Barts Liver Centre, Blizard Institute, Queen Mary University of London, London, United Kingdom.
Hepatology Department, UMR1149, Physiopathology and Treatment of Viral Hepatitis, Centre de Recherche sur l'Inflammation and Université Denis Diderot Paris 7, Beaujon Hospital, AP-HP, Clichy, France.
PLoS One. 2019 Jan 2;14(1):e0208506. doi: 10.1371/journal.pone.0208506. eCollection 2019.
Finding safe and effective treatments for chronic hepatitis C virus (HCV) infection in the elderly is of clinical interest given the comorbidities and associated polypharmacy in this population. However, the number of patients older than age 65 years enrolled into clinical trials of anti-HCV medications generally have been limited and thus reaching meaningful conclusions for this demographic has been difficult. Glecaprevir/pibrentasvir is a once-daily, all-oral, ribavirin-free, pangenotypic direct-acting antiviral (DAA) combination therapy that has demonstrated high sustained virologic response rates at post-treatment week 12 (SVR12) and a favorable safety profile in patients with chronic HCV infection. This analysis evaluated the safety and efficacy of glecaprevir/pibrentasvir in patients aged ≥65 years. Data were pooled for treatment-naïve and -experienced patients with chronic HCV genotype (GT) 1-6 infections who received glecaprevir/pibrentasvir for 8, 12, or 16 weeks in 9 Phase 2 and 3 trials. SVR12 and adverse events (AEs) were evaluated for patients aged ≥65 versus <65 years. Of the 2369 patients enrolled, 328 (14%) were aged ≥65 years. Among patients aged ≥65 years, 42% and 34% had GT1 and GT2, respectively; 40% were treatment-experienced and 20% had compensated cirrhosis. Glecaprevir/pibrentasvir treatment resulted in SVR12 rates of 97.9% (95% CI, 96.3-99.4; n/N = 321/328) for patients aged ≥65 years and 97.3% (95% CI, 96.6-98.0; n/N = 1986/2041) for patients aged <65 years. The rates were not significantly different between the two age groups (P = 0.555). DAA-related AEs leading to treatment discontinuation, or serious AEs were similarly rare (<0.5%) for patients ≥65 and <65 years old. Glecaprevir/pibrentasvir is an efficacious and well-tolerated treatment option for patients aged ≥65 years with chronic HCV infection.
在老年人中寻找安全有效的慢性丙型肝炎病毒 (HCV) 感染治疗方法具有临床意义，因为该人群存在合并症和相关的多种药物治疗。然而，一般来说，在临床试验中招募的年龄超过 65 岁的患者数量有限，因此难以得出对这一年龄段有意义的结论。格卡瑞韦/哌仑他韦是一种每日一次、全口服、无利巴韦林、泛基因型直接作用抗病毒药物 (DAA) 联合治疗药物，在慢性 HCV 感染患者中，治疗结束后第 12 周时（SVR12）显示出高持续病毒学应答率和良好的安全性。这项分析评估了格卡瑞韦/哌仑他韦在年龄≥65 岁的患者中的安全性和疗效。在 9 项 2 期和 3 期试验中，将初治和经治的慢性 HCV 基因型 (GT) 1-6 感染患者的数据汇总，这些患者接受格卡瑞韦/哌仑他韦治疗 8、12 或 16 周。评估了年龄≥65 岁和<65 岁的患者的 SVR12 和不良事件 (AE)。在 2369 名入组患者中，328 名（14%）年龄≥65 岁。在年龄≥65 岁的患者中，分别有 42%和 34%患有 GT1 和 GT2；40%为经治患者，20%患有代偿性肝硬化。对于年龄≥65 岁的患者，格卡瑞韦/哌仑他韦治疗的 SVR12 率为 97.9%（95%CI，96.3-99.4；n/N=321/328），对于年龄<65 岁的患者为 97.3%（95%CI，96.6-98.0；n/N=1986/2041）。两组之间的比率无显著差异（P=0.555）。对于年龄≥65 和<65 岁的患者，与 DAA 相关的导致停药或严重的 AE 同样罕见（<0.5%）。对于患有慢性 HCV 感染的年龄≥65 岁的患者，格卡瑞韦/哌仑他韦是一种有效且耐受性良好的治疗选择。
