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The SENSE trial: etravirine (ETR) QD shows fewer neuropsychiatric adverse events than efavirenz (EFV) in treatment-naïve HIV-1 infected patients
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Vienna 18th IAC July 2010
B. Gazzard1, G. Di Perri2, H. Furrer3, P. Domingo4, A. Hill5, Y. van Delft6, J. Vingerhoets7, T. Stark8, S. Marks6
1Chelsea and Westminster Hospital, St Stephens Centre, London, United Kingdom, 2Ospedale Amedeo Di Savoia, Turin, Italy, 3Universitätsspital Zürich, Zurich, Switzerland, 4Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 5University of Liverpool, Liverpool, United Kingdom, 6Janssen-Cilag, Tilburg, Netherlands, 7Tibotec BVBA, Mechelen, Belgium, 8Janssen-Cilag, Neuss, Germany
Background: Neuropsychiatric adverse events (AEs) are a common problem with efavirenz treatment.
Methods: In the double-blinded, placebo controlled SENSE trial, 157 treatment-naïve patients with HIV RNA >5000 copies/mL were randomised to ETR 400mg once daily (n=79) or EFV 600mg once daily (n=78), plus two investigator-selected NRTIs (TDF/FTC, ABC/3TC or ZDV/3TC). The primary endpoint was the percentage of patients with Grade 1-4 drug-related treatment-emergent neuropsychiatric AEs at Week 12.
Results: The patients were 81% male and 85% Caucasian, with median age 36 years, baseline CD4 count 302 cells/uL and HIV RNA 4.8 log10 copies/mL, well balanced between the arms.
In the Intent to Treat analysis, Grade 1-4 drug-related neuropsychiatric (NPS) AEs were reported in 13/79 patients (16.5%) in the ETR arm versus 36/78 (46.2%) in the EFV arm (p< 0.001).
Grade 2-4 drug-related NPS AE's were reported in 4/79 (5.1%) in the ETR arm versus 13/78 (16.7%) in the EFV arm (p=0.019). Consistent results were seen for the Per Protocol analysis.
Using the HIV-Patient Symptoms Profile questionnaire, patients in the ETR arm also reported better neuropsychiatric tolerability than patients in the EFV arm.
The reduction in HIV RNA to Week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 count was +146 cells/uL in the ETR arm and +121 cells/uL in the EFV arm. Eighteen patients discontinued the trial by Week 12 (10 in ETR arm, 8 in EFV arm). There were fewer Grade 2-4 elevations in total cholesterol and LDL cholesterol in the ETR arm (3 and 6 patients) versus the EFV arm (18 and 13 patients).
Conclusions: After 12 weeks, first-line treatment with ETR 400mg once daily +2NRTIs led to significantly fewer neuropsychiatric adverse events and an improved lipid profile, compared with EFV+2NRTIs. The virologic and immunologic efficacy profiles were similar in the two arms.
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