Now with The Moran Company, Arlington, Virginia.
Department of Health Policy and Administration, College of Health and Human Development, The Pennsylvania State University, University Park.
JAMA Netw Open. 2020 Jul 1;3(7):e2011055. doi: 10.1001/jamanetworkopen.2020.11055.
Direct-acting antiviral (DAA) drugs are highly effective in curing hepatitis C virus (HCV) infection. Previous simulations showed extended life as a key health advantage of DAA drugs, but real-world evidence on the association between DAA treatment and reduced mortality is limited.
To examine the association of DAA treatment with mortality among Medicare beneficiaries with hepatitis C.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study used Medicare claims data of beneficiaries who sought hepatitis C care for the first time between January 1, 2014, and December 31, 2016, after at least a 1-year washout period. Medicare Part D files were used in identifying DAA therapy initiation and completion. Death dates, demographic data, and indicators of health risks were obtained from the Master Beneficiary Summary Files. Beneficiaries with hepatitis C were considered as patients with DAA treatment if they initiated DAA therapy during the study period. Beneficiaries with hepatitis C who did not initiate DAA therapy during the study period were considered as patients without DAA treatment. Patients without DAA treatment were selected using 1-to-1 propensity score matching. Data were analyzed between September 1, 2019, and March 31, 2020.
Completion of DAA treatment.
Time to death from the index date of seeking hepatitis C care after at least a 1-year washout period. Cox proportional hazards regression models with time-varying exposure were used to compare mortality rates between propensity score-matched cohorts of patients with DAA treatment and those without DAA treatment. Separate analyses were performed for patients with or without cirrhosis. Heterogeneity in the association between DAA treatment and mortality by sex and dual-eligibility status was examined.
A propensity score-matched sample of 51 478 Medicare beneficiaries with a mean (SD) age of 59.4 (11.1) years and 30 473 men (59.2%) was assessed. Of this total, 8240 patients (16.0%) had cirrhosis (5224 men [63.4%]; mean [SD] age, 62.3 [9.7] years) and 43 238 patients (84.0%) had no cirrhosis (25 249 men [58.4%]; mean [SD] age, 58.8 [11.3] years). The adjusted hazard ratio (HR) of dying between patients with DAA treatment and those without DAA treatment in the cirrhosis group was 0.51 (95% CI, 0.46-0.57). The association of DAA treatment with mortality did not differ by sex (women vs men: HR, 0.46 [95% CI, 0.38-0.56] vs HR, 0.53 [95% CI, 0.47-0.60]; P = .27) or dual-eligibility status (non-dual-eligible HR, 0.52 [95% CI, 0.43-0.63] vs dual-eligible HR, 0.50 [95% CI, 0.44-0.57]; P = .80) in the cirrhosis group. The adjusted HR of dying between patients with DAA treatment and those without DAA treatment among patients without cirrhosis was 0.54 (95% CI, 0.50-0.58). The association of DAA treatment with mortality did not differ by sex (women vs men: HR, 0.53 [95% CI, 0.46-0.60] vs HR, 0.55 [95% CI, 0.50-0.60]; P = .66) among patients without cirrhosis. However, the survival advantage associated with DAAs for non-dual-eligible beneficiaries was statistically significantly higher than for dual-eligible beneficiaries among patients without cirrhosis (HR, 0.47 [95% CI, 0.41-0.55] vs HR, 0.57 [95% CI, 0.52-0.62]; P = .02).
In this cohort study, DAA treatment appeared to be associated with a decrease in mortality among Medicare beneficiaries with or without cirrhosis. These findings suggest that increasing access to DAA drugs for all patients with HCV infection, regardless of disease progression, could improve population health.
直接作用抗病毒 (DAA) 药物在治愈丙型肝炎病毒 (HCV) 感染方面非常有效。之前的模拟研究表明，延长寿命是 DAA 药物的一个关键健康优势，但关于 DAA 治疗与降低死亡率之间关联的真实世界证据有限。
研究 DAA 治疗与医疗保险受益人中丙型肝炎相关死亡率之间的关系。
设计、设置和参与者：这项队列研究使用了医疗保险索赔数据，该数据来自 2014 年 1 月 1 日至 2016 年 12 月 31 日期间至少有 1 年洗脱期后首次寻求丙型肝炎治疗的受益人。使用医疗保险部分 D 档案确定 DAA 治疗的开始和完成情况。死亡日期、人口统计数据和健康风险指标是从主受益人大纲文件中获得的。如果在研究期间开始 DAA 治疗，则将患有丙型肝炎的受益人视为接受 DAA 治疗的患者。如果在研究期间没有开始 DAA 治疗，则将患有丙型肝炎的受益人视为未接受 DAA 治疗的患者。使用 1:1 倾向评分匹配选择未接受 DAA 治疗的患者。数据分析于 2019 年 9 月 1 日至 2020 年 3 月 31 日进行。
DAA 治疗的完成情况。
从至少有 1 年洗脱期后首次寻求丙型肝炎治疗的索引日期起至死亡的时间。使用时变暴露的 Cox 比例风险回归模型比较了接受 DAA 治疗和未接受 DAA 治疗的倾向评分匹配队列患者之间的死亡率。分别对有或没有肝硬化的患者进行了分析。还检查了 DAA 治疗与死亡率之间的关联在性别和双重资格状况方面的异质性。
评估了一个平均（SD）年龄为 59.4（11.1）岁且 30473 名男性（59.2%）的 51478 名医疗保险受益人的倾向评分匹配样本。其中 8240 名患者（16.0%）患有肝硬化（5224 名男性[63.4%]；平均[SD]年龄为 62.3[9.7]岁），43238 名患者（84.0%）无肝硬化（25249 名男性[58.4%]；平均[SD]年龄为 58.8[11.3]岁）。肝硬化组中，接受 DAA 治疗的患者与未接受 DAA 治疗的患者相比，死亡的调整后的危险比（HR）为 0.51（95%CI，0.46-0.57）。DAA 治疗与死亡率之间的关联在性别（女性与男性：HR，0.46 [95%CI，0.38-0.56] vs HR，0.53 [95%CI，0.47-0.60]；P=0.27）或双重资格状况（非双重资格：HR，0.52 [95%CI，0.43-0.63] vs 双重资格：HR，0.50 [95%CI，0.44-0.57]；P=0.80）方面没有差异。在无肝硬化的患者中，接受 DAA 治疗的患者与未接受 DAA 治疗的患者相比，死亡的调整后的 HR 为 0.54（95%CI，0.50-0.58）。在无肝硬化的患者中，DAA 治疗与死亡率之间的关联在性别方面没有差异（女性与男性：HR，0.53 [95%CI，0.46-0.60] vs HR，0.55 [95%CI，0.50-0.60]；P=0.66）。然而，对于无肝硬化的非双重资格受益人的 DAA 治疗的生存优势明显高于双重资格受益人的生存优势（HR，0.47 [95%CI，0.41-0.55] vs HR，0.57 [95%CI，0.52-0.62]；P=0.02）。
在这项队列研究中，DAA 治疗似乎与医疗保险受益人的死亡率降低相关，无论是否患有肝硬化。这些发现表明，增加所有 HCV 感染患者（无论疾病进展如何）获得 DAA 药物的机会可能会改善人群健康。
