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
2015
Entecavir safety and effectiveness in a national cohort of treatment‐naïve chronic hepatitis B patients in the US – the ENUMERATE study
Ahn J, Lee HM, Lim JK, Pan CQ, Nguyen MH, Kim W, Mannalithara A, Trinh H, Chu D, Tran T, Min A, Do S, Te H, Reddy KR, Lok AS. Entecavir safety and effectiveness in a national cohort of treatment‐naïve chronic hepatitis B patients in the US – the ENUMERATE study. Alimentary Pharmacology & Therapeutics 2015, 43: 134-144. PMID: 26510638, PMCID: PMC4926997, DOI: 10.1111/apt.13440.Peer-Reviewed Original ResearchConceptsALT normalisationAdverse eventsHBV DNAHBeAg(-) patientsHBV patientsTreatment-naïve chronic hepatitis B patientsChronic hepatitis B patientsFive-year cumulative probabilityHBsAg loss/seroconversionLog 10 IU/Hepatitis B virus infectionEffectiveness of entecavirMedian HBV DNAUndetectable HBV DNAHepatitis B patientsB virus infectionAbnormal ALTEntecavir treatmentETV treatmentHBeAg lossHBsAg lossHepatic decompensationB patientsCohort studyMedian duration
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