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Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials

Christine Katlama, Bonaventura Clotet, Anthony Mills, Benoit Trottier, Jean-Michel Molina, Beatriz Grinsztejn, William Towner, Richard Haubrich, Steven Nijs, Johan Vingerhoets, Brian Woodfall, James Witek

Corresponding author name: Christine Katlama
Corresponding author e-mail: christine.katlama@psl.aphp.fr

Citation: Antiviral Therapy 2010; 15:1045-1052
doi: 10.3851/IMP1662

Date accepted: 22 April 2010
Date published online: 22 September 2010

Abstract

Background: Durable efficacy and long-term safety of antiretroviral therapy are important goals in the management of treatment-experienced patients. The 96-week efficacy and safety of the non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine were evaluated in the Phase III DUET trials.

Methods: HIV type-1-infected treatment-experienced adults with viral loads >5,000 copies/ml and NNRTI and protease inhibitor resistance were randomized to receive etravirine 200 mg or placebo, each twice daily and in combination with a background regimen of darunavir/ritonavir twice daily, nucleoside/nucleotide reverse transcriptase inhibitors and optional enfuvirtide. The primary end point was the proportion of patients with viral load <50 copies/ml (intent-to-treat analysis, time-to-loss of virological response algorithm) at week 24. Results from both trials were combined in the pre-specified pooled 96-week analysis.

Results: In total, 599 patients received etravirine and 604 received placebo. At week 96, 57% of patients in the etravirine group versus 36% in the placebo group had a viral load <50 copies/ml (P<0.0001); 91% and 88% of patients, respectively, had maintained this response from week 48. Mean increases in CD4+ T-cell count from baseline at week 96 were 128 cells/mm3 with etravirine versus 86 cells/mm3 with placebo (P<0.0001). With the exception of rash, which was reported more frequently with etravirine than placebo (21% versus 12%, respectively; P<0.0001), the safety and tolerability profile of etravirine was similar to placebo over the treatment period.

Conclusions: Etravirine, in combination with an antiretroviral background regimen, provided durable virological and immunological responses with no new safety concerns in treatment-experienced patients over 96 weeks in the DUET trials.

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