Flamm Steven, Peng Cheng-Yuan, Shibolet Oren, Nahass Ronald, Hwang Peggy, Barr Eliav, Robertson Michael N, Haber Barbara A
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
China Medical University Hospital, Taichung City.
Gerontol Geriatr Med. 2019 Jan 22;5:2333721418817398. doi: 10.1177/2333721418817398. eCollection 2019 Jan-Dec.
In elderly individuals aged ≥65 years with hepatitis C virus (HCV) infection, efficacious and safe HCV therapy is complicated by frequent comorbidities and concomitant medications. The aim of this analysis was to evaluate the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in people aged ≥65 years. This is an integrated retrospective analysis of EBR/GZR administered for 12 weeks in participants with HCV genotype 1 or 4 infection enrolled in 12 Phase 2/3 clinical trials. The primary end point was sustained virologic response 12 weeks after completing therapy (SVR12; HCV RNA below the lower limit of quantification). Most participants aged ≥65 years were receiving ≥1 concomitant medication (322/339; 95.0%) and had ≥1 comorbidity (334/339; 99%). SVR12 rates were 95.3% (323/339) in participants aged ≥65 years and 95.4% (2,041/2,139) in those aged <65 years. Rates of adverse events, drug-related adverse events, serious adverse events, and discontinuations were similar in participants aged ≥65 years and those aged <65 years. In participants aged ≥65 years, median estimated glomerular filtration rate was similar at baseline and at the end of treatment. The efficacy and safety of EBR/GZR were similar in participants with HCV infection aged ≥65 years and those aged <65 years.
在年龄≥65岁的丙型肝炎病毒(HCV)感染老年个体中,有效且安全的HCV治疗因频繁的合并症和伴随用药而变得复杂。本分析的目的是评估艾尔巴韦/格拉瑞韦(EBR/GZR)在≥65岁人群中的疗效和安全性。这是一项对参与12项2/3期临床试验、感染HCV 1型或4型且接受12周EBR/GZR治疗的患者进行的综合回顾性分析。主要终点是治疗完成后12周的持续病毒学应答(SVR12;HCV RNA低于定量下限)。大多数≥65岁的参与者正在接受≥1种伴随用药(322/339;95.0%)且患有≥1种合并症(334/339;99%)。≥65岁参与者的SVR12率为95.3%(323/339),<65岁参与者的SVR12率为95.4%(2041/2139)。≥65岁参与者和<65岁参与者的不良事件、药物相关不良事件、严重不良事件及停药率相似。在≥65岁的参与者中,基线时和治疗结束时的估算肾小球滤过率中位数相似。EBR/GZR在≥65岁的HCV感染参与者和<65岁的参与者中的疗效和安全性相似。