Efficacy and tolerance of a combination of tenofovir disoproxil fumarate plus emtricitabine in patients with chronic hepatitis B: a European multicenter study.

Abstract

BACKGROUND AND AIMS:

The combination of tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) is used extensively to treat HIV infection and also has potent activity against hepatitis B virus (HBV) infection. The aim of this study was to assess the efficacy and tolerance of TDF + FTC in patients with chronic hepatitis B (CHB).

METHODS:

Seventy eight consecutive CHB patients from five European centers were included. All started a TDF + FTC combination between October 2005 and March 2010. Virological, biochemical, and clinical data were recorded during follow-up. Tolerance was also monitored. Patients were classified into either treatment simplification (TS), where efficacy of the previous treatment was obtained at TDF + FTC initiation, and treatment intensification (TI), where the previous line of therapy had failed.

RESULTS:

TDF + FTC was given as a TI to 54 patients (69%) and as a TS to 24 (31%). Among patients with TI, 83% were males. The median baseline HBV-DNA was 4.4 log10 IU/mL, and median alanine-transaminase (ALT) was 1.10 × ULN. Sixty percent were HBeAg positive, 47% had significant fibrosis (≥ F3 Metavir equivalent), and 29% had confirmed cirrhosis. Median treatment duration was 76 weeks (interquartile range 60-116). Kaplan-Meier analysis showed that, 48 weeks after TI, the probability of being HBV-DNA becoming undetectable was 76%, and reached 94% at week 96. No viral breakthrough occurred. Patients with TS (87% males, median baseline HBV-DNA 1.1 log10 IU/mL, median ALT 0.79 × ULN, 33% HBeAg positive, 61% with significant fibrosis) were treated for a median duration of 76 weeks. In this subgroup, all patients but one remained HBV-DNA undetectable and no ALT flare-up occurred during follow-up. Creatinine levels did not show kidney-function deterioration in either group of patients.

CONCLUSIONS:

After a median follow-up of > 76 weeks, the TDF + FTC combination showed encouraging antiviral efficacy and a good safety profile in all patients with CHB. TDF + FTC may represent an interesting clinical option to simplify therapy and increase the barrier to resistance, which should be assessed in the long term.

• Authors: Si-Nafa Si-Ahmed, Pierre Pradat, Roeland Zoutendijk, Maria Buti, Vincent Mallet, Claire Cruiziat, Katja Deterding, Jérôme Dumortier, François Bailly, Rafael Esteban, Heiner Wedemeyer, Harry L Janssen, Fabien Zoulim
• Journal: Antiviral research (Antiviral Res) Vol. 92 Issue 1 Pg. 90-5 (Oct 2011) ISSN: 1872-9096 [Electronic] Netherlands
• PMID: 21767570 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 Elsevier B.V. All rights reserved.

Chemical References

• Antiviral Agents
• Organophosphonates
• Deoxycytidine
• Tenofovir
• Emtricitabine
• Adenine

Topics

• Adenine (administration & dosage, adverse effects, analogs & derivatives)
• Adult
• Aged
• Antiviral Agents (administration & dosage)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Drug Therapy, Combination
• Emtricitabine
• Europe
• Follow-Up Studies
• Hepatitis B, Chronic (drug therapy)
• Humans
• Male
• Middle Aged
• Organophosphonates (administration & dosage, adverse effects)
• Tenofovir