- 1Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, CA, USA.
- 2Gastroenterology Section Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, USA.
- 3Quest Diagnostics, Secaucus, NJ, USA.
- 4Hepatitis B Foundation, Doylestown, PA, USA.
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 U.S. CHB patients and propose stepwise simplification of CHB treatment criteria.
Methods: Using 2016-2020 Quest Diagnostics data, treatment eligibility among CHB patients (two positive HBV tests [HBsAg, HBeAg, or HBV DNA] ≥6 months apart) was evaluated 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 CHB patients, 6.7%, 6.2%, 5.8%, and 16.4% met AASLD, EASL, APASL, and AATA criteria, respectively. Among treatment-ineligible CHB patients, proportion with significant fibrosis (AST 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, proportion of CHB patients eligible for therapy increased from 10.3% for step 1 (HBV DNA >20,000 IU/mL, elevated ALT) to 14.1% for step 2 (HBV >2,000 IU/mL, elevated ALT), 33.5% for step 3 (HBV DNA >2,000 IU/mL, any ALT), and 87.2% for step 4 (detectable HBV DNA, any ALT).
Conclusions: A large proportion of CHB patients 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 towards HBV elimination.