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Clinical endpoints reduced through etravirine use in treatment-experienced, HIV-1-infected patients: pooled 96-week results from the phase III DUET trials
J. Eron1, R. Haubrich2, P. Reiss3, M. Thompson4, R. Weber5, S. Nijs6, J. Witek7
1University of North Carolina, Chapel Hill, NC, United States, 2University of California, San Diego, CA, United States, 3Universiteit van Amsterdam, Amsterdam, Netherlands, 4AIDS Research Consortium of Atlanta, Atlanta, GA, United States, 5University Hospital, Zurich, Switzerland, 6Tibotec BVBA, Mechelen, Belgium, 7Tibotec Inc., Yardley, PA, United States
Background: Etravirine (ETR) showed durable efficacy/safety in the Phase III DUET trials. Pooled 48-week results from DUET showed a significant reduction in adjudicated AIDS-defining illness and/or death (ADI/D) in patients receiving ETR versus placebo. We present pooled Week 96 adjudicated ADI/D results.
Methods: Treatment-experienced patients with documented NNRTI and PI resistance were randomised 1:1 to receive ETR 200mg or placebo, both bid following a meal, plus a background regimen (BR) of darunavir/ritonavir, investigator-selected NRTI(s) ± enfuvirtide. ADI/D was adjudicated prior to database lock by an independent 4-member panel blinded to study treatment. Analysis outcome 'per 100 patient years' was performed to account for the differences in treatment duration.
Results: 599/604 patients received ETR+BR/placebo+BR, with median treatment duration of 96.0/69.6 weeks, respectively. Overall, 57% of ETR patients and 36% of placebo patients achieved viral load < 50 copies/mL (TLOVR) at Week 96. Adjudicated clinical endpoints are shown.
[Clinical outcomes]
In both ETR and placebo groups since the previous analysis at Week 48, the number of patients adjudicated with new ADIs was low: herpes zoster multi-dermatomal (3; 3), herpes simplex (3; 0); Hodgkin's disease (2; 0); oesophageal candidiasis (1; 1); diffuse large B-cell lymphoma (1; 0); Kaposi's sarcoma (1; 0); cytomegalovirus gastritis (0;1); pneumonia (0; 1); pulmonary aspergillosis (0; 1).
Conclusions: In addition to improving virological endpoints, ETR demonstrated reductions in ADI/D versus placebo through 96 weeks of treatment. In both treatment groups, few patients had new adjudicated ADIs between Weeks 48 and 96.
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