Randomized comparison of Tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B

Scott Fung, Peter Kwan, Milotka Fabri, Andrzej Horban, Mijomir Pelemis, Hie Won Hann, Selim Gurel, Florin A. Caruntu, John F. Flaherty, Benedetta Massetto, Phillip Dinh, Amoreena Corsa, G. Mani Subramanian, John G. McHutchison, Petr Husa, Edward Gane

Research output: Contribution to journalArticle

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 44 umol/L], creatinine clearance 4

Original languageEnglish (US)
Pages (from-to)980-988
Number of pages9
JournalGastroenterology
Volume146
Issue number4
DOIs
StatePublished - 2014
Externally publishedYes

Fingerprint

Tenofovir
Lamivudine
Chronic Hepatitis B
Hepatitis B virus
Hepatitis B e Antigens
RNA-Directed DNA Polymerase
DNA
Virus Diseases
Amino Acid Substitution
Creatinine
Mutation
Emtricitabine

Keywords

  • HBV DNA
  • Hepatitis B e Antigen
  • Renal Function
  • Viral Suppression

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Randomized comparison of Tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B. / Fung, Scott; Kwan, Peter; Fabri, Milotka; Horban, Andrzej; Pelemis, Mijomir; Hann, Hie Won; Gurel, Selim; Caruntu, Florin A.; Flaherty, John F.; Massetto, Benedetta; Dinh, Phillip; Corsa, Amoreena; Subramanian, G. Mani; McHutchison, John G.; Husa, Petr; Gane, Edward.

In: Gastroenterology, Vol. 146, No. 4, 2014, p. 980-988.

Research output: Contribution to journalArticle

Fung, S, Kwan, P, Fabri, M, Horban, A, Pelemis, M, Hann, HW, Gurel, S, Caruntu, FA, Flaherty, JF, Massetto, B, Dinh, P, Corsa, A, Subramanian, GM, McHutchison, JG, Husa, P & Gane, E 2014, 'Randomized comparison of Tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B', Gastroenterology, vol. 146, no. 4, pp. 980-988. https://doi.org/10.1053/j.gastro.2013.12.028
Fung, Scott ; Kwan, Peter ; Fabri, Milotka ; Horban, Andrzej ; Pelemis, Mijomir ; Hann, Hie Won ; Gurel, Selim ; Caruntu, Florin A. ; Flaherty, John F. ; Massetto, Benedetta ; Dinh, Phillip ; Corsa, Amoreena ; Subramanian, G. Mani ; McHutchison, John G. ; Husa, Petr ; Gane, Edward. / Randomized comparison of Tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B. In: Gastroenterology. 2014 ; Vol. 146, No. 4. pp. 980-988.
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