Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
- VernacularTitle:Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
- Author:
Shunji WATANABE
1
;
Naoki MORIMOTO
1
;
Kouichi MIURA
1
;
Toshimitsu MUROHISA
2
;
Toshiyuki TAHARA
3
;
Takashi SATO
4
;
Shigeo TANO
5
;
Yukimura FUKAYA
6
;
Hidekazu KURATA
7
;
Yukishige OKAMURA
8
;
Norikatsu NUMAO
9
;
Keita UEHARA
10
;
Kozue MURAYAMA
11
;
Katsuyuki NAKAZAWA
12
;
Hitoshi SUGAYA
13
;
Hiroaki YOSHIZUMI
14
;
Makoto IIJIMA
15
;
Mamiko TSUKUI
2
;
Takuya HIROSAWA
16
;
Yoshinari TAKAOKA
1
;
Hiroaki NOMOTO
1
;
Hiroshi MAEDA
1
;
Rie GOKA
1
;
Norio ISODA
1
;
Hironori YAMAMOTO
1
Author Information
- Keywords: age disparities; chronic hepatitis C; glecaprevir; pibrentasvir
- From:Journal of Rural Medicine 2020;15(4):139-145
- CountryJapan
- Language:English
- 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.