Puenpatom Amy, Cao Yumei, Yu Xian, Kanwal Fasiha, El-Serag Hashem B, Kramer Jennifer R
Merck & Co., Inc., Kenilworth, NJ, USA.
Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey VA Medical Center, Houston, TX, USA.
Infect Dis Ther. 2020 Jun;9(2):355-365. doi: 10.1007/s40121-020-00293-7. Epub 2020 Apr 15.
Real-world treatment of hepatitis C virus (HCV) infection is complicated by many factors that are controlled for in the rigorous clinical trial setting. The aim of the present study was to assess the efficacy of elbasvir/grazoprevir in a Veterans Affairs population with chronic HCV genotype 1b infection.
This was a retrospective analysis of a cohort of patients aged ≥ 18 years with chronic HCV genotype 1b infection and ≥ 1 prescription of elbasvir/grazoprevir between February 1, 2016, and August 31, 2017. The primary analysis was conducted in the per-protocol population, which included all patients who had at least 11 weeks of treatment and had an available assessment for sustained virologic response (SVR) based on virologic data post-follow-up week 4.
The per-protocol population included 3371 patients. Overall, 97.3% of patients were male, 60.3% were black, and 85.5% were HCV treatment-experienced. Comorbidities in this population included hypertension (74.4%), history of alcohol use (55.7%), and depression (54.8%). In total, 97.5% of patients (3288/3371) achieved SVR. Among patient sub-groups, SVR was achieved by 96.0% (290/302) of those with chronic kidney disease stage 4/5, 97.8% (1527/1561) of those with a history of drug use, and 96.6% (831/860) of those with cirrhosis. No statistically significant differences were observed in the proportions of patients achieving SVR, regardless of age, race, HCV treatment history, viral load level, treatment regimen/duration, history of drug or alcohol use, HIV co-infection, or chronic kidney disease.
Elbasvir/grazoprevir was highly effective in individuals with HCV genotype 1b infection in a large national Veterans Affairs clinical setting.
丙型肝炎病毒(HCV)感染的实际治疗因诸多因素而变得复杂,这些因素在严格的临床试验环境中是受到控制的。本研究的目的是评估艾尔巴韦/格拉瑞韦在患有慢性HCV 1b基因型感染的退伍军人事务人群中的疗效。
这是一项对2016年2月1日至2017年8月31日期间年龄≥18岁、患有慢性HCV 1b基因型感染且至少有1次艾尔巴韦/格拉瑞韦处方的患者队列进行的回顾性分析。主要分析在符合方案人群中进行,该人群包括所有接受至少11周治疗且根据随访第4周后的病毒学数据可获得持续病毒学应答(SVR)评估的患者。
符合方案人群包括3371名患者。总体而言,97.3%的患者为男性,60.3%为黑人,85.5%有HCV治疗史。该人群的合并症包括高血压(74.4%)、饮酒史(55.7%)和抑郁症(54.8%)。共有97.5%的患者(3288/3371)实现了SVR。在患者亚组中,4/5期慢性肾病患者中有96.0%(290/302)实现了SVR,有药物使用史的患者中有97.8%(1527/1561)实现了SVR,有肝硬化的患者中有96.6%(831/860)实现了SVR。无论年龄、种族、HCV治疗史、病毒载量水平、治疗方案/疗程、药物或酒精使用史、HIV合并感染或慢性肾病如何,实现SVR的患者比例均未观察到统计学上的显著差异。
在大型全国退伍军人事务临床环境中,艾尔巴韦/格拉瑞韦对HCV 1b基因型感染患者非常有效。