 |
|
|
| |
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
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.
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.
|
| |
|
|
|
|
|
