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Rapid decline rather than absolute level of HBsAg predicts its seroclearance in untreated chronic hepatitis B patients from Taiwanese communities.

ABSTRACT:

Abstract

BackgroundHBsAg clearance leads to favorable outcomes in chronic hepatitis B (CHB) patients. Hepatitis B surface antigen (HBsAg) levels <200 IU/mL with HBsAg decline >0.5 log10 IU/mL in one year have been reported predictive of HBsAg loss. This study aimed to use the REVEAL-HBV cohort to validate and simplify this prediction rule, and verify whether the simplified algorithm can be used among various clinical subgroups.MethodWe analyzed 707 untreated CHB patients who had 3 or more HBsAg measurements within 5 years prior to HBsAg seroclearance or last visit, greater than 1 year apart from one another. Rapid HBsAg decline was defined as HBsAg decline >0.5 log10 IU/mL in 1 year or >1 log10 IU/mL in 2 years. Sensitivity, specificity, PPV and NPV were compared to assess the predictability of HBsAg seroclearance.ResultsDuring 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, PPV=0.5172, NPV=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, HBV DNA and ALT, and was independent of inactive carrier state.ConclusionHBsAg decline >0.5 log10 IU/mL/year was a practical predictor of HBsAg seroclearance within one year in our community-based untreated cohort.

SUBMITTER: Lin HC

PROVIDER: S-EPMC10461935 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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

Lin Hsin-Che HC Liu Jessica J Pan Mei-Hung MH Lee Mei-Hsuan MH Batrla-Utermann Richard R Lu Sheng-Nan SN Jeng Wen-Juei WJ Yang Hwai-I HI Yang Hwai-I HI Chen Chien-Jen CJ

Clinical and translational gastroenterology 20230801 8

<h4>Introduction</h4>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.<h4>Method</h4>We analyzed 707 patients with untreated ...[more]

PMID: 36988242

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Project description:IntroductionSpontaneous hepatitis B surface antigen (HBsAg) seroclearance, the functional cure of hepatitis B infection, occurs rarely. Prior original studies are limited by insufficient sample size and/or follow-up, and recent meta-analyses are limited by inclusion of only study-level data and lack of adjustment for confounders to investigate HBsAg seroclearance rates in most relevant subgroups. Using a cohort with detailed individual patient data, we estimated spontaneous HBsAg seroclearance rates through patient and virologic characteristics.MethodsWe analyzed 11,264 untreated patients with chronic hepatitis B with serial HBsAg data from 4 North American and 8 Asian Pacific centers, with 1,393 patients with HBsAg seroclearance (≥2 undetectable HBsAg ≥6 months apart) during 106,192 person-years. The annual seroclearance rate with detailed categorization by infection phase, further stratified by hepatitis B e antigen (HBeAg) status, sex, age, and quantitative HBsAg (qHBsAg), was performed.ResultsThe annual seroclearance rate was 1.31% (95% confidence interval: 1.25-1.38) and over 7% in immune inactive patients aged ≥55 years and with qHBsAg <100 IU/mL. The 5-, 10-, 15-, and 20-year cumulative rates were 4.74%, 10.72%, 18.80%, and 24.79%, respectively. On multivariable analysis, male (adjusted hazard ratio [aHR] = 1.66), older age (41-55 years: aHR = 1.16; >55 years: aHR = 1.21), negative HBeAg (aHR = 6.34), and genotype C (aHR = 1.82) predicted higher seroclearance rates, as did lower hepatitis B virus DNA and lower qHBsAg (P < 0.05 for all), and inactive carrier state.DiscussionThe spontaneous annual HBsAg seroclearance rate was 1.31%, but varied from close to zero to about 5% among most chronic hepatitis B subgroups, with older, male, HBeAg-negative, and genotype C patients with lower alanine aminotransferase and hepatitis B virus DNA, and qHBsAg independently associated with higher rates (see Visual Abstract, Supplementary Digital Content 2, http://links.lww.com/CTG/A367).