Hepatitis B Virus Treatment Gaps in the US.

Importance: Treatment of hepatitis B virus (HBV) infection reduces the risk of disease progression and negative outcomes such as hepatic decompensation and hepatocellular carcinoma (HCC). Studies from select populations in the US suggest that treatment levels are low; whether this pattern occurs nationally remains unclear. Objective: To identify HBV treatment levels among patients who met American Association for the Study of Liver Diseases 2016 and 2018 qualification criteria in a clinical setting. Design, Setting, and Participants: This cross-sectional study included adult patients (aged ≥18 years at index) with an HBV diagnosis in the TriNetX Dataworks-USA Network from April 1, 2016, to December 31, 2022, with an HBV DNA laboratory result (index date), measurement of alanine aminotransferase level (2 months before to 1 month after the index date), database encounter activity (6 months or more before the index date), and no evidence of HIV, hepatitis C or D virus infection, HCC, or liver transplant. Data were analyzed from April 1, 2016, to December 31, 2022. Exposures: International Statistical Classification of Disease, Tenth Revision, codes for HBV diagnosis, procedures, assessments, and dispensing of medication and demographic and laboratory data. Main Outcomes and Measures: Treatment was defined by receipt of a prescription for an anti-HBV agent identified in the data with RxNorm codes. Results: Among 14 693 patients with HBV, 8594 met inclusion criteria, and 2134 were treated. Median age (overall, 46 [IQR, 36-57] years) was similar among treated and untreated individuals (49 [IQR, 38-61] and 45 [IQR, 35-56] years, respectively). While 4423 patients (51.5%) were female, only 538 (12.2%) qualified for treatment, compared with 904 of 4171 male patients (21.7%). Only 414 of the 724 patients (57.2%) who qualified via elevated biochemical and viral levels received treatment. Among 723 patients with advanced fibrosis (Fibrosis-4 score > 3.25) and 587 with diagnosed cirrhosis or liver decompensation, 313 (43.3%) and 235 (40.0%), respectively, were untreated. In multivariable analysis among the overall cohort, female patients were 33.0% less likely to be treated than male patients (odds ratio [OR], 0.67; 95% CI, 0.60-0.75). Compared with Asian patients, lower treatment odds were observed for African American or Black patients (OR, 0.66; 95% CI, 0.58-0.75) and White patients (OR, 0.80; 95% CI, 0.69-0.93) and those of unknown or other race (OR, 0.72; 95% CI, 0.61-0.84). Conclusions and Relevance: In this cross-sectional study of patients with HBV infection in the US, substantial proportions of patients who met treatment criteria, including those with advanced disease, were untreated, with differences by sex and race. These findings highlight missed opportunities for prevention of negative HBV-related outcomes.