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- Title
Simeprevir in combination with sofosbuvir in treatment-naïve and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study ( PLUTO).
- Authors
Buti, M.; Calleja, J. L.; Lens, S.; Diago, M.; Ortega, E.; Crespo, J.; Planas, R.; Romero‐Gómez, M.; Rodríguez, F. G.; Pascasio, J. M.; Fevery, B.; Kurland, D.; Corbett, C.; Kalmeijer, R.; Jessner, W.
- Abstract
Background Hepatitis C virus ( HCV) infection is a leading cause of liver cirrhosis and subsequent hepatocellular carcinoma. HCV genotype 4 is found widely in the Middle East, Egypt and Africa, and has also spread into Europe. There are limited data available regarding the use of direct-acting antiviral agents in HCV genotype 4-infected patients with cirrhosis. Aim To evaluate in the phase III, open-label, single-arm PLUTO study the efficacy and safety of 12 weeks of simeprevir ( HCV NS3/4A protease inhibitor) plus sofosbuvir ( HCV nucleotide-analogue NS5B polymerase inhibitor) in treatment-naïve and (peg)interferon ± ribavirin-experienced HCV genotype 4-infected patients, with or without compensated cirrhosis. Methods Adult patients with chronic HCV genotype 4 infection received simeprevir 150 mg once-daily and sofosbuvir 400 mg once-daily for 12 weeks. The primary efficacy endpoint was sustained virologic response 12 weeks after the end of treatment ( SVR12). Safety was also assessed. Results Forty patients received treatment; the majority were male (73%) and treatment-experienced (68%). Overall, 7/40 (18%) patients had compensated cirrhosis. All patients achieved SVR12 [100% (Clopper-Pearson 95% confidence interval: 91-100%)]. Adverse events, all Grade 1 or 2, were reported in 20/40 (50%) patients. No serious adverse events were reported and no patients discontinued study treatment. Grade 3 treatment-emergent laboratory abnormalities were noted in 2/40 (5%) patients. Conclusions Treatment with simeprevir plus sofosbuvir for 12 weeks resulted in SVR12 rates of 100% in treatment-naïve and -experienced patients with HCV genotype 4 infection with or without compensated cirrhosis, and was well tolerated. [ NCT02250807]
- Subjects
HEPATITIS C treatment; SOFOSBUVIR; ANTIVIRAL agents; COMBINATION drug therapy; CIRRHOSIS of the liver; CANCER risk factors; LIVER cancer; DISEASE risk factors
- Publication
Alimentary Pharmacology & Therapeutics, 2017, Vol 45, Issue 3, p468
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.13883