Tenofovir Is Effective Alone or With Emtricitabine in Adefovir-Treated Patients With Chronic-Hepatitis B Virus Infection

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Volume 139, Issue 4 , Pages 1207-1217.e3, October 2010

Tenofovir Is Effective Alone or With Emtricitabine in Adefovir-Treated Patients

With Chronic-Hepatitis B Virus Infection

Berg

AffiliationsUniversitätsklinik Leipzig, Leipzig, Germany

, Marcellin

AffiliationsHopital Beaujon, Clichy, France

, Fabien Zoulim

AffiliationsINSERM, U871, Université de Lyon, France

, Bernd Moller

AffiliationsPrivate Practice, Berlin, Germany

, Huy Trinh

AffiliationsPrivate Practice, San , California

, Sing Chan

AffiliationsPrivate Practice, Flushing, New York

, Emilio Suarez

AffiliationsHospital Universitario de Valme, Sevilla, Spain

, Fabien Lavocat

AffiliationsINSERM, U871, Université de Lyon, France

, Snow–Lampart

AffiliationsGilead Sciences, Inc, Durham, North Carolina

, Frederick

AffiliationsGilead Sciences, Inc, Durham, North Carolina

, Jeff Sorbel

AffiliationsGilead Sciences, Inc, Durham, North Carolina

, Katyna Borroto–Esoda

AffiliationsGilead Sciences, Inc, Durham, North Carolina

, Oldach

AffiliationsGilead Sciences, Inc, Durham, North CarolinaReprint requests Address

requests for reprints to: Oldach, MD, Gilead Sciences, 4 University Place,

Durham, North Carolina 27707. fax: (919) 493-5925

, Franck Rousseau

AffiliationsGilead Sciences, Inc, Durham, North Carolina

Received 11 December 2009; accepted 16 June 2010. published online 21 June 2010.

Abstract

Background & Aims

We compared treatments for patients with chronic hepatitis B virus (HBV)

infection who had an incomplete response to adefovir dipivoxil (ADV). We

evaluated a combination of fixed-dose emtricitabine (FTC) and tenofovir

disoproxil fumarate (TDF) from the start (early combination) versus TDF as

monotherapy.

Methods

Patients (n = 105) were randomly assigned to groups given TDF (n = 53) or

FTC/TDF (n = 52). End points included HBV DNA suppression, biochemical and

serologic response, and response by baseline or developed resistance mutations

through 48 weeks of treatment. Patients given TDF monotherapy had the option to

receive FTC, as fixed-dose FTC/TDF, if viremia persisted after week 24.

Results

At baseline, patients' mean HBV DNA level was 5.97 log10 copies/mL, and 58% had

received lamivudine (LAM); LAM- and ADV-associated mutations were detected in 13

and 10 patients, respectively, by population sequencing and in 14 and 18

patients, respectively, by reverse hybridization line probe assay (INNO-LiPA HBV

DR). Through week 24 (direct comparison of blinded therapy), viral decay curves

were identical between groups. At week 48, 81% of patients initially given TDF

or TDF/FTC had HBV DNA levels below 400 copies/mL. The presence of baseline LAM-

or ADV-associated mutations did not affect response. Adherence to therapy

appeared to be the primary factor associated with HBV DNA levels below 400

copies/mL at week 48.

Conclusions

TDF monotherapy and the combination of FTC and TDF had similar efficacy in

patients with incomplete viral suppression after therapy with ADV; response was

not influenced by the presence of baseline LAM- or ADV-associated mutations.

Initial monotherapy followed by combination therapy was as effective as early

combination therapy.

Conflicts of interest A. Snow-Lampart, D. Frederick, J. Sorbel, K.

Borroto-Esoda, D. Oldach, and F. Rousseau are/were employees of Gilead Sciences.

All other authors received payment for their participation in the conduct of the

trial.

Funding Supported by Gilead Sciences, and all non-Gilead employees received

payment for their participation in the conduct of trial.

PII: S0016-5085(10)00962-5

doi:10.1053/j.gastro.2010.06.053

© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.