2015
Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade
Do A, Mittal Y, Liapakis A, Cohen E, Chau H, Bertuccio C, Sapir D, Wright J, Eggers C, Drozd K, Ciarleglio M, Deng Y, Lim JK. Drug Authorization for Sofosbuvir/Ledipasvir (Harvoni) for Chronic HCV Infection in a Real-World Cohort: A New Barrier in the HCV Care Cascade. PLOS ONE 2015, 10: e0135645. PMID: 26312999, PMCID: PMC4552165, DOI: 10.1371/journal.pone.0135645.Peer-Reviewed Original ResearchConceptsSofosbuvir/ledipasvirViral loadMedicaid coverageChild-Pugh class B diseaseInitial approvalEnd-stage liver disease (MELD) scoreStage liver disease scoreChronic HCV infectionClass B diseaseDrug authorizationHCV care cascadeSOF/LEDAdvanced liver diseaseBaseline viral loadHepatitis C infectionLiver Disease scoreRetrospective chart reviewHigh viral loadSignificant predictorsHigher likelihoodMedicare/MedicaidSOF/C infectionCare cascadeHCV infection
2014
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