120-204) months. Hepatitis B virus (HBV)-DNA negativity (<10 IU/mL) was achieved in 97.7% of all patients. Biochemical remission was achieved in 98.3% of all patients at the last visit. HBsAg became negative in only 5 (2.9%). Hepatocellular carcinoma (HCC) developed in 9 (5.2%) patients. All HCCs occurred after the 5th year of treatment. The age at HBV diagnosis was higher in HCC patients (P = .023), but the most important risk factor for the development of HCC was to have cirrhosis at baseline. Eight (4.6%) patients died in the follow-up, and 2 were due to liver disease and the remaining non-liver disease. At the end of follow-up, HBV-DNA negativity was achieved in almost all patients, and HBsAg sero-clearance was rarely achieved. Very few patients developed HCC and the long-term mortality rate was similar to the general population.