6533b7d1fe1ef96bd125cd7b
RESEARCH PRODUCT
Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency
Floriano RosinaMaria Elena TostiElisabetta BorghesioMaria MasoccoAlfonso MeleCarmine CoppolaMichele MilellaGuglielmo BorgiaPietro AndreoneMaurizio KochAnna Linda ZignegoMario RomanoMaurizio CarraraPiero Luigi AlmasioEmilio AzzolaGerardo NardoneAntonio BenedettiGiampiero CarosiFrancesco MazzottaEvangelista SagnelliMario RizzettoM. C. MascoloC. CursaroA. ScuteriC. CrespiA. GianstefaniJ. RanieriM. MontiG. CortiP. L. BlancF. BaragliS. BellentaniA. GasbarriniM. PompiliF. MecenateA. PicardiU. VespasianiNull NosottiA. GasbarriniM. PompiliF. MecenateA. Picardi NullNull NosottiG. L. RicciU. VespasianiA. PaffettiC. MastropietroA. MorettiA. L. SpagnoloC. PuotiL. BellisA. RegazzettiE. MaffezziniA. PietrangeloG. AbbatiA. BorghiC. SardiniG. RaimondoL. ScribanoD. MartinesG. Svegliati BaroniG. FaraciS. Schi AnchiG. FornaciariM. MassariP. FabrisT. BertinM. SalvagniniS. MadoniaA. CalìG. CivitavecchiaM. PirisiC. SmirneM. AndreolettiF. MoriscoN. CaporasoI. GentileG. BrancaccioG. B. GaetaA. LibertiM. D. IanneceA. RoccoA. FedericoC. LoguercioG. RieglerP. EspositoS. FargionE. FattaF. MasuttiM. E. BonaventuraA. AutolitanoM. RusselloA. BelliaP. ToniuttoD. BitettoL. PasuloM. G. LucàI. GrattaglianoG. PalascianoD. RomagnoG. GiannelliN. NapoliM. S. PlattellaP. CassanoG. GobboV. MontiA. RaspantiNull CuccoreseA. E. ColomboG. MandelliG. C. SpinziNull FloridiaV. MessinaS. BonfanteP. BellissimaM. TotiJ. VecchietK. FalascaV. PortelliG. De StefanoG. PietromateraP. ViganòT. ReM. AndreoniG. Raineri NullP. A. GrossiS. CaputoG. CassolaM. FeasiA. Di BiagioLaura Ambra NicoliniEdoardo Giovanni GianniniM. CorboG. FotiA. KunkarL. CateriniD. MiglioriniA. ChioderaG. CalleriC. SpeziaL. FramarinM. Berrutti NullA. CiancioC. BaigueraM. PuotiS. VentoC. ContiniS. BocciaM. A. CasiraghiL. SimoneD. TacconiM. CaremaniP. AlmiM. ChimentiNull CoscoD. MesseriF. C. EspertiL. LomonacoP. PazziF. FornariG. ComparatoT. CasettiF. G. FoschiA. SamoriE. FerrettiR. MarinN. CampoR. TestaS. Rizzosubject
RegistrieMaleCirrhosismedicine.disease_causePolyethylene GlycolGastroenterologyPolyethylene Glycolschemistry.chemical_compoundHepatitis VirusesHepatitis ViruseProspective StudiesViralRegistriesChronicProspective cohort studyDrug CarrierDrug CarriersSettore MED/12 - GastroenterologiaMedicine (all)GastroenterologyRecombinant ProteinMiddle AgedHepatitis CRecombinant ProteinsTreatment OutcomeItalyCombinationRNA ViralPopulation studyDrug Therapy CombinationFemaleHumanmedicine.medical_specialtyGenotypeHepatitis C virusAlpha interferonRibavirin; Sustained virological response (SVR); TreatmentAntiviral AgentsFollow-Up StudieRibavirin; Sustained virological response (SVR); Treatment; Hepatology; GastroenterologyDrug TherapyInternal medicineRibavirinmedicineHumansAntiviral AgentHepatologybusiness.industryRibavirinInterferon-alphaHCV therapyHepatitis C ChronicHepatologymedicine.diseaseClinical trialTreatmentProspective StudiechemistryImmunologyRNARibavirin; Sustained virological response (SVR); Treatment; Antiviral Agents; Drug Carriers; Drug Therapy Combination; Female; Follow-Up Studies; Genotype; Hepatitis C Chronic; Hepatitis Viruses; Humans; Interferon-alpha; Italy; Male; Middle Aged; Polyethylene Glycols; Prospective Studies; RNA Viral; Recombinant Proteins; Ribavirin; Treatment Outcome; RegistriesbusinessRibavirin; Sustained virological response (SVR); Treatment; Antiviral Agents; Drug Carriers; Drug Therapy Combination; Female; Follow-Up Studies; Genotype; Hepatitis C Chronic; Hepatitis Viruses; Humans; Interferon-alpha; Italy; Male; Middle Aged; Polyethylene Glycols; Prospective Studies; RNA Viral; Recombinant Proteins; Ribavirin; Treatment Outcome; Registries; Gastroenterology; Hepatology; Medicine (all)Follow-Up StudiesSustained virological response (SVR)description
a b s t r a c t Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in “real world” chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peginterferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and -glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in “real world” clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-totreat than among difficult-to-treat hepatitis C virus genotypes.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2014-01-01 |