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- Title
Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B.
- 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
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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]).<bold>Conclusion: </bold>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.
- Subjects
CHINA; CHRONIC hepatitis B; HEPATITIS B; HEPATITIS associated antigen; HEPATITIS B virus; HEPATITIS; ORAL drug administration; VIRAL antigens; RESEARCH; DNA; PURINES; FATTY liver; ANTIVIRAL agents; HEPATITIS viruses; DISEASE incidence; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; VIREMIA; LONGITUDINAL method; ALANINE aminotransferase; BILIRUBIN
- Publication
Journal of Infectious Diseases, 2021, Vol 224, Issue 11, p1890
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jiab241