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Etravirine demonstrates durable efficacy in treatment-experienced patients in the DUET trials: pooled 96-week results
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Reported by Jules Levin
5th IAS Capetown July 19-22 2009
Anthony Mills,1 Pedro Cahn,2 Jean-Michel Molina,3 Steven Nijs,4 Johan Vingerhoets,4 James Witek5
1Private Practice, Los Angeles, USA; 2Fundacion Huesped, Buenos Aires, Argentina; 3Assistance Publique Hopitaux de Paris and University of Paris,
Paris, France; 4Tibotec BVBA, Mechelen, Belgium; 5Tibotec, Yardley, USA
ABSTRACT
Background
The 24- and 48-week efficacy and safety of etravirine (ETR; TMC125) in treatmentexperienced, HIV-1-infected patients have been demonstrated in the Phase III DUET trials. We report detailed efficacy results from a pooled analysis at 96 weeks.
Methods
Patients were randomised 1:1 to either ETR 200mg or placebo, both bid following a meal, in combination with a background regimen (BR) of darunavir (DRV) with
low-dose ritonavir (DRV/r), investigator-selected NRTI(s) ± enfuvirtide (ENF).
Phenotypic Sensitivity Score (PSS; Antivirogram) was used to determine the
number of active agents; ETR was considered active if the fold-change in 50%
effective concentration (FC) was 23.
Results
Five hundred and ninety-nine and 604 patients received ETR + BR or placebo +
BR, respectively. Baseline characteristics were comparable between the treatment groups. Overall, 57% of ETR patients achieved viral load <50 copies/mL at Week 96 compared with 36% of placebo patients. Of patients who achieved viral load <50 copies/mL with ETR + BR at Week 48 (60%), 91% remained undetectable at Week 96. Response was consistently higher in the ETR group, irrespective of gender, race, age and region. Detailed efficacy results by baseline PSS, ETR FC and weighted genotypic score are shown in the table.
Conclusions
The results from the pooled DUET 96-week analysis demonstrate the superior durable efficacy of ETR over placebo. Patients in the ETR group maintained undetectable viral load through 96 weeks, with only a 3% drop from Week 48
(57% vs 60%). In addition, higher responses were observed with ETR versus placebo, irrespective of number of active agents, baseline ETR FC or weighted score.
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