Morgan Jake R, Kim Arthur Y, Naggie Susanna, Linas Benjamin P
Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts.
Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
Open Forum Infect Dis. 2017 Dec 8;5(1):ofx267. doi: 10.1093/ofid/ofx267. eCollection 2018 Jan.
Direct acting antiviral hepatitis C virus (HCV) therapies are highly effective but costly. Wider adoption of an 8-week ledipasvir/sofosbuvir treatment regimen could result in significant savings, but may be less efficacious compared with a 12-week regimen. We evaluated outcomes under a constrained budget and cost-effectiveness of 8 vs 12 weeks of therapy in treatment-naïve, noncirrhotic, genotype 1 HCV-infected black and nonblack individuals and considered scenarios of and NS5A resistance testing to determine treatment duration in sensitivity analyses.
We developed a decision tree to use in conjunction with Monte Carlo simulation to investigate the cost-effectiveness of recommended treatment durations and the population health effect of these strategies given a constrained budget. Outcomes included the total number of individuals treated and attaining sustained virologic response (SVR) given a constrained budget and incremental cost-effectiveness ratios.
We found that treating eligible (treatment-naïve, noncirrhotic, HCV-RNA <6 million copies) individuals with 8 weeks rather than 12 weeks of therapy was cost-effective and allowed for 50% more individuals to attain SVR given a constrained budget among both black and nonblack individuals, and our results suggested that NS5A resistance testing is cost-effective.
Eight-week therapy provides good value, and wider adoption of shorter treatment could allow more individuals to attain SVR on the population level given a constrained budget. This analysis provides an evidence base to justify movement of the 8-week regimen to the preferred regimen list for appropriate patients in the HCV treatment guidelines and suggests expanding that recommendation to black patients in settings where cost and relapse trade-offs are considered.
直接作用抗病毒药物治疗丙型肝炎病毒（HCV）非常有效，但成本高昂。更广泛地采用8周的来迪派韦/索磷布韦治疗方案可能会节省大量费用，但与12周的治疗方案相比，疗效可能较差。我们评估了在预算受限的情况下，初治、非肝硬化、基因1型HCV感染的黑人和非黑人个体接受8周与12周治疗的结果及成本效益，并在敏感性分析中考虑了NS5A耐药性检测及不进行检测的情况以确定治疗时长。
我们构建了一个决策树，结合蒙特卡洛模拟来研究推荐治疗时长的成本效益以及在预算受限的情况下这些策略对人群健康的影响。结果包括在预算受限的情况下接受治疗并获得持续病毒学应答（SVR）的个体总数以及增量成本效益比。
我们发现，对于符合条件（初治、非肝硬化、HCV-RNA<600万拷贝）的个体，采用8周而非12周的治疗方案具有成本效益，并且在预算受限的情况下，黑人和非黑人个体中能够获得SVR的人数可增加50%，我们的结果表明NS5A耐药性检测具有成本效益。
8周治疗方案具有良好的价值，在预算受限的情况下，更广泛地采用较短疗程的治疗方案可使更多个体在人群层面获得SVR。该分析为将8周治疗方案纳入丙型肝炎治疗指南中适合患者的首选治疗方案列表提供了证据基础，并建议在考虑成本和复发权衡的情况下，将该推荐扩展至黑人患者。
