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Stepped-Dose Efavirenz May Minimize Side Effects

Last Updated: July 07, 2009.

In HIV-positive patients, step-wise administration of efavirenz may reduce neuropsychiatric adverse events and prove just as effective as full-dose administration, according to a study published online July 7 in the Annals of Internal Medicine.

TUESDAY, July 7 (HealthDay News) -- In HIV-positive patients, step-wise administration of efavirenz may reduce neuropsychiatric adverse events and prove just as effective as full-dose administration, according to a study published online July 7 in the Annals of Internal Medicine.

Alicia Gutierrez-Valencia, of the Hospital Universitario de Valme in Seville, Spain, and colleagues randomly assigned 114 patients to receive either a stepped-dose of efavirenz (200 mg/d on days one to six, 400 mg/d on days seven to 13, and 600 mg/d thereafter) or full-dose efavirenz (600 mg/d) plus two nucleoside or nucleotide reverse transcriptase inhibitors.

The researchers found that there were no significant group differences in virologic and immunologic efficacy. During the first week, however, they found that stepped-dose treatment was associated with significantly lower incidences of dizziness (32.8 versus 66 percent), hangover (20.7 versus 45.8 percent), impaired concentration (8.9 versus 22.9 percent), and hallucinations (0 versus 6.1 percent). During the rest of the study, the relative incidences of these events continued to be similar, but event severity was more significant in the full-dose group.

"The sample size does not have enough statistical power for us to draw definitive conclusions about a similar virologic efficacy in both treatment groups," the authors write. "A much larger clinical non-inferiority trial would be required to appropriately evaluate this issue."

Several authors reported financial relationships with the pharmaceutical industry.

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