Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study
Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, DeJesus E, Pearlman B, Rabinovitz M, Gitlin N, Lim JK, Pockros PJ, Scott JD, Fevery B, Lambrecht T, Ouwerkerk-Mahadevan S, Callewaert K, Symonds WT, Picchio G, Lindsay KL, Beumont M, Jacobson IM. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. The Lancet 2014, 384: 1756-1765. PMID: 25078309, DOI: 10.1016/s0140-6736(14)61036-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntiviral AgentsConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationFemaleFollow-Up StudiesGenotypeHepacivirusHepatitis C, ChronicHeterocyclic Compounds, 3-RingHumansInterferon-alphaLiver Function TestsMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsReference ValuesRibavirinRisk AssessmentSeverity of Illness IndexSimeprevirSofosbuvirSulfonamidesTreatment OutcomeUridine MonophosphateConceptsTreatment-naive patientsAdverse eventsGroup 1Chronic HCV genotype 1 infectionHepatitis C virus genotype 1Grade 4 adverse eventsVirological response 12 weeksHCV genotype 1 infectionHepatitis C virus infectionC virus genotype 1C virus infectionCommon adverse eventsInterferon-free regimensSerious adverse eventsGenotype 1 infectionPrimary endpointWeek 12Study treatmentChronic infectionCohort 1Genotype 1Grade 3Virus infectionSafety dataAmylase concentration