Abstract
BACKGROUND AND AIMS: Tenofovir disoproxil fumarate (TDF) is the first-line therapy for chronic hepatitis B. This interim analysis presents the efficacy and safety data for TDF at Week 144 in patients with chronic hepatitis B and advanced fibrosis or compensated cirrhosis from China. METHODS: Patients were assessed for incidence of newly diagnosed hepatocellular carcinoma (HCC) and disease progression, liver stiffness measurement (LSM), virological suppression (serum hepatitis B virus DNA <20 IU/mL), alanine aminotransferase normalization, hepatitis B e antigen (HBeAg) loss and seroconversion, histological liver fibrosis score, and safety at Week 144. RESULTS: Overall, 197 patients were enrolled. At Week 144, the incidence of newly diagnosed HCC was observed in 2.1% patients, and the incidence of disease progression was observed in 3.6% patients. The mean (standard deviation) change in LSM from baseline was -5.1 (5.85) kPa. Serum hepatitis B virus DNA <20 IU/mL was observed in 94.1% patients, alanine aminotransferase normalization in 33.5% patients, HBeAg loss in 35.6% patients, and HBeAg seroconversion in 14.4% patients. Among patients with stage F3 or F4 fibrosis at baseline by LSM, 38.3% patients regressed to stage F0/1, and 22.0% of patients regressed to stage F2 at Week 144. Overall, 67.7% patients experienced ≥1 adverse events, 13.8% patients experienced TDF-related adverse events, and 16.4% patients experienced serious (none were TDF-related). CONCLUSIONS: At Week 144 of TDF treatment, low incidence of HCC and disease progression were reported. Virological suppression was observed in 94.1% patients, which was associated with fibrosis regression. No new safety events were identified.