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. Issue 11 (9th August 2019)

• Record Type: Journal Article
• Authors: Ikeda, Hiroki; Watanabe, Tsunamasa; Atsukawa, Masanori; Toyoda, Hidenori; Takaguchi, Koichi; Nakamuta, Makoto; Matsumoto, Nobuyuki; Okuse, Chiaki; Tada, Toshifumi; Tsutsui, Akemi; Yamashita, Naoki; Kondo, Chisa; Hayama, Korenobu; Kato, Keizo; Itokawa, Norio; Arai, Taeang; Shimada, Noritomo; Asano, Toru; Uojima, Haruki; Ogawa, Chikara; Mikami, Shigeru; Ikegami, Tadashi; Fukunishi, Shinya; Asai, Akira; Iio, Etsuko; Tsubota, Akihito; Hiraoka, Atsushi; Nozaki, Akito; Okubo, Hironao; Tachi, Yoshihiko; Moriya, Akio; Oikawa, Tsunekazu; Matsumoto, Yoshihiro; Tsuruoka, Shuichi; Tani, Joji; Kikuchi, Kan; Iwakiri, Katsuhiko; Tanaka, Yasuhito; Kumada, Takashi;
• Is Part Of: Journal of viral hepatitis. Volume 26:Issue 11(2019)
• Page Start: 1266
• Page End: 1275
• Publication Date: 2019-08-09
• Subjects: glecaprevir -- hepatitis C virus -- pibrentasvir -- real world -- sustained virologic response; Hepatitis, Viral -- Periodicals; Hepatitis, Viral, Animal; Hepatitis, Viral, Human; 616.3623
• DOI: 10.1111/jvh.13170
• Languages: English
• ISSNs: 1352-0504

Abstract

Abstract: 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.