0000000000306817

AUTHOR

Luca Pani

showing 5 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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Regulatory evaluation of Glybera in Europe — two committees, one mission

2013

Representing the first gene therapy to be approved in the Western world, alipogene tiparvovec (Glybera; Uniqure) has recently been said to have had a “substantial impact from a regulatory perspective” (Nature Rev. Drug Discov. 11, 664; 2012) 1 . The therapy was granted marketing authorization in the European Union for the treatment of lipoprotein lipase deficiency, which results in a clinically heterogeneous condition with a risk of potentially life-threatening pancreatitis 2 , at the end of 2012. The decision followed a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) 3

Pharmacologymedicine.medical_specialtybusiness.industryGenetic TherapyGeneral MedicineMarketing authorizationBiotechnologyAlipogene tiparvovecHuman useFamily medicineDrug DiscoveryAgency (sociology)Drug approvalHumansMedicineWestern worldmedia_common.cataloged_instanceHyperlipoproteinemia Type IEuropean UnionCooperative behaviorCooperative BehaviorEuropean unionbusinessDrug Approvalmedia_commonNature Reviews Drug Discovery
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Towards a framework for treatment effectiveness in schizophrenia

2014

Georg Juckel,1 Andrea de Bartolomeis,2 Philip Gorwood,3 Sergey Mosolov,4 Luca Pani,5 Alessandro Rossi,6 Julio Sanjuan7 1Department of Psychiatry, LWL-University Hospital, Ruhr-University Bochum, Bochum, Germany; 2Laboratory of Molecular Psychiatry and Unit of Treatment Resistant Psychosis, University School of Medicine of Naples Federico II, Napoli, Italy; 3Groupe Hospitalier Sainte-Anne (CMME), Paris-Descartes University, Paris, France; 4Moscow Research Institute of Psychiatry, Moscow, Russia; 5Institute of Translational Pharmacology, Italian National Research Council, Rome, Italy; 6Università de L’Aquila, L’Aquila, Italy; 7Clinic Hospital, Spanish Mental Hea…

medicine.medical_specialtyNeuropsychiatric Disease and Treatmentmedicine.medical_treatmentAlternative medicineSatisfactionNeurosciences. Biological psychiatry. NeuropsychiatryDiseaseAntipsychoticAssessment scaleExtrapyramidal symptomsmedicineFunctioningCognitive skillAntipsychoticPsychiatryRC346-429Biological PsychiatryDisease burdenOriginal Researchassessment scalesbusiness.industryMental illneMental illnessmedicine.diseasemental illnessAntipsychotic; Assessment scales; Functioning; Mental illness; SatisfactionPsychiatry and Mental HealthMental illnessSchizophreniaNeurology. Diseases of the nervous systemmedicine.symptombusinessAssessment scalesRC321-571Neuropsychiatric Disease and Treatment
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Association of neovascular age-related macular degeneration with month and season of birth in Italy

2016

In order to investigate the influence of season and month of birth on the risk of neovascular age-related macular degeneration (n-AMD) in Italy, we evaluated the month birth and sex of all patients, recorded in the anti-vascular endothelial growth factor (VEGF) monitoring registry of the Italian Medicines Agency, born between 1925-1944, who received intravitreal anti-VEGF injections for n-AMD between January 1, 2013 and July 29, 2015. The numbers of all births in Italy in the same years, extracted from the Italian National Institute of Statistics, were used to calculate the expected number of n-AMD cases. Overall, 45,845 patients (19,207 men, 26,638 women) received intravitreal anti-VEGF fo…

MaleVascular Endothelial Growth Factor AAginggenetic structuresMonth of birthVEGF receptorsneovascular AMDAngiogenesis InhibitorsAptamersMacular Degeneration0302 clinical medicineSeason of birthReceptors80 and overMedicineRegistriesAged 80 and overNeovascularization PathologicbiologyVascular Endothelial Growth FactorIncidenceIncidence (epidemiology)Aptamers NucleotideBevacizumabTreatment OutcomeItalyanti-VEGFFemaleSeasonsNucleotideNeovascular age-related macular degenerationResearch Papermedicine.drugAnti-VEGF; Month of birth; Neovascular age-related macular degeneration; Neovascular AMD; Season of birth; Aged; Aged 80 and over; Angiogenesis Inhibitors; Aptamers Nucleotide; Bevacizumab; Female; Humans; Incidence; Italy; Macular Degeneration; Male; Neovascularization Pathologic; Ranibizumab; Receptors Vascular Endothelial Growth Factor; Recombinant Fusion Proteins; Registries; Treatment Outcome; Vascular Endothelial Growth Factor A; Seasons; Aging; Cell BiologySeason of birthBevacizumabRecombinant Fusion ProteinsNeovascular AMDneovascular age-related macular degeneration03 medical and health sciencesRanibizumabAge relatedHumansNeovascularizationAgedPathologicseason of birthbusiness.industrymonth of birthAnti-VEGFCell BiologyMacular degenerationmedicine.diseaseeye diseasesanti-VEGF; month of birth; neovascular AMD; neovascular age-related macular degeneration; season of birthReceptors Vascular Endothelial Growth Factor030221 ophthalmology & optometrybiology.proteinsense organsRanibizumabbusinessMonth of birth030217 neurology & neurosurgeryDemographyAging
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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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