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The SENSE trial: Final 48-week analysis of etravirine (ETR) versus efavirenz (EFV) in treatment-naïve patients
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Reported by Jules Levin
6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, July 2011
Authors: J Rockstroh1, A Streinu-Cercel2, V Pokrovsky3, D Turner4, A. Hill5, Y. van Delft6, S. Marks6.
1. University of Bonn, Germany; 2. Institutul de Boli Infectioase Prof Dr Matei Bals, Bucharest, Romania 3. Federal Center of AIDS Prevention and Treatment , Moscow, Russia
4. Tel Aviv Sourasky Medical Center, Israel, 5. Liverpool University, UK, 6. Janssen, Tilburg, The Netherlands
Background
The Phase 2, double-blinded, placebo controlled SENSE Trial compared 2NRTI + etravirine or efavirenz in 157 treatment naïve patients, for 48 weeks. The primary endpoint was neuropsychiatric adverse events (AEs) up to Week 12; HIV RNA suppression at Week 48 was a secondary endpoint.
Methods
Patients with HIV RNA >5000 copies/mL were randomised to ETR 400mg OD (n=79) or EFV 600mg OD (n=78), plus investigator-selected NRTIs (TDF/FTC, ABC/3TC or ZDV/3TC).
In a pre-planned analysis, HIV RNA <50 copies/mL at Week 48 was assessed using the ITT Time to Loss of Virological Response (TLOVR) algorithm, and compared between arms using logistic regression, adjusted for baseline HIV RNA. Clinical adverse events and Grade 3 / 4 laboratory abnormalities were also evaluated.
RESULTS
Baseline characteristics: 81% male and 89% Caucasian, median age 36 years, median baseline CD4 count of 302 cells/uL and HIV RNA 4.8 log10 copies/mL.
In the ITT TLOVR analysis, 60/79 (76%) patients in the etravirine arm versus 58/78 (74%) in the efavirenz arm had HIV RNA <50 copies/mL at Week 48.
In the On Treatment analyses, there were 92% with HIV RNA <50 copies/mL in the etravirine arm versus 89% in the efavirenz arm. ETR showed non-inferiority versus the EFV (p<0.05), with a delta of -12%.
Four patients had virological failure in the ETR arm: none showed NRTI or NNRTI resistance. Seven patients had virological failure in the EFV arm: three had treatment-emergent NRTI and NNRTI resistance and sustained virological rebound.
The prevalence of Grade 1-4 drug-related NPS AEs peaked at Week 2 (13.9% in the ETR arm and 39.7% in the EFV arm, p<0.001); at the Week 48 visit, the percentage with ongoing NPS AE's was 6.3% for ETR and 21.5% for EFV, p=0.011).
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