索磷布韦和来迪派韦在75岁及以上日本丙型肝炎1型患者中的疗效与安全性。
Efficacy and safety of sofosbuvir and ledipasvir in Japanese patients aged 75 years or over with hepatitis C genotype 1.
作者信息
Ozono Yoshinori, Nagata Kenji, Hasuike Satoru, Iwakiri Hisayoshi, Nakamura Kenichi, Tsuchimochi Mai, Yamada Yuri, Takaishi Yuka, Sueta Mitsue, Miike Tadashi, Tahara Yoshihiro, Yamamoto Shojiro, Shide Kotaro, Hidaka Tomonori, Kubuki Yoko, Kusumoto Kazunori, Ochiai Toshimasa, Kato Junya, Komada Naoto, Hirono Shuichi, Kuroki Kazuo, Shigehira Masafumi, Shimoda Kazuya
机构信息
Department of Gastoroenterology and Hematology, Faculty of Medicine, University of Miyazaki, Miyazaki 889-1601, Japan.
Department of Liver Disease, University of Miyazaki Hospital, Miyazaki 889-1601, Japan.
出版信息
World J Hepatol. 2017 Dec 28;9(36):1340-1345. doi: 10.4254/wjh.v9.i36.1340.
AIM
To evaluate the efficacy and safety of a regimen containing sofosbuvir (SOF) and ledipasvir (LDV) in Japanese patients aged ≥ 75 years with hepatitis C genotype 1.
METHODS
This multicenter, retrospective study consisted of 246 Japanese patients with HCV genotype 1 at nine centers in Miyazaki prefecture in Japan. Demographic, clinical, virological, and adverse effects (AE)-related data obtained during and after SOF/LDV therapy were collected from medical records. These patients were divided into two groups, younger (aged < 75 years) and elderly (aged ≥ 75 years). Virological data and AEs were analyzed by age group.
RESULTS
The sustained virological response (SVR) rates at 12 wk after treatment were 99.2%, 99.4%, and 98.7% in the overall population and in patients aged < 75 and ≥ 75 years, respectively. Common AEs during therapy were headache, pruritus, constipation, and insomnia. These occurred in fewer than 10% of patients, and their incidence was not significantly different between the younger and elderly groups. Two patients discontinued treatment, one due to a skin eruption and the other due to cerebral bleeding.
CONCLUSION
Compared with younger patients, elderly patients had a similar virological response and tolerance to SOF/LDV therapy.
目的
评估索磷布韦（SOF）和来迪派韦（LDV）方案对年龄≥75岁的日本丙型肝炎1型患者的疗效和安全性。
方法
这项多中心回顾性研究纳入了日本宫崎县9个中心的246例丙型肝炎1型日本患者。从病历中收集索磷布韦/来迪派韦治疗期间及之后获得的人口统计学、临床、病毒学和不良反应（AE）相关数据。这些患者被分为两组，较年轻组（年龄<75岁）和老年组（年龄≥75岁）。按年龄组分析病毒学数据和不良反应。
结果
治疗后12周时，总体人群以及年龄<75岁和≥75岁患者的持续病毒学应答（SVR）率分别为99.2%、99.4%和98.7%。治疗期间常见的不良反应为头痛、瘙痒、便秘和失眠。这些不良反应在不到10%的患者中出现，其发生率在较年轻组和老年组之间无显著差异。两名患者停止治疗，一名因皮疹，另一名因脑出血。
结论
与较年轻患者相比，老年患者对索磷布韦/来迪派韦治疗的病毒学应答和耐受性相似。
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