Please use this identifier to cite or link to this item: https://observatorio.fm.usp.br/handle/OPI/3055
Full metadata record
DC FieldValueLanguage
dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP-
dc.contributor.authorMANNS, M.-
dc.contributor.authorMARCELLIN, P.-
dc.contributor.authorPOORDAD, F. P. Fred-
dc.contributor.authorARAUJO, E. Stanislau Affonso de-
dc.contributor.authorBUTI, M.-
dc.contributor.authorHORSMANS, Y.-
dc.contributor.authorJANCZEWSKA, E. J. Ewa-
dc.contributor.authorVILLAMIL, F.-
dc.contributor.authorPEETERS, M.-
dc.contributor.authorLENZ, O.-
dc.contributor.authorOUWERKERK-MAHADEVAN, S.-
dc.contributor.authorKALMEIJER, R.-
dc.contributor.authorBEUMONT-MAUVIEL, M.-
dc.date.accessioned2013-10-11T21:30:41Z-
dc.date.available2013-10-11T21:30:41Z-
dc.date.issued2013-
dc.identifier.citationJOURNAL OF HEPATOLOGY, v.58, suppl.1, p.S568-S568, 2013-
dc.identifier.issn0168-8278-
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/3055-
dc.description.abstractBackground and Aims: Simeprevir is a potent, once-daily, oral, investigational HCV NS3/4A protease inhibitor. QUEST-2 (NCT01290679) is a Phase III, randomised, double-blind, placebo-controlled trial assessing the efficacy, safety and tolerability of simeprevir versus placebo as part of a regimen including peginterferon a-2α (pegIFNα-2a) or pegIFNα-2b/ribavirin (PR) in treatment-naïve patients chronically infected with genotype-1 HCV.Safety and SVR12 results from a primary (Week 60) analysis are presented. Methods: Patients (n=391), randomised 2:1 and stratified by HCV genotype-1 subtype and host IL28B genotype, received simeprevir (150mg QD)+PR or placebo+PR for 12 weeks, followed by PR alone. Total treatment duration was 24 or 48 weeks (simeprevir group) based on response-guided therapy (RGT) criteria (HCVRNA < 25IU/mL Week 4 and undetectable Week 12) or 48 weeks (placebo group). Table 1 Percentage of patients achieving SVR12 Placebo/PR Simeprevir/PR All patients 50% 81% Treated with pegIFNα-2a/pegIFNα-2b 62%/42% 88%/78% Patients who met RGT criteria not applicable 86% IL28B genotype CC/CT/TT 81%/41%/19% 96%/80%/58% HCV subtype 1a or other/1b 46%/53% 80%/82% METAVIR score F0–F2/F3–F4 51%/47% 85%/66% Results: Simeprevir/PR was superior to placebo/PR; SVR12: 81 vs 50%, respectively (p < 0.001). The majority (91%) of simeprevir-treated patients met RGT criteria and completed treatment at Week 24. Overall, 79% of simeprevir and 13% of placebo-treated patients achieved RVR. Treatment with simeprevir/PR led to lower rates of on-treatment failure and relapse compared to placebo/PR (7 vs 32% and 13 vs 24%, respectively). The incidence of AEs was similar between groups, regardless of the pegIFN used. The most common AEs were fatigue, influenza-like illness, pruritus and headache. A slightly higher proportion of simeprevir patients experienced rash and photosensitivity, compared to placebo (27 vs 20% and 4 vs 1%, respectively). There was no difference in the proportion of patients experiencing anaemia. Conclusions: Simeprevir 150mg QD was well tolerated, leading to a high SVR12 rate of 81% when administered with either pegIFNα-2a or pegIFNα-2b. The majority of patients (91%) receiving simeprevir was able to shorten therapy to 24 weeks.-
dc.language.isoeng-
dc.publisherELSEVIER SCIENCE BV-
dc.relation.ispartofJournal of Hepatology-
dc.rightsrestrictedAccess-
dc.titleSIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR TREATMENT OF CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAIVE PATIENTS: RESULTS FROM QUEST-2, A PHASE III TRIAL-
dc.typeconferenceObject-
dc.rights.holderCopyright ELSEVIER SCIENCE BV-
dc.description.conferencedateAPR 24-28, 2013-
dc.description.conferencelocalAmsterdam, NETHERLANDS-
dc.description.conferencenameInternational Liver Congress / 48th Annual Meeting of the European-Association-for-the-Study-of-the-Liver (EASL)-
dc.subject.wosGastroenterology & Hepatology-
dc.type.categorymeeting abstract-
dc.type.versionpublishedVersion-
hcfmusp.author.externalMANNS, M.:Hannover Med Sch, Hannover, Germany-
hcfmusp.author.externalMARCELLIN, P.:Hop Beaujon, Serv Hepatol, Clichy, France-
hcfmusp.author.externalPOORDAD, F. P. Fred:Univ Texas Hlth Sci Ctr San Antonio, Texas Liver Inst, San Antonio, TX 78229 USA-
hcfmusp.author.externalBUTI, M.:Hosp Valle De Hebron, Barcelona, Spain; Ciberhed Inst Carlos III, Barcelona, Spain-
hcfmusp.author.externalHORSMANS, Y.:UCL St Luc, Brussels, Belgium-
hcfmusp.author.externalJANCZEWSKA, E. J. Ewa:NZOZ Pol SaNa Med, Czeladz, Poland-
hcfmusp.author.externalVILLAMIL, F.:CIPREC, Buenos Aires, DF, Argentina-
hcfmusp.author.externalPEETERS, M.:Janssen Infect Dis BVBA, Beerse, Belgium-
hcfmusp.author.externalLENZ, O.:Janssen Infect Dis BVBA, Beerse, Belgium-
hcfmusp.author.externalOUWERKERK-MAHADEVAN, S.:Jansssen Res & Dev, Beerse, Belgium-
hcfmusp.author.externalKALMEIJER, R.:Janssen Global Serv, Titusville, NJ USA-
hcfmusp.author.externalBEUMONT-MAUVIEL, M.:Janssen Infect Dis BVBA, Beerse, Belgium-
hcfmusp.description.beginpageS568-
hcfmusp.description.endpageS568-
hcfmusp.description.issuesuppl 1-
hcfmusp.description.volume58-
hcfmusp.origemWOS-
hcfmusp.origem.idWOS:000322983001671-
hcfmusp.publisher.cityAMSTERDAM-
hcfmusp.publisher.countryNETHERLANDS-
dc.description.indexMEDLINE-
Appears in Collections:

Comunicações em Eventos - HC/ICHC
Instituto Central - HC/ICHC

Comunicações em Eventos - LIM/47
LIM/47 - Laboratório de Hepatologia por Vírus


Files in This Item:
There are no files associated with this item.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.