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The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
- Source :
-
Journal of gastroenterology [J Gastroenterol] 2017 Apr; Vol. 52 (4), pp. 520-533. Date of Electronic Publication: 2016 Nov 21. - Publication Year :
- 2017
-
Abstract
- Background: Elbasvir (EBR) in combination with grazoprevir (GZR) has demonstrated efficacy in patients with hepatitis C virus (HCV) infections in trials primarily conducted in the USA and Europe. We investigated the safety and efficacy of EBR in combination with GZR in Japanese patients with chronic HCV infection, with or without cirrhosis.<br />Methods: The study was conducted in two parts. In part 1, noncirrhotic patients were randomized 1:1 to receive EBR (50 mg) in combination with GZR (50 or 100 mg) once daily for 12 weeks. In part 2, noncirrhotic patients were randomized 3:1 to receive immediate or deferred treatment with EBR (50 mg) and GZR (100 mg, determined in part 1) for 12 weeks; cirrhotic patients received open-label immediate treatment. The primary efficacy end point was the rate of sustained virologic response 12 weeks after completion of the study treatment.<br />Results: In part 1, 63 patients were randomized to receive EBR in combination with GZR at a dose of 50 mg (n = 31) or 100 mg (n = 32). The SVR12 rates were 100% with GZR at a dose of 50 mg and 96.8% with GZR at a dose of 100 mg. Tolerability was similar in both arms. In part 2, 301 noncirrhotic patients were randomized to receive immediate treatment (n = 227) or deferred treatment (n = 74), and 35 cirrhotic patients were enrolled. The SVR12 rates were 96.5% and 97.1% after immediate treatment in noncirrhotic and cirrhotic patients respectively. Safety was generally similar between immediate and deferred treatment.<br />Conclusion: Treatment with EBR in combination with GZR for 12 weeks is effective and well tolerated in Japanese patients with chronic HCV infection. CLINICALTRIALS.<br />Gov Identifier: NCT02203149.
- Subjects :
- Administration, Oral
Adult
Aged
Aged, 80 and over
Amides
Antiviral Agents administration & dosage
Antiviral Agents adverse effects
Antiviral Agents blood
Benzofurans administration & dosage
Benzofurans adverse effects
Benzofurans blood
Carbamates
Cyclopropanes
Double-Blind Method
Drug Administration Schedule
Drug Resistance, Viral
Drug Therapy, Combination
Female
Hepacivirus drug effects
Hepacivirus genetics
Hepacivirus isolation & purification
Hepatitis C, Chronic blood
Hepatitis C, Chronic complications
Hepatitis C, Chronic virology
Humans
Imidazoles administration & dosage
Imidazoles adverse effects
Imidazoles blood
Liver Cirrhosis drug therapy
Liver Cirrhosis virology
Male
Middle Aged
Quinoxalines administration & dosage
Quinoxalines adverse effects
Quinoxalines blood
RNA, Viral blood
Sulfonamides
Sustained Virologic Response
Treatment Outcome
Young Adult
Antiviral Agents therapeutic use
Benzofurans therapeutic use
Hepatitis C, Chronic drug therapy
Imidazoles therapeutic use
Quinoxalines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1435-5922
- Volume :
- 52
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 27873094
- Full Text :
- https://doi.org/10.1007/s00535-016-1285-y