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| |  Sustiva First Anti-HIV Drug Approved By FDA Based On Long-Term Efficacy WILMINGTON, DE -- February 11, 2000 -- DuPont Pharmaceuticals announced that its anti-HIV medication SustivaTM (efavirenz) is the first to receive traditional (full) approval based on a new U.S. Food and Drug Administration (FDA) standard that measures the long-term efficacy of anti-HIV drugs. Sustiva is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other anti-HIV medications for the treatment of HIV infection. "It is not only important for HIV medications to bring the level of virus in the blood down to below detectable levels, but maintain it this way for as long as possible," said Cal Cohen, M.D., Director, Community Research Initiative of New England. "The long-term data on Sustiva used by the FDA clearly show that this drug, in combination with others, can be successful in achieving this goal." The new FDA standard, duration of response, was measured using a methodology known to medical researchers as Kaplan-Meier/time-to-treatment failure (TTF) analysis. Well-known and long used as a measurement of a drug's clinical efficacy in oncology, time-to-treatment failure measures the efficacy of a drug as a function of the durability of its action over time. The Anti-Viral Drugs Advisory Committee to the FDA first adopted this measurement for anti-HIV drug approval in 1997. DuPont Pharmaceuticals is the first to receive full approval based on this method using results of studies DPC 006 and the AIDS Clinical Trials Group (ACTG) study 364. DuPont Pharmaceuticals will also be the first antiretroviral manufacturer to include this method of analysis in their product labeling. The company will also be the first to include data analyzed using the ultrasensitive assay (less than 50 copies/mL) in their product labeling. DuPont Pharmaceuticals' 006 study involved 1266 protease inhibitor (PI)-, NNRTI- and 3TC-naive patients and is the first randomized, open-label study powered to allow for a duration of response analysis. The data demonstrated that patients taking Sustiva/AZT/3TC experienced greater duration of response (i.e., longer TTF) through 110 weeks of treatment than those patients taking combinations with indinavir/AZT/3TC. In ACTG 364, nucleoside reverse transcriptase inhibitor (NRTI)-experienced patients taking Sustiva plus two NRTIs achieved better virologic suppression than patients taking nelfinavir plus two NRTIs after 48-weeks of treatment. "This represents a new milestone for Sustiva," said Nicholas L. Teti, President, DuPont Pharmaceuticals. "First, we were able to make Sustiva available to approximately 9000 people in the U.S. through our expanded access program, then the FDA granted us accelerated approval so that more people living with HIV might benefit from this medication. Now, thanks to the rapid review by the FDA, we have received full approval based on the long-term data that will give physicians and patients even more confidence in utilizing regimens containing Sustiva." In January 2000, the U.S. Department of Health and Human Services (DHHS) named Sustiva as the only non-nucleoside reverse transcriptase inhibitor (NNRTI) to be a "strongly recommended" antiretroviral agent for use in first- line combination treatment of HIV-infected individuals. Sustiva has been studied in 9200 patients and is generally well tolerated. The most common adverse events are nervous system symptoms (e.g., dizziness, insomnia, impaired concentration, somnolence, and abnormal dreaming) and mild to moderate rash. These symptoms occur early in treatment and generally resolve within two to four weeks. Rash in children is generally similar to that observed in adults with the exception of a higher incidence and a higher frequency of severe rash. In a small number of patients, serious psychiatric adverse experiences have been reported. In controlled trials, serious psychiatric symptoms observed were severe depression (0.9 percent), suicidal ideation or attempts (0.5 percent), aggressive behavior (0.3 percent), paranoid reactions (0.2 percent) and manic reactions (0.1 percent). These problems were seen at a similar frequency in control groups and tended to occur more often in patients with a history of mental illness. A few suicides have been reported; however, a causal relationship to Sustiva has not been established. Patients with serious psychiatric experiences should contact their physician. Women should not become pregnant while taking Sustiva because birth defects have been seen in animals given Sustiva. Patients should be cautioned not to operate hazardous machinery or drive if they experience nervous system symptoms. Sustiva is administered as three 200 mg capsules once-daily. Sustiva should not be administered concurrently with Hismanal® (astemizole), Propulsid® (cisapride), Versed® (midasolam), Halcion® (triazolam) or ergot derivatives. Resistant virus emerges rapidly when NNRTIs are administered as monotherapy. Therefore, Sustiva must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. The choice of new antiretroviral agents to be used in combination with Sustiva should take into consideration the potential for viral cross-resistance. Sustiva therapy should always be initiated in combination with at least one other antiretroviral agent to which the patient has not been previously exposed. Related links:Sustiva[TM</a>], DuPont Pharmaceuticals.
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