6533b7d7fe1ef96bd12690c6

RESEARCH PRODUCT

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

Giada CaroloVeronica BernabucciLuchino ChessaMaria Luisa RussoGiorgio Maria SaraccoMarzia MontalbanoBarbara MenzaghiGiovanni Di PerriAdriano LazzarinSilvia La MonicaRaffaele BrunoGian Ludovico RapacciniMario U. MondelliAnna Maria SchimizziCaterina PasquazziMaurizia Rossana BrunettoAntonio CraxìFilomena MoriscoCarmela Lo GuercioVania GiacometAlessia GiorginiMario MasaroneFrancesca Paolo RussoT. ZolfinoVincenzo SangiovanniAlessia CiancioAntonella D'arminio MonforteSavino BrunoE.m. ErneAntonio GasbarriniFrancesco CastelliSergio NovaraG. NardoneAndrea De LucaClaudio Maria MastroianniGioacchino AngaranoChiara DentoneRenato MaseratiAnna Maria PiscagliaTiziana QuirinoGiuseppe TarantinoM. LichtnerAntonio ChirianniGiuseppina BrancaccioS. PaganinAlfredo AlbertiSilvia CorradoriEdoardo G. GianniniCarlo TortiChiara BoariniRaffaele CozzolongoMarco Di StefanoAlessandro SoriaPaolo TundiGiovanni CassolaDebora AngrisaniAntonio GriecoCecilia PravadelliGiuliano RizzardiniRoberto GulminettiVincenzo MessinaMaria RendinaMassimo PirisiIrene CacciolaRoberto GangaRaffaella LionettiPaolo CalabreseLaura PontiFilomena SimeoneMaurizio RusselloMonica MontiNicola BoffaPierluigi TarquiniFranco CapraIvo AvanciniDomenico SansonnoStefano FagiuoliMichele BaroneGiacomo VecchietSalvatore RizzoCarlo Federico PernoTeresa SantantonioPierluigi ToniuttoMassimo ZuinNicola CaporasoAlessandra OrlandiniGrazielle Marie PigozziMartina FelderAntonio CristaudoRoberto CecereMassimo MarignaniVincenza CalvarusoG. AbbatiDomenico PotenzaMaria Chiara PirasMario RizzettoSerena CimaMarco Delle MonacheAlessio AghemoD. IeluzziGuglielmo BorgiaGiampaolo CortiPaolo PoggioManuela MerliElena DanieliAndrea GiacomettiMassimo AndreoniAntonino PicciottoMario AngelicoBenedetta CanovariSara PiovesanAnna Linda ZignegoAntonio BenedettiEmanuele DuranteErica VillaMarcello PersicoAntonio Patrizio TermiteBarbara CocoMaria VinciLucio BoglioneCristina RossiPaolo AngeliMassimo MemoliMaria Teresa GiordaniMassimo De LucaLuisa PasuloVincenzo VulloMario MelazziniAttilio SolinasPietro GattiMichele GuerraSilvia MartiniAntonio AscioneMassimo PuotiRoberto CaudaGiovanna OnnelliSilvia MagnaniSalvatore MadonnaGiovanni RaimondoMarco TaboneGloria TalianiDante RomagnoliAldo MarroneUmberto Vespasiani GentilucciLuca MieleMarcello TavioAndrea AntinoriGiampiero D'offiziMirella OnofrioValentina IodiceLucio CoscoGuido PiaiLuca PaniFrancesca Ceccherini SilbersteinSimona MontillaMarco LenziLuca FontanellaAlessandro FedericoCarlo FerrariGiustino ParrutiAntonio Di BiagioGabriella VerucchiFabio MarsettiMichele MilellaMaria Grazia RumiAntonio IzziMarco MarzioniFrancesca DonatoVanni BorghiMariano QuartiniMassimo ColomboMichele ImparatoGiovanni Battista GaetaP.l. BlancAlfredo Di LeoNicola CoppolaAlessandro ChioderaIvana MaidaDavide CampagnoloCinzia AntoniniAntonietta RomanoA. GianstefaniKatia FalascaMassimo LevreroGaetano ServiddioMaria Paola TrottaOlivia MorelliSalvatore PettaElisabetta TetiMaria Rita ParisiPietro Andreone

subject

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

description

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 defined as HCV RNA negative 12 weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5 g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2 mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

yearjournalcountryeditionlanguage
2018-01-01
10.1007/s15010-018-1157-xhttp://hdl.handle.net/11577/3270983