title: Efficacy and tolerance of a combination of tenofovir disoproxil fumarate plus emtricitabine in patients with chronic hepatitis B: a European multicenter study.
abstract: OBJECTIVE
  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.affiliation: Hospices Civils de Lyon, Hepatology Department, Lyon, France.
authors.forename: Si-Nafa
authors.initials: SN
authors.lastname: Si-Ahmed
authors.forename: Pierre
authors.initials: P
authors.lastname: Pradat
authors.forename: Roeland
authors.initials: R
authors.lastname: Zoutendijk
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.forename: Vincent
authors.initials: V
authors.lastname: Mallet
authors.forename: Claire
authors.initials: C
authors.lastname: Cruiziat
authors.forename: Katja
authors.initials: K
authors.lastname: Deterding
authors.forename: Jérôme
authors.initials: J
authors.lastname: Dumortier
authors.forename: François
authors.initials: F
authors.lastname: Bailly
authors.forename: Rafael
authors.initials: R
authors.lastname: Esteban
authors.forename: Heiner
authors.initials: H
authors.lastname: Wedemeyer
authors.forename: Harry L
authors.initials: HL
authors.lastname: Janssen
authors.forename: Fabien
authors.initials: F
authors.lastname: Zoulim
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005060:Europe; D005500:Follow-Up Studies; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D000068698:Tenofovir
chemical_list: D000998:Antiviral Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine