icon-folder.gif   Conference Reports for NATAP  
 
  EACS - 12th European AIDS Conference
November 11-14, 2009
Cologne, Germany
Back grey_arrow_rt.gif
 
 
 
Etravirine demonstrates a favourable safety and tolerability profile versus placebo irrespective of hepatitis co-infection:
Week 96 analysis from the DUET trials

 
 
  Reported by Jules Levin
EACS Nov 13 2009 Cologne Germany
 
Bonaventura Clotet,1 Christine Katlama,2 Nathan Clumeck,3 Steven Nijs,4 James Witek5 1Hospital Universitari Germans Trias i Pujol and irsiCaixa Foundation, UAB, Barcelona, Spain; 2Groupe Hospitalier Pitie-Salpetriere, Paris, France; 3Saint-Pierre University Hospital, Department of Infectious Diseases, Brussels, Belgium; 4Tibotec BVBA, Mechelen, Belgium; 5Tibotec Inc., Yardley, PA, USA
 

image002.gif

ABSTRACT
 
Objectives

Etravirine (ETR; TMC125) has demonstrated long-term, durable efficacy, with a safety profile similar to placebo in treatment-experienced, HIV-1-infected patients. We report 96-week pooled safety and tolerability data from the Phase III DUET trials in patients co-infected with hepatitis B and/or C virus (HBV/HCV).
 
Methods
Stable, virologically failing HIV-1-infected patients with documented resistance were randomised to either ETR 200mg bid or placebo, with a background regimen (BR) of darunavir with low-dose ritonavir (DRV/r), investigator-selected NRTIs ± enfuvirtide (ENF). HBV/HCV co-infection status was confirmed by hepatitis B surface antigen or HCV antibody and qualitative HCV ribonucleic acid. Co-infected patients were eligible if they did not require anti-hepatitis treatment and were clinically stable, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <5 x the upper limit of normal (ULN). Adverse events (AEs) and laboratory parameters were analysed.
 
Results
Co-infection data were available for 566 ETR + BR and 564 placebo + BR patients, of which 12.4% were co-infected with HBV/HCV. Sample numbers were too small to allow individual HBV and HCV analyses. In co-infected patients, the incidence of grade 3 or 4 AEs, serious AEs (SAEs) and deaths was comparable among the treatment groups. Consistent with the underlying hepatitis co-infection, the incidence of hepatic AEs and grade 3 or 4 AST/ALT elevations was higher in co-infected patients than in non-co-infected patients in both treatment groups; co-infected patients in the ETR + BR group reported the highest incidence of hepatic events although discontinuation due to hepatic AEs was low and comparable between the treatment groups.
 

image004.gif

Conclusions
Patients co-infected with HBV/HCV reported a higher incidence of hepatic AEs and grade 3 or 4 ALT/AST elevations versus those patients not co-infected. The incidence and severity of overall AEs with ETR + BR was comparable to placebo + BR, regardless of co-infection status.
 

image006.gif

image008.gif

image010.gif

image012.gif

image014.gif

image016.gif

image018.gif

image020.gif

image022.gif

image024.gif

image026.gif

image028.gif

image030.gif