2-YEAR RESULTS OF TELBIVUDINE (LDT) ROADMAP STUDY VERIFY THE OPTIMAL EFFICACY AND SAFETY RESULTS IN HBEAG POSITIVE CHRONIC HEPATITIS B (CHB) PATIENTS

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dc.contributor Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.author PIRATVISUTH, T.
KOMOLMIT, P.
TANWANDEE, T.
SUKEEPAISARNJAROEN, W.
CHAN, H. L.
PESSOA, M. G. FMUSP-HC
FASSIO, E.
ONO-NITA, S. FMUSP-HC
BESSONE, F.
DARUICH, J.
ZEUZEM, S.
CHEINQUER, H.
DONG, Y.
TRYLESINSKI, A.
dc.date.issued 2012
dc.identifier.citation JOURNAL OF HEPATOLOGY, v.56, suppl.2, p.S214-S214, 2012
dc.identifier.issn 0168-8278
dc.identifier.uri http://observatorio.fm.usp.br/handle/OPI/3094
dc.description.abstract Background 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.iso eng
dc.publisher ELSEVIER SCIENCE BV
dc.relation.ispartof Journal of Hepatology
dc.rights restrictedAccess
dc.title 2-YEAR RESULTS OF TELBIVUDINE (LDT) ROADMAP STUDY VERIFY THE OPTIMAL EFFICACY AND SAFETY RESULTS IN HBEAG POSITIVE CHRONIC HEPATITIS B (CHB) PATIENTS
dc.type conferenceObject
dc.rights.holder Copyright ELSEVIER SCIENCE BV
dc.description.conferencedate APR 18-22, 2012
dc.description.conferencelocal Barcelona, SPAIN
dc.description.conferencename 47th Annual Meeting of the European-Association-for-the-Study-of-the-Liver (EASL)
dc.description.group LIM/07
dc.type.category meeting abstract
dc.type.version publishedVersion
hcfmusp.author PESSOA, M. G.:HC:ICHC
hcfmusp.author ONO-NITA, S.:HC:ICHC
hcfmusp.author.external · PIRATVISUTH, T.:Prince Songkla Univ, Songklanagarind Hosp, NKC Inst Gastroenterol & Hepatol, Hat Yai, Taiwan
· KOMOLMIT, P.:Chulalongkorn Univ Hosp, Gastroenterol Unit, Dept Med, Bangkok, Thailand
· TANWANDEE, T.:Siriraj Hosp, Bangkok, Thailand
· SUKEEPAISARNJAROEN, W.:Khon Kaen Univ, Srinagarind Hosp, Khon Kaen, Thailand
· CHAN, H. L.:Chinese Univ Hong Kong, Hong Kong, Hong Kong, Peoples R China
· FASSIO, E.:Hosp Nacl Prof Alejandro Posadas, Buenos Aires, DF, Argentina
· BESSONE, F.:Univ Nacl Rosario, Catedra Clin Med, Rosario, Antigua & Barbu
· DARUICH, J.:Univ Buenos Aires, Hosp Clin San Martin, Buenos Aires, DF, Argentina
· ZEUZEM, S.:Klinikum Johann Wolfgang Goethe Univ, Frankfurt, Germany
· CHEINQUER, H.:Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil
· DONG, Y.:Novartis Pharma AG, Basel, Switzerland
· TRYLESINSKI, A.:Novartis Pharma AG, Basel, Switzerland
hcfmusp.origem.id WOS:000303241301099
hcfmusp.publisher.city AMSTERDAM
hcfmusp.publisher.country NETHERLANDS
dc.description.index MEDLINE
hcfmusp.citation.wos 5
hcfmusp.affiliation.country Brasil
hcfmusp.affiliation.country Suíça
hcfmusp.affiliation.country Taiwan
hcfmusp.affiliation.country Tailândia
hcfmusp.affiliation.country China
hcfmusp.affiliation.country Argentina
hcfmusp.affiliation.country Alemanha


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