Efficacy and safety of glecaprevir and pibrentasvir combination therapy in          old-aged patients with chronic hepatitis C virus infection

Shunji Watanabe; Naoki Morimoto; Kouichi Miura; Toshimitsu Murohisa; Toshiyuki Tahara; Takashi Sato; Shigeo Tano; Yukimura Fukaya; Hidekazu Kurata; Yukishige Okamura; Norikatsu Numao; Keita Uehara; Kozue Murayama; Katsuyuki Nakazawa; Hitoshi Sugaya; Hiroaki Yoshizumi; Makoto Iijima; Mamiko Tsukui; Takuya Hirosawa; Yoshinari Takaoka; Hiroaki Nomoto; Hiroshi Maeda; Rie Goka; Norio Isoda; Hironori Yamamoto

doi:10.2185/jrm.2020-004

Original article

Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection

Shunji Watanabe, Naoki Morimoto, Kouichi Miura, Toshimitsu Murohisa, Toshiyuki Tahara, Takashi Sato, Shigeo Tano, Yukimura Fukaya, Hidekazu Kurata, Yukishige Okamura, Norikatsu Numao, Keita Uehara, Kozue Murayama, Katsuyuki Nakazawa, Hitoshi Sugaya, Hiroaki Yoshizumi, Makoto Iijima, Mamiko Tsukui, Takuya Hirosawa, Yoshinari Takaoka, Hiroaki Nomoto, Hiroshi Maeda, Rie Goka, Norio Isoda, Hironori Yamamoto

Author information

Shunji Watanabe
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Naoki Morimoto
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Kouichi Miura
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Toshimitsu Murohisa
Department of Gastroenterology, Dokkyo Medical University, Japan
Toshiyuki Tahara
Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Japan
Takashi Sato
Department of Gastroenterology, Nasu Red Cross Hospital, Japan
Shigeo Tano
Department of Gastroenterology, Shin-Oyama City Hospital, Japan
Yukimura Fukaya
Department of Internal Medicine, Nasu Minami Hospital, Japan
Hidekazu Kurata
Department of Gastroenterology, Tochigi Medical Center Shimotsuga, Japan
Yukishige Okamura
Department of Gastroenterology, Sano Kousei General Hospital, Japan
Norikatsu Numao
Department of Gastroenterology, Haga Red Cross Hospital, Japan
Keita Uehara
Department of Gastroenterology, Tochigi Medical Center, Japan
Kozue Murayama
Department of Gastroenterology, Koga Red Cross Hospital, Japan
Katsuyuki Nakazawa
Department of Gastroenterology, JCHO Utsunomiya Hospital, Japan
Hitoshi Sugaya
Department of Internal Medicine, Utsunomiya Higashi Hospital, Japan
Department of Gastroenterology, Ashikaga Red Cross Hospital, Japan
Hiroaki Yoshizumi
Department of Internal Medicine, Kamitsuga General Hospital, Japan
Makoto Iijima
Department of Gastroenterology, Dokkyo Medical University, Japan
Department of Gastroenterology, Yuai Memorial Hospital, Japan
Mamiko Tsukui
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Takuya Hirosawa
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Yoshinari Takaoka
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Hiroaki Nomoto
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Hiroshi Maeda
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Rie Goka
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Norio Isoda
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan
Hironori Yamamoto
Department of Medicine, Division of Gastroenterology, Jichi Medical University, Japan

Keywords: age disparities, chronic hepatitis C, glecaprevir, pibrentasvir

JOURNAL OPEN ACCESS

2020 Volume 15 Issue 4 Pages 139-145

DOI https://doi.org/10.2185/jrm.2020-004

Details

Abstract

Objective: 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.

Patients and Methods: 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.

Results: 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.

Conclusion: G/P therapy is effective and safe for old-aged patients.

Corresponding author

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