Supplement-HIV drug fully approved
Supplement-HIV drug fully approved
Sustiva (efavirenz), manufactured by DuPont Pharmaceuticals in Wilmington, DE, recent ly became the first anti-HIV drug to receive full approval based on a new Food and Drug Administration standard that measures the long-term efficacy of anti-HIV drugs.
The standard duration of response was measured using a methodology known as Kaplan-Meier/time to treatment failure analysis. Sustiva clinical trials included 1,266 protease inhibitor-, non-nucleoside reverse transcriptase inhibitor-, 3TC-naive patients and is the first randomized, open-label study to allow for a duration of response analysis. The data showed patients taking Sustiva with AZT and 3TC experienced greater duration of response through 110 weeks of treatment than patients taking the combination with indinavir/AZT/3TC.
Sustiva is a once-daily, non-nucleoside reverse transcriptase inhibitor used in combination with other anti-HIV drugs to bring the level of virus in the blood below detectable levels. The drug has been studied in more than 9,000 patients.
For prescribing information, call (800) 474-2762 or visit www.sustiva.com.
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