Background & aims: The occurrence of HBV-associated liver complications is reduced by antiviral therapy. However, prior studies using local institutional cohorts have suggested that evaluation and treatment are suboptimal. We aimed to determine the proportion of patients with chronic HBV infection who received adequate evaluation, were treatment eligible, and received antiviral treatment using a large, nationwide cohort.

Methods: This retrospective analysis utilized claims data of approximately 73 million enrollees across the US from Optum's de-identified Clinformatics® Data Mart Database, 2003-2019. Adults observed for ≥6 months before and after an index diagnosis of chronic HBV infection were identified via ICD-9/ICD-10 codes, with the diagnosis confirmed by positive HBsAg, HBeAg or HBV DNA PCR.

Results: We included 12,608 eligible patients in the study analysis (mean age 45.7 years, 52.1% male, 54.6% Asian, 18.1% Caucasian, 10.5% African American). About half of the cohort (n = 6,559, 52.3%) did not have a complete laboratory evaluation (defined as having HBeAg, HBV DNA, and ALT tests) and only 72.4% (n = 9,129) had an "adequate" evaluation (at least HBV DNA and ALT) during the entire study period. Of those with an adequate evaluation, 11.2% were treatment eligible by AASLD criteria and 13.9% by EASL criteria; 60.4% of AASLD eligible patients and 54.3% of EASL eligible patients received treatment within 12 months from becoming eligible.

Conclusions: Half of patients with chronic HBV infection in the US with private insurance did not have a complete laboratory assessment. Over one-third of treatment-eligible patients did not receive antiviral therapy. Patients who visited a specialist had a higher chance of receiving adequate evaluation and treatment. Urgent intervention is needed to identify and address the barriers to optimal care.

Lay summary: In this study, we used a national database that includes laboratory data in addition to medical and pharmacy claims data to assess the current real-world management of chronic HBV infection in the US. Among the 12,608 patients with chronic HBV infection included in our study, 52.3% never had a complete laboratory evaluation and only 73% had an adequate evaluation. Among those who were treatment eligible according to major society guidelines, only 60.4% and 54.3% received treatment within 12 months, respectively.