Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B. (17th May 2021)

• Record Type: Journal Article
• Authors: Hsu, Yao-Chun; Yeh, Ming-Lun; Wong, Grace Lai-Hung; Chen, Chien-Hung; Peng, Cheng-Yuan; Buti, Maria; Enomoto, Masaru; Xie, Qing; Trinh, Huy; Preda, Carmen; Liu, Li; Cheung, Ka-Shing; Yeo, Yee Hui; Hoang, Joseph; Huang, Chung-Feng; Riveiro-Barciela, Mar; Kozuka, Ritsuzo; Istratescu, Doina; Tsai, Pei-Chien; Accarino, Elena Vargas; Lee, Dong-Hyun; Wu, Jia-Ling; Huang, Jee Fu; Dai, Chia-Yen; Cheung, Ramsey; Chuang, Wan-Long; Yuen, Man-Fung; Wong, Vincent Wai-Sun; Yu, Ming-Lung; Nguyen, Mindie H
• Is Part Of: Journal of infectious diseases. Volume 224:Number 11(2021)
• Page Start: 1890
• Page End: 1899
• Publication Date: 2021-05-17
• Subjects: hepatitis B virus -- functional cure -- entecavir -- tenofovir -- hepatitis B surface antigens -- REAL-B; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiab241
• Languages: English
• ISSNs: 0022-1899

Abstract

Abstract: Background: Long-term incidences and baseline determinants of functional cure (hepatitis B surface antigen [HBsAg] seroclearance) during entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment are incompletely understood. Methods: This is an international multicenter cohort study of treatment-naive patients with chronic hepatitis B who started ETV or TDF treatment without baseline cancer. Patients were observed for HBsAg seroclearance until death or loss to follow-up. We calculated the incidences and explored the baseline determinants of HBsAg seroclearance using competing risk regression. Results: The analysis included 4769 patients (median age, 50 years; 69.05% male), with a median follow-up of 5.16 years (26 614.47 person-years). HBsAg clearance occurred in 58 patients, yielding a 10-year cumulative incidence of 2.11% (95% confidence interval, 1.54%–2.88%) and an annual rate of 0.22% (.17%–.28%). Baseline predictors included low-level viremia with hepatitis B virus DNA <2000 IU/mL (adjusted subdistribution hazard ratio, 3.14 [95% confidence interval, 1.80–5.49]), elevated serum alanine aminotransferase >200 U/L (3.68 [2.07–6.53]), serum bilirubin (1.11 per mg/dL; [1.06–1.17 mg/dL]), and fatty liver (1.84 [1.03–3.29]). Conclusion: HBsAg seroclearance rarely occurs in patients with chronic hepatitis B treated with ETV or TDF and is associated with low-level viremia, alanine aminotransferase flare, bilirubin level, and fatty liver. Functional cure of hepatitis B virus infection rarely occurred at an average annual rate of 0.22% during first-line oral antiviral treatment, with higher chances observed in patients with low-level viremia, high-level aminotransferase flare, elevation of serum bilirubin, and fatty liver.