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Simplifying Treatment Criteria in Chronic Hepatitis B: Reducing Barriers to Elimination
Robert J Wong1,2, Harvey W Kaufman3, Justin K Niles3
1Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, California, USA.
Insights
Simplifying chronic hepatitis B (CHB) treatment criteria could increase patient eligibility for therapy. Many CHB patients not meeting current guidelines show significant fibrosis, highlighting the need for broader treatment access.
Area of Science:
- Hepatology
- Virology
- Public Health
Background:
- Hepatitis B virus (HBV) DNA suppression is crucial for reducing hepatocellular carcinoma risk in chronic hepatitis B (CHB) patients.
- Current CHB treatment criteria are complex, potentially delaying necessary therapy.
- Simplifying these criteria can improve timely access to treatment.
Purpose of the Study:
- To evaluate treatment eligibility patterns among US patients with CHB using various established guidelines.
- To propose a stepwise simplification of CHB treatment criteria to enhance treatment accessibility.
Main Methods:
- Analysis of 2016-2020 Quest Diagnostics data for patients meeting CHB criteria.
- Evaluation of treatment eligibility using AASLD, EASL, APASL, and AATA criteria.
- Assessment of significant fibrosis in treatment-ineligible patients.
Main Results:
- Only a small percentage of CHB patients met AASLD (6.7%), EASL (6.2%), APASL (5.8%), and AATA (16.4%) criteria.
- A notable proportion (7.7%-10.8%) of treatment-ineligible patients had significant fibrosis.
- Proposed simplification increased eligibility from 10.3% to 87.2% by including patients with detectable HBV DNA.
Conclusions:
- Many CHB patients not meeting current criteria exhibit significant fibrosis.
- Simplifying criteria to include all patients with detectable HBV DNA can streamline eligibility assessment.
- Broader treatment initiation is essential for improving CHB management and advancing HBV elimination efforts.
Background:
Early, sustained hepatitis B virus (HBV) DNA suppression reduces long-term risks of hepatocellular carcinoma. Chronic hepatitis B (CHB) treatment criteria are complex. Simplifying criteria will improve timely linkage to therapy. We evaluated treatment eligibility patterns among US patients with CHB and propose stepwise simplification of CHB treatment criteria.
Methods:
Using 2016-2020 Quest Diagnostics data, we evaluated treatment eligibility among patients with CHB (2 positive HBV tests [HBV surface antigen, HBV e antigen, or HBV DNA] ≥6 months apart) using American Association for the Study of Liver Disease (AASLD), European Association for Study of the Liver (EASL), Asian Pacific Association for Study of the Liver (APASL), and Asian American Treatment Algorithm (AATA) criteria.
Results:
Among 84 916 patients with CHB, 6.7%, 6.2%, 5.8%, and 16.4% met AASLD, EASL, APASL, and AATA criteria, respectively. Among treatment-ineligible patients with CHB, proportion with significant fibrosis (aspartate aminotransferase platelet ratio index >0.5) were 10.4%, 10.4%, 10.8%, and 7.7% based on AASLD, EASL, APASL, and AATA, respectively. In the proposed treatment simplification, the proportion of patients with CHB eligible for therapy increased from 10.3% for step 1 (HBV DNA >20 000 IU/mL, elevated alanine aminotransferase [ALT] level) to 14.1% for step 2 (HBV >2000 IU/mL, elevated ALT level), 33.5% for step 3 (HBV DNA >2000 IU/mL, any ALT level), and 87.2% for step 4 (detectable HBV DNA, any ALT level).
Conclusions:
A large proportion of patients with CHB not meeting established treatment criteria have significant fibrosis. Simplifying criteria to treat all patients with detectable HBV DNA will reduce complexity and heterogeneity in assessing treatment eligibility, improving treatment rates and progress toward HBV elimination.
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