Abstract
BACKGROUND: Compared to patients with chronic hepatitis B (CHB) in the immune tolerance phase, those in the indeterminate phase (IP) tend to have a higher proportion of liver inflammation and fibrosis, and they usually progress more rapidly to hepatocellular carcinoma (HCC). However, no definitive conclusion has been reached regarding the necessity of antiviral therapy (AVT) for patients in the IP. The present study aims to evaluate the cost-effectiveness of oral antiviral treatment in CHB patients who are in the IP [indeterminate phase-chronic hepatitis B (IP-CHB)] from a healthcare system perspective. METHODS: Cost and effectiveness, measured in quality-adjusted life years (QALYs), were compared in a virtual cohort of 100,000 CHB patients in the IP receiving AVT (scenario I) vs. no treatment (scenario II). A Markov model was used to simulate seven health states related to CHB progression. Transition probabilities and cost data were primarily sourced from published studies. One-way deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Over 50 years, AVT provided an additional 1.4541 QALYs per patient, with an incremental cost-effectiveness ratio (ICER) of $253.51 per QALY. In a cohort of 100,000 patients, scenario I reduced the incidence of compensated cirrhosis by 11,581 cases, decompensated cirrhosis by 15,436 cases, orthotopic liver transplantation by 718 cases, and HCC by 15,112 cases, while preventing 28,923 deaths, saving over 30% more lives compared to scenario II. Sensitivity analyses confirmed the robustness of our findings, with progression to decompensated cirrhosis being the most influential factor. Probabilistic sensitivity analysis indicated a 100% probability of cost-effectiveness at a willingness-to-pay threshold of one time China's per capita gross domestic product (GDP) in 2023 ($12,690.1). CONCLUSIONS: Oral AVT for IP-CHB is highly cost-effective and significantly reduces the global burden of hepatitis B virus (HBV)-related diseases and mortality.