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Comparison of Side Effects With 2 Doses of the HIV Drug Efavirenz FREE

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The summary below is from the full report titled “Stepped-Dose Versus Full-Dose Efavirenz for HIV Infection and Neuropsychiatric Adverse Events. A Randomized Trial.” It is in the 4 August 2009 issue of Annals of Internal Medicine (volume 151, pages 149-156). The authors are A. Gutiérrez-Valencia, P. Viciana, R. Palacios, R. Ruiz-Valderas, F. Lozano, A. Terrón, A. Rivero, and L.F. López-Cortés, for the Sociedad Andaluza de Enfermedades Infecciosas.

Ann Intern Med. 2009;151(3):I24. doi:10.7326/0003-4819-151-3-200908040-00128
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What is the problem and what is known about it so far?

A virus called HIV causes AIDS, an illness that interferes with the body's ability to fight infection and some types of cancer. Transmission of HIV is caused by contact with blood or other body fluids that contain the virus. Treatments containing multiple drugs have improved outcomes for HIV-infected patients. These treatment combinations are known as highly active antiretroviral therapy (HAART). Efavirenz is 1 of the drugs used in HAART and is very effective at fighting HIV infection. However, about one half of persons who take efavirenz develop neuropsychiatric side effects, including trouble sleeping, nightmares, dizziness, depression, suicidal thoughts, hallucinations, and trouble thinking clearly. Although these symptoms usually go away after the first few weeks, some patients have to stop taking the drug because of them.

Why did the researchers do this particular study?

To see whether starting efavirenz at a lower dose and gradually increasing to the full dose over 2 weeks would reduce the side effects.

Who was studied?

144 patients with HIV infection from 7 HIV clinics in Spain who were eligible to start a HAART regimen that included efavirenz plus 2 other drugs.

How was the study done?

The researchers assigned patients at random to a HAART regimen that included either full-dose efavirenz, 600 mg/d from the first day, or stepped-dose efavirenz, at 200 mg/d on days 1 through 6, 400 mg/d on days 7 through 13, and 600 mg/d from day 14 onward. The researchers used questionnaires to collect information on side effects at the beginning of the study and after 7, 14, and 30 days of treatment. They also collected information on viral load after 24 weeks. Viral load is a blood test that measures how well the drugs are working to fight HIV infection.

What did the researchers find?

During the first week of treatment, patients receiving full-dose efavirenz reported more side effects than patients who were receiving the gradually increasing dose. After 24 weeks, the viral load test results were similar in both groups, suggesting that both doses were effective at fighting HIV infection.

What were the limitations of the study?

The study was too small to prove for certain that the 2 doses fought HIV infection equally well.

What are the implications of the study?

Gradually increasing the efavirenz dose for 2 weeks leads to fewer side effects than starting at full dose. This may be a good strategy to prevent side effects that require some patients to stop using this effective drug during the first few weeks of treatment.





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