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Neuropscyh Side Effect Rate Lower With Etravirine Than Efavirenz at 12 Weeks
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Tenth International Congress on Drug Therapy in HIV Infection, November 7-11, 2010, Glasgow
Mark Mascolini
Rates of neuropsychiatric side effects and grade 2 to 4 drug-related adverse events were significantly lower with etravirine than with efavirenz after 12 weeks of SENSE, a double-blind, placebo-controlled trial that enrolled antiretroviral-naive people in six European countries [1].
Study participants had a viral load above 5000 copies and no genotypic or phenotypic evidence of resistance. The SENSE investigators randomized 167 enrollees to once-daily etravirine or efavirenz with zidovudine/lamivudine, abacavir/lamivudine, or tenofovir/emtricitabine. The primary objective was to compare rates of treatment-emergent grade 1 to 4 neuropsychiatric side effects judged possibly related to study drugs at week 12.
Age averaged 38 years in both treatment arms, and 55% randomized to etravirine versus 77% randomized to efavirenz were men. If it is true that men are less willing to report neuropsych symptoms than women, that gender distribution would favor the efavirenz group. More than 80% of enrollees were white, and only 2% had AIDS. Pretreatment CD4 count averaged 331 in the etravirine group and 302 in the efavirenz group. Respective pretreatment viral loads were 4.8 and 4.9 log. About one third in each group had a viral load above 100,000 copies.
At week 12, with treatment assignment still unknown to participants and physicians, SENSE investigators counted 13 drug-related grade 1 to 4 neuropsychiatric events in the etravirine arm and 36 in the efavirenz arm, a highly significant difference (16.5% versus 46.2%, P < 0.001). Twenty-two people randomized to etravirine and 43 randomized to efavirenz had any neuropsychiatric complaint (27.8% versus 55.1%, P < 0.001).
Treatment-emergent neuropsychiatric problems requiring new medication affected 13 people taking efavirenz (16.7%) and 6 (7.6%) taking etravirine. People taking efavirenz reported dizziness and sleep disorders significantly more often than those taking etravirine.
Twenty-five people assigned to efavirenz (32.1%) versus 16 (20.3%) assigned to etravirine had any grade 2 to 4 drug-related adverse event. Nine people (11.6%) taking efavirenz and 1 taking etravirine (1%) reported central nervous system problems. Eight people in the efavirenz group (10.3%) and 3 in the etravirine group (4%) had psychiatric problems. Nine people taking efavirenz (11.5%) and 8 taking etravirine (10.1%) had skin or subcutaneous adverse events.
Reference
1. Stellbrink HJ, Rugina S, Zagler C, et al. The SENSE trial: etravirine shows lower prevalence and severity of neuropychiatric adverse events compared to efavirenz in treatment-naive patients. Tenth International Congress on Drug Therapy in HIV Infection. November 7-11, 2010. Glasgow. Abstract O431.
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