Evaluation of 8-week glecaprevir/pibrentasvir treatment in direct-acting antiviral-naïve noncirrhotic HCV genotype 1 and 2infected patients in a real-world setting in Japan
Hiroki Ikeda
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorTsunamasa Watanabe
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorCorresponding Author
Masanori Atsukawa
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Correspondence
Masanori Atsukawa, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, 1-1-5, Sendagi, Bunkyou-Ku, Tokyo, 113-8603, Japan.
Email: [email protected]
Search for more papers by this authorHidenori Toyoda
Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan
Search for more papers by this authorKoichi Takaguchi
Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan
Search for more papers by this authorMakoto Nakamuta
National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
Search for more papers by this authorNobuyuki Matsumoto
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorChiaki Okuse
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorToshifumi Tada
Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan
Search for more papers by this authorAkemi Tsutsui
Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan
Search for more papers by this authorNaoki Yamashita
National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
Search for more papers by this authorChisa Kondo
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorKorenobu Hayama
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorKeizo Kato
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Shinmatusdo Central General Hospital, Matsudo, Japan
Search for more papers by this authorNorio Itokawa
Department of Internal Medicine, Division of Gastroenterology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan
Search for more papers by this authorTaeang Arai
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorNoritomo Shimada
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Otakanomori Hospital, Kashiwa, Japan
Search for more papers by this authorToru Asano
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan
Search for more papers by this authorHaruki Uojima
Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Kanagawa, Japan
Search for more papers by this authorChikara Ogawa
Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan
Search for more papers by this authorShigeru Mikami
Department of Internal Medicine, Division of Gastroenterology, Kikkoman General Hospital, Noda, Japan
Search for more papers by this authorTadashi Ikegami
Ibaraki Medical Center, Tokyo Medical University, Ibaraki, Japan
Search for more papers by this authorShinya Fukunishi
Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan
Search for more papers by this authorAkira Asai
Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan
Search for more papers by this authorEtsuko Iio
Department of Virology & Liver Unit, Graduate School of Medical Sciences, Nagoya City University, Aichi, Japan
Search for more papers by this authorAkihito Tsubota
Core Research Facilities for Basic Science, The Jikei University School of Medicine, Tokyo, Japan
Search for more papers by this authorAtsushi Hiraoka
Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan
Search for more papers by this authorAkito Nozaki
Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan
Search for more papers by this authorHironao Okubo
Department of Gastroenterology, Juntendo Nerima University Hospital, Tokyo, Japan
Search for more papers by this authorYoshihiko Tachi
Bantane Hospital, Fujita Health University School of Medicine, Nagoya, Japan
Search for more papers by this authorAkio Moriya
Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan
Search for more papers by this authorTsunekazu Oikawa
Department of Gastroenterology and Hepatology, The Jikei University School of Medicine, Tokyo, Japan
Search for more papers by this authorYoshihiro Matsumoto
Department of Gastroenterology and Hepatology, The Jikei University School of Medicine, Kashiwa Hospital, Kashiwa, Japan
Search for more papers by this authorShuichi Tsuruoka
Department of Internal Medicine, Division of Nephrology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorJoji Tani
Department of Internal Medicine, Yashima General Hospital, Takamatsu, Japan
Search for more papers by this authorKatsuhiko Iwakiri
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorYasuhito Tanaka
Department of Virology & Liver Unit, Graduate School of Medical Sciences, Nagoya City University, Aichi, Japan
Search for more papers by this authorTakashi Kumada
Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan
Search for more papers by this authorHiroki Ikeda
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorTsunamasa Watanabe
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorCorresponding Author
Masanori Atsukawa
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Correspondence
Masanori Atsukawa, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, 1-1-5, Sendagi, Bunkyou-Ku, Tokyo, 113-8603, Japan.
Email: [email protected]
Search for more papers by this authorHidenori Toyoda
Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan
Search for more papers by this authorKoichi Takaguchi
Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan
Search for more papers by this authorMakoto Nakamuta
National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
Search for more papers by this authorNobuyuki Matsumoto
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorChiaki Okuse
Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan
Search for more papers by this authorToshifumi Tada
Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan
Search for more papers by this authorAkemi Tsutsui
Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan
Search for more papers by this authorNaoki Yamashita
National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
Search for more papers by this authorChisa Kondo
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorKorenobu Hayama
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorKeizo Kato
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Shinmatusdo Central General Hospital, Matsudo, Japan
Search for more papers by this authorNorio Itokawa
Department of Internal Medicine, Division of Gastroenterology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan
Search for more papers by this authorTaeang Arai
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorNoritomo Shimada
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Otakanomori Hospital, Kashiwa, Japan
Search for more papers by this authorToru Asano
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan
Search for more papers by this authorHaruki Uojima
Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Kanagawa, Japan
Search for more papers by this authorChikara Ogawa
Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan
Search for more papers by this authorShigeru Mikami
Department of Internal Medicine, Division of Gastroenterology, Kikkoman General Hospital, Noda, Japan
Search for more papers by this authorTadashi Ikegami
Ibaraki Medical Center, Tokyo Medical University, Ibaraki, Japan
Search for more papers by this authorShinya Fukunishi
Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan
Search for more papers by this authorAkira Asai
Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan
Search for more papers by this authorEtsuko Iio
Department of Virology & Liver Unit, Graduate School of Medical Sciences, Nagoya City University, Aichi, Japan
Search for more papers by this authorAkihito Tsubota
Core Research Facilities for Basic Science, The Jikei University School of Medicine, Tokyo, Japan
Search for more papers by this authorAtsushi Hiraoka
Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan
Search for more papers by this authorAkito Nozaki
Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan
Search for more papers by this authorHironao Okubo
Department of Gastroenterology, Juntendo Nerima University Hospital, Tokyo, Japan
Search for more papers by this authorYoshihiko Tachi
Bantane Hospital, Fujita Health University School of Medicine, Nagoya, Japan
Search for more papers by this authorAkio Moriya
Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan
Search for more papers by this authorTsunekazu Oikawa
Department of Gastroenterology and Hepatology, The Jikei University School of Medicine, Tokyo, Japan
Search for more papers by this authorYoshihiro Matsumoto
Department of Gastroenterology and Hepatology, The Jikei University School of Medicine, Kashiwa Hospital, Kashiwa, Japan
Search for more papers by this authorShuichi Tsuruoka
Department of Internal Medicine, Division of Nephrology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorJoji Tani
Department of Internal Medicine, Yashima General Hospital, Takamatsu, Japan
Search for more papers by this authorKatsuhiko Iwakiri
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
Search for more papers by this authorYasuhito Tanaka
Department of Virology & Liver Unit, Graduate School of Medical Sciences, Nagoya City University, Aichi, Japan
Search for more papers by this authorTakashi Kumada
Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan
Search for more papers by this authorAbstract
Based on high efficacy and safety demonstrated in clinical trials, treatment with glecaprevir/pibrentasvir (G/P) for 8 weeks is recommended for hepatitis C virus (HCV)–infected patients who are direct-acting antiviral (DAA) naïve, genotype 1 or 2, and noncirrhotic. The aim of this study was to validate real-world experience with 8-week G/P treatment in Japan. We conducted a prospective observational cohort study in 554 patients who underwent 8-week treatment from among 1,022 patients who initiated G/P therapy. The majority (54.5%) were male, with a median age of 66 years, and HCV genotype distribution was genotype 1, 43.8%; genotype 2, 55.3%; and mixed subtype, 0.9%. Overall, the sustained virologic response rate at 12 weeks (SVR12) was 92.8% (530/571) in the intention-to-treat population and 99.3% (526/530) in the per-protocol population. The SVR12 rates by subgroups were as follows: subtype 1a, 100% (6/6); 1b, 100% (189/189); 2a, 99.3% (150/151); 2b, 99.0% (103/104); and mixed subtype, 50% (2/4). Among four patients with virologic failure following 8-week treatment with G/P, none had baseline polymorphisms or treatment-emergent amino acid substitutions in NS3. However, 2 of 4 patients with virologic failure had treatment-emergent amino acid substitutions in NS5A. Adverse events (AEs) were reported in 21.5% of patients and 1.2% of patients discontinued due to drug-related AEs. In conclusion, G/P treatment for 8 weeks was safe and effective for DAA-naïve noncirrhotic genotype 1 or 2 patients in a real-world clinical setting in Japan.
CONFLICT OF INTEREST
HI has served as a speaker for AbbVie, unrelated to this study. TW has served as a speaker for AbbVie and received research funding from AbbVie, unrelated to this study. MA has served as a speaker for AbbVie and received research funding from AbbVie, unrelated to this study. HT has served as a speaker and received research funding from MSD and AbbVie, unrelated to this study. KT has served as a speaker for AbbVie, unrelated to this study. AN has received research funding from AbbVie and Gilead Sciences, unrelated to this study. YT has served as a speaker for Gilead Sciences and received research funding from AbbVie, unrelated to this study. TK has served as a speaker for Gilead Sciences and AbbVie, and has received research funding from Gilead Sciences, unrelated to this study.
Supporting Information
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