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Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older
BACKGROUND: It is estimated that approximately 50% of patients with hepatitis C virus (HCV) infection in Japan are currently over 75 years old. However, patients aged ≥ 75 years are typically underrepresented in clinical trials of direct-acting antivirals. This study aimed to evaluate the efficacy a...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9052496/ https://www.ncbi.nlm.nih.gov/pubmed/35484503 http://dx.doi.org/10.1186/s12876-022-02284-z |
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author | Komaki, Yuri Ozono, Yoshinori Nakamura, Kenichi Iwakiri, Hisayoshi Hasuike, Satoru Sueta, Mitsue Miike, Tadashi Yamamoto, Shojiro Uto, Hirofumi Kusumoto, Kazunori Ochiai, Toshimasa Kato, Junya Komada, Naoto Kuroki, Kazuo Eto, Toshiharu Shigehira, Masafumi Hirono, Shuichi Nagata, Kenji Kawakami, Hiroshi |
author_facet | Komaki, Yuri Ozono, Yoshinori Nakamura, Kenichi Iwakiri, Hisayoshi Hasuike, Satoru Sueta, Mitsue Miike, Tadashi Yamamoto, Shojiro Uto, Hirofumi Kusumoto, Kazunori Ochiai, Toshimasa Kato, Junya Komada, Naoto Kuroki, Kazuo Eto, Toshiharu Shigehira, Masafumi Hirono, Shuichi Nagata, Kenji Kawakami, Hiroshi |
author_sort | Komaki, Yuri |
collection | PubMed |
description | BACKGROUND: It is estimated that approximately 50% of patients with hepatitis C virus (HCV) infection in Japan are currently over 75 years old. However, patients aged ≥ 75 years are typically underrepresented in clinical trials of direct-acting antivirals. This study aimed to evaluate the efficacy and safety of glecaprevir and pibrentasvir (G/P) treatment in Japanese patients with HCV infection aged ≥ 75 years. METHODS: This multicenter, retrospective study included 271 Japanese patients with HCV infection from 12 centers in Miyazaki Prefecture, Japan. Demographic, clinical, virological, and adverse events (AEs) data obtained during and after G/P treatment were collected from medical records. The patients were divided into two groups: younger (n = 199, aged < 75 years) and older (n = 72, aged ≥ 75 years). Virological data and AEs were analyzed according to the age group. RESULTS: In intention-to-treat (ITT) and per-protocol analyses, the overall sustained virological response 12 (SVR12) rates were 93% and 98.8%, respectively. Two patients in the older group and 14 patients in the younger group dropped out before SVR12 assessment. Although patients in the older group tended to have liver cirrhosis, 95.8% in the older group and 92% in the younger group achieved SVR12 in the ITT analysis (P = 0.404). In total, 48 (17.7%) patients experienced treatment-related AEs. Common AEs during treatment included pruritus, headache, and fatigue. The AEs were not significantly different between the two groups. CONCLUSIONS: Compared with younger patients, older patients showed similar virological response and tolerance to G/P treatment. |
format | Online Article Text |
id | pubmed-9052496 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-90524962022-04-30 Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older Komaki, Yuri Ozono, Yoshinori Nakamura, Kenichi Iwakiri, Hisayoshi Hasuike, Satoru Sueta, Mitsue Miike, Tadashi Yamamoto, Shojiro Uto, Hirofumi Kusumoto, Kazunori Ochiai, Toshimasa Kato, Junya Komada, Naoto Kuroki, Kazuo Eto, Toshiharu Shigehira, Masafumi Hirono, Shuichi Nagata, Kenji Kawakami, Hiroshi BMC Gastroenterol Research BACKGROUND: It is estimated that approximately 50% of patients with hepatitis C virus (HCV) infection in Japan are currently over 75 years old. However, patients aged ≥ 75 years are typically underrepresented in clinical trials of direct-acting antivirals. This study aimed to evaluate the efficacy and safety of glecaprevir and pibrentasvir (G/P) treatment in Japanese patients with HCV infection aged ≥ 75 years. METHODS: This multicenter, retrospective study included 271 Japanese patients with HCV infection from 12 centers in Miyazaki Prefecture, Japan. Demographic, clinical, virological, and adverse events (AEs) data obtained during and after G/P treatment were collected from medical records. The patients were divided into two groups: younger (n = 199, aged < 75 years) and older (n = 72, aged ≥ 75 years). Virological data and AEs were analyzed according to the age group. RESULTS: In intention-to-treat (ITT) and per-protocol analyses, the overall sustained virological response 12 (SVR12) rates were 93% and 98.8%, respectively. Two patients in the older group and 14 patients in the younger group dropped out before SVR12 assessment. Although patients in the older group tended to have liver cirrhosis, 95.8% in the older group and 92% in the younger group achieved SVR12 in the ITT analysis (P = 0.404). In total, 48 (17.7%) patients experienced treatment-related AEs. Common AEs during treatment included pruritus, headache, and fatigue. The AEs were not significantly different between the two groups. CONCLUSIONS: Compared with younger patients, older patients showed similar virological response and tolerance to G/P treatment. BioMed Central 2022-04-28 /pmc/articles/PMC9052496/ /pubmed/35484503 http://dx.doi.org/10.1186/s12876-022-02284-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Komaki, Yuri Ozono, Yoshinori Nakamura, Kenichi Iwakiri, Hisayoshi Hasuike, Satoru Sueta, Mitsue Miike, Tadashi Yamamoto, Shojiro Uto, Hirofumi Kusumoto, Kazunori Ochiai, Toshimasa Kato, Junya Komada, Naoto Kuroki, Kazuo Eto, Toshiharu Shigehira, Masafumi Hirono, Shuichi Nagata, Kenji Kawakami, Hiroshi Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older |
title | Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older |
title_full | Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older |
title_fullStr | Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older |
title_full_unstemmed | Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older |
title_short | Efficacy and safety of glecaprevir and pibrentasvir in Japanese patients with hepatitis C virus infection aged 75 years or older |
title_sort | efficacy and safety of glecaprevir and pibrentasvir in japanese patients with hepatitis c virus infection aged 75 years or older |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9052496/ https://www.ncbi.nlm.nih.gov/pubmed/35484503 http://dx.doi.org/10.1186/s12876-022-02284-z |
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