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Once-daily HIV drug OK'd
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September 18, 1998: 11:03 a.m. ET
FDA approves DuPont's Sustiva for treatment of the AIDS virus
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NEW YORK (CNNfn) - The U.S. Food and Drug Administration Friday approved a new once-a-day drug to treat children and adults with HIV, the virus that causes AIDS.
Efavirenz, manufactured under the brand name Sustiva by DuPont (DD), is the third non-nucleoside, reverse transcriptase inhibitor (NNRTI) the FDA has approved.
Although in recent years new HIV drugs have helped reduce the disease from a certain death sentence into a chronic condition, the number of pills patients have to swallow daily has been considered a major obstacle to treatment.
The drug was approved in combination with other anti-HIV drugs after a 24-week study showed it is effective in suppressing HIV, according to the FDA. The effects of efavirenz after 24 weeks hasn't yet been determined.
Efavirenz was granted an accelerated approval by the FDA under regulations that speed the approval of drugs in cases of life-threatening illnesses.
Under those same "fast-track" regulations, the FDA can revoke its approval of efavirenz if the clinical benefits of the drug aren't verified after it has been marketed. 
-- from staff and wire reports
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DuPont
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