Five-year comparative risk of hepatocellular carcinoma development under entecavir or tenofovir treatment-naïve patients with chronic hepatitis B-related compensated cirrhosis in Taiwan.

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.

• Authors: Tsung-Hui Hu, Sherry Yueh-Hsia Chiu, Po-Lin Tseng, Chien-Hung Chen, Sheng-Nan Lu, Jing-Houng Wang, Chao-Hung Hung, Kwong-Ming Kee, Ming-Tsung Lin, Kuo-Chin Chang, Meng-Chih Lin, Rong-Nan Chien
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 52 Issue 11-12 Pg. 1695-1706 (12 2020) ISSN: 1365-2036 [Electronic] England
• PMID: 33111400 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 John Wiley & Sons Ltd.

Chemical References

• Antiviral Agents
• alpha-Fetoproteins
• entecavir
• Guanine
• Tenofovir

Topics

• Adult
• Aged
• Antiviral Agents (therapeutic use)
• Carcinoma, Hepatocellular (epidemiology)
• Cohort Studies
• Female
• Guanine (analogs & derivatives, therapeutic use)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Liver Cirrhosis (drug therapy)
• Liver Neoplasms (epidemiology)
• Longitudinal Studies
• Male
• Middle Aged
• Retrospective Studies
• Taiwan
• Tenofovir (therapeutic use)
• alpha-Fetoproteins (metabolism)