Top Ten Research Reports of 20033. ACTG 5097s: Impact of Efavirenz on Neuropsychological Performance, Mood and Sleep Behavior in HIV-Positive Individuals
February 2004 Clifford D. B., Evans S., Yang Y. et al. ACTG 5097s: Impact of Efavirenz (EFV) on Neuropsychological Performance, Mood and Sleep Behavior in HIV-Positive Individuals. Presented at: 2nd IAS Conference on HIV Pathogenesis and Treatment; July 13-16, 2003; Paris, France. Abstract 54.
BackgroundThere seem to be two types of U.S. HIV care providers, at least in areas in which potent combination antiretroviral agents are available: those who like efavirenz and those who don't. The latter often predicate their distaste for the current king of antiretrovirals based on the neuropsychiatric toxicities associated with it. Dizziness, sleep disturbance, depression and dissociation have been ascribed to efavirenz, something which has prompted most patients to take this drug prior to going to sleep (despite the additional adverse event of vivid dreams). Although these central nervous system (CNS) adverse effects are reported by the manufacturer to be short-lived, subsiding after a few weeks, there are few data supporting this claim and many providers remain unconvinced, believing the drug has longer-lasting toxicity.As a substudy of A5095 (described earlier) the neuropsychological effects of efavirenz were carefully evaluated with a battery of tests in a subset of 303 participants. What Is New Here?A concentrated evaluation of the CNS effects of efavirenz has not previously been done in a large number of patients. The blinded nature of the study offered added opportunities to dissect efavirenz's impact on patients' thinking and functioning and, in so doing, separate fact from the myth regarding this popular agent.The Bottom LineEfavirenz clearly led to some of the adverse effects it has become well known for, especially dream disturbance, but these side effects vanished by week four. Other neuropsychological adverse effects were not seen to be different from those taking ZDV + 3TC + abacavir. These data are important and help explain the relatively low treatment discontinuation rates (5-10%) observed in the clinical trials of efavirenz. Given the reliance on efavirenz as a preferred anchor of initial antiretroviral therapy and the concerns expressed regarding the CNS effects of this drug (sometimes by competitors), this study is reassuring and finally settles some popularly held beliefs with some real facts.For a complete index of The Body Pro's HIV JournalViews, click here! Please note: Knowledge about HIV changes rapidly. Note the date of this article, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this article.
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