PE-046 : Safety and Efficacy with Entecavir and Two Types of Tenofovir Prodrug for Chronic Hepatitis B Infection

Aims: Chronic hepatitis B (CHB) is a major cause of cirrhosis and hepatocellular carcinoma (HCC), and the use of antiviral agents that suppress the viral replication is the most effective way to control it. As a treatment for chronic hepatitis B, tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and entecavir (ETV) are recommended as primary treatment. This study aimed to evaluate the efficacy and safety of ETV, TDF and TAF in real world clinical data. Methods: We reviewed the data retrospectively from electronic medical record at the Kyung Hee University Hospital at Gangdong. 363 CHB patients who were treated with ETV (n=163), TDF (n=154) or TAF (n=46) from July 2007 to September 2019 were enrolled. To evaluate the efficacy and safely of the three groups after treatment of each regimen, HBeAg seroconversion, the changes in HBV DNA levels, presence of liver cirrhosis (LC), liver function tests and creatinine were checked. We also evaluated cumulative incidence rate of complete virological response (CVR), LC-related complications and HCC during the treatment period. Results: The mean age of patients was 51 years and male patients were 66.4%. The mean duration of treated with ETV, TDF and TAF was 49.0 months (interquartile range, 27.0~74.0). The proportion of NA naive patients was 93.3%, 73.4%, and 78.2% in ETV, TDF, and TAF groups (P<0.001). In terms of safety, cholesterol was mildly increased in ETV and TAF groups and statistically decreased in TDF group. (P<0.001) ALP and eGFR change was not significantly different in the three groups at 48 weeks. (P=0.826, 0.048, respectively). There was no significant difference in LC related complications after 48 weeks in each group (P=0.235). In terms of efficacy, HBeAg seroconversion, CVR and ALT normalization at 48 weeks were evaluated, but these were not statistically different among the three groups (P=0.142, 0.538, 0.520, respectively). Cumulative incidence rate of LC-related complications requiring hospitalization were not statistically difference between ETV and TDF group. (P=0.959) Also there was no significant difference in cumulative incidence rate of HCC between ETV and TDF group. (P=0.894) Conclusions: ETV, TDF and TAF are similarly safe and effective antiviral agents for CHB at 48weeks. CVR, cirrhosis related complications, HCC incidence rates, creatinine clearance are not statistically different in the three groups during the follow up period