Watanabe Shunji, Morimoto Naoki, Miura Kouichi, Murohisa Toshimitsu, Tahara Toshiyuki, Sato Takashi, Tano Shigeo, Fukaya Yukimura, Kurata Hidekazu, Okamura Yukishige, Numao Norikatsu, Uehara Keita, Murayama Kozue, Nakazawa Katsuyuki, Sugaya Hitoshi, Yoshizumi Hiroaki, Iijima Makoto, Tsukui Mamiko, Hirosawa Takuya, Takaoka Yoshinari, Nomoto Hiroaki, Maeda Hiroshi, Goka Rie, Isoda Norio, Yamamoto Hironori
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan.
Department of Gastroenterology, Dokkyo Medical University, Japan.
J Rural Med. 2020 Oct;15(4):139-145. doi: 10.2185/jrm.2020-004. Epub 2020 Oct 1.
Combination therapy with glecaprevir and pibrentasvir (G/P) has been shown to provide a sustained virologic response (SVR) rate of >97% in patients with chronic hepatitis C virus (HCV) infection in the first published real-world Japanese data. However, a recently published study showed that the treatment was often discontinued in patients ≥75 years old, resulting in low SVR in intention-to-treat (ITT) analysis. Thus, our aim was to evaluate real-world data for G/P therapy in patients ≥75 years of age, the population density of which is high in "rural" regions. We conducted a multicenter study to assess the efficacy and safety of G/P therapy for chronic HCV infection, in the North Kanto area in Japan. Of the 308 patients enrolled, 294 (95.5%) completed the treatment according to the protocol. In ITT and per-protocol analyses, the overall SVR12 rate was 97.1% and 99.7%, respectively. The old-aged patients group consisted of 59 participants, 56 of whom (94.9%) completed the scheduled protocol. Although old-aged patients tended to have non-SVR factors such as liver cirrhosis, history of HCC, and prior DAA therapies, the SVR12 rates in old-aged patients were 98.3% and 100% in the ITT and PP analyses, respectively. Of 308 patients enrolled, adverse events were observed in 74 patients (24.0%), with grade ≥3 events in 8 patients (2.6%). There was no significant difference in any grade and grade ≥3 adverse events between the old-aged group and the rest of the study participants. Only one patient discontinued the treatment because of adverse events. G/P therapy is effective and safe for old-aged patients.
在日本首次公布的真实世界数据中，glecaprevir和pibrentasvir（G/P）联合疗法已被证明在慢性丙型肝炎病毒（HCV）感染患者中可提供>97%的持续病毒学应答（SVR）率。然而，最近发表的一项研究表明，在≥75岁的患者中，该治疗常常中断，导致意向性治疗（ITT）分析中的SVR较低。因此，我们的目的是评估≥75岁患者接受G/P治疗的真实世界数据，该人群在“农村”地区的人口密度较高。我们在日本关东地区北部进行了一项多中心研究，以评估G/P治疗慢性HCV感染的疗效和安全性。在308名入组患者中，294名（95.5%）按照方案完成了治疗。在ITT分析和符合方案分析中，总体SVR12率分别为97.1%和99.7%。老年患者组由59名参与者组成，其中56名（94.9%）完成了预定方案。尽管老年患者往往有诸如肝硬化、HCC病史和既往直接抗病毒药物（DAA）治疗等非SVR因素，但在ITT分析和符合方案分析中，老年患者的SVR12率分别为98.3%和100%。在308名入组患者中，74名患者（24.0%）观察到不良事件，8名患者（2.6%）发生≥3级事件。老年组与其他研究参与者之间在任何级别和≥3级不良事件方面均无显著差异。仅有1名患者因不良事件中断治疗。G/P治疗对老年患者有效且安全。
