Search results for "Sofosbuvir"

showing 10 items of 31 documents

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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Early changes in dynamic biomarkers of liver fibrosis in hepatitis C virus-infected patients treated with sofosbuvir

2016

Abstract Background Chronic hepatitis C is a major cause of liver-associated mortality caused by decompensated cirrhosis and hepatocellular carcinoma. With the approval of sofosbuvir, therapeutic efficacy has markedly increased. Early changes in non-invasive biomarkers of liver fibrosis under effective antiviral therapy are widely unknown. Aim To evaluate early changes of fibrosis markers determined by enhanced liver fibrosis (ELF) scores and liver stiffness measurement (FibroScan®) in patients treated with sofosbuvir. Methods A total of 32 hepatitis C patients treated prospectively with sofosbuvir were included. The ELF-panel and FibroScan measurements were performed at baseline, week 4, e…

Liver CirrhosisMaleNon-invasive serum markersmedicine.medical_specialtySofosbuvirLiver fibrosisHepatitis C virusLiver fibrosisHepacivirusmedicine.disease_causeAntiviral AgentsGastroenterology03 medical and health sciences0302 clinical medicineFibrosisInternal medicinemedicineHumansAspartate AminotransferasesProspective StudiesLiver stiffness measurementHepatitisFibroScanHepatologymedicine.diagnostic_testbusiness.industryGastroenterologyHepatitis CHepatitis C ChronicMiddle AgedViral Loadmedicine.diseaseTreatment OutcomeELF030220 oncology & carcinogenesisLiver biopsyHepatocellular carcinomaElasticity Imaging TechniquesRNA ViralFemale030211 gastroenterology & hepatologySofosbuvirbusinessmedicine.drugDigestive and Liver Disease
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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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Sofosbuvir plus daclatasvir with or without ribavirin is safe and effective for post-transplant hepatitis C recurrence and severe fibrosis and cirrho…

2018

Background: In 2012, an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. The aim of this “real-life” study was to assess treatment efficacy and safety with an extended course of daclatasvir (DCV) plus sofosbuvir (SOF) with or without ribavirin (RBV). Methods: All HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOF±RBV for 24 weeks; sustained virological response was assessed at 12 weeks post-treatment (SVR12). Results: Eighty-seven patients were enrolled (75.9% males, mean age 58.4 ±…

Liver CirrhosisMalehepatitis C virusPyrrolidinesCirrhosisSofosbuvirmedicine.medical_treatmentantiviral treatmentHepacivirus030230 surgeryLiver transplantationmedicine.disease_causeGastroenterologychemistry.chemical_compound0302 clinical medicineRecurrencehepatitis C viruProspective StudiesProspective cohort studySettore MED/12 - Gastroenterologialiver transplantationdirect antiviral agentsImidazolesValineHepatitis CMiddle AgedPrognosisHepatitis CItalyHCVDrug Therapy CombinationFemale030211 gastroenterology & hepatologymedicine.drugmedicine.medical_specialtyDaclatasvirHepatitis C virusAntiviral Agentsantiviral treatment; cirrhosis; direct antiviral agents; hepatitis C virus; liver transplantation03 medical and health sciencesInternal medicineRibavirinmedicineHumansTransplantationdirect antiviral agentbusiness.industryRibavirincirrhosismedicine.diseasechemistryCarbamatesSofosbuvirbusinessFollow-Up Studiescirrhosi
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Aminopyrine breath test predicts liver-related events and death in HCV-related cirrhosis on SVR after DAA therapy

2019

Background & Aims: In patients with hepatitis C virus (HCV)-related advanced cirrhosis, the effects of sustained virological response (SVR) by direct antiviral agents (DAAs) on decompensation and liver deaths are less clearcut, since up to 30% of patients do not improve, and no predictors of outcome have been identified. We used 13C-aminopyrine breath test (ABT) to assess whether its changes can predict liver-related outcomes after DAA treatment in patients with HCV cirrhosis. Methods: Fifty consecutive patients with HCV cirrhosis were enrolled. Patients were included if they had Child A cirrhosis at risk for decompensation – defined as Child A6 (N = 22, 44%) or previous decompensation …

Liver Cirrhosismedicine.medical_specialtyCirrhosisSofosbuvirHepatitis C virusHepacivirusmedicine.disease_causeAntiviral AgentsGastroenterologyInternal medicineHumansMedicineDecompensationAminopyrineChildCIRRHOSISHepatic encephalopathyaminopyrine breath testBreath testHepatologymedicine.diagnostic_testdirect antiviral agentCumulative dosebusiness.industryHepatitis C Chronicmedicine.diseaseHepatitis CBreath Testsliver functionLiver functionbusinessDIRECT ANTIVIRAL AGENTSAMINOPYRINE BREATH TEST; CIRRHOSIS; DIRECT ANTIVIRAL AGENTS; LIVER FUNCTIONmedicine.drugcirrhosi
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Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

2018

AbstractNatural resistance-associated substitutions (RASs) are reported with highly variable prevalence across different HCV genotypes (GTs). Frequency of natural RASs in a large Italian real-life cohort of patients infected with the 4 main HCV-GTs was investigated. NS3, NS5A and NS5B sequences were analysed in 1445 HCV-infected DAA-naïve patients. Sanger-sequencing was performed by home-made protocols on 464 GT1a, 585 GT1b, 92 GT2c, 199 GT3a, 16 GT4a and 99 GT4d samples. Overall, 20.7% (301/1455) of patients showed natural RASs, and the prevalence of multiclass-resistance was 7.3% (29/372 patients analysed). NS3-RASs were particularly common in GT1a and GT1b (45.2-10.8%, respectively), mai…

Male0301 basic medicineSofosbuvirHepacivirusDrug Resistancelcsh:MedicineHepacivirusViral Nonstructural Proteinsmedicine.disease_causeGastroenterologyHepatitis C Virus; HCV resistance-testchemistry.chemical_compound0302 clinical medicineGenotypePrevalenceVirallcsh:ScienceHCV resistance-testMultidisciplinarybiologyHepatitis CMiddle AgedSettore MED/07 - Microbiologia e Microbiologia ClinicaHepatitis CItalyCohortHCVFemale030211 gastroenterology & hepatologymedicine.drugAdultmedicine.medical_specialtyHepatitis C VirusGenotypeHCV RASHepatitis C virus03 medical and health sciencesInternal medicineDrug Resistance ViralmedicineHumansAdult; Aged; Drug Resistance Viral; Female; Hepacivirus; Hepatitis C; Humans; Italy; Male; Middle Aged; Prevalence; Viral Nonstructural Proteins; GenotypeNS5ANS5BAgedbusiness.industrylcsh:RHepatitis C Virus HCV resistance-testbiology.organism_classificationmedicine.disease030104 developmental biologychemistrylcsh:Qbusiness
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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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Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Respons…

2015

UNLABELLED Although sofosbuvir has been approved for patients with genotypes 2/3 (G2/3), many parts of the world still consider pegylated Interferon alpha (P) and ribavirin (R) as standard of care for G2/3. Patients with rapid virological response (RVR) show response rates >80%. However, SVR (sustained virological response) in non-RVR patients is not satisfactory. Longer treatment duration may be required but evidence from prospective trials are lacking. A total of 1006 chronic HCV genotype 2/3 patients treated with P/R were recruited into a German HepNet multicenter screening registry. Of those, only 226 patients were still HCV RNA positive at week 4 (non-RVR). Non-RVR patients with ongoin…

Malemedicine.medical_specialtyGenotypeSofosbuvirlcsh:MedicineAlpha interferonHepaciviruslaw.inventionchemistry.chemical_compoundRandomized controlled trialRecurrencelawPegylated interferonSurveys and QuestionnairesInternal medicineRibavirinClinical endpointmedicineHumansProspective Studiesddc:610lcsh:ScienceProspective cohort studyMultidisciplinarybusiness.industryRibavirinlcsh:RInterferon-alphaHepatitis C ChronicMiddle AgedSurgeryClinical trialLogistic ModelsTreatment OutcomechemistryMultivariate AnalysisFemalelcsh:QbusinessResearch Articlemedicine.drugPLOS ONE
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