Search results for " sofosbuvir"

showing 10 items of 10 documents

Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program

2019

AbstractWe reported the efficacy and safety data for daclatasvir (DCV)-based all-oral antiviral therapy in patients treated in the Italian compassionate-use program. 275 patients were included (202 male-73.5%, mean age: 57.4 years, 62 HIV-coinfected, 94 with recurrence of hepatitis C post-OLT). Forty-nine patients (17.8%) had Child-Pugh B, Genotype(G) distribution was: G1a:72 patients (26.2%), G1b:137 (49.8%); G3:40 (14.5%) and G4:26 (9.5%). Patients received DCV with sofosbuvir(SOF) (n = 221, 129 with ribavirin(RBV) or with simeprevir (SMV) or asunaprevir (ASU) (n = 54, 19 with RBV) for up to 24 weeks. Logistic regression was used to identify baseline characteristics associated with sustai…

0301 basic medicineSimeprevirLiver CirrhosisMalePyrrolidinesSofosbuvirSustained Virologic Responselcsh:MedicineSettore MED/05Gastroenterologychemistry.chemical_compound0302 clinical medicineLiver Function TestsINFECTIONMedicinePLUS SOFOSBUVIRlcsh:ScienceSulfonamidesMultidisciplinaryImidazolesValineHepatitis CMiddle AgedTreatment OutcomeItalySAFETYHCVSUSTAINED VIROLOGICAL RESPONSEDrug Therapy CombinationFemaleRIBAVIRINSettore BIO/19 - MICROBIOLOGIA GENERALECHRONIC HEPATITIS-Cmedicine.drugAdultmedicine.medical_specialtyDaclatasvirDrug-Related Side Effects and Adverse ReactionsAntiviral AgentsArticle03 medical and health sciencesInternal medicineHumansAgedADVANCED LIVER-DISEASEbusiness.industryRibavirinVIRUS GENOTYPE 3lcsh:RHepatitis C ChronicHCV HIV Daclatasvirmedicine.diseaseIsoquinolinesEFFICACYRegimen030104 developmental biologychemistryAsunaprevirlcsh:QLiver functionCarbamatesSofosbuvirbusiness030217 neurology & neurosurgeryScientific Reports
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Improvement of ALT decay kinetics by all-oral HCV treatment: Role of NS5A inhibitors and differences with IFN-based regimens

2017

Background Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR. Study design Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR. Kinetic-models and Cox-analysis were used to assess determinants of ALT-decay and normalization. Results HCV-RNA kinetics was biphasic, reflecting …

Genetics and Molecular Biology (all)SimeprevirMaleHepacivirusHepacivirusPharmacologyBiochemistryStiffness0302 clinical medicineAnimal CellsMedicineAmino Acidslcsh:ScienceAlanineOrganic CompoundsLiver Diseases3. Good healthCirrhosisPhysical SciencesAdministrationInterferon030211 gastroenterology & hepatologyDrug Therapy CombinationCellular TypesOligopeptidesHumanOralMaterials ScienceGastroenterology and HepatologyMicrobiologyAntiviral Agents03 medical and health sciencesDrug TherapyHumansAgedKineticPharmacologyHepaciviruBiochemistry Genetics and Molecular Biology (all)Mathematical Modelinglcsh:RChemical CompoundsBiology and Life SciencesProteinsmedicine.diseasedigestive system diseasesAdministration Oral; Aged; Alanine Transaminase; Antiviral Agents; Drug Therapy Combination; Female; Hepacivirus; Hepatitis C; Humans; Interferons; Kinetics; Male; Middle Aged; Oligopeptides; RNA Viral; Ribavirin; Simeprevir; Sofosbuvir; Treatment Outcome; Viral Nonstructural Proteins; Biochemistry Genetics and Molecular Biology (all); Agricultural and Biological Sciences (all)030104 developmental biologyAgricultural and Biological Sciences (all)chemistryAliphatic Amino Acidslcsh:Q0301 basic medicineSofosbuvirlcsh:MedicineAdministration OralMedicine (all); Biochemistry Genetics and Molecular Biology (all); Agricultural and Biological Sciences (all)Viral Nonstructural ProteinsTelaprevirchemistry.chemical_compoundSimeprevirMedicine and Health SciencesViralMultidisciplinarybiologyAntimicrobialsMedicine (all)Simulation and ModelingDrugsAlanine TransaminaseHepatitis CMiddle AgedAntiviralsHepatitis CChemistryTreatment OutcomeLiverCombinationOligopeptideRNA ViralFemaleAnatomymedicine.drugResearch ArticleSettore MED/17 - Malattie InfettiveGeneral Science & TechnologyMaterial PropertiesResearch and Analysis MethodsMicrobial ControlVirologyRibavirinMechanical PropertiesNS5AAntiviral Agentbusiness.industryRibavirinHCV DAA ALTViral Nonstructural ProteinOrganic ChemistryCell Biologybiology.organism_classificationKineticsAlanine transaminaseAdministration Oral; Aged; Alanine Transaminase; Antiviral Agents; Drug Therapy Combination; Female; Hepacivirus; Hepatitis C; Humans; Interferons; Kinetics; Male; Middle Aged; Oligopeptides; RNA Viral; Ribavirin; Simeprevir; Sofosbuvir; Treatment Outcome; Viral Nonstructural Proteinsbiology.proteinHepatocytesRNAInterferonsSofosbuvirbusiness
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Incidence of Hepatocellular Carcinoma in Patients With HCV-Associated Cirrhosis Treated With Direct-Acting Antiviral Agents.

2018

Background & Aims: Studies have produced conflicting results of the incidence of hepatocellular carcinoma (HCC) in patients with hepatitis C virus–associated cirrhosis treated with direct-acting antivirals (DAAs). Data from clinics are needed to accurately assess the occurrence rate of HCC in patients with cirrhosis in the real world. Methods: We collected data from a large prospective study of 2,249 consecutive patients (mean age = 65.4 years, 56.9% male) with hepatitis C virus–associated cirrhosis (90.5% with Child-Pugh class A and 9.5% with Child-Pugh class B) treated with DAAs from March 2015 through July 2016 at 22 academic and community liver centers in Sicily, Italy. HCC occurren…

Liver CirrhosisMaleCirrhosisSettore MED/09 - Medicina InternaSustained Virologic ResponseHepacivirusGastroenterology0302 clinical medicineRESIST-HCVRisk FactorsHepatocellular Carcinoma (HCC)MedicineLiver Cancer RiskProspective StudiesProspective cohort studySettore MED/12 - GastroenterologiaIncidence (epidemiology)IncidenceLiver NeoplasmsGastroenterologyHepatitis CMiddle AgedCirrhosis; Direct Antiviral Agents (DAAs); Hepatocellular Carcinoma (HCC); RESIST-HCV; Sustained Virological Response (SVR); hepatitis C Virus (HCV); liver cancer risk; reduction; sofosbuvirCirrhosisItalyLiver Neoplasm030220 oncology & carcinogenesisHepatocellular carcinomahepatitis C Virus (HCV)030211 gastroenterology & hepatologyFemaleHumanmedicine.medical_specialtyCarcinoma HepatocellularDirect Antiviral Agents (DAAs)Liver CirrhosiRESIST-HCV Liver Cancer Risk Reduction SofosbuvirAntiviral AgentsFollow-Up Studie03 medical and health sciencesInternal medicineHumansIn patientSustained Virological Response (SVR)AgedReductionAntiviral AgentHepaciviruHepatologybusiness.industryProportional hazards modelRisk FactorHepatitis C Chronicmedicine.diseasedigestive system diseasesProspective StudieChild-Pugh Class BSofosbuvirbusinessFollow-Up Studies
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High efficacy of direct-acting anti-viral agents in hepatitis C virus-infected cirrhotic patients with successfully treated hepatocellular carcinoma

2018

Background: The efficacy of direct-acting anti-viral (DAA) therapy in patients with a history of hepatocellular carcinoma (HCC) is unknown. Aim: We prospectively evaluated whether previously treated HCC affects DAA efficacy in a large real-life cohort of cirrhotic patients. Methods: From January to December 2015 all consecutive HCV mono-infected patients with cirrhosis and/or history of HCC attending 10 Italian tertiary liver centres were enrolled. Baseline characteristics and response to therapy were recorded. 1927 patients were enrolled (mean age: 62.1 10.9 years; 1.205 males). Genotype 1 was the most frequent (67.9%) followed by genotypes 3 (12.4%), 2 (11.2%) and 4 (8.6%). 88.4% and 10.9…

Liver CirrhosisMaleSimeprevirPyrrolidinesSustained Virologic ResponseSofosbuvirHepacivirusAged; Antiviral Agents; Benzimidazoles; Carcinoma Hepatocellular; Cohort Studies; Drug Therapy Combination; Female; Fluorenes; Genotype; Hepacivirus; Hepatic Encephalopathy; Hepatitis C Chronic; Humans; Imidazoles; Interferons; Italy; Liver Cirrhosis; Liver Neoplasms; Male; Middle Aged; Prospective Studies; Ribavirin; Simeprevir; Sofosbuvir; Sustained Virologic Response; Uridine Monophosphatemedicine.disease_causeGastroenterologyCohort Studieschemistry.chemical_compound0302 clinical medicineSimeprevirPharmacology (medical)Prospective Studies030212 general & internal medicineChronicLiver NeoplasmsImidazolesGastroenterologyValineHepatitis CMiddle AgedHepatitis CItalyHepatocellular carcinomaCombinationHCVDrug Therapy CombinationFemale030211 gastroenterology & hepatologyUridine Monophosphatemedicine.drugLedipasvirmedicine.medical_specialtyCarcinoma HepatocellularDaclatasvirGenotypeHepatitis C virusAntiviral Agents03 medical and health sciencesDrug TherapyInternal medicineRibavirinmedicineHumansAgedFluorenesHepatologybusiness.industryCarcinomaHepatocellularHepatitis C Chronicmedicine.diseasedigestive system diseasesRegimenchemistryHepatic EncephalopathyBenzimidazolesCarbamatesInterferonsSofosbuvirbusinessAlimentary Pharmacology & Therapeutics
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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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A model-based meta-analysis of sofosbuvir-based treatments in chronic hepatitis C patients.

2016

The objective of this study was to compare the efficacy of sofosbuvir-based treatments in patients with chronic hepatitis C virus (HCV) infection using a model-based meta-analysis (MBMA). A bibliographic search was performed to identify clinical trials involving sofosbuvir as a unique direct-acting antiviral (DAA) agent or together with daclatasvir, ledipasvir or simeprevir for the treatment of diagnosed HCV infection. The time course of the virological response (VR) was modelled to estimate the effect of treatment and the influence of population characteristics on the longitudinal efficacy profile. The model was validated and simulations of 10 different treatment schedules were performed. …

MaleMicrobiology (medical)OncologyLedipasvirSimeprevirmedicine.medical_specialtyPyrrolidinesDaclatasvirSofosbuvirHepatitis C virusPopulationHepacivirusPharmacologymedicine.disease_causeAntiviral Agents03 medical and health scienceschemistry.chemical_compound0302 clinical medicineSimeprevirInternal medicinemedicineHepatitis C virus Meta-analysis Modelling Simulation SofosbuvirHumansPharmacology (medical)030212 general & internal medicineeducationFluoreneseducation.field_of_studybusiness.industryImidazolesValineGeneral MedicineHepatitis C ChronicModels TheoreticalClinical trialInfectious DiseaseschemistryMeta-analysisBenzimidazolesDrug Therapy CombinationFemale030211 gastroenterology & hepatologyCarbamatesSofosbuvirbusinessmedicine.drug
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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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Impiego del sofosbuvir nel trattamento del virus da epatite C, in pazienti ospedalizzati presso l’Istituto Mediterraneo per i trapianti e terapie ad …

2015

Introduzione: L’epatiteC è stata generalmente trattata con PEGinterferone associato alla Ribavirina per un periodo di 24-48 settimane in funzione del genotipo. L’Azienda Gilead ha sviluppato un antivirale per il trattamento dell’infezione cronica da HCV: il Sofosbuvir GS-7977. L’ISMETT di Palermo ha avviato nel 2014 l’utilizzo per i propri pazienti. Il farmaco verrà fornito gratuitamente dalla stessa azienda farmaceutica grazie al DM 8/5/2003. Materiali e Metodi: Sono state valutate le cartelle cliniche informatizzate e condotta una ricognizione bibliografica su Pubmed e bancadati AIFA. Risultati: I candidati al trattamento con Sofosbuvir sono pazienti con cirrosi epatica HCV+ in lista d’at…

Settore BIO/14 - FarmacologiaEpatite C ISMETT Sofosbuvir
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Cost-effectiveness of sofosbuvir-based triple therapy for untreated patients with genotype 1 chronic hepatitis C

2013

We assessed the cost-effectiveness of sofosbuvir (SOF)-based triple therapy (TT) compared with boceprevir (BOC)- and telaprevir (TVR)-based TT in untreated genotype 1 (G1) chronic hepatitis C (CHC) patients discriminated according to IL28B genotype, severity of liver fibrosis, and G1 subtype. The available published literature provided the data source. The target population was made up of untreated Caucasian patients, aged 50 years, with G1CHC and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs (in euros at 2013 value), life-years gained (LYG), quality-adju…

Settore MED/12 - Gastroenterologiamedicine.medical_specialtyCirrhosisHepatologySofosbuvirCost effectivenessbusiness.industryGastroenterologyPharmacologyHepatologycost-effectiveness sofosbuvir boceprevir telaprevir chronic hepatitis Cmedicine.diseaseTelaprevirchemistry.chemical_compoundchemistryTolerabilityBoceprevirInternal medicineGenotypemedicineSettore SECS-S/05 - Statistica SocialeSettore SECS-S/01 - Statisticabusinesshealth care economics and organizationsmedicine.drugDigestive and Liver Disease
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Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experi…

2022

HCV elimination; Mental health disorders; Sofosbuvir/velpatasvir Eliminación del VHC; Trastornos de salud mental; Sofosbuvir/velpatasvir Eliminació del VHC; Trastorns de salut mental; Sofosbuvir/velpatasvir Hepatitis C virus (HCV) is prevalent in people with mental health disorders, a priority population to diagnose and cure in order to achieve HCV elimination. This integrated analysis pooled data from 20 cohorts in seven countries to evaluate the real-world effectiveness of the pangenotypic direct-acting antiviral (DAA) sofosbuvir/velpatasvir (SOF/VEL) in people with mental health disorders. HCV-infected patients diagnosed with mental health disorders who were treated with SOF/VEL for 12 w…

real-worldGenotype:Mental Disorders [PSYCHIATRY AND PSYCHOLOGY]:Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores]Hepacivirus:Other subheadings::Other subheadings::/drug therapy [Other subheadings]Antiviral AgentsMental health disordersVirologyMedicaments antivírics - Ús terapèuticHumans:Other subheadings::/therapeutic use [Other subheadings]sofosbuvir/velpatasvir:trastornos mentales [PSIQUIATRÍA Y PSICOLOGÍA]:Otros calificadores::/uso terapéutico [Otros calificadores]Mental Disorders:virosis::hepatitis viral humana::hepatitis C [ENFERMEDADES]:Virus Diseases::Hepatitis Viral Human::Hepatitis C [DISEASES]HCV elimination; HCV; mental health disorders; real-world; sofosbuvir/velpatasvirHepatitis C:Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents [CHEMICALS AND DRUGS]Infectious DiseasesReal-worldSofosbuvir/velpatasvirHCV elimination:acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos [COMPUESTOS QUÍMICOS Y DROGAS]HCVmental health disordersSofosbuvirMalalties mentalsHepatitis C - TractamentViruses
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