Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection
| Autor: | Marc, Bourlière, Stuart C, Gordon, Steven L, Flamm, Curtis L, Cooper, Alnoor, Ramji, Myron, Tong, Natarajan, Ravendhran, John M, Vierling, Tram T, Tran, Stephen, Pianko, Meena B, Bansal, Victor, de Lédinghen, Robert H, Hyland, Luisa M, Stamm, Hadas, Dvory-Sobol, Evguenia, Svarovskaia, Jie, Zhang, K C, Huang, G Mani, Subramanian, Diana M, Brainard, John G, McHutchison, Elizabeth C, Verna, Peter, Buggisch, Charles S, Landis, Ziad H, Younes, Michael P, Curry, Simone I, Strasser, Eugene R, Schiff, K Rajender, Reddy, Michael P, Manns, Kris V, Kowdley, Stefan, Zeuzem, Shyamasundaran, Kottilil |
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| Přispěvatelé: | Service d'hépatologie et de gastroentérologie [Hôpital Saint-Joseph - Marseille], Aix Marseille Université (AMU)-Hôpital Saint-Joseph [Marseille], Henry Ford Health System, Feinberg School of Medicine, Northwestern University [Evanston], Baylor College of Medicine (BCM), Baylor University, Monash Medical Centre [Clayton, Australia], Département d'hépatologie et de gastroentérologie [CHU Bordeaux], Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Gilead Sciences, Inc. [Foster City, CA, USA], Institute for Interdisciplinary Medicine Hamburg, University of Washington [Seattle], Gastro One, Miami University [Ohio] (MU), Pennsylvania State University (Penn State), Penn State System, Dept. of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School [Hannover] (MHH), Virginia Mason Medical Center, Saarland University [Saarbrücken], POLARIS-1 Investigators, POLARIS-4 Investigators |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Cyclopropanes
Liver Cirrhosis Male 0301 basic medicine Aminoisobutyric Acids Sofosbuvir Hepacivirus Viral Nonstructural Proteins medicine.disease_cause Gastroenterology 0302 clinical medicine ComputingMilieux_MISCELLANEOUS Aged 80 and over Sulfonamides virus diseases General Medicine Hepatitis C Middle Aged Pibrentasvir 3. Good health Drug Combinations Female 030211 gastroenterology & hepatology medicine.drug Adult medicine.medical_specialty Macrocyclic Compounds Genotype Proline Lactams Macrocyclic Voxilaprevir Hepatitis C virus Antiviral Agents Heterocyclic Compounds 4 or More Rings Sofosbuvir/velpatasvir 03 medical and health sciences Leucine Quinoxalines Internal medicine Drug Resistance Viral medicine Humans Protease Inhibitors Aged business.industry Glecaprevir medicine.disease Virology digestive system diseases Regimen 030104 developmental biology Carbamates business [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Zdroj: | New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2017, 376 (22), pp.2134-2146. ⟨10.1056/NEJMoa1613512⟩ |
| ISSN: | 0260-7735 0028-4793 1533-4406 |
| DOI: | 10.1056/NEJMoa1613512⟩ |
| Popis: | Patients who are chronically infected with hepatitis C virus (HCV) and who do not have a sustained virologic response after treatment with regimens containing direct-acting antiviral agents (DAAs) have limited retreatment options.We conducted two phase 3 trials involving patients who had been previously treated with a DAA-containing regimen. In POLARIS-1, patients with HCV genotype 1 infection who had previously received a regimen containing an NS5A inhibitor were randomly assigned in a 1:1 ratio to receive either the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the protease inhibitor voxilaprevir (150 patients) or matching placebo (150 patients) once daily for 12 weeks. Patients who were infected with HCV of other genotypes (114 patients) were enrolled in the sofosbuvir-velpatasvir-voxilaprevir group. In POLARIS-4, patients with HCV genotype 1, 2, or 3 infection who had previously received a DAA regimen but not an NS5A inhibitor were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir-voxilaprevir (163 patients) or sofosbuvir-velpatasvir (151 patients) for 12 weeks. An additional 19 patients with HCV genotype 4 infection were enrolled in the sofosbuvir-velpatasvir-voxilaprevir group.In the three active-treatment groups, 46% of the patients had compensated cirrhosis. In POLARIS-1, the rate of sustained virologic response was 96% with sofosbuvir-velpatasvir-voxilaprevir, as compared with 0% with placebo. In POLARIS-4, the rate of response was 98% with sofosbuvir-velpatasvir-voxilaprevir and 90% with sofosbuvir-velpatasvir. The most common adverse events were headache, fatigue, diarrhea, and nausea. In the active-treatment groups in both trials, the percentage of patients who discontinued treatment owing to adverse events was 1% or lower.Sofosbuvir-velpatasvir-voxilaprevir taken for 12 weeks provided high rates of sustained virologic response among patients across HCV genotypes in whom treatment with a DAA regimen had previously failed. (Funded by Gilead Sciences; POLARIS-1 and POLARIS-4 ClinicalTrials.gov numbers, NCT02607735 and NCT02639247 .). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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