0000000000306828

AUTHOR

Alfredo Di Leo

0000-0003-2026-1200

showing 9 related works from this author

Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

2018

Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter def…

CyclopropanesLiver CirrhosisMaleCirrhosis;Dasabuvir;Elderly;Ombitasvir;ParitaprevirCirrhosis; Dasabuvir; Elderly; Ombitasvir; Paritaprevir; Aged; Aged; 80 and over; Anilides; Antiviral Agents; Biomarkers; Carbamates; Female; Hepacivirus; Hepatitis C; Chronic; Humans; Liver Cirrhosis; Macrocyclic Compounds; Male; Ribavirin; Ritonavir; Sulfonamides; Treatment Outcome; Uracil; Drug Therapy; Combination; GenotypeParitaprevirCirrhosis Dasabuvir Elderly Ombitasvir Paritaprevir Microbiology (medical) Infectious DiseasesCirrhosis; Dasabuvir; Elderly; Ombitasvir; Paritaprevir; Aged; Aged 80 and over; Anilides; Antiviral Agents; Biomarkers; Carbamates; Female; Hepacivirus; Hepatitis C Chronic; Humans; Liver Cirrhosis; Macrocyclic Compounds; Male; Ribavirin; Ritonavir; Sulfonamides; Treatment Outcome; Uracil; Drug Therapy Combination; Genotype; Microbiology (medical); Infectious DiseasesHepacivirusGastroenterologychemistry.chemical_compound0302 clinical medicineElderly2-Naphthylamine80 and overMedicineAnilides030212 general & internal medicineChronicAged 80 and overSulfonamidesDasabuvirValineGeneral MedicineHepatitis CHepatitis CTreatment OutcomeInfectious DiseasesCirrhosisCombination030211 gastroenterology & hepatologyDrug Therapy CombinationFemaleDasabuvirMacrocyclic CompoundCirrhosis; Dasabuvir; Elderly; Ombitasvir; Paritaprevir; Microbiology (medical); Infectious Diseasesmedicine.drugHumanMicrobiology (medical)medicine.medical_specialtyMacrocyclic CompoundsProlineGenotypeLactams MacrocyclicSettore MED/12 - GASTROENTEROLOGIALiver CirrhosiSulfonamideAntiviral Agents03 medical and health sciencesDrug TherapyInternal medicineRibavirinHumansDecompensationUracilAgedHepatitisAntiviral AgentCirrhosiHepaciviruRitonavirbusiness.industryRibavirinSettore MED/09 - MEDICINA INTERNAAnilideBiomarkerHepatitis C Chronicmedicine.diseaseCirrhosis; Dasabuvir; Elderly; Ombitasvir; Paritaprevir; Aged; Aged 80 and over; Anilides; Antiviral Agents; Biomarkers; Carbamates; Female; Hepacivirus; Hepatitis C Chronic; Humans; Liver Cirrhosis; Macrocyclic Compounds; Male; Ribavirin; Ritonavir; Sulfonamides; Treatment Outcome; Uracil; Drug Therapy Combination; GenotypeOmbitasvirOmbitasvirchemistryParitaprevirCarbamateRitonavirCarbamatesbusinessBiomarkers
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White Paper of Italian Gastroenterology: Delivery of services for digestive diseases in Italy: Weaknesses and strengths

2014

In 2011 the three major Italian gastroenterological scientific societies (AIGO, the Italian Society of Hospital Gastroenterologists and Endoscopists; SIED, the Italian Society of Endoscopy; SIGE, the Italian Society of Gastroenterology) prepared their official document aimed at analysing medical care for digestive diseases in Italy, on the basis of national and regional data (Health Ministry and Lombardia, Veneto, Emilia-Romagna databases) and to make proposals for planning of care. Digestive diseases were the first or second cause of hospitalizations in Italy in 1999–2009, with more than 1,500,000 admissions/year; however only 5–9% of these admissions was in specialized Gastroenterology un…

MaleGastrointestinal DiseasesTreatment outcomeDiseasesMedical careGastroenterologyCancer; Digestive diseases; Emergency; Gastroenterology; Gastrointestinal bleeding; Hospital discharge record; Hospital stay; Mortality; Adolescent; Adult; Aged; Aged 80 and over; Child; Child Preschool; Emergencies; Female; Gastroenterology; Gastrointestinal Diseases; Gastrointestinal Hemorrhage; Health Planning; Health Services; Health Services Needs and Demand; Hospital Mortality; Hospital Units; Humans; Incidence; Infant; Infant Newborn; Italy; Length of Stay; Male; Middle Aged; Prevalence; Societies Medical; Treatment Outcome; Young AdultHealth servicesWhite paperDigestive diseaseitaly80 and overPrevalenceMedicineCancer; Digestive diseases; Emergency; Gastroenterology; Gastrointestinal bleeding; Hospital discharge record; Hospital stay; Mortality; Adolescent; Adult; Aged; Aged 80 and over; Child; Child Preschool; Emergencies; Female; Gastroenterology; Gastrointestinal Diseases; Gastrointestinal Hemorrhage; Health Planning; Health Services; Health Services Needs and Demand; Hospital Mortality; Hospital Units; Humans; Incidence; Infant; Infant Newborn; Italy; Length of Stay; Male; Middle Aged; Prevalence; Societies Medical; Treatment Outcome; Young Adult; Hepatology; GastroenterologyHospital MortalityChildSocieties MedicalCancerAged 80 and overSettore MED/12 - GastroenterologiaHospital stayIncidenceIncidence (epidemiology)GastroenterologyHealth ServicesMiddle AgedDigestive diseases Emergency Gastroenterology Gastrointestinal bleeding Hospital discharge record Hospital stay MortalityTreatment OutcomeChild PreschoolFemaleChristian ministryGastrointestinal HemorrhageHospital UnitsHospital discharge recordAdultgastroenterology; Diseases; italymedicine.medical_specialtyAdolescentYoung AdultCase mix indexMedicalInternal medicineHumansCancer Digestive diseases Emergency Gastroenterology Gastrointestinal bleeding Hospital discharge record Hospital stay MortalityMortalityPreschoolGastrointestinal bleedingAgedHealth Services Needs and DemandHepatologybusiness.industryInfant NewbornInfantLength of StayHepatologyNewbornHealth PlanningEmergencyDigestive diseasesEmergenciesSocietiesbusinessDigestive and Liver Disease
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Early menopause is associated with lack of response to antiviral therapy in women with chronic hepatitis C.

2011

Background & Aims Chronic hepatitis C (CHC) and liver fibrosis progress more rapidly in men and menopausal women than in women of reproductive age. We investigated the associations among menopause, sustained virologic response (SVR), and liver damage in patients with CHC. Methods We performed a prospective study of 1000 consecutive, treatment-naive patients 18 years of age and older with compensated liver disease from CHC. Liver biopsy samples were analyzed (for fibrosis, inflammation, and steatosis) before patients received standard antiviral therapy. From women (n = 442), we collected data on the presence, type, and timing of menopause; associated hormone and metabolic features; serum lev…

Liver CirrhosisMaleTime Factorsmedicine.medical_treatmentBiopsyMenopause PrematuremenopauseHepacivirusmedicine.disease_causeGastroenterologySeverity of Illness IndexRisk FactorsOdds RatioProspective StudiesTreatment FailureProspective cohort studymedicine.diagnostic_testGastroenterologyAge FactorsHormone replacement therapy (menopause)Hepatitis CMiddle AgedViral LoadImmunohistochemistryMenopauseItalyLiver biopsyRNA ViralFemaleInflammation Mediatorshcv svr menopauseViral loadAdultmedicine.medical_specialtyantiviral therapy; menopause; prognostic factors; hcv therapyGenotypeHepatitis C virusAntiviral AgentsRisk AssessmentSex FactorsInternal medicinehcvmedicineHumanshcv; ifn; menopauseHepatologybusiness.industryInterleukin-6Tumor Necrosis Factor-alphaOdds ratioHepatitis C Chronicmedicine.diseaseifnEndocrinologyLogistic ModelsbusinessBiomarkersGastroenterology
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Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluat…

2017

Background: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. Aim: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. Methods: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. Results: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin lev…

SimeprevirMaleGenetics and Molecular Biology (all)HepacivirusPediatricsGastroenterologyBiochemistry0302 clinical medicineAnimal Cells80 and overBileMedicinePublic and Occupational HealthProspective Studieslcsh:ScienceAged 80 and overAdult; Aged; Aged 80 and over; Antiviral Agents; Drug Therapy Combination; Female; Hepatitis C; Humans; Incidence; Liver Diseases; Male; Middle Aged; Prospective Studies; Biochemistry Genetics and Molecular Biology (all); Agricultural and Biological Sciences (all)Liver DiseaseIncidenceLiver DiseasesChild HealthBloodCirrhosisPhysical SciencesRegression Analysis030211 gastroenterology & hepatologyDrug Therapy CombinationCellular TypesStatistics (Mathematics)Humanmedicine.medical_specialtyGastroenterology and HepatologyMicrobiologyAntiviral Agents03 medical and health sciencesDrug TherapyHumansStatistical MethodsAgedBlood CellsBiochemistry Genetics and Molecular Biology (all)Flaviviruseslcsh:ROrganismsBiology and Life Sciencesmedicine.diseaseRegimenProspective Studie030104 developmental biologychemistryAgricultural and Biological Sciences (all)lcsh:QMathematicsDevelopmental BiologyRNA viruses0301 basic medicineDAA HCV resistanceSofosbuvirPhysiologylcsh:MedicineLiver diseasechemistry.chemical_compoundMathematical and Statistical TechniquesMedicine and Health SciencesPathology and laboratory medicineMultidisciplinaryHepatitis C virusHepatitis CMedical microbiologyMiddle AgedHepatitis CBody FluidsVirusesCombinationFemaleAnatomyPathogensResearch Articlemedicine.drugPlateletsLedipasvirAdultDaclatasvirSettore MED/12 - GASTROENTEROLOGIAHCV liver diseases Cirrhosis DAA failureResearch and Analysis MethodsInternal medicineAntiviral Agentbusiness.industryViral pathogensBilirubinCell BiologyFibrosisHepatitis virusesMicrobial pathogensSurgeryLiver functionbusiness
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Predictors of hepatocellular carcinoma in HCV cirrhotic patients treated with direct acting antivirals

2018

Background: Despite the dramatic improvement in viral eradication rates that has been reached with direct antiviral agents (DAAs),the real benefit of viral eradication after DAAs on hepatocellular carcinoma (HCC) development is still controversial. Aim: To prospectively assess the risk of HCC occurrence and early recurrence in a large cohort of DAAtreated HCV-cirrhotic patients and to identify potential predictors of HCC development. Methods: We analyzed data prospectively collected from 1927 consecutive HCV-infected cirrhotic patients treated with DAA from January to December 2015 in 10 tertiary liver centers in Italy and followed-up for one year after therapy. 161 patients had a previous …

Liver CirrhosisMaleCirrhosisSustained Virologic ResponseHepatocellular carcinomaDirect antiviral agentsDIRECT ACTING ANTIVIRALSGastroenterologyCohort Studies0302 clinical medicineRisk FactorsChronicIncidence (epidemiology)Liver NeoplasmsGastroenterologyMiddle AgedHepatitis CTumor recurrenceCirrhosis; Direct antiviral agents; HCV; Hepatocellular carcinoma; Aged; Antiviral Agents; Carcinoma Hepatocellular; Cohort Studies; Disease Progression; Female; Hepatitis C Chronic; Humans; Italy; Liver Cirrhosis; Liver Neoplasms; Male; Middle Aged; Neoplasm Recurrence Local; Risk Factors; alpha-Fetoproteins; Sustained Virologic ResponseItalyLocalCirrhosis030220 oncology & carcinogenesisHepatocellular carcinomaHCVDisease ProgressionPortal hypertension030211 gastroenterology & hepatologyFemalealpha-FetoproteinsCohort studymedicine.medical_specialtyCarcinoma HepatocellularEarly RecurrenceAntiviral Agents03 medical and health sciencesInternal medicinemedicineHumansneoplasmsAgedCirrhosiHepatologybusiness.industryCarcinomaHepatocellularHepatitis C Chronicmedicine.diseasedigestive system diseasesNeoplasm RecurrenceDirect antiviral agentNeoplasm Recurrence LocalCirrhosis; Direct antiviral agents; HCV; Hepatocellular carcinomabusiness
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Reproductive status is associated with the severity of fibrosis in women with hepatitis C.

2012

Introduction Chronic hepatitis C is the main cause of death in patients with end-stage liver disease. Prognosis depends on the increase of fibrosis, whose progression is twice as rapid in men as in women. Aim of the study was to evaluate the effects of reproductive stage on fibrosis severity in women and to compare these findings with age-matched men. Materials and Methods A retrospective study of 710 consecutive patients with biopsy-proven chronic hepatitis C was conducted, using data from a clinical database of two tertiary Italian care centers. Four age-matched groups of men served as controls. Data about demographics, biochemistry, liver biopsy and ultrasonography were analyzed. Contrib…

Liver CirrhosisMalemedicine.medical_specialtyGastroenterology and hepatologyLiver CirrhosiPhysiologylcsh:MedicineViral diseasesChronic hepatitis CSeverity of Illness IndexHepatitisLiver diseaseEndocrinologyFibrosisRetrospective StudieSeverity of illnessmedicinegenderHumansReproductive EndocrinologyChronic hepatitis C; genderlcsh:ScienceTestosteroneLiver diseasesRetrospective StudiesGynecologyMultidisciplinarymedicine.diagnostic_testbusiness.industrylcsh:RCase-control studyHepatitis Cmedicine.diseaseHepatitis CMenopauseInfectious hepatitisCirrhosisLiver biopsyCase-Control StudiesMedicineInfectious diseasesWomen's HealthFemalelcsh:QbusinessCase-Control StudieInfertility FemaleResearch ArticleHumanPLoS ONE
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Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER …

2021

Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both gro…

MaleHCV genotypesEthnic groupLinked-to-care patientComorbidityHepacivirusLogistic regressionmedicine.disease_causeComorbidities; Direct acting antivirals; HCV Cohort; Linked-to-care patients; Aged; Antiviral Agents; Coinfection; Comorbidity; Female; Hepacivirus; Hepatitis C Chronic; Humans; Italy; Male; Middle Aged; Transients and MigrantsComorbidities0302 clinical medicineMedicineComorbidities; Direct acting antivirals; HCV Cohort; Linked-to-care patientsChronicTransients and MigrantsCoinfectionGastroenterologyvirus diseasesMiddle AgedHepatitis CLife evaluationItaly030220 oncology & carcinogenesisLinked-to-care patientsCohort030211 gastroenterology & hepatologyFemaleComorbiditieHumanHepatitis C virusSettore MED/12 - GASTROENTEROLOGIAAntiviral AgentsDirect acting antivirals03 medical and health sciencesDisease severityHumansAgedAntiviral AgentHepaciviruHepatologybusiness.industrySettore MED/09 - MEDICINA INTERNAHepatitis C Chronicmedicine.diseaseComorbiditydigestive system diseasesDirect acting antiviralHCV CohortbusinessDemography
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The Applicability of a Checklist for the Diagnosis and Treatment of Exocrine Pancreatic Insufficiency: Results of the Italian Exocrine Pancreatic Ins…

2020

Objective To evaluate a rapid checklist capable of identifying exocrine pancreatic insufficiency in outpatients. Methods Prospective observational study of a multicenter cohort. Results One hundred and two patients were enrolled; 61.8% of the patients had medically-treated benign or malignant pancreatic disease, and 38.2% had a pancreatic resection. Visual examination of the feces was evaluated in 84 patients and it was related to steatorrhea in 51 patients (50.0%). Receiver operating characteristic curves were evaluated for each symptom or clinical sign and four of them (ie, increase in daily bowel movements, number of bowel movements, fatty stools, >10% weight loss) had a satisfactory …

AdultMalemedicine.medical_specialtyPancreatic diseaseSettore MED/09 - Medicina InternaEndocrinology Diabetes and MetabolismPancreatic Extractsmedicine.medical_treatmentGastroenterology03 medical and health sciences0302 clinical medicineEndocrinologyWeight lossInternal medicineOutpatientsInternal MedicinemedicineHumansEnzyme Replacement TherapyProspective StudiesRegistriesExocrine pancreatic insufficiencyPancreas enzymeAgedHepatologybusiness.industrydigestive oral and skin physiologyFeces analysisexocrine pancreatic insufficiency fecal elastase-1 maldigestion pancreatic diseases steatorrhea.Middle Agedmedicine.diseaseChecklistSteatorrheaPancreatic Function TestsItalyROC Curve030220 oncology & carcinogenesisPancreatectomyExocrine Pancreatic InsufficiencyFemale030211 gastroenterology & hepatologymedicine.symptombusiness
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Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with…

2017

Summary Background We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. Methods In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015. Patients with HCV genotype 1 infection and cirrhosis at high risk of decompensation were given coformulated ombitasvir (25 mg), …

CyclopropanesCompassionate Use TrialsLiver CirrhosisMalechemistry.chemical_compound0302 clinical medicine2-NaphthylamineHCV direct-acting antiviral mixed cryoglobulinemia RBVAnilides030212 general & internal medicineLongitudinal StudiesProspective StudiesChronicAdult; Aged; Anilides; Antiviral Agents; Carbamates; Compassionate Use Trials; Drug Therapy Combination; Female; Genotype; Hepatitis C Chronic; Humans; Liver Cirrhosis; Longitudinal Studies; Macrocyclic Compounds; Male; Middle Aged; Prospective Studies; Ribavirin; Ritonavir; Sulfonamides; Treatment Outcome; UracilSettore MED/12 - GastroenterologiaSulfonamidesDasabuvirHCV DAAGastroenterologyvirus diseasesValineMiddle AgedSettore MED/07 - Microbiologia e Microbiologia ClinicaHepatitis CTreatment OutcomeGastroenterology; HepatologyCombinationDrug Therapy Combination030211 gastroenterology & hepatologyFemalemedicine.drugAdultmedicine.medical_specialtyMacrocyclic CompoundsProlineGenotypeLactams MacrocyclicAdult; Aged; Anilides; Antiviral Agents; Carbamates; Compassionate Use Trials; Drug Therapy Combination; Female; Genotype; Hepatitis C Chronic; Humans; Liver Cirrhosis; Longitudinal Studies; Macrocyclic Compounds; Male; Middle Aged; Prospective Studies; Ribavirin; Ritonavir; Sulfonamides; Treatment Outcome; Uracil; Hepatology; GastroenterologyHepatitis C virus genotype 1 Hepatitis C virus genotype 4 decompensated liver cirrhosis antiviral therapy dasabuvir ombitasvir paritaprevirHepatology; GastroenterologyAntiviral Agents03 medical and health sciencesDrug TherapyInternal medicineRibavirinmedicineHumansDecompensationAdverse effectUracilAgedRitonavirHepatologybusiness.industryRibavirinHepatitis C ChronicVirologyOmbitasvirClinical trialchemistryParitaprevirRitonavirCarbamatesbusiness
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