Daclatasvir/asunaprevir/beclabuvir, all-oral, fixed-dose combination for patients with chronic hepatitis C virus genotype 1
- Authors
- Kao, JH[Kao, Jia-Horng]; Yu, ML[Yu, Ming-Lung]; Peng, CY[Peng, Cheng-Yuan]; Heo, J[Heo, Jeong]; Chu, CJ[Chu, Chi-Jen]; Chang, TT[Chang, Ting-Tsung]; Lee, YJ[Lee, Youn-Jae]; Hu, TH[Hu, Tsung-Hui]; Yoon, KT[Yoon, Ki Tae]; Paik, SW[Paik, Seung Woon]; Lim, YS[Lim, Young Suk]; Ahn, SH[Ahn, Sang Hoon]; Isakov, V[Isakov, Vasily]; McPhee, F[McPhee, Fiona]; Hu, WH[Hu, Wenhua]; Swenson, ES[Swenson, Eugene Scott]; Yin, PD[Yin, Philip D.]; Treitel, M[Treitel, Michelle]
- Issue Date
- Dec-2017
- Publisher
- WILEY
- Keywords
- Asia; hepatitis; NS5A; treatment
- Citation
- JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, v.32, no.12, pp.1998 - 2005
- Indexed
- SCIE
SCOPUS
- Journal Title
- JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
- Volume
- 32
- Number
- 12
- Start Page
- 1998
- End Page
- 2005
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/26130
- DOI
- 10.1111/jgh.13796
- ISSN
- 0815-9319
- Abstract
- Background and AimThis multinational (Taiwan, South Korea, Russia) phase 3 study evaluated the all-oral, ribavirin-free, fixed-dose combination (DCV-TRIO) of daclatasvir (NS5A inhibitor) 30mg, asunaprevir (NS3 inhibitor) 200mg, and beclabuvir (NS5B inhibitor) 75mg, in patients with chronic hepatitis C virus genotype-1 infection, with or without compensated cirrhosis. MethodsUNITY-4 (NCT02170727) was an open-label, two-cohort study in which 169 patients, treatment-naive (n=138) or treatment-experienced (n=31), received twice-daily DCV-TRIO for 12weeks with 24weeks of post-treatment follow-up. The primary efficacy end point was sustained virologic response at post-treatment week 12 (SVR12) in treatment-naive patients. ResultsEighty-eight (52%) patients were men, 81 (48%) Taiwanese, 78 (46%) Korean, and 10 (6%) Russian; 23 (14%) had compensated cirrhosis, and 52 (31%) were IL28B (rs1297860) non-CC genotype. Baseline resistance-associated NS5A polymorphisms (L31 and/or Y93) were detected in 25/165 (15%) patients with available genotype-1 sequencing data. SVR12 was achieved by 98.6% (136/138; 95% confidence interval: 94.9-99.8%) of treatment-naive and 100% (31/31; 95% confidence interval: 88.8-100%) of treatment-experienced patients. Both virologic failures were found to be infected with hepatitis C virus genotype-6g; 100% SVR12 was observed for genotype-1a (n=8) and genotype-1b (n=157). Two patients experienced serious adverse events. Eight (5%) patients experienced reversible grade 3/4 alanine aminotransferase or aspartate aminotransferase elevations, leading to discontinuation in four (2%); all achieved SVR12. There were no grade 3/4 total bilirubin increases and no deaths. ConclusionsTwelve weeks of DCV-TRIO was well tolerated and provided 100% SVR12 in treatment-naive and treatment-experienced patients with genotype-1 infection, with or without cirrhosis, including those with baseline NS5A-L31 or NS5A-Y93 resistance-associated substitutions.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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