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Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases

Glecaprevir/pibrentasvir (G/P) are direct-acting antivirals (DAAs) that achieve a high sustained virological response (SVR) rate for hepatitis C virus (HCV) infection. We investigated G/P effectiveness for HCV patients based on real-world experience and the clinical features of retreatment cases. HC...

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Autores principales: Sugiura, Ayumi, Joshita, Satoru, Yamashita, Yuki, Yamazaki, Tomoo, Fujimori, Naoyuki, Kimura, Takefumi, Matsumoto, Akihiro, Wada, Shuichi, Mori, Hiromitsu, Shibata, Soichiro, Yoshizawa, Kaname, Morita, Susumu, Furuta, Kiyoshi, Kamijo, Atsushi, Iijima, Akihiro, Kako, Satoko, Maruyama, Atsushi, Kobayashi, Masakazu, Komatsu, Michiharu, Matsumura, Makiko, Miyabayashi, Chiharu, Ichijo, Tetsuya, Takeuchi, Aki, Koike, Yuriko, Gibo, Yukio, Tsukadaira, Toshihisa, Inada, Hiroyuki, Nakano, Yoshiyuki, Usuda, Seiichi, Kiyosawa, Kendo, Tanaka, Eiji, Umemura, Takeji
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7235710/
https://www.ncbi.nlm.nih.gov/pubmed/32260271
http://dx.doi.org/10.3390/biomedicines8040074
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author Sugiura, Ayumi
Joshita, Satoru
Yamashita, Yuki
Yamazaki, Tomoo
Fujimori, Naoyuki
Kimura, Takefumi
Matsumoto, Akihiro
Wada, Shuichi
Mori, Hiromitsu
Shibata, Soichiro
Yoshizawa, Kaname
Morita, Susumu
Furuta, Kiyoshi
Kamijo, Atsushi
Iijima, Akihiro
Kako, Satoko
Maruyama, Atsushi
Kobayashi, Masakazu
Komatsu, Michiharu
Matsumura, Makiko
Miyabayashi, Chiharu
Ichijo, Tetsuya
Takeuchi, Aki
Koike, Yuriko
Gibo, Yukio
Tsukadaira, Toshihisa
Inada, Hiroyuki
Nakano, Yoshiyuki
Usuda, Seiichi
Kiyosawa, Kendo
Tanaka, Eiji
Umemura, Takeji
author_facet Sugiura, Ayumi
Joshita, Satoru
Yamashita, Yuki
Yamazaki, Tomoo
Fujimori, Naoyuki
Kimura, Takefumi
Matsumoto, Akihiro
Wada, Shuichi
Mori, Hiromitsu
Shibata, Soichiro
Yoshizawa, Kaname
Morita, Susumu
Furuta, Kiyoshi
Kamijo, Atsushi
Iijima, Akihiro
Kako, Satoko
Maruyama, Atsushi
Kobayashi, Masakazu
Komatsu, Michiharu
Matsumura, Makiko
Miyabayashi, Chiharu
Ichijo, Tetsuya
Takeuchi, Aki
Koike, Yuriko
Gibo, Yukio
Tsukadaira, Toshihisa
Inada, Hiroyuki
Nakano, Yoshiyuki
Usuda, Seiichi
Kiyosawa, Kendo
Tanaka, Eiji
Umemura, Takeji
author_sort Sugiura, Ayumi
collection PubMed
description Glecaprevir/pibrentasvir (G/P) are direct-acting antivirals (DAAs) that achieve a high sustained virological response (SVR) rate for hepatitis C virus (HCV) infection. We investigated G/P effectiveness for HCV patients based on real-world experience and the clinical features of retreatment cases. HCV patients (n = 182) were compared for clinical features and outcomes between first treatment (n = 159) and retreatment (n = 23) G/P groups. Overall, 77 patients (42.3%) were male, the median age was 68 years, and 86/66/1/4 cases had genotype 1/2/1 + 2/3, respectively. An SVR was achieved in 97.8% (178/182) of cases by intention-to-treat analysis and 99.4% (178/179) of cases by per-protocol analysis. There were no remarkable differences between the first treatment and retreatment groups for male (42.8% vs. 39.1%, p = 0.70), median age (68 vs. 68 years, p = 0.36), prior hepatocellular carcinoma (5.8% vs. 8.7%, p = 0.59), or the fibrosis markers AST-to-platelet ratio index (APRI) (0.5 vs. 0.5, p = 0.80) and fibrosis-4 (FIB-4) index (2.2 vs. 2.6, p = 0.59). The retreatment group had a significantly more frequent history of interferon treatment (12.3% vs. 52.2%, p < 0.01) and the Y93H mutation (25.0% vs. 64.7%, p = 0.02). The number of retreatment patients who had experienced 3, 2, and 1 DAA treatment failures was 1, 3, and 19, respectively, all of whom ultimately achieved an SVR by G/P treatment. In conclusion, G/P was effective and safe for both HCV first treatment and retreatment cases despite the retreatment group having specific resistance mutations for other prior DAAs. As G/P treatment failure has been reported for P32 deletions, clinicians should consider resistance mutations during DAA selection.
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spelling pubmed-72357102020-05-22 Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases Sugiura, Ayumi Joshita, Satoru Yamashita, Yuki Yamazaki, Tomoo Fujimori, Naoyuki Kimura, Takefumi Matsumoto, Akihiro Wada, Shuichi Mori, Hiromitsu Shibata, Soichiro Yoshizawa, Kaname Morita, Susumu Furuta, Kiyoshi Kamijo, Atsushi Iijima, Akihiro Kako, Satoko Maruyama, Atsushi Kobayashi, Masakazu Komatsu, Michiharu Matsumura, Makiko Miyabayashi, Chiharu Ichijo, Tetsuya Takeuchi, Aki Koike, Yuriko Gibo, Yukio Tsukadaira, Toshihisa Inada, Hiroyuki Nakano, Yoshiyuki Usuda, Seiichi Kiyosawa, Kendo Tanaka, Eiji Umemura, Takeji Biomedicines Article Glecaprevir/pibrentasvir (G/P) are direct-acting antivirals (DAAs) that achieve a high sustained virological response (SVR) rate for hepatitis C virus (HCV) infection. We investigated G/P effectiveness for HCV patients based on real-world experience and the clinical features of retreatment cases. HCV patients (n = 182) were compared for clinical features and outcomes between first treatment (n = 159) and retreatment (n = 23) G/P groups. Overall, 77 patients (42.3%) were male, the median age was 68 years, and 86/66/1/4 cases had genotype 1/2/1 + 2/3, respectively. An SVR was achieved in 97.8% (178/182) of cases by intention-to-treat analysis and 99.4% (178/179) of cases by per-protocol analysis. There were no remarkable differences between the first treatment and retreatment groups for male (42.8% vs. 39.1%, p = 0.70), median age (68 vs. 68 years, p = 0.36), prior hepatocellular carcinoma (5.8% vs. 8.7%, p = 0.59), or the fibrosis markers AST-to-platelet ratio index (APRI) (0.5 vs. 0.5, p = 0.80) and fibrosis-4 (FIB-4) index (2.2 vs. 2.6, p = 0.59). The retreatment group had a significantly more frequent history of interferon treatment (12.3% vs. 52.2%, p < 0.01) and the Y93H mutation (25.0% vs. 64.7%, p = 0.02). The number of retreatment patients who had experienced 3, 2, and 1 DAA treatment failures was 1, 3, and 19, respectively, all of whom ultimately achieved an SVR by G/P treatment. In conclusion, G/P was effective and safe for both HCV first treatment and retreatment cases despite the retreatment group having specific resistance mutations for other prior DAAs. As G/P treatment failure has been reported for P32 deletions, clinicians should consider resistance mutations during DAA selection. MDPI 2020-04-03 /pmc/articles/PMC7235710/ /pubmed/32260271 http://dx.doi.org/10.3390/biomedicines8040074 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sugiura, Ayumi
Joshita, Satoru
Yamashita, Yuki
Yamazaki, Tomoo
Fujimori, Naoyuki
Kimura, Takefumi
Matsumoto, Akihiro
Wada, Shuichi
Mori, Hiromitsu
Shibata, Soichiro
Yoshizawa, Kaname
Morita, Susumu
Furuta, Kiyoshi
Kamijo, Atsushi
Iijima, Akihiro
Kako, Satoko
Maruyama, Atsushi
Kobayashi, Masakazu
Komatsu, Michiharu
Matsumura, Makiko
Miyabayashi, Chiharu
Ichijo, Tetsuya
Takeuchi, Aki
Koike, Yuriko
Gibo, Yukio
Tsukadaira, Toshihisa
Inada, Hiroyuki
Nakano, Yoshiyuki
Usuda, Seiichi
Kiyosawa, Kendo
Tanaka, Eiji
Umemura, Takeji
Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
title Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
title_full Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
title_fullStr Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
title_full_unstemmed Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
title_short Effectiveness of Glecaprevir/Pibrentasvir for Hepatitis C: Real-World Experience and Clinical Features of Retreatment Cases
title_sort effectiveness of glecaprevir/pibrentasvir for hepatitis c: real-world experience and clinical features of retreatment cases
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7235710/
https://www.ncbi.nlm.nih.gov/pubmed/32260271
http://dx.doi.org/10.3390/biomedicines8040074
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