Koren David E, Zuckerman Autumn, Teply Robyn, Nabulsi Nadia A, Lee Todd A, Martin Michelle T
Temple University Health System, Philadelphia, Pennsylvania.
Specialty Pharmacy Services, Vanderbilt University Medical Center, Nashville, Tennessee.
Open Forum Infect Dis. 2019 Jul 1;6(7). doi: 10.1093/ofid/ofz316.
The US National Viral Hepatitis Action Plan depends on additional providers to expand hepatitis C virus (HCV) treatment capacity in order to achieve elimination goals. Clinical pharmacists manage treatment and medication within interdisciplinary teams. The study's objective was to determine sustained virologic response (SVR) rates for clinical pharmacist-delivered HCV therapy in an open medical system.
Investigators conducted a multicenter retrospective cohort study of patients initiating direct-acting antivirals from January 1, 2014, through March 12, 2018. Data included demographics, comorbidities, treatment, and clinical outcomes. The primary outcome of SVR was determined for patients initiating (intent-to-treat) and those who completed (per-protocol) treatment. Chi-square tests were conducted to identify associations between SVR and adverse reactions, drug-drug interactions, and adherence.
A total of 1253 patients initiated treatment; 95 were lost to follow-up, and 24 discontinued therapy. SVR rates were 95.1% (1079/1134) per protocol and 86.1% (1079/1253) intent to treat. The mean age (SD) was 57.4 (10.1) years, the mean body mass index (SD) was 28.7 (6.2) kg/m2, 63.9% were male, 53.7% were black, 40.3% were cirrhotic, 88.4% were genotype 1, and 81.6% were treatment-naïve. Patients missing ≥1 dose had an SVR of 74.9%; full adherence yielded 90% (P < .0001).
HCV treatment by clinical pharmacists in an open medical system resulted in high SVR rates comparable to real-world studies with specialists and nonspecialists. These findings demonstrate the success of a clinical pharmacist-delivered method for HCV treatment expansion and elimination.
美国国家病毒性肝炎行动计划依赖更多医疗服务提供者来扩大丙型肝炎病毒（HCV）治疗能力，以实现消除目标。临床药剂师在跨学科团队中管理治疗和药物。本研究的目的是在开放医疗系统中确定临床药剂师提供的HCV治疗的持续病毒学应答（SVR）率。
研究人员对2014年1月1日至2018年3月12日开始使用直接抗病毒药物的患者进行了一项多中心回顾性队列研究。数据包括人口统计学、合并症、治疗和临床结果。确定开始治疗（意向性治疗）和完成治疗（符合方案）的患者的SVR主要结局。进行卡方检验以确定SVR与不良反应、药物相互作用和依从性之间的关联。
共有1253名患者开始治疗；95名失访，24名停止治疗。符合方案的SVR率为95.1%（1079/1134），意向性治疗的SVR率为86.1%（1079/1253）。平均年龄（标准差）为57.4（10.1）岁，平均体重指数（标准差）为28.7（6.2）kg/m²，63.9%为男性，53.7%为黑人，40.3%为肝硬化患者，88.4%为基因1型，81.6%为初治患者。错过≥1剂的患者SVR为74.9%；完全依从的患者SVR为90%（P < .0001）。
在开放医疗系统中，临床药剂师进行的HCV治疗产生了较高的SVR率，与专科医生和非专科医生的真实世界研究相当。这些发现证明了临床药剂师提供的HCV治疗扩展和消除方法的成功。
