Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B
Yao-Chun Hsu, Ming-Lun Yeh, Grace Lai-Hung Wong, Chien-Hung Chen, Cheng-Yuan Peng, Maria Buti, Masaru Enomoto, Qing Xie, Huy Trinh, Carmen Preda ... Show more
The Journal of Infectious Diseases, Volume 224, Issue 11, 1 December 2021, Pages 1890–1899, https://doi.org/10.1093/infdis/jiab241
Published:
17 May 2021
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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.
hepatitis B virus, functional cure, entecavir, tenofovir, hepatitis B surface antigens, REAL-B
Topic:
bilirubin fatty liver follow-up hepatitis b surface antigens hepatitis b, chronic hepatitis b virus dna hepatitis b virus tenofovir entecavir