魏霞 杨莉

中圖分类号 R956 文献标志码 A 文章编号 1001-0408（2021）08-0979-07

DOI 10.6039/j.issn.1001-0408.2021.08.14

摘 要 目的：评价泛基因型直接抗病毒药物（DAAs）治疗慢性丙型肝炎患者的成本-效用，为相关医疗卫生决策提供药物经济学证据。方法：从全社会角度出发，以中国初治慢性丙型肝炎患者为目标人群，参考文献资料建立Markov模型，以索磷布韦维帕他韦为对照，分析格卡瑞韦派伦他韦、索磷布韦+可洛派韦治疗慢性丙型肝炎患者的质量调整生命年（QALYs）和增量成本-效用比（ICERs）;采用敏感性分析验证结果的稳健性。结果：与索磷布韦维帕他韦相比，格卡瑞韦哌仑他韦增加了0.002 1 QALYs，成本增加25 021元，ICERs为12 129 031元/QALY（意愿支付阈值为70 892元/QALY），不具有成本-效用;当其单价下降至1 679元时（降价64.65%）将具有成本-效用。索磷布韦+可洛派韦增加了0.002 0 QALYs，成本减少515元，是成本节约的绝对优势方案。敏感性分析显示，持续病毒学应答率和药品价格对结果的影响最大，索磷布韦+可洛派韦具有成本-效用的概率高于格卡瑞韦哌仑他韦。结论：格卡瑞韦哌仑他韦需大幅降低价格，才可达到更好的可负担性;索磷布韦+可洛派韦具有良好的经济性。

关键词 慢性丙型肝炎;直接抗病毒药物;成本-效用分析;Markov模型;泛基因型

Cost-utility Analysis of the Pan-genotypic Direct-acting Antivirals in the Treatment of Chronic Hepatitis C Infection

WEI Xia，YANG Li（School of Public Health， Peking University/Health Policy and Technology Assessment Center， Peking University Health Science Center， Beijing 100191， China）

ABSTRACT   OBJECTIVE： To evaluate the cost-utility of the pan-genotypic direct-acting antivirals （DAAs） in the treatment of patients with chronic hepatitis C infection， and to provide pharmacoeconomic evidence for relevant health care decisions. METHODS： A Markov model was established from a societal perspective with newly diagnosed chronic hepatitis C patients in China as the target population， and analyzed quality-adjusted life years （QALYs） and incremental cost-utility ratios （ICERs） of patients with chronic hepatitis C with sofosbuvir/velpatasvir， glecaprevir/pibrentasvir， sofosbuvir+coblopasvir. Sensitivity analysis was used to verity the robustness of the results. RESULTS： Glecaprevir/pibrentasvir increased QALYs by 0.002 1 and costs by 25 021 RMB， compared to sofosbuvir/velpatasvir; its ICERs was 12 129 031 yuan/QALY （willingness to pay threshold was 70 892 yuan/QALY）， which had no cost-utility; glecaprevir/pibrentasvir need to cut down the price by 64.65% to have cost-utility. Sofosbuvir+coblopasvir increased QALYs by 0.002 0 and saved costs by 515 yuan， so it was the optimal regimen which was cost-saving. Sensitivity analysis showed that SVR rates and drug prices were the most influential factors. The probability of having cost-utility for sofosbuvir+coblopasvir was higher than glecaprevir/pibrentasvir. CONCLUSIONS： Glecaprevir/pibrentasvir need to reduce the price to achieve better affordability. Sofosbuvir+coblopasvir shows economical advantage.

KEYWORDS   Chronic hepatitis C virus infection; Direct-acting antivirals; Cost-utility analysis; Markov model; Pan-genotypic

丙型肝炎是由丙型肝炎病毒（HCV）感染引起的传染性肝病。HCV是多变异病毒，主要包括7种基因型，我国丙型肝炎患者常见的HCV基因型从多到少依次为1b型（56.8%）、2型（24.1%）、3型（9.1%）及6型（6.3%），少见4型和5型的相关报道[1]。HCV慢性感染可导致肝脏慢性炎症坏死和纤维化，并可发展为肝硬化甚至肝癌，对患者的健康和生命危害极大，已成为严重的社会和公共卫生问题[1]。……