Among patients with chronic hepatitis B virus (HBV) infection, seroclearance of hepatitis B surface antigens (HBsAg) rarely occurred after therapy with entecavir or tenofovir disoproxil fumarate, according to the results of an international, multicenter, retrospective cohort study published in the Journal of Infectious Diseases.

Data from patients (N=4769) who were treatment naive before receiving antiviral therapy for chronic HBV infection at 13 centers in China, Taiwan, United States, Japan, Romania, South Korea, and Spain were analyzed for this study. Patients were assessed for HBsAg and mortality for up to 10 years.

The median age of participants was 50 years (interquartile range [IQR], 40-58); 69.05% were men, 88.78% were Asian, 28.24% had fatty liver, and 25.02% had liver cirrhosis.  Most patients (84.25%) received treatment with entecavir.


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Over the 10-year follow-up period (median, 5.16; IQR, 3.01-8.37 years), the annual rate of HBsAg seroclearance varied between 0.11% (at year 7) and 0.30% (at year 1) for a cumulative incidence of 2.11% (95% CI, 1.54-2.88) by year 10. During this time, 58 patients achieved HBsAg clearance, and 213 patients died while remaining positive for HBsAg.

Among patients without fatty liver, HBsAg seroclearance was associated with alanine aminotransferase >200 U/L (adjusted subhazard ratio [aSHR], 3.79; 95% CI, 1.06-3.25; P =.029), hepatitis B viral load <2000 IU/mL (aSHR, 2.60; 95% CI, 1.49-4.52; P =.001), and bilirubin >2 mg/mL (aSHR, 1.11; 95% CI, 1.06-1.16; P <.001).

For patients with fatty liver, HBsAg seroclearance was associated with alanine aminotransferase >200 U/L (aSHR, 3.85; 95% CI, 2.15-6.89; P <.001), hepatitis B viral load <2000 IU/mL (aSHR, 3.22; 95% CI, 1.84-5.65; P <.001), imaging evidence of fatty liver (aSHR, 1.89; 1.05-3.40; P =.033), and bilirubin >2 mg/mL (aSHR, 1.11; 95% CI, 1.06-1.16; P <.001).

Among patients with these determined cut-offs (alanine aminotransferase >200 U/L, viral load <2000 IU/mL, and bilirubin >2 mg/mL), the seroclearance rate was 16.45% (95% CI, 8.91-29.27) compared with 1.13% (95% CI, 0.69-1.86) among patients without these criteria.

This study may have been limited by lack of a standardized procedure to assess HBsAg across study sites.

These data indicated that seroclearance of HBsAg was rare among patients with chronic HBV infection treated with entecavir or tenofovir disoproxil fumarate and was influenced by alanine aminotransferase and bilirubin concentrations, viral load, and fatty liver status.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Hsu Y-C, Yeh M-L, Wong GL-H, et al. Incidences and determinants of functional cure during entecavir or tenofovir disoproxil fumarate for chronic hepatitis B. J Infect Dis. 2021;jiab241. doi:10.1093/infdis/jiab241