Health Services Management Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.
Middle East Liver Diseases (MELD) Center, Tehran, Iran.
BMJ Open. 2022 Jun 8;12(6):e058757. doi: 10.1136/bmjopen-2021-058757.
Low-cost generic direct-acting antiviral (DAA) regimens for treatment of hepatitis C virus (HCV) are available in several low-income/middle-income countries, important for treatment scale-up. This study evaluated the cost-effectiveness of genotype-dependent and pan-genotypic DAA regimens in Iran as an example of a resource-limited setting.
A Markov model was developed to simulate HCV natural history. A decision tree was developed for HCV treatment, assuming four scenarios, including scenario 1: genotyping, sofosbuvir/ledipasvir (SOF/LDV) for genotype 1, and sofosbuvir/daclatasvir (SOF/DCV) for genotype 3; scenario 2: genotyping, SOF/LDV for genotype 1, and sofosbuvir/velpatasvir (SOF/VEL) for genotype 3; scenario 3: no genotyping and SOF/DCV for all; and scenario 4: no genotyping and SOF/VEL for all. A 1-year cycle length was used to calculate the cumulative cost and effectiveness over a lifetime time horizon. We calculated quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) using a health system perspective. Costs were converted to US dollars using purchasing power parity exchange rate ($PPP). All costs and outcomes were discounted at an annual rate of 3%.
Among people with no cirrhosis, scenario 3 had the minimum cost, compared with which scenario 4 was cost-effective with an ICER of 4583 $PPP per QALY (willingness-to-pay threshold: 9,311 $PPP per QALY). Among both people with compensated or decompensated cirrhosis, scenario 4 was cost saving. In sensitivity analysis, scenario 4 would be also cost-saving among people with no cirrhosis provided a 39% reduction in the cost of 12 weeks SOF/VEL.
Initiating all patients on pan-genotypic generic DAA regimens with no pretreatment genotyping was cost-effective compared with scenarios requiring pretreatment HCV genotype tests. Among generic pan-genotypic DAA regimens, SOF/VEL was cost-effective, for people with no cirrhosis and cost-saving for those with cirrhosis.
在一些低收入和中等收入国家，已经有了价格低廉的通用直接作用抗病毒药物（DAA）疗法，用于治疗丙型肝炎病毒（HCV），这对扩大治疗规模很重要。本研究以资源有限的伊朗为例，评估了基于基因型和泛基因型的 DAA 疗法的成本效益。
我们开发了一个 Markov 模型来模拟 HCV 的自然史。为 HCV 治疗开发了一个决策树，假设了四种情况，包括情况 1：进行基因分型，对于基因型 1 使用索磷布韦/维帕他韦（SOF/LDV），对于基因型 3 使用索磷布韦/达卡他韦（SOF/DCV）；情况 2：进行基因分型，对于基因型 1 使用 SOF/LDV，对于基因型 3 使用索磷布韦/维帕他韦（SOF/VEL）；情况 3：不进行基因分型，所有患者均使用 SOF/DCV；情况 4：不进行基因分型，所有患者均使用 SOF/VEL。采用 1 年的周期长度，在终生时间范围内计算累积成本和效果。我们从卫生系统角度计算了质量调整生命年（QALY）和增量成本效益比（ICER）。使用购买力平价汇率（$PPP）将成本转换为美元。所有成本和结果均以每年 3%的贴现率贴现。
在无肝硬化患者中，与方案 3 相比，方案 4 的成本最低，而方案 4 的增量成本效益比（ICER）为每 QALY 4583 美元 PPP（意愿支付阈值：每 QALY 9311 美元 PPP）。在代偿期和失代偿期肝硬化患者中，方案 4 也具有成本效益。在敏感性分析中，如果 12 周 SOF/VEL 的成本降低 39%，方案 4 在无肝硬化患者中也具有成本效益。
与需要 HCV 基因型检测的方案相比，对所有患者初始使用无预处理基因分型的泛基因型通用 DAA 方案具有成本效益。在通用泛基因型 DAA 方案中，SOF/VEL 具有成本效益，对于无肝硬化患者具有成本效益，对于肝硬化患者具有成本节约。
