Please use this identifier to cite or link to this item:
https://open.uns.ac.rs/handle/123456789/7974
DC Field | Value | Language |
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dc.contributor.author | Fung S. | en_US |
dc.contributor.author | Kwan P. | en_US |
dc.contributor.author | Fabri, Milotka | en_US |
dc.contributor.author | Horban A. | en_US |
dc.contributor.author | Pelemis M. | en_US |
dc.contributor.author | Hann H. | en_US |
dc.contributor.author | Gurel S. | en_US |
dc.contributor.author | Caruntu F. | en_US |
dc.contributor.author | Flaherty J. | en_US |
dc.contributor.author | Massetto B. | en_US |
dc.contributor.author | Dinh P. | en_US |
dc.contributor.author | Corsa A. | en_US |
dc.contributor.author | Subramanian G. | en_US |
dc.contributor.author | McHutchison J. | en_US |
dc.contributor.author | Husa P. | en_US |
dc.contributor.author | Gane E. | en_US |
dc.date.accessioned | 2019-09-30T09:05:45Z | - |
dc.date.available | 2019-09-30T09:05:45Z | - |
dc.date.issued | 2014-01-01 | - |
dc.identifier.issn | 00165085 | en_US |
dc.identifier.uri | https://open.uns.ac.rs/handle/123456789/7974 | - |
dc.description.abstract | Background & Aims Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited. Methods In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination of emtricitabine (FTC, 200 mg; n = 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg)-positive or HBeAg-negative, with levels of HBV DNA ≥3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V ± rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA <69 IU/mL (Roche COBAS Taqman assay; Roche Molecular Systems, Inc, Pleasanton, CA). Results Patient groups were well matched for demographic and disease characteristics, including region (60% from Europe), HBV genotype (45% genotype D), HBeAg status (47% HBeAg-positive), and duration of lamivudine treatment (mean, 3.8 years). At week 96 of treatment, 89.4% of patients in the TDF group and 86.3% in the FTC/TDF group had levels of HBV DNA <69 IU/mL (P =.43). HBeAg loss and seroconversion did not differ between groups; only 1 patient (0.7%) in the FTC/TDF group lost hepatitis B surface antigen. Treatment was well tolerated; confirmed renal events (creatinine increase of ≥0.5 mg/dL [>44 umol/L], creatinine clearance <50 mL/min, or level of PO4 <2 mg/dL [<0.65 mmol/L]) were generally mild and infrequent (<1%). Small reductions (<2%) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups. No TDF resistance developed through 96 weeks of treatment. Conclusions TDF alone is safe and effective for treatment of patients with lamivudine-resistant, chronic HBV infection. Clinical Trials.gov No, NCT00737568. © 2014 by the AGA Institute. | en |
dc.relation.ispartof | Gastroenterology | en |
dc.title | Randomized comparison of Tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B | en_US |
dc.type | Journal/Magazine Article | en_US |
dc.identifier.doi | 10.1053/j.gastro.2013.12.028 | - |
dc.identifier.scopus | 2-s2.0-84896491915 | - |
dc.identifier.url | https://api.elsevier.com/content/abstract/scopus_id/84896491915 | - |
dc.description.version | Unknown | en_US |
dc.relation.lastpage | 988.e1 | en |
dc.relation.firstpage | 980 | en |
dc.relation.issue | 4 | en |
dc.relation.volume | 146 | en |
item.fulltext | No Fulltext | - |
item.grantfulltext | none | - |
Appears in Collections: | MDF Publikacije/Publications |
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