Specialty Pharmacy Services, Vanderbilt University Medical Center,; Nashville, Tennessee, United States of America.
Christy Houston Foundation Drug Information Center, Belmont University College of Pharmacy; Nashville, Tennessee, United States of America.
PLoS One. 2019 Nov 21;14(11):e0225434. doi: 10.1371/journal.pone.0225434. eCollection 2019.
Sustained virologic response (SVR) rates in patients with hepatitis C virus (HCV) monoinfection and human immunodeficiency virus (HIV)/HCV coinfection treated with direct acting antiviral (DAA) therapy are similar in clinical trials. The objective of this study was to examine differences in patient characteristics, drug-drug interactions, and treatment pathways between these groups in a real-world clinical setting.
We performed an ambispective review of patients prescribed DAA therapy between September 2015 and April 2018 at a tertiary academic center. The primary endpoint was time from a decision to treat to treatment initiation. Secondary endpoints included patient characteristics; frequency and type of DAA medication interactions; frequency, type, and timing of antiretroviral therapy (ART) changes; and treatment outcomes.
Three hundred and twelve patients were included. Almost half (43%) were HIV/HCV coinfected. Patients with HIV/HCV coinfection were more likely to be African American (p<0.001), have a diagnosed psychiatric disorder (p<0.001) and have a higher pill burden (p = 0.014). Patients with HIV/HCV coinfection were more likely to report an alcohol abuse history (p<0.001), injection drug use history (p<0.024), or active use of illicit substances (p = 0.019). In a multivariable regression model assessing the primary endpoint, time to treatment initiation was increased in patients requiring a change in ART therapy (OR = 9.2, p < 0.001) or a non-ART medication adjustment (OR = 2.4, p = 0.003), and in patients with Medicaid (OR = 6.7, p < 0.001). After controlling for all these factors, HIV/HCV coinfection still significantly impacted time to treatment initiation (OR = 1.7, p = 0.020). The groups had similar rates of drug interaction frequency, treatment completion, observed SVR, and side effects.
Patients with HIV/HCV coinfection are more likely to have a variety of factors that add complexities to HCV treatment. In addition to these challenges, patients with HIV/HCV coinfection experience a longer time to treatment initiation while patients with HCV monoinfection were more frequently lost to care. Care delivery models may incorporate this data to improve patient engagement, access, and outcomes.
在临床试验中，丙型肝炎病毒（HCV）单感染和人类免疫缺陷病毒（HIV）/HCV 合并感染患者接受直接作用抗病毒（DAA）治疗的持续病毒学应答（SVR）率相似。本研究的目的是在真实临床环境中检查这两组患者在患者特征、药物相互作用和治疗途径方面的差异。
我们对 2015 年 9 月至 2018 年 4 月在一家三级学术中心接受 DAA 治疗的患者进行了前瞻性回顾。主要终点是从决定治疗到开始治疗的时间。次要终点包括患者特征；DAA 药物相互作用的频率和类型；抗逆转录病毒治疗（ART）变化的频率、类型和时间；以及治疗结果。
共纳入 312 例患者。近一半（43%）为 HIV/HCV 合并感染。HIV/HCV 合并感染患者更可能为非裔美国人（p<0.001），患有诊断性精神障碍（p<0.001），且用药负担更高（p = 0.014）。HIV/HCV 合并感染患者更可能报告有酒精滥用史（p<0.001）、注射吸毒史（p<0.024）或正在使用非法物质（p = 0.019）。在评估主要终点的多变量回归模型中，需要改变 ART 治疗（OR = 9.2，p < 0.001）或非 ART 药物调整（OR = 2.4，p = 0.003）的患者以及接受医疗补助的患者（OR = 6.7，p < 0.001），治疗开始的时间延长。在控制所有这些因素后，HIV/HCV 合并感染仍然显著影响治疗开始的时间（OR = 1.7，p = 0.020）。两组药物相互作用频率、治疗完成率、观察到的 SVR 和副作用发生率相似。
HIV/HCV 合并感染患者更有可能存在各种增加 HCV 治疗复杂性的因素。除了这些挑战外，HIV/HCV 合并感染患者的治疗开始时间更长，而 HCV 单感染患者更频繁地失去治疗。医疗服务模式可以结合这些数据，以改善患者参与度、可及性和治疗结果。
