TY - JOUR
T1 - Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection
AU - for the NORTE Study Group
AU - Suda, Goki
AU - Hasebe, Chitomi
AU - Abe, Masami
AU - Kurosaki, Masayuki
AU - Itakura, Jun
AU - Izumi, Namiki
AU - Uchida, Yoshihito
AU - Mochida, Satoshi
AU - Haga, Hiroaki
AU - Ueno, Yoshiyuki
AU - Abe, Kazumichi
AU - Takahashi, Atsushi
AU - Ohira, Hiromasa
AU - Tsukuda, Yoko
AU - Furuya, Ken
AU - Baba, Masaru
AU - Yamamoto, Yoshiya
AU - Kobayashi, Tomoe
AU - Inoue, Jun
AU - Terasita, Katsumi
AU - Ohara, Masatsugu
AU - Kawagishi, Naoki
AU - Izumi, Takaaki
AU - Nakai, Masato
AU - Sho, Takuya
AU - Natsuizaka, Mitsuteru
AU - Morikawa, Kenichi
AU - Ogawa, Koji
AU - Sakamoto, Naoya
N1 - Funding Information:
Funding This study was supported in part by by the Japan Agency for Medical Research and Development (AMED) Grant: JP18fk0210018h0002 and JSPS KAKENHI (Grant Number 16K09334).
Funding Information:
Conflicts of interest Professor Naoya Sakamoto has received lecture fees from Bristol Myers Squibb, and Pharmaceutical K.K., grants and endowments from MSD, K. K. and Chugai Pharmaceutical Co., Ltd, and a research grant from Gilead Sciences Inc and AbbVie GK. Dr. Goki Suda has received research grants from Merck & Co and Bristol Myers Squibb. Dr. Masayuki Kurosaki received lecture fee from Abbvie GK and Gilead Sciences. Dr. Yoshihito Uchida has received research grant from AbbVie GK. Professor Satoshi Mochida has received speaking fees or honoraria from AbbVie GK, Ajinomoto Pharmaceuticals Co. Ltd., Bristol Myers Squibb Co., Gilead Sciences Inc., MSD K.K., Sumitomo Dainippon Pharma Co., Toray Medical Co. Ltd., has received research grants from A2 Healthcare Co., AbbVie GK, Bristol Myers Squibb Co., Chugai Pharmaceutical Co. Ltd., EA Pharma Co. Ltd., Mitsubishi Tanabe Pharma Co., MSD K.K., Sumitomo Dainippon Pharma Co., Toray Medical Co. Ltd., has received patent royalties from SRL Inc. Dr. Hiroaki Haga has received grants and endowments from Gilead Sciences. Professor Yoshiyuki Ueno has received grants and endowments from Gilead Sciences, MSD K.K., and AbbVie GK.Dr Ikuto Masakane has received lecture fee from Bristol Myers Squibb and AbbVie GK. The other authors have no conflicts of interest to disclose.
PY - 2019/7/12
Y1 - 2019/7/12
N2 - Background: Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysis patients was an unfulfilled medical need. Recent clinical trials of glecaprevir and pibrentasvir (G/P) for hemodialysis patients showed high efficacy and safety; however, the number of GT2 HCV-infected patients, especially Asian patients, was limited and most of them were treated with a 12-week regimen. In this prospective multicenter study, we aimed to investigate the efficacy and safety of G/P in Japanese hemodialysis patients with GT2 HCV infection. Methods: Twenty-seven Japanese hemodialysis patients with GT2 HCV infection who were started on with 8- or 12-week G/P regimen between November 2017 and June 2018 were included and followed up for around 12 weeks after treatment completion. Results: Among the 27 included patients, 13 non-liver cirrhosis (LC) and direct-acting antivirals (DAAs)-naïve patients were treated with 8 weeks of G/P and 14 patients with LC (n = 13) or history of failure of DAAs (n = 1) were treated with a 12-week regimen. The overall sustained virological response at 12 weeks after treatment completion (SVR 12) was 96.3% (26/27). All patients with 8 weeks of treatment achieved SVR12. Two patients discontinued the therapy at 2 and 11 weeks after treatment initiation. The patient who discontinued at 2 weeks due to pruritus alone failed to respond to G/P. No patients experienced lethal adverse events during the therapy, and the most common adverse event was pruritus. Conclusions: An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.
AB - Background: Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysis patients was an unfulfilled medical need. Recent clinical trials of glecaprevir and pibrentasvir (G/P) for hemodialysis patients showed high efficacy and safety; however, the number of GT2 HCV-infected patients, especially Asian patients, was limited and most of them were treated with a 12-week regimen. In this prospective multicenter study, we aimed to investigate the efficacy and safety of G/P in Japanese hemodialysis patients with GT2 HCV infection. Methods: Twenty-seven Japanese hemodialysis patients with GT2 HCV infection who were started on with 8- or 12-week G/P regimen between November 2017 and June 2018 were included and followed up for around 12 weeks after treatment completion. Results: Among the 27 included patients, 13 non-liver cirrhosis (LC) and direct-acting antivirals (DAAs)-naïve patients were treated with 8 weeks of G/P and 14 patients with LC (n = 13) or history of failure of DAAs (n = 1) were treated with a 12-week regimen. The overall sustained virological response at 12 weeks after treatment completion (SVR 12) was 96.3% (26/27). All patients with 8 weeks of treatment achieved SVR12. Two patients discontinued the therapy at 2 and 11 weeks after treatment initiation. The patient who discontinued at 2 weeks due to pruritus alone failed to respond to G/P. No patients experienced lethal adverse events during the therapy, and the most common adverse event was pruritus. Conclusions: An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.
KW - Genotype 2
KW - Glecaprevir
KW - HCV
KW - Hemodialysis
KW - Pibrentasvir
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U2 - 10.1007/s00535-019-01556-y
DO - 10.1007/s00535-019-01556-y
M3 - Article
C2 - 30778716
AN - SCOPUS:85061751493
VL - 54
SP - 641
EP - 649
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
SN - 0944-1174
IS - 7
ER -