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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Japanese Association of Rural Medicine
2020
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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. |
format | Online Article Text |
id | pubmed-7530586 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | The Japanese Association of Rural Medicine |
record_format | MEDLINE/PubMed |
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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