1.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
Journal of Rural Medicine 2020;15(4):139-145
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.
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