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

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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Japanese Association of Rural Medicine 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7530586/
https://www.ncbi.nlm.nih.gov/pubmed/33033533
http://dx.doi.org/10.2185/jrm.2020-004
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author 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
author_facet 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
author_sort Watanabe, Shunji
collection PubMed
description 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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spelling pubmed-75305862020-10-07 Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection 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 J Rural Med Original Article 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. The Japanese Association of Rural Medicine 2020-10-01 2020-10 /pmc/articles/PMC7530586/ /pubmed/33033533 http://dx.doi.org/10.2185/jrm.2020-004 Text en ©2020 The Japanese Association of Rural Medicine http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (by-nc-nd) License.
spellingShingle Original Article
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
Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
title Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
title_full Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
title_fullStr Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
title_full_unstemmed Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
title_short Efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis C virus infection
title_sort efficacy and safety of glecaprevir and pibrentasvir combination therapy in old-aged patients with chronic hepatitis c virus infection
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7530586/
https://www.ncbi.nlm.nih.gov/pubmed/33033533
http://dx.doi.org/10.2185/jrm.2020-004
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