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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 IkedaTsunamasa WatanabeMasanori AtsukawaHidenori ToyodaKoichi TakaguchiMakoto NakamutaNobuyuki MatsumotoChiaki OkuseToshifumi TadaAkemi TsutsuiNaoki YamashitaChisa KondoKorenobu HayamaKeizo KatoNorio ItokawaTaeang AraiNoritomo ShimadaToru AsanoHaruki UojimaChikara OgawaShigeru MikamiTadashi IkegamiShinya FukunishiAkira AsaiEtsuko IioAkihito TsubotaAtsushi HiraokaAkito NozakiHironao OkuboYoshihiko TachiAkio MoriyaTsunekazu OikawaYoshihiro MatsumotoShuichi TsuruokaJoji TaniKan KikuchiKatsuhiko IwakiriYasuhito TanakaTakashi Kumada
Published in: Journal of viral hepatitis (2019)
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.
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