Zhuo Hai-Yan, Lin Yong, Song Hui-Wen, Hong Mei-Zhu, Yao Lv-Feng, Pan Jin-Shui
Department of Hepatology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
Department of Hepatology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical University, Fuzhou, China.
Transl Gastroenterol Hepatol. 2025 Jul 14;10:43. doi: 10.21037/tgh-24-163. eCollection 2025.
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) 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.
背景：与免疫耐受期的慢性乙型肝炎（CHB）患者相比，不确定期（IP）的患者肝脏炎症和纤维化的比例往往更高，并且通常更快进展为肝细胞癌（HCC）。然而，对于IP期患者是否有必要进行抗病毒治疗（AVT）尚未得出明确结论。本研究旨在从医疗保健系统的角度评估口服抗病毒治疗对处于IP期（不确定期 - 慢性乙型肝炎，IP-CHB）的CHB患者的成本效益。 方法：在一个虚拟队列中，对100,000名接受AVT的IP期CHB患者（方案I）与未接受治疗的患者（方案II）进行成本和以质量调整生命年（QALYs）衡量的效果比较。使用马尔可夫模型模拟与CHB进展相关的七种健康状态。转移概率和成本数据主要来源于已发表的研究。进行单向确定性和概率敏感性分析以评估模型的稳健性。 结果：在50年期间，AVT使每位患者额外获得1.4541个QALYs，增量成本效益比（ICER）为每QALY 253.51美元。在一个100,000名患者的队列中，方案I使代偿期肝硬化的发生率减少11,581例，失代偿期肝硬化减少15,436例，原位肝移植减少718例，HCC减少15,112例，同时预防28,923例死亡，与方案II相比多挽救超过30%的生命。敏感性分析证实了我们研究结果的稳健性，进展为失代偿期肝硬化是最有影响的因素。概率敏感性分析表明，在支付意愿阈值为2023年中国人均国内生产总值（GDP）的一倍（12,690.1美元）时，成本效益的概率为100%。 结论：IP-CHB的口服AVT具有很高的成本效益，并显著降低了乙型肝炎病毒（HBV）相关疾病的全球负担和死亡率。
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