Efficacy and Safety of Direct-Acting Antivirals in Elderly Patients with Chronic Hepatitis C: A Nationwide Real-Life, Observational, Multicenter Study from Turkey.
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引用次数: 1
Abstract
Background: The number and proportion of elderly patients living with chronic hepatitis C are expected to increase in the coming years. We aimed to compare the real-world efficacy and safety of direct-acting antiviral treatment in elderly and younger Turkish adults infected with chronic hepatitis C.
Methods: In this multicenter prospective study, 2629 eligible chronic hepatitis C patients treated with direct-acting antivirals between April 2017 and December 2019 from 37 Turkish referral centers were divided into 2 age groups: elderly (≥65 years) and younger adults (<65 years) and their safety was compared between 2 groups in evaluable population. Then, by matching the 2 age groups for demographics and pretreatment risk factors for a non-sustained virological response, a total of 1516 patients (758 in each group) and 1244 patients (622 in each group) from the modified evaluable population and per-protocol population were included in the efficacy analysis and the efficacy was compared between age groups.
Results: The sustained virological response in the chronic hepatitis C patients was not affected by the age and the presence of cirrhosis both in the modified evaluable population and per-protocol population (P = .879, P = .508 for modified evaluable population and P = .058, P = .788 for per-protocol population, respectively). The results of the per-protocol analysis revealed that male gender, patients who had a prior history of hepatocellular carcinoma, patients infected with non-genotype 1 hepatitis C virus, and patients treated with sofosbuvir+ribavirin had a significantly lower sustained virological response 12 rates (P < .001, P = .047, P = .013, and P = .025, respectively).
Conclusion: Direct-acting antivirals can be safely used to treat Turkish elderly chronic hepatitis C patients with similar favorable efficacy and safety as that in younger adults.
背景:老年慢性丙型肝炎患者的数量和比例预计在未来几年将会增加。我们的目的是比较直接作用抗病毒治疗对土耳其老年和年轻慢性丙型肝炎感染成人的实际疗效和安全性。方法:在这项多中心前瞻性研究中，2017年4月至2019年12月，来自37个土耳其转诊中心的2629名符合条件的慢性丙型肝炎患者接受直接作用抗病毒治疗，分为两个年龄组:在可评估人群中，比较两组老年人(≥65岁)和年轻人(65岁)及其安全性。然后，通过匹配2个年龄组的人口统计学和非持续性病毒学反应的预处理危险因素，来自修改的可评估人群和按方案人群的1516例患者(每组758例)和1244例患者(每组622例)被纳入疗效分析，并在年龄组之间进行疗效比较。结果:慢性丙型肝炎患者的持续病毒学应答不受年龄和肝硬化存在的影响，在改良的可评估人群和按方案人群中分别为P = 0.879, P = 0.508和P = 0.058, P = 0.788。方案分析的结果显示，男性、既往有肝细胞癌病史的患者、感染非基因1型丙型肝炎病毒的患者以及接受索非布韦+利巴韦林治疗的患者的持续病毒学应答率显著降低(P <0.001, P = 0.047, P = 0.013, P = 0.025)。结论:直接作用抗病毒药物可安全用于土耳其老年慢性丙型肝炎患者，其疗效和安全性与青壮年相似。
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