SILEN-C3, a Phase 2 Randomized Trial with Faldaprevir plus Pegylated Interferon α-2a and Ribavirin in Treatment-Naive Hepatitis C Virus Genotype 1-Infected Patients

Autor: Thomas Berg, Yakov Datsenko, Tarik Asselah, Peter Ferenci, Stefan Mauss, Marcus Schuchmann, Wulf O. Böcher, Andreas Maieron, Dominique Larrey, Jerry O. Stern, Melek Ozan, Douglas T. Dieterich, Gerhard G. Steinmann, Vlad Ratziu, Dominique Guyader
Jazyk: angličtina
Rok vydání: 2014
Předmět:
Male
Aminoisobutyric Acids
Hepacivirus
Viral Nonstructural Proteins
medicine.disease_cause
Gastroenterology
law.invention
Polyethylene Glycols
chemistry.chemical_compound
Randomized controlled trial
law
Pegylated interferon
Pharmacology (medical)
Intracellular Signaling Peptides and Proteins
virus diseases
Middle Aged
Hepatitis C
Recombinant Proteins
3. Good health
Infectious Diseases
Quinolines
RNA
Viral
Drug Therapy
Combination
Female
Oligopeptides
medicine.drug
Adult
medicine.medical_specialty
Adolescent
Genotype
Proline
Hepatitis C virus
Antiviral Agents
Young Adult
Leucine
Internal medicine
Ribavirin
medicine
Humans
Protease inhibitor (pharmacology)
Rapid Virologic Response
Aged
Pharmacology
business.industry
Interferon-alpha
Hepatology
Virology
digestive system diseases
Thiazoles
chemistry
Faldaprevir
business
Carrier Proteins
Zdroj: Antimicrobial Agents and Chemotherapy
ISSN: 1098-6596
0066-4804
0098-4620
Popis: Faldaprevir is an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor which, when administered for 24 weeks in combination with pegylated interferon α-2a and ribavirin (PegIFN/RBV) in treatment-naive patients in a prior study (SILEN-C1; M. S. Sulkowski et al., Hepatology 57:2143–2154, 2013, doi:10.1002/hep.26276), achieved sustained virologic response (SVR) rates of 72 to 84%. The current randomized, open-label, parallel-group study compared the efficacy and safety of 12 versus 24 weeks of 120 mg faldaprevir administered once daily, combined with 24 or 48 weeks of PegIFN/RBV, in 160 treatment-naive HCV genotype 1 patients. Patients with maintained rapid virologic response (HCV RNA of IL28B genotype imbalances; IL28B genotype was not tested, as its significance was not known at the time of the study. These results supported phase 3 evaluation. (This study has been registered at ClinicalTrials.gov under registration no. NCT00984620).
Databáze: OpenAIRE
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