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奥比他韦/帕利瑞韦/利托那韦和达沙布韦治疗丙型肝炎的持续病毒学应答:来自大型医疗服务机构的真实世界数据。

Sustained virological response to ombitasvir/paritaprevir/ritonavir and dasabuvir treatment for hepatitis C: Real-world data from a large healthcare provider.

作者信息

Weil C, Mehta D, Koren G, Pinsky B, Samp J C, Chodick G, Shalev V

机构信息

Epidemiology and Database Research, Maccabi Healthcare Services, Tel Aviv, Israel.

Health Economics and Outcomes Research, AbbVie, North Chicago, IL, USA.

出版信息

J Viral Hepat. 2018 Feb;25(2):144-151. doi: 10.1111/jvh.12800. Epub 2017 Nov 7.

Abstract

Treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin (OPrD ± RBV), was the first interferon-free direct-acting antiviral for hepatitis C virus (HCV) introduced to Israel's national basket of health services in February 2015. Patients with HCV genotype 1 (GT1) and advanced fibrosis (F3-F4) were eligible for treatment in 2015. This study aimed to characterize patients initiating OPrD ± RBV and assess sustained virological response (SVR). A retrospective cohort study was performed using the database of Maccabi Healthcare Services (MHS), a 2-million-member health plan in Israel. The study population included adults who initiated OPrD ± RBV through December 2015 per health basket criteria. A gap in medication fills (>14 days between a fill's run-out and the next fill) was used to estimate adherence. SVR was defined by the viral tests at least 12-week post-treatment. The study population consisted of 403 patients (56.3% male), with a mean age of 60.7 years (SD 11.0). Overall, 71.0% were naïve to prior HCV treatment, and 95.6% were treated with a 12-week regimen. A total of 348 patients (86.4%) completed the regimen in the usual time frame (highly adherent), whereas 8.2% completed with a gap, and 4.7% purchased less than the recommended dose. SVR rates overall and among highly adherent patients were 395/403 (98.0%; 95% CI 96.1-99.1) and 346/348 (99.4%; 95% CI 97.9-99.9), respectively. GT1b patients on 12-week regimens attained SVR rates of 194/196 (fibrosis F3) and 170/176 (cirrhosis). After a first year of provision of OPrD ± RBV with good adherence, high SVR rates were achieved in various patient subgroups and comorbidities.

摘要

奥比他韦/帕利瑞韦/利托那韦与达沙布韦联合治疗,无论是否联用利巴韦林(OPrD±RBV),是2015年2月引入以色列国家医疗服务体系的首个用于治疗丙型肝炎病毒(HCV)的无干扰素直接抗病毒药物。2015年,HCV基因1型(GT1)且有重度肝纤维化(F3-F4)的患者符合治疗条件。本研究旨在描述开始接受OPrD±RBV治疗的患者特征并评估持续病毒学应答(SVR)。利用以色列拥有200万成员的健康计划——马卡比医疗服务(MHS)的数据库进行了一项回顾性队列研究。研究人群包括根据医疗服务标准在2015年12月前开始接受OPrD±RBV治疗的成年人。用药间隔(一次配药用完到下次配药之间间隔>14天)用于评估依从性。SVR通过治疗后至少12周的病毒检测来定义。研究人群包括403例患者(56.3%为男性),平均年龄60.7岁(标准差11.0)。总体而言,71.0%既往未接受过HCV治疗,95.6%接受了为期12周的治疗方案。共有348例患者(86.4%)在正常时间内完成了治疗方案(依从性高),而8.2%在有间隔的情况下完成治疗,4.7%购买的药物剂量低于推荐剂量。总体SVR率以及依从性高的患者的SVR率分别为395/403(98.0%;95%置信区间96.1-99.1)和346/348(99.4%;95%置信区间97.9-99.9)。接受12周治疗方案的GT1b患者的SVR率为194/196(肝纤维化F3)和170/176(肝硬化)。在良好依从性下提供OPrD±RBV的第一年之后,在不同患者亚组和合并症中均实现了高SVR率。

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