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Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection

Glecaprevir (nonstructural protein 3/4A protease inhibitor) and pibrentasvir (nonstructural protein 5A inhibitor) (G/P), a coformulated once‐daily, all oral, ribavirin (RBV)‐free, direct‐acting antiviral regimen, was evaluated for safety and efficacy in hepatitis C virus genotype 2 (GT2)–infected Ja...

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Autores principales: Toyoda, Hidenori, Chayama, Kazuaki, Suzuki, Fumitaka, Sato, Ken, Atarashi, Tomofumi, Watanabe, Tsunamasa, Atsukawa, Masanori, Naganuma, Atsushi, Notsumata, Kazuo, Osaki, Yukio, Nakamuta, Makoto, Takaguchi, Koichi, Saito, Satoru, Kato, Koji, Pugatch, David, Burroughs, Margaret, Redman, Rebecca, Alves, Katia, Pilot‐Matias, Tami J., Oberoi, Rajneet K., Fu, Bo, Kumada, Hiromitsu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5814891/
https://www.ncbi.nlm.nih.gov/pubmed/28865152
http://dx.doi.org/10.1002/hep.29510
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author Toyoda, Hidenori
Chayama, Kazuaki
Suzuki, Fumitaka
Sato, Ken
Atarashi, Tomofumi
Watanabe, Tsunamasa
Atsukawa, Masanori
Naganuma, Atsushi
Notsumata, Kazuo
Osaki, Yukio
Nakamuta, Makoto
Takaguchi, Koichi
Saito, Satoru
Kato, Koji
Pugatch, David
Burroughs, Margaret
Redman, Rebecca
Alves, Katia
Pilot‐Matias, Tami J.
Oberoi, Rajneet K.
Fu, Bo
Kumada, Hiromitsu
author_facet Toyoda, Hidenori
Chayama, Kazuaki
Suzuki, Fumitaka
Sato, Ken
Atarashi, Tomofumi
Watanabe, Tsunamasa
Atsukawa, Masanori
Naganuma, Atsushi
Notsumata, Kazuo
Osaki, Yukio
Nakamuta, Makoto
Takaguchi, Koichi
Saito, Satoru
Kato, Koji
Pugatch, David
Burroughs, Margaret
Redman, Rebecca
Alves, Katia
Pilot‐Matias, Tami J.
Oberoi, Rajneet K.
Fu, Bo
Kumada, Hiromitsu
author_sort Toyoda, Hidenori
collection PubMed
description Glecaprevir (nonstructural protein 3/4A protease inhibitor) and pibrentasvir (nonstructural protein 5A inhibitor) (G/P), a coformulated once‐daily, all oral, ribavirin (RBV)‐free, direct‐acting antiviral regimen, was evaluated for safety and efficacy in hepatitis C virus genotype 2 (GT2)–infected Japanese patients, including those with compensated cirrhosis. CERTAIN‐2 is a phase 3, open‐label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in treatment‐naive and interferon ± RBV treatment–experienced Japanese patients without cirrhosis but with GT2 infection. Patients were randomized 2:1 to receive 8 weeks of G/P (arm A) or 12 weeks of sofosbuvir (400 mg once daily) + RBV (600‐1000 mg weight‐based, twice daily) (arm B). The primary endpoint was noninferiority of G/P compared to sofosbuvir + RBV by assessing sustained virologic response at posttreatment week 12 (SVR12) among patients in the intent‐to‐treat population. SVR12 was also assessed in treatment‐naive and interferon ± RBV treatment‐experienced patients with GT2 infection and compensated cirrhosis who received G/P for 12 weeks in the CERTAIN‐1 study. A total of 136 patients were enrolled in CERTAIN‐2. SVR12 was achieved by 88/90 (97.8%) patients in arm A and 43/46 (93.5%) patients in arm B. No patient in arm A experienced virologic failure, while 2 did in arm B. The primary endpoint was achieved. In CERTAIN‐1, 100% (18/18) of GT2‐infected patients with compensated cirrhosis achieved SVR12. Treatment‐emergent serious adverse events were experienced by 2 patients without cirrhosis in each arm and no patient with cirrhosis. Conclusion: The results demonstrate high efficacy and favorable tolerability of G/P in GT2‐infected Japanese patients. (Hepatology 2018;67:505‐513).
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spelling pubmed-58148912018-02-27 Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection Toyoda, Hidenori Chayama, Kazuaki Suzuki, Fumitaka Sato, Ken Atarashi, Tomofumi Watanabe, Tsunamasa Atsukawa, Masanori Naganuma, Atsushi Notsumata, Kazuo Osaki, Yukio Nakamuta, Makoto Takaguchi, Koichi Saito, Satoru Kato, Koji Pugatch, David Burroughs, Margaret Redman, Rebecca Alves, Katia Pilot‐Matias, Tami J. Oberoi, Rajneet K. Fu, Bo Kumada, Hiromitsu Hepatology Original Articles Glecaprevir (nonstructural protein 3/4A protease inhibitor) and pibrentasvir (nonstructural protein 5A inhibitor) (G/P), a coformulated once‐daily, all oral, ribavirin (RBV)‐free, direct‐acting antiviral regimen, was evaluated for safety and efficacy in hepatitis C virus genotype 2 (GT2)–infected Japanese patients, including those with compensated cirrhosis. CERTAIN‐2 is a phase 3, open‐label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in treatment‐naive and interferon ± RBV treatment–experienced Japanese patients without cirrhosis but with GT2 infection. Patients were randomized 2:1 to receive 8 weeks of G/P (arm A) or 12 weeks of sofosbuvir (400 mg once daily) + RBV (600‐1000 mg weight‐based, twice daily) (arm B). The primary endpoint was noninferiority of G/P compared to sofosbuvir + RBV by assessing sustained virologic response at posttreatment week 12 (SVR12) among patients in the intent‐to‐treat population. SVR12 was also assessed in treatment‐naive and interferon ± RBV treatment‐experienced patients with GT2 infection and compensated cirrhosis who received G/P for 12 weeks in the CERTAIN‐1 study. A total of 136 patients were enrolled in CERTAIN‐2. SVR12 was achieved by 88/90 (97.8%) patients in arm A and 43/46 (93.5%) patients in arm B. No patient in arm A experienced virologic failure, while 2 did in arm B. The primary endpoint was achieved. In CERTAIN‐1, 100% (18/18) of GT2‐infected patients with compensated cirrhosis achieved SVR12. Treatment‐emergent serious adverse events were experienced by 2 patients without cirrhosis in each arm and no patient with cirrhosis. Conclusion: The results demonstrate high efficacy and favorable tolerability of G/P in GT2‐infected Japanese patients. (Hepatology 2018;67:505‐513). John Wiley and Sons Inc. 2017-11-24 2018-02 /pmc/articles/PMC5814891/ /pubmed/28865152 http://dx.doi.org/10.1002/hep.29510 Text en © 2017 The Authors. Hepatology published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Toyoda, Hidenori
Chayama, Kazuaki
Suzuki, Fumitaka
Sato, Ken
Atarashi, Tomofumi
Watanabe, Tsunamasa
Atsukawa, Masanori
Naganuma, Atsushi
Notsumata, Kazuo
Osaki, Yukio
Nakamuta, Makoto
Takaguchi, Koichi
Saito, Satoru
Kato, Koji
Pugatch, David
Burroughs, Margaret
Redman, Rebecca
Alves, Katia
Pilot‐Matias, Tami J.
Oberoi, Rajneet K.
Fu, Bo
Kumada, Hiromitsu
Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection
title Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection
title_full Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection
title_fullStr Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection
title_full_unstemmed Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection
title_short Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection
title_sort efficacy and safety of glecaprevir/pibrentasvir in japanese patients with chronic genotype 2 hepatitis c virus infection
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5814891/
https://www.ncbi.nlm.nih.gov/pubmed/28865152
http://dx.doi.org/10.1002/hep.29510
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