SNFGE SNFGE
 
Thématique :
- Foie
Originalité :
Intermédiaire
Solidité :
Intermédiaire
Doit faire évoluer notre pratique :
Dans certains cas
 
 
Nom du veilleur :
Docteur Bertrand HANSLIK
Coup de coeur :
 
 
Gut
  2016/05  
 
  2016 May;65(5):852-60  
  doi: 10.1136/gutjnl-2014-308353  
 
  Tenofovir monotherapy versus tenofovir and entecavir combination therapy in patients with entecavir-resistant chronic hepatitis B with multiple drug failure: results of a randomised trial.  
 
  Lim YS, Byun KS, Yoo BC, Kwon SY, Kim YJ, An J, Lee HC, Lee YS  
  http://www.ncbi.nlm.nih.gov/pubmed/25596179  
 
 

OBJECTIVE:

Little clinical data are available regarding the optimal treatment of patients who harbour entecavir (ETV)-resistant HBV.

DESIGN:

In this multicentre randomised trial, patients who had HBV with ETV resistance-associated mutations and serum HBV DNA concentrations >60 IU/mL were randomised to receive tenofovir disoproxil fumarate (TDF, 300 mg/day) monotherapy (n=45) or TDF and ETV (1 mg/day) combination therapy (n=45) for 48 weeks.

RESULTS:

Baseline characteristics were comparable between groups, including HBV DNA levels (median, 4.02 log10 IU/mL) and hepatitis B e antigen-positivity (89%). All patients had at least one ETV-resistance mutation: rtT184A/C/F/G/I/L/S (n=49), rtS202G (n=43) and rtM250L/V (n=7), in addition to rtM204V/I (n=90). All except one patient in the TDF group completed 48 weeks of treatment. At week 48, the proportion of patients with HBV DNA <15 IU/mL, the primary efficacy endpoint, was not significantly different between the TDF and TDF+ETV groups (71% vs 73%; p>0.99). The mean change in HBV DNA levels from baseline was not significantly different between groups (-3.66 vs -3.74 log10 IU/mL; p=0.81). Virological breakthrough occurred in one patient on TDF, which was attributed to poor drug adherence. At week 48, six and three patients in the TDF and TDF+ETV groups, respectively, retained their baseline resistance mutations (p>0.99). None developed additional resistance mutations. Safety profiles were comparable in the two groups.

CONCLUSIONS:

TDF monotherapy for 48 weeks provided a virological response comparable to that of TDF and ETV combination therapy in patients infected with ETV-resistant HBV.

 
Question posée
 
Patients résistants à l’entécavir : comparaison entre addition ou remplacement par le ténofovir.
 
Question posée
 
Le switch fait aussi bien que l’add on (ADN <15 UI : 72% à 48 semaines).
 
Commentaires

Etude ouverte chez des patients asiatiques (89% HBe). Seulement 5% de seroconversion HBe.

 
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