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Tibotec, a division of Janssen-Cilag, today announced that a new study of treatment-naïve, HIV-1-infected adults met its primary endpoint, showing that after 12 weeks of treatment, significantly fewer patients taking an INTELENCE® (etravirine)-based regimen experienced a drug-related neuropsychiatric event compared with patients taking an efavirenz (EFV)-based regimen (16.5% vs 46.2%, p<0.001).
Data from this Phase 2b trial, known as SENSE, were presented today as a late-breaker presentation at the XVIII International AIDS Conference in Vienna, Austria.
Etravirine, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.
Etravirine is not approved for use in treatment-naïve patients. SENSE was an exploratory trial conducted among treatment-naïve patients so that the neuropsychiatric profile of etravirine could be evaluated in comparison with another ARV in its class, known as non-nucleoside reverse transcriptase inhibitors (NNRTIs).
“Neuropsychiatric events are a common side effect of several antiretroviral therapies, and they can be a significant source of suffering and treatment discontinuation for people with HIV,” said Brian Gazzard, MD, Professor of HIV Medicine and Clinical Research Director at the Chelsea and Westminster Hospital, London. “These findings add to the growing body of data for etravirine and help us better understand the neuropsychiatric profiles of two frequently-used NNRTIs.”
The study showed that at 12 weeks of treatment, at least one drug-related neuropsychiatric adverse event (grades 1-4) occurred in 16.5% of patients taking etravirine compared with 46.2 percent of patients taking EFV, p<0.001.
Neuropsychiatric events included nervous system events (20% for etravirine vs 33% for EFV) and psychiatric events (11% for etravirine vs 39% for EFV). Major differences between etravirine and EFV were seen in dizziness (N=3 vs N=15), somnolence (N=1 vs N=5), abnormal dreams/sleep disorders (N=7 vs N=25), anxiety (N=0 vs N=3), and depression/euphoria (N=1 vs N=6).
The most commonly reported grade 2-4, drug-related adverse events (>=10%) among patients in the etravirine arm vs EFV arm were rash (10.1% vs 11.5%), nervous system disorders (0% vs 11.5%) and psychiatric events (4% vs 10.3%). Discontinuation rates were 12.7% for etravirine and 10.3% EFV.
The study also evaluated lipid elevations for the etravirine group vs the EFV group. Key changes were as follows: total cholesterol elevation, 26.6% vs 43.6%; LDL cholesterol elevation, 16.5% vs 38.5%; and triglyceride elevation, 0.0% vs. 5.2%.
Reductions in HIV RNA at week 12 were the same in both arms (-2.9 log10). The week 12 endpoint is too early to assess percentage of patients whose HIV RNA was reduced to below 50 copies/mL, as many patients are still showing reductions at this stage. Efficacy analyses will be repeated at week 48.
“These findings complement data presented earlier this year at the British HIV Association annual meeting showing that patients who were suffering from grade 2-4 neuropsychiatric events whilst receiving efavirenz showed significant improvements when switched to etravirine,” said Dr. Gazzard.