Top Ten Research Reports of 2003
3. ACTG 5097s: Impact of Efavirenz on Neuropsychological Performance, Mood and Sleep Behavior in HIV-Positive Individuals
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.
There 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.
Of the 303 subjects enrolled, 200 were taking efavirenz. All the patients were tested at baseline and then again at weeks one, four, 12 and 24 of therapy. Looking strictly at neuropsychological function, there were no statistically or clinically significant differences at the time points between patients who were and those who were not assigned efavirenz. Some efavirenz-specific symptoms, such as bad dreams, were more common in those receiving this drug, but only at the week one evaluation. Interestingly, sleep quality was recorded as better in the efavirenz arms at week four, but subsequently there were differences. Depression and anxiety scales also found no differences between the groups.
The Bottom Line
Efavirenz 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.
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