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Long-term safety profile of etravirine in treatment-experienced, HIV-1-infected
patients: pooled 96-week results from the Phase III DUET trials
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Reported by Jules Levin
5th IAS Capetown July 19-22 2009
Thomas Campbell,1 Beatriz Grinsztejn,2 Jukka Hartikainen,3 Steven Nijs,4 James Witek5
1University of Colorado Denver, Denver, USA; 2Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil;
3Epimed c/o Auguste Viktoria Klinikum, Berlin, Germany; 4Tibotec BVBA, Mechelen, Belgium; 5Tibotec, Yardley, USA
CONCLUSIONS
ABSTRACT
Background
Etravirine (ETR; TMC125) is a next-generation NNRTI with superior efficacy versus placebo in treatment-experienced, HIV-1-infected patients in the DUET-1 and DUET-2 trials. Previous analyses of 48-week data from DUET showed that, except for rash, the incidence/severity of adverse events (AEs) with ETR were similar to placebo. We report the safety profile of ETR at 96 weeks.
Methods
Patients with documented NNRTI resistance and 33 primary protease inhibitor (PI) mutations were randomised to ETR 200mg or placebo bid with a background regimen (BR) of darunavir (DRV) with low-dose ritonavir (DRV/r), investigator-selected NRTI(s) ± enfuvirtide (ENF). Safety data from DUET-1 and DUET-2 were pooled and the frequency, severity and type of AEs were compared between arms by Fisher's exact test.
Results
One thousand, two hundred and three patients were randomised to ETR or placebo (599 and 604, respectively). Overall median age was 45 years; 10.7% were female. Median duration of treatment was 96 vs 70 weeks. The most common reasons for treatment discontinuation were virological endpoints (16% vs 40%) and AEs (9% vs 7%). Serious AEs occurred in 26% of both arms, death in 3% vs 4%.
Rash in the ETR + BR group was mild-to-moderate, occurred early with 2 weeks median duration and led to discontinuation in 2.2% of patients. The occurrence of nervous system, psychiatric and hepatic AEs was low in both arms. Grade 3/4 treatment-emergent laboratory abnormalities were similar between groups.
Conclusions
ETR was well tolerated in treatment-experienced, HIV-1-infected adults over 96 weeks and continues to demonstrate a tolerability profile similar to placebo. Rash, which was mostly mild-to-moderate and occurred early, was the only AE associated with ETR treatment.
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