Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Department of Internal Medicine, Naga Municipal Hospital, Wakayama, Japan.
Gut Liver. 2018 Jan 15;12(1):86-93. doi: 10.5009/gnl17048.
BACKGROUND/AIMS: Although daclatasvir with asunaprevir was approved in Japan for interferon ineligible or intolerant patients, patients aged ≥75 years were excluded in the phase III trial. The present study aimed to evaluate the safety and efficacy of this therapy for elderly patients aged ≥75 years and to clarify whether an extremely high sustained virological response (SVR) rate can be achieved, even in a real-world setting when patients with resistance-associated substitutions (RASs) to nonstructural protein 5A (NS5A) inhibitors or prior simeprevir failure are excluded.
Daclatasvir (60 mg) and asunaprevir (100 mg) were orally administered daily for 24 weeks. Patients without pre-existing NS5A RASs and simeprevir failure were enrolled in this study.
Overall, 110 patients were treated. The median age was 73 years old. The SVR rates of total patients, those aged ≥75 years, and those aged ＜75 years were 97% (107/110), 98% (46/47), and 97% (61/63), respectively. The treatment of two patients (2%) was discontinued because of adverse events.
Daclatasvir with asunaprevir was a safe treatment, even in patients aged ≥75 years. When patients without pre-existing NS5A RASs and prior simeprevir failure were selected, an extremely high SVR rate could be achieved irrespective of age.
背景/目的：虽然达拉他韦联合asunaprevir 在日本已被批准用于不适合或不耐受干扰素的患者，但在 III 期临床试验中排除了年龄≥75 岁的患者。本研究旨在评估该疗法在年龄≥75 岁的老年患者中的安全性和疗效，并阐明即使在排除对非结构蛋白 5A（NS5A）抑制剂有耐药相关取代（RAS）或先前simeprevir 治疗失败的患者的真实世界环境中，是否仍能实现极高的持续病毒学应答（SVR）率。
达拉他韦（60mg）和asunaprevir（100mg）每日口服，疗程为 24 周。未发生预先存在的 NS5A RAS 和 simeprevir 失败的患者被纳入本研究。
共有 110 例患者接受了治疗。中位年龄为 73 岁。总患者、年龄≥75 岁患者和年龄＜75 岁患者的 SVR 率分别为 97%（107/110）、98%（46/47）和 97%（61/63）。因不良反应，有 2 例患者（2%）停止治疗。
达拉他韦联合asunaprevir 的治疗是安全的，即使在年龄≥75 岁的患者中也是如此。当选择无预先存在的 NS5A RAS 和先前 simeprevir 失败的患者时，无论年龄如何，都能实现极高的 SVR 率。
