- Oral presentation
- Open Access
The SENSE trial: etravirine shows lower prevalence and severity of neuropsychiatric adverse events compared to efavirenz in treatment-naïve patients
© Stellbrink et al; licensee BioMed Central Ltd. 2010
Published: 8 November 2010
Efavirenz (EFV) treatment is associated with a range of neuropsychiatric (NPS) adverse events (AEs), which differ in duration and severity.
In this double-blind placebo-controlled trial, 157 treatment-naïve patients with HIV RNA >5000 copies/mL, were randomised 1:1 to either etravirine (ETR) 400mg once daily (n=79), or EFV 600mg once daily (n=78), plus two NRTIs. After 12 weeks of randomised treatment, the type and frequency of NPS AEs was compared between treatment arms.
Overall, the patients were 81% male, 85% Caucasian, with a median age of 36 years. Median baseline CD4 Count was 302 cells/uL, median HIV RNA 4.8 log10 copies/mL. In the primary analysis, 13/79 patients (16.5%) in the ETR arm, versus 36/78 (46.2%) in the EFV arm, showed at least one Grade 1-4 treatment-emergent drug-related NPS AE (p<0.001). The most common nervous system was dizziness, reported for 3 patients in the ETR arm versus 15 in the EFV arm. The most common psychiatric adverse events were sleep disorders, reported in 7 patients in the ETR arm versus 25 patients in the EFV arm. The prevalence of Grade 1-4 all cause NPS AEs showed a peak at Week 2 (21.5% in the ETR arm and 43.6% in the EFV arm), but at the Week 12 visit, the percentage with an ongoing Grade 1-4 all cause NPS AE remained different between the arms (21.7% with ETR and 35.7% with EFV). In the ETR arm, 29 all cause NPS adverse events were reported: 20 Grade 1, 7 Grade 2 and 2 Grade 3. In the EFV arm, 93 NPS adverse events were reported: 55 Grade 1, 34 Grade 2 and four Grade 3. New medication for NPS adverse events was started for 7.6% of patients in the ETR arm versus 16.7% of patients in the EFV arm. One patient in the ETR arm and five in the EFV arm discontinued randomized treatment with NPS AE’s.
In the SENSE trial, first-line treatment with ETR 400mg once daily +2NRTIs led to significantly fewer NPS AEs, compared with EFV + 2NRTIs. These NPS AEs were mainly Grade 1 or 2 in severity. The difference between the arms emerged at Week 2, but persisted through Week 12.
This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.