Search results for "Direct-acting antivirals"

showing 10 items of 10 documents

Resistance analysis and treatment outcomes in hepatitis C virus genotype 3-infected patients within the Italian network VIRONET-C

2021

Aim: This study aimed to investigate the role of resistance-associated substitutions (RASs) to direct-acting-antivirals (DAAs) in HCV genotype 3 (GT3). Methods: Within the Italian VIRONET-C network, a total of 539 GT3-infected patients (417 DAA-naïve and 135 DAA-failures, of them, 13 at both baseline and failure) were analysed. Sanger sequencing of NS3/NS5A/NS5B was performed following home-made protocols. Results: The majority of patients were male (79.4%), 91.4% were injection drug users, 49.3% were cirrhotic and 13.9% were HIV co-infected. Phylogenetic analysis classified sequences as GT3a-b-g-h (98%-0.4%-0.2%-1.2%) respectively. Overall, 135 patients failed a DAA regimen: sofosbuvir (SO…

MaleSofosbuvirSustained Virologic ResponseDrug ResistanceHepacivirusViral Nonstructural ProteinsGastroenterologySettore MED/06direct-acting antivirals; failure; genotype 3; HCV; resistancechemistry.chemical_compound0302 clinical medicineMedicineViralChronicPhylogenyDasabuvirdirect-acting antivirals; failure; genotype 3; hcv; resistancevirus diseasesHepatitis CPibrentasvirfailureItaly030220 oncology & carcinogenesisHCVCombinationDrug Therapy Combination030211 gastroenterology & hepatologyFemalemedicine.drugLedipasvirmedicine.medical_specialtyDaclatasvirGenotypedirect-acting antivirals; failure; genotype 3; HCV; resistance; Antiviral Agents; Drug Resistance Viral; Drug Therapy Combination; Female; Genotype; Humans; Italy; Male; Phylogeny; Sofosbuvir; Sustained Virologic Response; Viral Nonstructural Proteins; Hepacivirus; Hepatitis C ChronicAntiviral Agentsresistance03 medical and health sciencesDrug TherapyInternal medicineDrug Resistance ViralHumansgenotype 3direct-acting antiviralsAntiviral Agentdirect-acting antiviralHepaciviruHepatologybusiness.industryViral Nonstructural ProteinGlecaprevirHepatitis C ChronicHCV; direct acting antivirals; failure; genotype 3; resistanceRegimenchemistryParitaprevirSofosbuvirbusinessHepatitis C Chronic.
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Optimizing patient referral and center capacity in the management of chronic hepatitis C: Lessons from the Italian experience

2019

Abstract Aims In 2017 the Italian Drug Agency (Agenzia Italiana del Farmaco, AIFA) revised the criteria for access to therapy for patients with chronic hepatitis C as part of a three-year plan to eradicate HCV. We conducted a Delphi study to determine strategies to identify and treat patients with HCV and to develop through a shared pathway, a model to manage patient referral and optimize prescription center capacity with the overall aim of increasing access to therapy. Methods The process took place in two phases – Phase I (January 2017), before the criteria for treatment of HCV were revised and Phase II (May 2017) when AIFA developed a framework for the eradication of HCV infection in Ita…

AdultMalemedicine.medical_specialtyDelphi TechniqueGeneral PracticeDelphi methodDelphi methodAntiviral AgentsDrug PrescriptionsHealth Services AccessibilityMedication AdherencemodelsPatient referralTreatment targetsChronic hepatitismedicineHumansdelphi method; direct-acting antivirals; disease eradication; hepatitis c virus; adult; aged; antiviral agents; disease eradication; drug prescriptions; female; general practice; health care surveys; health services accessibility; hepatitis c chronic; humans; italy; male; medication adherence; middle aged; models theoretical; quality Improvement; referral and consultation; delphi techniquehepatitis cMedical prescriptiontheoreticalReferral and Consultationdirect-acting antiviralsAgedHepatitisdirect-acting antiviralHepatologyDisease Eradicationbusiness.industryHepatitis C virusGastroenterologyDrug agencyHepatitis C ChronicMiddle AgedModels Theoreticalmedicine.diseaseQuality ImprovementchronicItalyHealth Care SurveysFamily medicineFemaledisease eradicationbusiness
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Ethical assessment of hepatitis C virus treatment: The lesson from first generation protease inhibitors

2015

Abstract Since chronic hepatitis C has mostly become curable, issues concerning choice and allocation of treatment are of major concern. We assessed the foremost ethical issues in hepatitis C virus therapy with 1st generation protease inhibitors using the personalist ethical framework within the health technology assessment methodology. Our aim was to identify values at stake/in conflict and to support both the physicians’ choices in hepatitis C therapy and social (macro-) allocation decision-making. The ethical assessment indicates that: (1) safety/effectiveness profile of treatment is guaranteed if its use is restricted to the patients subgroups who may benefit from it; (2) patients shoul…

AdultMalehepatitis C virusmedicine.medical_specialtyPathologyCost-Benefit AnalysisHepatitis C virusDecision MakingProtease InhibitoreducationAlternative medicineHepacivirusDirect-acting antiviralmedicine.disease_causeAntiviral AgentsSettore MED/02 - Storia Della MedicinaResource (project management)medicineHumansProtease InhibitorsEthics MedicalEthichealth technology assessmentCost-Benefit AnalysiDeferralIntensive care medicineEthical frameworkdirect-acting antiviralsAgedAntiviral AgentSettore MED/12 - GastroenterologiaHepaciviruHepatologybusiness.industryGastroenterologyHealth technologyHepatitis CMiddle AgedSettore MED/43 - MEDICINA LEGALEmedicine.diseaseHepatitis CethicsFirst generationDrug Therapy CombinationFemaleHepatitis C virubusinessHuman
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Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapy

2021

Background & Aims There are limited data on patients with chronic HCV infection in whom combination voxilaprevir (VOX), velpatasvir (VEL), sofosbuvir (SOF) retreatment fails. Thus, we aimed to assess treatment failure and rescue treatment options in these patients. Methods Samples from 40 patients with HCV genotypes (GT) 1-4 in whom VOX/VEL/SOF retreatment failed were collected within the European Resistance Study Group. Population-based resistance analyses were conducted and clinical parameters and retreatment efficacies were evaluated retrospectively in 22 patients. Results Most VOX/VEL/SOF failure patients were infected with HCV GT3a (n = 18, 45%) or GT1a (n = 11, 28%) and had cirrhosis …

0301 basic medicineHepatitis C Virusmedicine.medical_specialtySofosbuvirVoxilaprevirPopulationresistance-associated substitutionsDirect-acting antiviralVoxilaprevir/velpatasvir/sofosbuvir.GastroenterologySettore MED/07Telaprevir03 medical and health scienceschemistry.chemical_compound0302 clinical medicineVoxilaprevir/Velpatasvir/SofosbuvirInternal medicineBoceprevirRescue therapymedicineResistance-associated substitutioneducationdirect-acting antiviralsDAAeducation.field_of_studyHepatologybusiness.industryvirus diseasesGlecaprevirDAA; HCV; Hepatitis C Virus; Voxilaprevir/Velpatasvir/Sofosbuvir; direct-acting antivirals; rescue therapy; resistance-associated substitutionsdigestive system diseasesPibrentasvirRegimen030104 developmental biologychemistryHCV030211 gastroenterology & hepatologyHepatitis C virubusinessmedicine.drugJournal of Hepatology
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Optimising management of patients with hepatitis C virus in the age of direct-acting antivirals: results of a Delphi consensus.

2018

OBJECTIVE: To optimize the management of patients with chronic hepatitis C virus (HCV). MATERIALS AND METHODS: We developed two questionnaires to determine Italian healthcare professionals’ opinions on the overall management of HCV chronic liver disease and the use of direct-acting antivirals (DAAs) in the treatment of HCV. A Delphi consensus method using the RAND/UCLA appropriateness method was used to determine opinions of an expert panel (EP) of specialists. RESULTS: Overall 443 physicians from 167 Italian centres completed the two questionnaires. The EP confirmed the importance of collaboration with general practitioners (GPs) and HCV testing in high-risk groups, but did not agree on tr…

AdultAged 80 and overLiver CirrhosisMaleConsensusGenotypedelphi methodhepatitis c virus; direct-acting antivirals; delphi method; consensus; adult; aged 80 and over; antiviral agents; consensus; elasticity imaging techniques; female; genotype; hepacivirus; hepatitis c chronic; humans; liver cirrhosis; male; middle aged; surveys and questionnairesHepacivirushepatitis c virusHepatitis C ChronicMiddle AgedAntiviral AgentschronicagedSurveys and QuestionnairesHCV80 and overElasticity Imaging TechniquesHumansFemalehepatitis cdirect-acting antiviralsEuropean review for medical and pharmacological sciences
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Executive summary of the 2018 KDIGO Hepatitis C in CKD Guideline: welcoming advances in evaluation and management

2018

Infection with the hepatitis C virus (HCV) has adverse liver, kidney, and cardiovascular consequences in patients with chronic kidney disease (CKD), including those on dialysis therapy and in those with a kidney transplant. Since the publication of the original Kidney Disease: Improving Global Outcomes (KDIGO) HCV Guideline in 2008, major advances in HCV management, particularly with the advent of direct-acting antiviral therapies, have now made the cure of HCV possible in CKD patients. In addition, diagnostic techniques have evolved to enable the noninvasive diagnosis of liver fibrosis. Therefore, the Work Group undertook a comprehensive review and update of the KDIGO HCV in CKD Guideline.…

Liver Cirrhosishepatitis C virusmedicine.medical_treatment030232 urology & nephrologylcsh:RC870-923medicine.disease_causecryoglobulinemialiver testingantivirals0302 clinical medicinesystematic reviewMedicineInfection controlKidney transplantationKDIGOCross Infectionhemodialysisnosocomial transmissionvirus diseasesHepatitis CHepatitis Cinfection controlNephrologyPractice Guidelines as Topic030211 gastroenterology & hepatologyHemodialysisguidelineGlomerular Filtration Ratemedicine.medical_specialtyHepatitis C viruskidney transplantationAntiviral Agents03 medical and health sciencesRenal DialysisDisease Transmission InfectiousHumansRenal Insufficiency ChronicIntensive care medicineglomerular diseasesdirect-acting antiviralsDialysisbusiness.industryscreeningGuidelinelcsh:Diseases of the genitourinary system. Urologymedicine.diseaseKidney Transplantationdialysisbusinesschronic kidney diseaseKidney diseaseKidney International
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HCV cirrhosis at the edge of decompensation: Will paritaprevir with ritonavir, ombitasvir, dasabuvir, and ribavirin solve the need for treatment?

2014

BACKGROUND: The interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r) and the NS5A inhibitor ombitasvir (also known as ABT-267) plus the nonnucleoside polymerase inhibitor dasabuvir (also known as ABT-333) and ribavirin has shown efficacy against the hepatitis C virus (HCV) in patients with HCV genotype 1 infection. In this phase 3 trial, we evaluated this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis. METHODS: In this multicenter, randomized, double-blind, placebocontrolled trial, we assigned previously untreated patients with HCV genotype 1 infection, in a 3:1 ratio, to an active regimen consisting of a single-ta…

Malemedicine.medical_specialtyMacrocyclic CompoundsDirect-acting antiviralsLiver functionGastroenterologyAntiviral Agents03 medical and health scienceschemistry.chemical_compound0302 clinical medicinePegylated interferonInternal medicineRibavirinmedicineHumansAnilidesPortal hypertensionUracilAdvanced liver diseaseSulfonamidesDasabuvirRitonavirHepatologybusiness.industryRibavirinvirus diseasesHepatitis C ChronicVirologyOmbitasvir3. Good healthRegimenchemistryParitaprevir030220 oncology & carcinogenesis030211 gastroenterology & hepatologyRitonavirFemaleLiver functionCarbamatesbusinessmedicine.drugJournal of Hepatology
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Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting

2018

International audience; BACKGROUNDS & AIMS: Treating patients with decompensated cirrhosis with direct-acting antiviral (DAA) therapy while on the waiting list for liver transplantation results in substantial improvement of liver function allowing 1 in 4 patients to be removed from the waiting list or delisted, as reported in a previous study promoted by the European Liver and Intestine Transplant Association (ELITA). The aim of this study was to report on clinical outcomes of delisted patients, including mortality risk, hepatocellular carcinoma development and clinical decompensation requiring relisting. METHODS: One hundred and forty-two HCV-positive patients on the liver transplant waiti…

MaleLiver Cirrhosismedicine.medical_specialtyCirrhosisCarcinoma HepatocellularWaiting Listsmedicine.medical_treatment[SDV]Life Sciences [q-bio]Liver transplantationSeverity of Illness IndexAntiviral Agents03 medical and health sciences0302 clinical medicineInternal medicineAscitesmedicineHumansDecompensationChronicdirect-acting antiviralsdirect-acting antiviralHepatologyliver transplantationbusiness.industrydelistingcirrhosisCarcinomaLiver NeoplasmsHepatocellularHepatitis CTransplant Waiting ListHepatitis C ChronicMiddle Agedmedicine.diseaseHepatitis C3. Good healthItaly030220 oncology & carcinogenesisHepatocellular carcinoma030211 gastroenterology & hepatologyFemaleLiver functionmedicine.symptombusinesscirrhosi
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Multiclass HCV resistance to direct-acting antiviral failure in real-life patients advocates for tailored second-line therapies

2017

Background & Aims: Despite the excellent efficacy of direct-acting antivirals (DAA) reported in clinical trials, virological failures can occur, often associated with the development of resistance-associated substitutions (RASs). This study aimed to characterize the presence of clinically relevant RASs to all classes in real-life DAA failures. Methods: Of the 200 virological failures that were analyzed in 197 DAA-treated patients, 89 with pegylated-interferon+ribavirin (PegIFN+RBV) and 111 without (HCV-1a/1b/1g/2/3/4=58/83/1/6/24/25; 56.8% treatment experienced; 65.5% cirrhotic) were observed. Sanger sequencing of NS3/NS5A/NS5B was performed by home-made protocols, at failure (N= 200) and w…

Male0301 basic medicinehepatitis C virusSustained Virologic ResponseSofosbuvirHepacivirusDrug ResistanceHepacivirusresistance-associated substitutionsViral Nonstructural ProteinsVARIANTSNS5Amedicine.disease_causeGastroenterologychemistry.chemical_compound0302 clinical medicineRecurrenceINFECTIONantiviral therapyMedicinehepatitis C viruViralTreatment FailureChronicantiviral therapy; direct-acting antivirals; hepatitis C virus; resistance test; resistance-associated substitutions; hepatologybiologyGENOTYPE 1virus diseasesMiddle Agedantiviral therapy; direct-acting antivirals; hepatitis C virus; resistance test; resistance-associated substitutionsSettore MED/07 - Microbiologia e Microbiologia ClinicaHepatitis CItalyCombinationInterferonDrug Therapy CombinationFemale030211 gastroenterology & hepatologyAuthor Keywords:antiviral therapyRIBAVIRINSequence AnalysisHumanmedicine.drugmedicine.medical_specialtyDaclatasvirGenotypeHepatitis C virusAntiviral AgentsLONG-TERM PERSISTENCEDACLATASVIR03 medical and health sciencesDrug Therapyantiviral therapy; direct-acting antivirals; hepatitis C virus; resistance test; resistance-associated substitutions; Aged; Antiviral Agents; Drug Resistance Viral; Drug Therapy Combination; Female; Genotype; Hepacivirus; Hepatitis C Chronic; Humans; Interferons; Italy; Male; Middle Aged; Mutation; Recurrence; Ribavirin; Sequence Analysis DNA; Sofosbuvir; Sustained Virologic Response; Treatment Failure; Viral Nonstructural Proteins; HepatologyTREATMENT-NAIVEInternal medicineDrug Resistance ViralRibavirinHumansNS5Aresistance testdirect-acting antiviralsAgedAntiviral Agentresistance-associated substitutiondirect-acting antiviralHepaciviruHepatologyresistance test KeyWords Plus:HEPATITIS-C VIRUSbusiness.industryRibavirinViral Nonstructural ProteinSequence Analysis DNADNAHepatitis C ChronicHepatologybiology.organism_classificationClinical trial030104 developmental biologySOFOSBUVIRchemistrySequence AnalysihepatologyMutationImmunologyInterferonsSofosbuvirbusiness
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Direct-acting antiviral agents and risk of Hepatocellular carcinoma: Critical appraisal of the evidence

2021

Direct-acting antivirals (DAAs) revolutionized the treatment of chronic HCV-related disease achieving high rates of sustained virological response (SVR), even in advanced cirrhosis, with modest contraindications and a low rate of adverse events. However, the risk of hepatocellular carcinoma (HCC) persists due to the underlying chronic liver disease, both in patients with and without history of HCC. Although some initial studies reported a presumptive high risk of HCC development after DAA therapy, more recent observational studies denied this hypothesis. The residual risk for HCC occurrence after HCV eradication seems being progressively reduced with time after SVR. Data on recurrence of HC…

Oncologymedicine.medical_specialtyCarcinoma HepatocellularSustained Virologic ResponseSurvivalHepatocellular carcinomaHepatitis C virusSpecialties of internal medicineDiseaseDirect-acting antiviralsDirect-acting antiviralmedicine.disease_causeChronic liver diseaseAntiviral AgentsRecurrenceInternal medicineCarcinomaHumansMedicineAdverse effectRetrospective StudiesHepatologyHepatitis C virusbusiness.industryLiver NeoplasmsGeneral MedicineHepatitis C Chronicmedicine.diseasedigestive system diseasesResidual riskRC581-951Hepatocellular carcinomaObservational studyHepatitis C virubusinessAnnals of Hepatology
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