Substantial Gaps in Evaluation and Treatment of Hepatitis B Patients in the US: A Nationwide Study of 14,693 Patients

Background: Liver cirrhosis and hepatocellular carcinoma risks associated with chronic hepatitis B (CHB) is reduced by antiviral therapy. Prior studies using local institutional cohorts have suggested suboptimal evaluation and treatment of HBV patients in the US. We aimed to determine the proportion of CHB patients who received adequate evaluation, who were treatment eligible, and the proportion of eligible patients who received antiviral treatment in a large nationwide cohort.   Methods: We performed a retrospective analysis using laboratory, administrative and pharmacy claims data of approximately 73 million enrollees across the US from the Optum™ 2003-2019 database. Adult CHB patients observed for ≥ 6 months before and after index CHB diagnosis were identified and confirmed via ICD-9/ICD-10 codes and positive HBsAg, HBeAg or HBV DNA PCR. Organ transplant recipients, hepatitis C or HIV co-infected patients were excluded. Findings: We identified 19,132 confirmed CHB patients and included 14,693 eligible CHB patients in study analysis (mean age 48·4 years, 54·3% male, 54·4% Asian, 18 · 6% Caucasian, 10·2% African American, 5·7% Hispanic). Half of the cohort (50·2%, N=7,383) never had complete laboratory evaluation (defined as having HBeAg, HBV DNA, and ALT tests) and only 73·8% (N=10,837/14,693) had “adequate” evaluation (at least HBV DNA and ALT) during the entire study observation period. Of those with adequate evaluation, 11·1% (N=1,208/10,837) were treatment eligible by AASLD criteria; and of these, only 782 (64·7%) received treatment within 12 months from their eligibility assessment, and 339 (28·1%) never received any treatment. Interpretation: Half of CHB patients in the US with private insurance did not have complete laboratory assessment. Among those with adequate assessment, 11% were eligible for treatment, of which one third never received antiviral therapy. Urgent intervention is needed to identify and address the barriers for these care gaps. Funding Statement: There was no external funding to disclose in our research. Declaration of Interests: Personal disclosures: Daniel Q. Huang: Research support: Exxon Mobil-NUS Research Fellowship for Clinicians, NMRC Research Training Fellowship. Ramsey Cheung: Research support from Gilead Mindie H. Nguyen: Research support: Gilead, Pfizer, Enanta, Vir, Glycotest, National Cancer Institute, B. K. Kee Foundation; Consulting or advisory board: Intercept, Gilead, Exact Sciences, Laboratory of Advanced Medicine, Bayer, Eisai, Novartis. All other authors have nothing to disclose. Ethics Approval Statement: The study was approved by the Institutional Review Board at Stanford University, Stanford, California, US.