Please use this identifier to cite or link to this item:
https://open.uns.ac.rs/handle/123456789/4296
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 | Kim K. | en_US |
dc.contributor.author | Kitrinos K. | en_US |
dc.contributor.author | Subramanian G. | en_US |
dc.contributor.author | McHutchison J. | en_US |
dc.contributor.author | Yee L. | en_US |
dc.contributor.author | Elkhashab M. | en_US |
dc.contributor.author | Berg T. | en_US |
dc.contributor.author | Sporea I. | en_US |
dc.contributor.author | Yurdaydin C. | en_US |
dc.contributor.author | Husa P. | en_US |
dc.contributor.author | Jablkowski M. | en_US |
dc.contributor.author | Gane E. | en_US |
dc.date.accessioned | 2019-09-23T10:33:15Z | - |
dc.date.available | 2019-09-23T10:33:15Z | - |
dc.date.issued | 2017-01-01 | - |
dc.identifier.issn | 01688278 | en_US |
dc.identifier.uri | https://open.uns.ac.rs/handle/123456789/4296 | - |
dc.description.abstract | © 2016 European Association for the Study of the Liver Background & Aims Long-term treatment with tenofovir disoproxil fumarate (TDF) alone, or in combination with emtricitabine (FTC) is associated with sustained viral suppression in patients with lamivudine resistant (LAM-R) chronic hepatitis B (CHB). Methods LAM-R CHB patients were randomised 1:1 to receive TDF 300 mg or FTC 200 mg and TDF 300 mg once daily in a prospective, double blind, study. The proportion of patients with plasma hepatitis B virus (HBV) DNA <69 IU/ml (<400 copies/ml) at week 96 (primary efficacy endpoint) was reported previously. Here we present week 240 follow-up data. Results Overall, 280 patients were randomised to receive TDF (n = 141) or FTC/TDF (n = 139), and 85.4% completed 240 weeks of treatment. At week 240, 83.0% of patients in the TDF arm, and 82.7% of patients in the FTC/TDF treatment arm had HBV DNA <69 IU/ml (p = 0.96). Rates of normal alanine aminotransferase (ALT) and normalised ALT were similar between groups (p = 0.41 and p = 0.97 respectively). Hepatitis B e antigen loss and seroconversion at week 240 were similar between groups, (p = 0.41 and p = 0.67 respectively). Overall, six patients achieved hepatitis B surface antigen (HBsAg) loss and one patient (FTC/TDF arm) had HBsAg seroconversion by week 240. No TDF resistance was observed up to week 240. Treatment was generally well tolerated, and renal events were mild and infrequent (∼8.6%). The mean change in bone mineral density at week 240 was −0.98% and −2.54% at the spine and hip, respectively. Conclusions TDF monotherapy was effective and well tolerated in LAM-R CHB patients for up to 240 weeks. Lay summary The goal of oral antiviral treatment for chronic hepatitis B (CHB) is to achieve and maintain undetectable HBV DNA levels. Treatment options with enhanced potency, and low risk of resistance development for patients infected with lamivudine resistant (LAM-R) HBV are required. Tenofovir disoproxil fumarate (TDF) monotherapy was effective and well tolerated without TDF resistance development in CHB patients with LAM-R, for up to 240 weeks. Clinical trial number: NCT00737568. | en |
dc.relation.ispartof | Journal of Hepatology | en |
dc.title | Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study | en_US |
dc.type | Journal/Magazine Article | en_US |
dc.identifier.doi | 10.1016/j.jhep.2016.08.008 | - |
dc.identifier.scopus | 2-s2.0-85000692609 | - |
dc.identifier.url | https://api.elsevier.com/content/abstract/scopus_id/85000692609 | - |
dc.description.version | Unknown | en_US |
dc.relation.lastpage | 18 | en |
dc.relation.firstpage | 11 | en |
dc.relation.issue | 1 | en |
dc.relation.volume | 66 | en |
item.fulltext | No Fulltext | - |
item.grantfulltext | none | - |
Appears in Collections: | MDF Publikacije/Publications |
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