Five-year comparative risk of hepatocellular carcinoma development under entecavir or tenofovir treatment-naïve patients with chronic hepatitis B-related compensated cirrhosis in Taiwan
Tsung-Hui Hu 1 , Sherry Yueh-Hsia Chiu 2 , Po-Lin Tseng 1 , Chien-Hung Chen 1 , Sheng-Nan Lu 1 , Jing-Houng Wang 1 , Chao-Hung Hung 1 , Kwong-Ming Kee 1 , Ming-Tsung Lin 1 , Kuo-Chin Chang 1 , Meng-Chih Lin 3 , Rong-Nan Chien 4
Affiliations
Affiliations
1
Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
2
Department of Health Care Management, College of Management; and Healthy Aging Research Center, Chang Gung University, Taoyuan, Taiwan.
3
Division of Pulmonary and Critical Care Medicine and Department of Respiratory Therapy, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
4
Division of Hepato-Gastroenterology, Department of Internal Medicine, Linko Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taoyuan, Taiwan.
PMID: 33111400 DOI: 10.1111/apt.16116
Abstract
Background: Comparative long-term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) for prevention of disease progression to hepatocellular carcinoma (HCC) among high-risk patients with chronic hepatitis B (CHB)-related compensated cirrhosis is controversial.
Aims: To compare the long-term efficacy of ETV and TDF in HCC prevention in patients with CHB-related cirrhosis, and to evaluate predictive risk factors for HCC development.
Methods: From January 2008 to March 2018, 894 treatment-naïve patients with CHB-related compensated cirrhosis on ETV or TDF were enrolled based on the longitudinal cohort study. Data were originally collected for 7.3 years of follow-up or after the launch of TDF in 2011. Only the 5-year cumulative incidence and risk factors of HCC were assessed.
Result: Total 678 and 216 patients received ETV and TDF, respectively. The cumulative risk of HCC at 1, 3 and 5 years of follow-up was 1.6%, 11.3% and 18.7%, respectively, in the ETV group; and 0.9%, 6.7% and 10.7%, respectively, in the TDF group (P = 0.0305). Univariate and adjusted-multivariable models revealed that platelet count, alpha-fetoprotein (AFP) levels and upper gastrointestinal (UGI) varices were independent risk factors for HCC development. TDF resulted in risk of HCC development compared to ETV with adjusted hazard ratios (aHRs) of 0.66 (95% confidence interval [CI]:0.40, 1.08; P = 0.0971), 0.69 (95% CI: 0.42, 1.14; P = 0.1488) and 0.66 (95% CI: 0.38, 1.14; P = 0.1407) under stepwise selection, propensity score adjustment, and propensity score matching multivariable models, respectively.
Conclusions: For treatment-naïve patients with CHB-related compensated cirrhosis with 5-year follow-up, after variable adjustments, propensity score approaches and subgroup analyses, TDF showed a lower rate of HCC development that did not reach statistical significance, compared to the ETV.
结果：分别有678名和216名患者接受了ETV和TDF。在ETV组，随访1年，3年和5年的HCC累积风险分别为1.6％，11.3％和18.7％。 TDF组分别为0.9％，6.7％和10.7％（P = 0.0305）。单变量和调整后的多变量模型显示，血小板计数，甲胎蛋白（AFP）水平和上消化道（UGI）静脉曲张是肝癌发生的独立危险因素。与ETV相比，TDF导致的HCC发生风险为0.66（95％置信区间[CI]：0.40，1.08; P = 0.0971），0.69（95％CI：0.42，1.14; P = 0.1488） ）和0.66（95％CI：0.38、1.14； P = 0.1407）分别在逐步选择，倾向得分调整和倾向得分匹配多变量模型下进行。
