University of Florida, College of Pharmacy, Department of Pharmaceutical Outcomes & Policy, FL.
University of Florida Pharmacotherapy and Translational Research, College of Pharmacy, Gainesville, FL.
J Manag Care Spec Pharm. 2021 Jul;27(7):873-881. doi: 10.18553/jmcp.2021.27.7.873.
There is evidence that barriers exist for the initiation of direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) for those with substance use disorders (SUDs). However, real world clinical evidence of DAA treatment initiation following receipt of a prescription and continuation among those with SUDs and HCV is lacking. To (1) compare HCV treatment initiation (prescription fill) rates and early discontinuation rates between HCV-infected patients with and without SUDs in the DAA era, and (2) identify patient-level factors associated with HCV treatment initiation and early discontinuation in patients with SUDs. A retrospective cohort analysis of the MarketScan databases (January 2012-December 2018) was conducted for newly diagnosed treatment naïve HCV-infected patients (age ≥ 18) with and without SUDs. We used multivariable Cox regression to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals of treatment initiation and early discontinuation in those with SUDs versus those without. We identified a total of 29,228 newly diagnosed HCV-infected patients (6,385 with SUDs and 22,843 without SUDs). Overall, DAA treatment initiation for patients with SUDs was significantly lower than that for those without SUDs (24% vs 34%; < 0.01). After adjusting for demographics and clinical characteristics, patients with SUDs were less likely to initiate DAA treatments than those without SUDs (aHR, 0.87 [0.82-0.92]). There was no difference in discontinuation of DAA treatment between those with and without SUDs (4% vs 3%: aHR, 1.13 [0.81-1.60]). Among patients with SUDs (n = 6,385), lower rates of initiating DAA treatment was associated with younger age, and comorbidities including alcoholic liver disease (ALD; aHR, 0.44 [0.33-0.57), chronic kidney disease (CKD) (aHR, 0.52 [0.36-0.75]), and hepatitis B virus (HBV; aHR, 0.64 [0.44-0.92]). DAA treatment discontinuation was associated with younger age, ribavirin (RBV) therapy (aHR, 3.78 [2.21-6.47]), and cirrhosis diagnosis (aHR, 2.42 [1.21-4.84]) but not SUD treatment (aHR, 0.68 [0.34-1.34]). HCV-infected patients with SUDs had significantly lower treatment initiation rates, especially in young females and those with ALD, CKD, and HBV. No difference was found in DAA discontinuation. However, younger patients with RBV treatment and/or cirrhosis were more likely to stop treatment. Interventions directed towards these groups are needed to enhance DAA initiation and treatment maintenance among HCV-infected patients with SUDs. Research reported in this publication was supported in part by the National Institute on Drug Abuse of the National Institutes of Health under award number K01DA045618 (to Park). The other authors have nothing to disclose that may present a potential conflict of interest.
有证据表明，对于有物质使用障碍 (SUD) 的丙型肝炎病毒 (HCV) 患者，启动直接作用抗病毒 (DAA) 治疗存在障碍。然而，缺乏 SUD 合并 HCV 患者接受处方后启动 DAA 治疗和持续治疗的真实世界临床证据。（1）比较 DAA 时代 HCV 感染患者中有无 SUD 的 HCV 治疗启动（处方填写）率和早期停药率，（2）确定与 SUD 患者 HCV 治疗启动和早期停药相关的患者水平因素。对 MarketScan 数据库（2012 年 1 月至 2018 年 12 月）进行了新诊断的治疗初治 HCV 感染患者（年龄≥18 岁）的回顾性队列分析，无论是否有 SUD。我们使用多变量 Cox 回归估计了 SUD 患者与无 SUD 患者治疗启动和早期停药的调整后危险比 (aHR) 和 95%置信区间。我们确定了总共 29228 名新诊断的 HCV 感染患者（6385 名有 SUD，22843 名无 SUD）。总体而言，SUD 患者的 DAA 治疗启动率明显低于无 SUD 患者（24% vs 34%；<0.01）。在调整了人口统计学和临床特征后，与无 SUD 患者相比，有 SUD 的患者更不可能开始 DAA 治疗（aHR，0.87 [0.82-0.92]）。有 SUD 的患者和无 SUD 的患者在 DAA 治疗的停药率上没有差异（4% vs 3%：aHR，1.13 [0.81-1.60]）。在有 SUD 的患者中（n=6385），较低的 DAA 治疗启动率与年龄较小以及合并症有关，包括酒精性肝病（ALD；aHR，0.44 [0.33-0.57），慢性肾脏病（CKD）（aHR，0.52 [0.36-0.75]）和乙型肝炎病毒（HBV；aHR，0.64 [0.44-0.92]）。DAA 治疗停药与年龄较小、利巴韦林（RBV）治疗（aHR，3.78 [2.21-6.47]）和肝硬化诊断（aHR，2.42 [1.21-4.84]）有关，但与 SUD 治疗无关（aHR，0.68 [0.34-1.34]）。有 SUD 的 HCV 感染患者治疗启动率明显较低，尤其是年轻女性以及患有 ALD、CKD 和 HBV 的患者。在 DAA 停药方面没有差异。然而，接受 RBV 治疗和/或患有肝硬化的年轻患者更有可能停止治疗。需要针对这些群体的干预措施来提高 HCV 感染合并 SUD 患者的 DAA 启动和治疗维持率。本研究报告的研究得到了美国国立卫生研究院国家药物滥用研究所的部分支持，资助编号为 K01DA045618（授予 Park）。其他作者没有任何可能构成潜在利益冲突的披露。
