- Poster presentation
- Open Access
Reduction in AIDS defining events/deaths with etravirine (ETR; TMC125) compared to placebo: pooled DUET 48-week results
© Haubrich et al; licensee BioMed Central Ltd. 2008
- Published: 10 November 2008
- Mycobacterium Avium
- Mycobacterium Avium Complex
- Nucleoside Reverse Transcriptase Inhibitor
The benefit of newer antiretroviral regimens on clinical end-points for treatment-experienced, HIV-1-infected patients remains to be determined. Etravirine (ETR) demonstrated durable efficacy and safety in HIV-1 infected, treatment-experienced patients in the phase III DUET trials. We report adjudicated clinical end-points from a pre-specified pooled analysis of DUET-1 and DUET-2 after 48 weeks of treatment.
Patients were randomised 1:1 to receive either ETR 200 mg BID or placebo, both in combination with a background regimen of darunavir/r, investigator-selected nucleoside reverse transcriptase inhibitors and optional enfuvirtide (ENF). AIDS-defining events/deaths (ADE/D) were adjudicated by a 4-member independent panel masked to treatment assignment. All events were adjudicated, and only those confirmed or probable ADE/D were included in the analysis. Pre-specified analyses were stratified by de novo or not de novo (including recycled ENF or ENF not used) ENF use.
In addition to virological and immunological benefits, use of ETR was associated with a reduction in ADE/D and a significantly longer time to ADE/D than placebo in treatment-experienced, HIV-1-infected patients.
This article is published under license to BioMed Central Ltd.