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Substantial gaps in evaluation and treatment of patients with hepatitis B in the US
Qing Ye1, Leslie Y Kam2, Yee Hui Yeo3
1Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, CA, United States; The Third Central Clinical College of Tianjin Medical University, Tianjin, China; Department of Hepatology of the Third Central Hospital of Tianjin, China; Tianjin Institute of Hepatobiliary Disease, Tianjin, China.
Insights
Antiviral therapy reduces liver complications in chronic Hepatitis B (HBV) infection. However, many US patients with private insurance receive suboptimal evaluation and treatment, highlighting a need for improved care pathways.
Area of Science:
- Hepatology
- Infectious Diseases
- Public Health
Background:
- Antiviral therapy is effective in reducing HBV-associated liver complications.
- Previous studies indicated suboptimal evaluation and treatment for chronic HBV infection.
- A nationwide cohort analysis was needed to assess current management practices.
Purpose of the Study:
- To determine the proportion of chronic HBV patients receiving adequate evaluation.
- To identify the percentage of treatment-eligible patients receiving antiviral therapy.
- To analyze factors influencing adequate evaluation and treatment receipt.
Main Methods:
- Retrospective analysis of de-identified US claims data (2003-2019).
- Inclusion of ~73 million enrollees, identifying 12,608 patients with chronic HBV.
- Confirmation of diagnosis via laboratory markers (HBsAg, HBeAg, HBV DNA PCR).
Main Results:
- 52.3% of patients lacked complete laboratory evaluation (HBeAg, HBV DNA, ALT).
- Only 72.4% had adequate evaluation (HBV DNA, ALT).
- 60.4% (AASLD criteria) and 54.3% (EASL criteria) of eligible patients received treatment within 12 months.
Conclusions:
- Suboptimal laboratory evaluation affects over half of chronic HBV patients with private insurance.
- More than one-third of treatment-eligible patients do not receive timely antiviral therapy.
- Specialist care is associated with improved evaluation and treatment rates, indicating a need to address care gaps.
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.
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