0000000000217071

AUTHOR

Fred Poordad

showing 4 related works from this author

Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1–6 Hepatitis C Virus Infections and Compensated Liver Disease

2019

Background: Untreated, chronic hepatitis C virus (HCV) infection may lead to progressive liver damage, which can be mitigated by successful treatment. This integrated analysis reports the safety, efficacy, and pharmacokinetics (PK) of the ribavirin-free, direct-acting, antiviral, fixed-dose combination of glecaprevir/pibrentasvir (G/P) in patients with chronic HCV genotype 1-6 infections and compensated liver disease, including patients with chronic kidney disease stages 4 or 5 (CKD 4/5). Methods: Data from 9 Phase II and III clinical trials, assessing the efficacy and safety of G/P treatment for 8-16 weeks, were included. The presence of cirrhosis was determined at screening using a liver …

CyclopropanesLiver CirrhosisMaleAminoisobutyric AcidsPyrrolidinesCirrhosisSustained Virologic Responseadverse eventHepacivirusmedicine.disease_causeGastroenterology0302 clinical medicine030212 general & internal medicinePathologie maladies infectieusesSulfonamidesmedicine.diagnostic_testLiver DiseasesPibrentasvirMicrobiologie et protistologie [entomologiephytoparasitolog.]Infectious DiseasesData Interpretation StatisticalLiver biopsyglecaprevir/pibrentasvirHCVDrug Therapy CombinationFemale030211 gastroenterology & hepatologycompensated cirrhosisMicrobiologie et protistologie [parasitologie hum. et anim.]Microbiology (medical)medicine.medical_specialtyGenotypeProlineLactams MacrocyclicHepatitis C virusAntiviral Agents03 medical and health sciencesLeucineQuinoxalinesInternal medicinemedicineHumansAdverse effectAgedbusiness.industryGlecaprevirHepatitis C Chronicmedicine.diseaseBenzimidazolesMicrobiologie et protistologie [bacteriol.virolog.mycolog.]Transient elastographybusinesschronic kidney diseaseKidney diseaseClinical Infectious Diseases
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Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-alpha and -delta, Induces Resolution of Nonalcoholic Steatohepatitis Withou…

2016

International audience; BACKGROUND & AIMS: Elafibranor is an agonist of the peroxisome proliferator-activated receptor-α and peroxisome proliferator-activated receptor-δ. Elafibranor improves insulin sensitivity, glucose homeostasis, and lipid metabolism and reduces inflammation. We assessed the safety and efficacy of elafibranor in an international, randomized, double-blind placebo-controlled trial of patients with nonalcoholic steatohepatitis (NASH).METHODS: Patients with NASH without cirrhosis were randomly assigned to groups given elafibranor 80 mg (n = 93), elafibranor 120 mg (n = 91), or placebo (n = 92) each day for 52 weeks at sites in Europe and the United States. Clinical and …

0301 basic medicineLiver CirrhosisMaleTime FactorsIntention to Treat Analysi[SDV]Life Sciences [q-bio]BiopsyPLACEBO-CONTROLLED TRIALTHERAPYGastroenterologySeverity of Illness IndexChalcone0302 clinical medicineChalconesNon-alcoholic Fatty Liver DiseaseGastrointestinal AgentNonalcoholic fatty liver diseasePropionateMedicine and Health SciencesOdds RatioMedicineGlucose homeostasisVITAMIN-Eeducation.field_of_studyGastrointestinal agentFatty liverRemission InductionGastroenterologyMiddle Aged3. Good healthIntention to Treat AnalysisPPARDEuropeTreatment OutcomeLiverACIDPIOGLITAZONE030211 gastroenterology & hepatologyFemalePPARAHumanSignal TransductionAdultCLINICAL-OUTCOMESmedicine.medical_specialtyLogistic ModelTime FactorLiver CirrhosiPopulationfatty liver; NAFLD; PPARA; PPARD; Adult; Biomarkers; Biopsy; Chalcones; Double-Blind Method; Europe; Female; Gastrointestinal Agents; Humans; Intention to Treat Analysis; Liver; Liver Cirrhosis; Logistic Models; Male; Middle Aged; Non-alcoholic Fatty Liver Disease; Odds Ratio; PPAR alpha; PPAR gamma; Propionates; Remission Induction; Severity of Illness Index; Signal Transduction; Time Factors; Treatment Outcome; United States; GastroenterologyPlacebo03 medical and health sciencesDouble-Blind MethodGastrointestinal AgentsInternal medicineNAFLDHumansPPAR alphaeducationFATTY LIVER-DISEASEfatty liverHepatologybusiness.industryBiomarkerAMERICAN ASSOCIATIONOdds ratiomedicine.diseaseConfidence intervalUnited StatesPPAR gammaRenal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11]030104 developmental biologyEndocrinologyLogistic ModelsHuman medicinePropionatesbusinessBiomarkers
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Effects of Ribavirin Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A…

2013

International audience; Background & AimsTreatment of hepatitis C virus (HCV) infection with boceprevir, peginterferon, and ribavirin can lead to anemia, which has been managed by reducing ribavirin dose and/or erythropoietin therapy. We assessed the effects of these anemia management strategies on rates of sustained virologic response (SVR) and safety.MethodsPatients (n = 687) received 4 weeks of peginterferon and ribavirin followed by 24 or 44 weeks of boceprevir (800 mg, 3 times each day) plus peginterferon and ribavirin. Patients who became anemic (levels of hemoglobin approximately ≤10 g/dL) during the study treatment period (n = 500) were assigned to groups that were managed by ribavi…

Maleviruses[SDV]Life Sciences [q-bio]Hepacivirusmedicine.disease_causeGastroenterologyPolyethylene Glycolslaw.inventionchemistry.chemical_compound0302 clinical medicineRandomized controlled triallawErythropoiesisIncidenceGastroenterologyDisease Managementvirus diseasesAnemiaMiddle AgedRecombinant Proteins3. Good healthTreatment Outcome030220 oncology & carcinogenesisDrug Therapy CombinationFemale030211 gastroenterology & hepatologyAlgorithmsmedicine.drugmedicine.medical_specialtyGenotypeProlineSide effectAnemiaHepatitis C virusInterferon alpha-2Antiviral Agents03 medical and health sciencesInternal medicineBoceprevirRibavirinmedicineHumansErythropoietinDAADose-Response Relationship DrugHepatologybusiness.industryRibavirinInterferon-alphaHepatitis C Chronicbiochemical phenomena metabolism and nutritionmedicine.diseasedigestive system diseasesSide EffectLogistic ModelschemistryErythropoietinImmunologyHemoglobinbusinessEPO
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Factors that predict response of patients with hepatitis C virus infection to boceprevir

2012

Background & Aims Little is known about factors associated with a sustained virologic response (SVR) among patients with hepatitis C virus (HCV) infection to treatment with protease inhibitors. Methods Previously untreated patients (from the Serine Protease Inhibitor Therapy 2 [SPRINT-2] trial) and those who did not respond to prior therapy (from the Retreatment with HCV Serine Protease Inhibitor Boceprevir and PegIntron/Rebetol 2 [RESPOND-2] trial) received either a combination of peginterferon and ribavirin for 48 weeks or boceprevir, peginterferon, and ribavirin (triple therapy) after 4 weeks of peginterferon and ribavirin (total treatment duration, 28–48 wk). A good response to interfer…

MaleCirrhosisMESH: Logistic ModelsHepacivirusMESH: Risk AssessmentGastroenterologyPolyethylene GlycolsMESH: Recombinant ProteinsMESH: Genotype0302 clinical medicineOdds RatioProspective StudiesMESH: Treatment OutcomeResponse to Therapy0303 health sciencesMESH: Polymorphism Single NucleotideGastroenterologyvirus diseases3. Good healthMESH: RNA ViralHCVDrug Therapy Combination030211 gastroenterology & hepatologyClinical Trial; Genetic; Prognostic Factors; Response to Therapy; Adult; Antiviral Agents; Biomarkers; Canada; Drug Therapy Combination; Europe; Female; Genotype; Hepacivirus; Hepatitis C; Humans; Interferon-alpha; Interleukins; Logistic Models; Male; Multivariate Analysis; Odds Ratio; Phenotype; Polyethylene Glycols; Polymorphism Single Nucleotide; Proline; Prospective Studies; RNA Viral; Recombinant Proteins; Ribavirin; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States; Viral Load; GastroenterologyViral loadmedicine.medical_specialtyMESH: InterleukinsGenotypeProlineInterferon alpha-2MESH: PhenotypeAntiviral AgentsRisk Assessment03 medical and health sciencesDrug TherapyGeneticMESH: RibavirinMESH: CanadaBoceprevirHumansPolymorphismMESH: ProlineMESH: HumansPrognostic FactorsInterleukinsMESH: AdultOdds ratiomedicine.diseaseUnited Statesdigestive system diseasesClinical trialLogistic ModelschemistryImmunologyMESH: FemaleBiomarkersTime Factorsmedicine.disease_causechemistry.chemical_compoundRisk FactorsInterferonMESH: Risk FactorsMESH: HepacivirusViralSingle NucleotideViral LoadHepatitis CClinical TrialRecombinant ProteinsEuropePhenotypeTreatment OutcomeCombinationRNA ViralFemaleMESH: Interferon-alphaMESH: Viral Loadmedicine.drugAdultMESH: Antiviral AgentsCanadaHepatitis C virusPolymorphism Single NucleotideMESH: Multivariate AnalysisInternal medicineRibavirinmedicineMESH: United States030304 developmental biologyMESH: Hepatitis CHepatologybusiness.industryRibavirinMESH: Time FactorsMESH: Biological MarkersInterferon-alpha[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and GastroenterologyMESH: Prospective StudiesMESH: MaleMESH: Odds RatioMESH: Drug Therapy CombinationMESH: Polyethylene GlycolsMultivariate AnalysisRNAInterferonsMESH: Europebusiness
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