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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
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Reported by Jules Levin
5th IAS Capetown July 19-22 2009
Joseph Eron,1 Richard Haubrich,2 Peter Reiss,3 Melanie Thompson,4 Rainer Weber,5 Steven Nijs,6 James Witek7
1University of North Carolina, North Carolina, USA; 2University of California San Diego, San Diego, USA; 3Universiteit van Amsterdam, Amsterdam,
The Netherlands; 4AIDS Research Consortium of Atlanta, Atlanta, USA; 5University Hospital, Zurich, Switzerland; 6Tibotec BVBA, Mechelen, Belgium;
7Tibotec, Yardley, USA
Abstract
Background
Etravirine (ETR; TMC125) 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 protease inhibitor (PI) resistance were randomised 1:1 to receive ETR 200mg or placebo, both bid following a meal, plus a background regimen (BR) of darunavir (DRV) with low-dose ritonavir (DRV/r), investigator-selected NRTI(s) ± enfuvirtide (ENF). ADI/D was adjudicated prior to database lock by an independent four-member panel blinded to study treatment. Analysis outcome 'per 100 patient years' was performed to account for the differences in treatment duration.
Results
Five hundred and ninety-nine and 604 patients received ETR + BR or placebo + BR, respectively 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 (time-to-loss of virological response [TLOVR]) at Week 96. Adjudicated clinical endpoints are shown.
In both ETR and placebo groups since the previous analysis at Week 48, the number of patients adjudicated with new ADIs was low (ETR; placebo): 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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