Tenofovir disoproxil fumarate therapy in patients with chronic hepatitis B and advanced fibrosis or compensated cirrhosis

Elsevier, iLIVER, Volume 1, Issue 3, September 2022, Pages 145-153
Huiying Rao, Jia Shang, Qing Xie, Jianqi Lian, Pujun Gao, Junping Shi, Xinyue Chen, Jiefei Wang, Min Xu, Liaoyun Zhang, Yingren Zhao, Qing Mao, Maorong Wang, Wei Zhao, Zong Zhang, Jidong Jia, Hong Tang, Jiming Zhang, Xin Zheng, Chang Liu, Lai Wei

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.