2018
Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis
Lim JK, Liapakis AM, Shiffman ML, Lok AS, Zeuzem S, Terrault NA, Park JS, Landis CS, Hassan M, Gallant J, Kuo A, Pockros PJ, Vainorius M, Akushevich L, Michael L, Fried MW, Nelson DR, Ben-Ari Z, Group H. Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis. Clinical Gastroenterology And Hepatology 2018, 16: 1811-1819.e4. PMID: 29306043, PMCID: PMC6034985, DOI: 10.1016/j.cgh.2017.12.037.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntiviral AgentsBenzimidazolesDrug Therapy, CombinationDrug-Related Side Effects and Adverse ReactionsEuropeFemaleFluorenesGenotypeHepacivirusHepatitis C, ChronicHumansLiver CirrhosisLongitudinal StudiesMaleMiddle AgedNorth AmericaProspective StudiesRibavirinSofosbuvirSustained Virologic ResponseTreatment OutcomeYoung AdultConceptsTreatment-experienced patientsGenotype 1 HCV infectionAddition of ribavirinHCV infectionGenotype 1 hepatitis C virus infectionChronic genotype 1 HCV infectionHepatitis C virus infectionHCV-TARGET studyRate of SVR12Treatment-experienced adultsC virus infectionPrimary efficacy endpointGenotype 1 infectionObservational cohort studyWeeks of treatmentEnd of treatmentRoutine clinical practiceSofosbuvir treatmentVirologic outcomesVirologic responseEfficacy endpointHepatitis CProtocol populationAdverse eventsCohort study
2017
Medicaid Reimbursement for Oral Direct Antiviral Agents for the Treatment of Chronic Hepatitis C
Ooka K, Connolly JJ, Lim JK. Medicaid Reimbursement for Oral Direct Antiviral Agents for the Treatment of Chronic Hepatitis C. The American Journal Of Gastroenterology 2017, 112: 828. PMID: 28374816, DOI: 10.1038/ajg.2017.87.Peer-Reviewed Original Research
2016
Optimal timing for hepatitis C therapy in US patients eligible for liver transplantation: a cost‐effectiveness analysis
Njei B, McCarty TR, Fortune BE, Lim JK. Optimal timing for hepatitis C therapy in US patients eligible for liver transplantation: a cost‐effectiveness analysis. Alimentary Pharmacology & Therapeutics 2016, 44: 1090-1101. PMID: 27640785, DOI: 10.1111/apt.13798.Peer-Reviewed Original ResearchMeSH KeywordsAntiviral AgentsBenzimidazolesCarcinoma, HepatocellularCost-Benefit AnalysisDisease ProgressionDrug Therapy, CombinationFluorenesGenotypeHepacivirusHepatitis CHumansLiver CirrhosisLiver NeoplasmsLiver TransplantationNeoplasm Recurrence, LocalQuality-Adjusted Life YearsRibavirinSofosbuvirUnited StatesConceptsHepatitis C virusLiver transplantationTime of transplantHCV recurrencePost-LTCost-effective strategyTreatment of HCVEnd-stage liver disease (MELD) scoreOptimal timingDonor LT recipientsLiver Disease scoreHCV genotype 1Hepatitis C therapyMarkov state transition modelHepatocellular carcinoma casesBase-case analysisSeparate treatment strategiesCost-effectiveness analysisAllograft failureDecompensated diseaseOngoing viraemiaPre-LTHCV treatmentLT recipientsMELD score
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