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. 2023 Aug 1;14(8):e00586.
doi: 10.14309/ctg.0000000000000586.

Rapid Decline Rather Than Absolute Level of HBsAg Predicts Its Seroclearance in Untreated Chronic Hepatitis B Patients From Taiwanese Communities

Hsin-Che Lin  1   2 , Jessica Liu  3 , Mei-Hung Pan  1 , Mei-Hsuan Lee  4 , Richard Batrla-Utermann  5 , Sheng-Nan Lu  6 , Wen-Juei Jeng  7   8 , Hwai-I Yang  1   4   9   10 , Chien-Jen Chen  1
Affiliations

Rapid Decline Rather Than Absolute Level of HBsAg Predicts Its Seroclearance in Untreated Chronic Hepatitis B Patients From Taiwanese Communities

Hsin-Che Lin et al. Clin Transl Gastroenterol. .

Abstract

Introduction: Hepatitis B surface antigen (HBsAg) clearance leads to favorable outcomes in patients with chronic hepatitis B. HBsAg levels <200 IU/mL with HBsAg decline >0.5 log 10 IU/mL in 1 year have been reportedly predictive of HBsAg loss. This study aimed to use the REVEAL-hepatitis B virus cohort to validate and simplify this prediction rule and verify whether the simplified algorithm can be used among various clinical subgroups.

Method: We analyzed 707 patients with untreated chronic hepatitis B who had 3 or more HBsAg measurements within 5 years before HBsAg seroclearance or last visit, greater than 1 year apart from one another. Rapid HBsAg decline was defined as HBsAg decline >0.5 log 10 IU/mL in 1 year or >1 log 10 IU/mL in 2 years. Sensitivity, specificity, positive predictive values, and negative predictive values were compared to assess the predictability of HBsAg seroclearance.

Results: During a median follow-up of 10.7 years, 41 of the 707 patients cleared serum HBsAg. HBsAg levels at all measurements were lower ( P < 0.0001) and HBsAg decline was greater ( P < 0.0001) in patients with seroclearance compared with non-seroclearance patients. The predictive accuracy of predicting 1-year HBsAg loss using only the rapid decline algorithm (sensitivity = 0.4412, specificity = 0.9792, positive predictive value = 0.5172, negative predictive value = 0.972) was the same as the model combining rapid HBsAg decline and HBsAg levels <200 IU/mL. The simplified algorithm including only the rapid decline performed similarly among various levels of HBsAg, hepatitis B virus DNA, and alanine aminotransferase and was independent of inactive carrier state.

Discussion: HBsAg decline >0.5 log 10 IU/mL/yr was a practical predictor of HBsAg seroclearance within 1 year in our community-based untreated cohort.

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Conflict of interest statement

Guarantor of the article: Hwai-I Yang, PhD.

Specific author contributions: H.-C.L. contributed to study planning, data interpreting, and manuscript drafting. J.L. contributed to study planning and manuscript revising. M.-H.P., M.-H.L., R.B.-U., and C.-J.C. contributed to data collection. H.-I.Y. and W.-J.J. contributed to study planning and manuscript drafting and revising. All authors approved the final draft submitted.

Financial support: This study was funded by Academia Sinica and Roche Diagnostics for the assay of quantitative HBsAg level; National Science and Technology Council, Taiwan (MOST 110-2314-B-001-003; MOST 111-2314-B-001-009); and Ministry of Health and Welfare, Taiwan (MOHW 111-TDU-B-221-114007). The sponsors of this study had no role in study design, data collection, data analysis, data interpretation, or writing of this report.

Potential competing interests: None to report.

Figures

Figure 1.
Figure 1.
Flowchart of participant selection. HBe, hepatitis B e; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus.
Figure 2.
Figure 2.
(a) Box plot of HBsAg levels among the clearance and non-clearance groups: HBsAg levels were significantly higher in the non-clearance group for all measurements (P < 0.001). (b and c) Box plot of HBsAg decline rates in the clearance and non-clearance groups: The decline rate was greater in the clearance group (P < 0.001), but decline rates were not different within groups (P = 0.4507 for the non-seroclearance group; P = 0.3173 for the seroclearance group). HBsAg, hepatitis B surface antigen.
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