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FDA approves Sustiva (efavirenz) capsules, first once-daily anti-HIV drug. Food and Drug Administration.


RITA Newsl. 1998 Oct;4(6):13-4. Unique Identifier : AIDSLINE

The U.S. Food and Drug Administration (FDA) has approved Sustiva (efavirenz) as the first HIV drug to have a once-daily dosing schedule. The drug, developed by DuPont Pharmaceuticals, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and will be used in combination with other anti-HIV drugs for both adult and pediatric patients. Results from clinical trials show that Sustiva reduces plasma viral loads to below quantifiable levels in a majority of treatment naive and experienced individuals in two, three, and four drug combinations. It can be taken with or without food, although high fat meals may interfere with absorption and should be avoided. The drug is generally well tolerated, with the most significant side effects being nervous system related, such as insomnia and dizziness. Mild to moderate skin rashes were also reported in one out of four patients. Women should not become pregnant while taking Sustiva because birth defects have been noted in animal studies. Contact information is provided.

NEWSLETTER ARTICLE Clinical Trials *Drug Approval Drug Therapy, Combination HIV Infections/*DRUG THERAPY Human Oxazines/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Reverse Transcriptase Inhibitors/ADMINISTRATION & DOSAGE/ *THERAPEUTIC USE United States *United States Food and Drug Administration


Information in this article was accurate in October 30, 1999. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.