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- Title
Efficacy and safety of glecaprevir/pibrentasvir in HCV-infected Japanese patients with prior DAA experience, severe renal impairment, or genotype 3 infection.
- Authors
Kumada, Hiromitsu; Watanabe, Tsunamasa; Suzuki, Fumitaka; Ikeda, Kenji; Sato, Ken; Toyoda, Hidenori; Atsukawa, Masanori; Ido, Akio; Takaki, Akinobu; Enomoto, Nobuyuki; Kato, Koji; Alves, Katia; Burroughs, Margaret; Redman, Rebecca; Pugatch, David; Pilot-Matias, Tami J.; Krishnan, Preethi; Oberoi, Rajneet K.; Xie, Wangang; Chayama, Kazuaki
- Abstract
<bold>Background: </bold>Once-daily, orally administered, co-formulated glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P) demonstrated pangenotypic activity and high sustained virologic response (SVR) rates in studies outside Japan. Here we report safety and efficacy in a subset of Japanese patients with chronic HCV infection who received G/P 300/120 mg in a phase 3, open-label, multicenter study (CERTAIN-1).<bold>Methods: </bold>This analysis focuses on three difficult-to-treat subgroups: HCV GT1/2-infected patients who failed to achieve SVR after treatment with a direct acting antiviral (DAA)-containing regimen; GT1/2-infected patients with severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2); and GT3-infected patients. Patients in the renal impairment and GT3 cohorts were treatment-naive or interferon treatment-experienced. Noncirrhotic GT1/2-infected, DAA-naïve patients in the renal impairment cohort received G/P for 8 weeks; all other patients were treated for 12 weeks. Primary outcome was SVR (HCV RNA < 15 IU/mL) 12 weeks post-treatment (SVR12).<bold>Results: </bold>The study enrolled 33 GT1/2-infected patients who failed previous DAA treatment (four with cirrhosis); 12 GT1/2-infected patients with severe renal impairment (two with cirrhosis); and 12 GT3-infected patients (two with cirrhosis). SVR12 was achieved by 31/33 (93.9%), 12/12 (100%), and 10/12 (83.3%) patients, respectively. One serious adverse event (fluid overload, not related to G/P) occurred in a patient on chronic intermittent hemodialysis.<bold>Conclusions: </bold>G/P achieved high SVR12 rates and was well tolerated in three difficult-to-treat patient subgroups with limited treatment options in Japan (DAA-experienced patients, patients with severe renal impairment, and GT3-infected patients). These results support the potential suitability of this regimen for these special populations in Japan.
- Subjects
HEPATITIS C treatment; HEPATITIS C; JAPANESE people; GENOTYPES; MEDICATION safety; DRUG efficacy; GENETICS; DISEASES
- Publication
Journal of Gastroenterology, 2018, Vol 53, Issue 4, p566
- ISSN
0944-1174
- Publication type
journal article
- DOI
10.1007/s00535-017-1396-0