PE-115 : Entecavir versus Tenofovir in Hepatitis-B Related Hepatocellular Carcinoma Arising in Treatment-naive Chronic Hepatitis B Patients

Aims: Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are potent nucleoside analogues (NAs) recommended as firstline monotherapies for chronic hepatitis B. There have been some hot debates on the clinical outcomes of the two agents regarding hepatocellular carcinoma (HCC) occurrence or recurrence among chronic hepatitis B patients. The objective of this study was to compare the survival of hepatitis B virus (HBV)-related HCC patients who started ETV or TDF at the time of HCC diagnosis. Methods: A total of 1,031 consecutive antiviral treatment-naive patients who started ETV (n=516) or TDF (n=515) monotherapy during two months before and after the initial HCC diagnosis between September 2012 and December 2017 were analyzed. Patients who had hepatitis C co-infection or received liver transplantation as the initial cancer-specific treatment were excluded. Overall survival of patients were compared between ETV and TDF groups. Results: The median age of the study patients was 55 years, and 80.3% were male. Barcelona Clinic Liver Cancer (BCLC) stage 0 and A patients were 42.0%, B for 14.5%, C for 40.8%, and D for 2.7%. Most (85.4%) had Child-Pugh class A. Hepatitis B e antigen-positive patients was 36.3%. There were no differences between ETV and TDF groups in the baseline characteristics. During a median follow-up period of 28.0 months (range: 0.1 - 92.1 months), 441 (42.8%) patients died. Entecavir group and tenofovir group did not show any difference in overall survival (median 28.0 vs 29.0 months, P=0.972). When stratified with BCLC stage, the results were similar. By both univariable and multivariable cox regression analysis, the type of NA was not an independent factor for overall survival, while male sex, albumin-bilirubin grade, fibrosis-4 score, serum alpha-fetoprotein, and BCLC stage were revealed to be significant factors. Conclusions: Among antiviral treatment-naive patients newly diagnosed with HBV-related HCC, ETV and TDF therapy did not differ for overall survival.