TY - JOUR
T1 - 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
AU - Ikeda, Hiroki
AU - Watanabe, Tsunamasa
AU - Atsukawa, Masanori
AU - Toyoda, Hidenori
AU - Takaguchi, Koichi
AU - Nakamuta, Makoto
AU - Matsumoto, Nobuyuki
AU - Okuse, Chiaki
AU - Tada, Toshifumi
AU - Tsutsui, Akemi
AU - Yamashita, Naoki
AU - Kondo, Chisa
AU - Hayama, Korenobu
AU - Kato, Keizo
AU - Itokawa, Norio
AU - Arai, Taeang
AU - Shimada, Noritomo
AU - Asano, Toru
AU - Uojima, Haruki
AU - Ogawa, Chikara
AU - Mikami, Shigeru
AU - Ikegami, Tadashi
AU - Fukunishi, Shinya
AU - Asai, Akira
AU - Iio, Etsuko
AU - Tsubota, Akihito
AU - Hiraoka, Atsushi
AU - Nozaki, Akito
AU - Okubo, Hironao
AU - Tachi, Yoshihiko
AU - Moriya, Akio
AU - Oikawa, Tsunekazu
AU - Matsumoto, Yoshihiro
AU - Tsuruoka, Shuichi
AU - Tani, Joji
AU - Kikuchi, Kan
AU - Iwakiri, Katsuhiko
AU - Tanaka, Yasuhito
AU - Kumada, Takashi
N1 - Publisher Copyright:
© 2019 John Wiley & Sons Ltd
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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.
AB - 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.
KW - glecaprevir
KW - hepatitis C virus
KW - pibrentasvir
KW - real world
KW - sustained virologic response
UR - http://www.scopus.com/inward/record.url?scp=85070325533&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85070325533&partnerID=8YFLogxK
U2 - 10.1111/jvh.13170
DO - 10.1111/jvh.13170
M3 - Article
C2 - 31278795
AN - SCOPUS:85070325533
SN - 1352-0504
VL - 26
SP - 1266
EP - 1275
JO - Journal of Viral Hepatitis
JF - Journal of Viral Hepatitis
IS - 11
ER -