Please use this identifier to cite or link to this item: https://observatorio.fm.usp.br/handle/OPI/3094
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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP-
dc.contributor.authorPIRATVISUTH, T.-
dc.contributor.authorKOMOLMIT, P.-
dc.contributor.authorTANWANDEE, T.-
dc.contributor.authorSUKEEPAISARNJAROEN, W.-
dc.contributor.authorCHAN, H. L.-
dc.contributor.authorPESSOA, M. G.-
dc.contributor.authorFASSIO, E.-
dc.contributor.authorONO-NITA, S.-
dc.contributor.authorBESSONE, F.-
dc.contributor.authorDARUICH, J.-
dc.contributor.authorZEUZEM, S.-
dc.contributor.authorCHEINQUER, H.-
dc.contributor.authorDONG, Y.-
dc.contributor.authorTRYLESINSKI, A.-
dc.date.accessioned2013-10-11T21:30:47Z-
dc.date.available2013-10-11T21:30:47Z-
dc.date.issued2012-
dc.identifier.citationJOURNAL OF HEPATOLOGY, v.56, suppl.2, p.S214-S214, 2012-
dc.identifier.issn0168-8278-
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/3094-
dc.description.abstractBackground and Aims: The roadmap concept based on Week 24 HBV DNA levels was prospectively validated with 1year results of Roadmap study (A2410) as previously reported. The 2 year results are reported here. Patients and Methods: All patients were HBeAg positive and started LDT monotherapy from baseline and Tenofovir (LDT) was added to patients with detectable (≥300 copies/ml) HBV DNA at 24w until 104w. Results: 105 patients were enrolled and 100 patients were eligible for modified ITT (mITT) analysis (1 patient with baseline M204I mutation, 2 lost follow-up and 2 didn’t follow roadmap concept). At 24w, 55 patients achieved undetectable HBV DNA and 45 patients with detectable HBV DNA added with TDF (73% of the 45 patients with baseline HBV DNA > 9log10 copies/ml). At 104w, 94% had undetectable HBV DNA, 50%/44% HBeAg loss/seroconversion, 7%/4% HBsAg loss/seroconversion. One patient in LDT mono-treated arm had Virologic Breakthrough (VB) at Week 72 and detected M204I mutation; achieved undetectable HBV DNA 8wks after TDF add-on. One LDT mono-treated patient had one time of HBV DNA increase of 1 log10 above nadir (assessment ongoing). Both patients had baseline HBV DNA > 9log10 copies/ml. In the overall safety population, Serious Adverse Events (SAEs) was reported in 6/105 (5.7%) patients and all unrelated to treatment. No case of myopathy/myositis was reported. Overall GFR (by MDRD formula) improvement was +6.4 and +8.6ml/min/1.73m2 in LDT mono and LDT+TDF group respectively. In patients with abnormal baseline GFR (60–90ml/min/1.73m2), GFR improvement at 2yr was +12.0 and +1.5ml/min/1.73m2 in LDT and LDT+TDF respectively. 50% and 40% of patients with abnormal baseline GFR (60–90ml/min/1.73m2) in LDT and LDT+TDF group respectively shifted to normal (>90ml/min/1.73m2) at 2yr. Only 1 patient in TDF add-on group had once creatinine increase to 232 μmol/L at Week 96, and returned to 91 μmol/L within 4 days. Conclusion: Telbivudine roadmap with tenofovir add-on at 24 weeks in patients with detectable HBVDNA improved GFR in both LDT and LDT+TDF treated patients, as well as favorable efficacy and safety profiles.-
dc.language.isoeng-
dc.publisherELSEVIER SCIENCE BV-
dc.relation.ispartofJournal of Hepatology-
dc.rightsrestrictedAccess-
dc.title2-YEAR RESULTS OF TELBIVUDINE (LDT) ROADMAP STUDY VERIFY THE OPTIMAL EFFICACY AND SAFETY RESULTS IN HBEAG POSITIVE CHRONIC HEPATITIS B (CHB) PATIENTS-
dc.typeconferenceObject-
dc.rights.holderCopyright ELSEVIER SCIENCE BV-
dc.description.conferencedateAPR 18-22, 2012-
dc.description.conferencelocalBarcelona, SPAIN-
dc.description.conferencename47th 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.externalPIRATVISUTH, T.:Prince Songkla Univ, Songklanagarind Hosp, NKC Inst Gastroenterol & Hepatol, Hat Yai, Taiwan-
hcfmusp.author.externalKOMOLMIT, P.:Chulalongkorn Univ Hosp, Gastroenterol Unit, Dept Med, Bangkok, Thailand-
hcfmusp.author.externalTANWANDEE, T.:Siriraj Hosp, Bangkok, Thailand-
hcfmusp.author.externalSUKEEPAISARNJAROEN, W.:Khon Kaen Univ, Srinagarind Hosp, Khon Kaen, Thailand-
hcfmusp.author.externalCHAN, H. L.:Chinese Univ Hong Kong, Hong Kong, Hong Kong, Peoples R China-
hcfmusp.author.externalFASSIO, E.:Hosp Nacl Prof Alejandro Posadas, Buenos Aires, DF, Argentina-
hcfmusp.author.externalBESSONE, F.:Univ Nacl Rosario, Catedra Clin Med, Rosario, Antigua & Barbu-
hcfmusp.author.externalDARUICH, J.:Univ Buenos Aires, Hosp Clin San Martin, Buenos Aires, DF, Argentina-
hcfmusp.author.externalZEUZEM, S.:Klinikum Johann Wolfgang Goethe Univ, Frankfurt, Germany-
hcfmusp.author.externalCHEINQUER, H.:Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil-
hcfmusp.author.externalDONG, Y.:Novartis Pharma AG, Basel, Switzerland-
hcfmusp.author.externalTRYLESINSKI, A.:Novartis Pharma AG, Basel, Switzerland-
hcfmusp.description.beginpageS214-
hcfmusp.description.endpageS214-
hcfmusp.description.issuesuppl 2-
hcfmusp.description.volume56-
hcfmusp.origemWOS-
hcfmusp.origem.idWOS:000303241301099-
hcfmusp.publisher.cityAMSTERDAM-
hcfmusp.publisher.countryNETHERLANDS-
dc.description.indexMEDLINE-
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Comunicações em Eventos - HC/ICHC
Instituto Central - HC/ICHC

Comunicações em Eventos - LIM/07
LIM/07 - Laboratório de Gastroenterologia Clínica e Experimental


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