Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial
| Autor: | Yao Yu, Chih-Wei Lin, David R. Nelson, Holger Hinrichsen, Xavier Forns, Yves Horsmans, Jens Kort, Reem Ghalib, Joaquin Mario Valdes, Preethi Krishnan, Stefan Zeuzem, Federico J. Mensa, Diego Rincón, Humberto Aguilar, Samuel S. Lee, Sabela Lens, Rosa Maria Morillas, Franco Felizarta, Tarek Hassanein |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Cyclopropanes Liver Cirrhosis Male medicine.medical_specialty Aminoisobutyric Acids Pyrrolidines Sofosbuvir Genotype Proline Voxilaprevir Lactams Macrocyclic Hepacivirus Gastroenterology Antiviral Agents 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Pegylated interferon Leucine Internal medicine Quinoxalines medicine Humans 030212 general & internal medicine Aged Aged 80 and over Sulfonamides business.industry Ribavirin Glecaprevir Hepatitis C Middle Aged medicine.disease Pibrentasvir Surgery Regimen Infectious Diseases chemistry 030211 gastroenterology & hepatology Benzimidazoles Drug Therapy Combination Female business medicine.drug |
| Zdroj: | LANCET INFECTIOUS DISEASES r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol instname |
| ISSN: | 1474-4457 1473-3099 |
| Popis: | Background The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis. Methods We did this single-arm, open-label, multicentre phase 3 study at 40 sites in Belgium, Canada, Germany, South Africa, Spain, and the USA. We enrolled patients aged 18 years or older with HCV genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis. Patients were either HCV treatment-naive or had not responded to treatment with interferon or pegylated interferon with or without ribavirin, or sofosbuvir plus ribavirin with or without pegylated interferon. Oral glecaprevir (300 mg) coformulated with pibrentasvir (120 mg) was administered once daily for 12 weeks. The primary efficacy endpoint was sustained virological response at post-treatment week 12 (HCV RNA |
| Databáze: | OpenAIRE |
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