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
2016
Hepatic Safety of Buprenorphine in HIV-Infected and Uninfected Patients With Opioid Use Disorder: The Role of HCV-Infection
Tetrault JM, Tate JP, Edelman EJ, Gordon AJ, Re V, Lim JK, Rimland D, Goulet J, Crystal S, Gaither JR, Gibert CL, Rodriguez-Barradas MC, Fiellin LE, Bryant K, Justice AC, Fiellin DA. Hepatic Safety of Buprenorphine in HIV-Infected and Uninfected Patients With Opioid Use Disorder: The Role of HCV-Infection. Journal Of Substance Use And Addiction Treatment 2016, 68: 62-67. PMID: 27431048, PMCID: PMC4976086, DOI: 10.1016/j.jsat.2016.06.002.Peer-Reviewed Original ResearchConceptsLiver enzyme elevationAlcohol use disorderUninfected patientsHepatotoxic medicationsHCV infectionUse disordersComposite endpointLiver injuryHIV/HCV co-infected patientsHCV co-infected patientsHIV/HCV statusPre-existing liver injuryCo-infected patientsCohort of HIVHepatitis C infectionHIV/HCVOpioid use disorderRisk of hepatotoxicityHCV statusHepatic safetyMedian ALTC infectionChart reviewEnzyme elevationHIV infection
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