1. Incidences and Determinants of Functional Cure During Entecavir or Tenofovir Disoproxil Fumarate for Chronic Hepatitis B.
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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, and Accarino, Elena Vargas
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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 - 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. [ABSTRACT FROM AUTHOR]- Published
- 2021
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