Tibotec Pharma SENSE Phase 2b Study Met Primary Endpoint

SENSE is an ongoing multi-center, open-label, double-blind, controlled Phase 2b trial designed to show differences in the incidence of treatment-related neuropsychiatric events in treatment-naive patients with no evidence of primary resistance.

The Phase 2b study showed that after 12 weeks of treatment, 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%).

Tibotec Pharma said that the SENSE study was an exploratory trial conducted among treatment-naive 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).

Brian Gazzard, professor of HIV medicine and clinical research director at the Chelsea and Westminster Hospital, London, said: “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. These findings add to the growing body of data for etravirine and help us better understand the neuropsychiatric profiles of two frequently-used NNRTIs.”

“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.”