TY - JOUR
T1 - Efficacy and safety of glecaprevir/pibrentasvir in HCV-infected Japanese patients with prior DAA experience, severe renal impairment, or genotype 3 infection
AU - Kumada, Hiromitsu
AU - Watanabe, Tsunamasa
AU - Suzuki, Fumitaka
AU - Ikeda, Kenji
AU - Sato, Ken
AU - Toyoda, Hidenori
AU - Atsukawa, Masanori
AU - Ido, Akio
AU - Takaki, Akinobu
AU - Enomoto, Nobuyuki
AU - Kato, Koji
AU - Alves, Katia
AU - Burroughs, Margaret
AU - Redman, Rebecca
AU - Pugatch, David
AU - Pilot-Matias, Tami J.
AU - Krishnan, Preethi
AU - Oberoi, Rajneet K.
AU - Xie, Wangang
AU - Chayama, Kazuaki
N1 - Funding Information:
Conflict of interest AbbVie sponsored the study (NCT02707952), contributed to its design, the collection, analysis, and interpretation of the data, and participated in the writing, review, and approval of the abstract. All authors had access to relevant data. H Kumada: received payment for lectures from AbbVie, MSD, Gilead, Sumitomo Dainippon Pharma Co. Ltd, and BMS. T Watanabe and A Takaki: nothing to disclose. F Suzuki: received payment for lectures from AbbVie, Gilead, and BMS. K Ikeda: received payment for lectures from Sumitomo Dainippon Pharma Co. Ltd, Olympus, Eisai Co., Ltd., Otsuka Pharmaceutical, Nippon Kayaku Co., Ltd., and Bayer. K Sato: received research funding from AbbVie and MSD. H Toyoda: received payment for lectures from AbbVie and BMS. M Atsukawa: received research funding from AbbVie, and payment for lecture from AbbVie. A Ido: received payment for lectures from AbbVie, Gilead, and BMS. N Enomoto: received honoraria from AbbVie, Gilead, MSD, BMS, Otsuka, Daiichi-Sankyo, Dainippon-Sumitomo, Astellas; and received research funding from AbbVie, Gilead, MSD, Eisai, Taisho-Toyama, Daiichi-Sankyo, Astellas, Otsuka, Takeda, BMS. K Kato, K Alves, M Burroughs, R Redman, D L Pugatch, T J Pilot-Matias, P Krishnan, R K. Oberoi, W Xie: Employees of AbbVie; may hold AbbVie stock or options. K Chayama: receives payment for lectures from MSD, AbbVie, BMS, Ajinomoto Pharmaceuticals Co., Ltd., Abbott , Astellas Phama Inc., Chugai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Gilead, Mitsubishi Tanabe Pharma; received research funding from Ajinomoto Pharmaceuticals Co., Ltd., AbbVie, MSD, EA Pharma Co., Ltd., Toray Industries, Inc., Otsuka Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Mitsubishi Tanabe Pharma, Chugai Pharmaceutical Co., Ltd., BMS, Roche Diagnostics K.K., Janssen Pharmaceutical K.K.
Funding Information:
Medical writing support was provided by Maher Quraan, Ph.D., of AbbVie, Scott Battle, Ph.D., and Blair Jarvis, M.Sc., ELS of Medical Expressions, funded by AbbVie. The original version of this article was revised: The copyright line was corrected and the CC-BY description was included in the PDF. A correction to this article is available online at https://doi.org/10.1007/s00535-017-1409-z. AbbVie sponsored the study (NCT02707952), contributed to its design, the collection, analysis, and interpretation of the data, and participated in the writing, review, and approval of the abstract. All authors had access to relevant data. H Kumada: received payment for lectures from AbbVie, MSD, Gilead, Sumitomo Dainippon Pharma Co. Ltd, and BMS. T Watanabe and A Takaki: nothing to disclose. F Suzuki: received payment for lectures from AbbVie, Gilead, and BMS. K Ikeda: received payment for lectures from Sumitomo Dainippon Pharma Co. Ltd, Olympus, Eisai Co., Ltd., Otsuka Pharmaceutical, Nippon Kayaku Co., Ltd., and Bayer. K Sato: received research funding from AbbVie and MSD. H Toyoda: received payment for lectures from AbbVie and BMS. M Atsukawa: received research funding from AbbVie, and payment for lecture from AbbVie. A Ido: received payment for lectures from AbbVie, Gilead, and BMS. N Enomoto: received honoraria from AbbVie, Gilead, MSD, BMS, Otsuka, Daiichi-Sankyo, Dainippon-Sumitomo, Astellas; and received research funding from AbbVie, Gilead, MSD, Eisai, Taisho-Toyama, Daiichi-Sankyo, Astellas, Otsuka, Takeda, BMS. K Kato, K Alves, M Burroughs, R Redman, D L Pugatch, T J Pilot-Matias, P Krishnan, R K. Oberoi, W Xie: Employees of AbbVie; may hold AbbVie stock or options. K Chayama: receives payment for lectures from MSD, AbbVie, BMS, Ajinomoto Pharmaceuticals Co., Ltd., Abbott , Astellas Phama Inc., Chugai Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Gilead, Mitsubishi Tanabe Pharma; received research funding from Ajinomoto Pharmaceuticals Co., Ltd., AbbVie, MSD, EA Pharma Co., Ltd., Toray Industries, Inc., Otsuka Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Mitsubishi Tanabe Pharma, Chugai Pharmaceutical Co., Ltd., BMS, Roche Diagnostics K.K., Janssen Pharmaceutical K.K.
Publisher Copyright:
© 2017, The Author(s).
PY - 2018/4/1
Y1 - 2018/4/1
N2 - Background: Once-daily, orally administered, co-formulated glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P) demonstrated pangenotypic activity and high sustained virologic response (SVR) rates in studies outside Japan. Here we report safety and efficacy in a subset of Japanese patients with chronic HCV infection who received G/P 300/120 mg in a phase 3, open-label, multicenter study (CERTAIN-1). Methods: This analysis focuses on three difficult-to-treat subgroups: HCV GT1/2-infected patients who failed to achieve SVR after treatment with a direct acting antiviral (DAA)-containing regimen; GT1/2-infected patients with severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m 2 ); and GT3-infected patients. Patients in the renal impairment and GT3 cohorts were treatment-naive or interferon treatment-experienced. Noncirrhotic GT1/2-infected, DAA-naïve patients in the renal impairment cohort received G/P for 8 weeks; all other patients were treated for 12 weeks. Primary outcome was SVR (HCV RNA < 15 IU/mL) 12 weeks post-treatment (SVR 12 ). Results: The study enrolled 33 GT1/2-infected patients who failed previous DAA treatment (four with cirrhosis); 12 GT1/2-infected patients with severe renal impairment (two with cirrhosis); and 12 GT3-infected patients (two with cirrhosis). SVR 12 was achieved by 31/33 (93.9%), 12/12 (100%), and 10/12 (83.3%) patients, respectively. One serious adverse event (fluid overload, not related to G/P) occurred in a patient on chronic intermittent hemodialysis. Conclusions: G/P achieved high SVR 12 rates and was well tolerated in three difficult-to-treat patient subgroups with limited treatment options in Japan (DAA-experienced patients, patients with severe renal impairment, and GT3-infected patients). These results support the potential suitability of this regimen for these special populations in Japan.
AB - Background: Once-daily, orally administered, co-formulated glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P) demonstrated pangenotypic activity and high sustained virologic response (SVR) rates in studies outside Japan. Here we report safety and efficacy in a subset of Japanese patients with chronic HCV infection who received G/P 300/120 mg in a phase 3, open-label, multicenter study (CERTAIN-1). Methods: This analysis focuses on three difficult-to-treat subgroups: HCV GT1/2-infected patients who failed to achieve SVR after treatment with a direct acting antiviral (DAA)-containing regimen; GT1/2-infected patients with severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m 2 ); and GT3-infected patients. Patients in the renal impairment and GT3 cohorts were treatment-naive or interferon treatment-experienced. Noncirrhotic GT1/2-infected, DAA-naïve patients in the renal impairment cohort received G/P for 8 weeks; all other patients were treated for 12 weeks. Primary outcome was SVR (HCV RNA < 15 IU/mL) 12 weeks post-treatment (SVR 12 ). Results: The study enrolled 33 GT1/2-infected patients who failed previous DAA treatment (four with cirrhosis); 12 GT1/2-infected patients with severe renal impairment (two with cirrhosis); and 12 GT3-infected patients (two with cirrhosis). SVR 12 was achieved by 31/33 (93.9%), 12/12 (100%), and 10/12 (83.3%) patients, respectively. One serious adverse event (fluid overload, not related to G/P) occurred in a patient on chronic intermittent hemodialysis. Conclusions: G/P achieved high SVR 12 rates and was well tolerated in three difficult-to-treat patient subgroups with limited treatment options in Japan (DAA-experienced patients, patients with severe renal impairment, and GT3-infected patients). These results support the potential suitability of this regimen for these special populations in Japan.
KW - Cirrhosis
KW - Glecaprevir
KW - Pibrentasvir
KW - Renal failure
KW - Special population
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U2 - 10.1007/s00535-017-1396-0
DO - 10.1007/s00535-017-1396-0
M3 - Article
C2 - 29052790
AN - SCOPUS:85031921224
VL - 53
SP - 566
EP - 575
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
SN - 0944-1174
IS - 4
ER -