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| |  Sustiva (Efavirenz) Prescribed More Often Than Crixivan (Indinavir) For HIV/AIDS WILMINGTON, DE -- March 20, 2000 -- As evidence of a shifting trend away from the widespread use of protease inhibitors, more prescriptions were written for DuPont Pharmaceuticals' Sustiva(TM) (efavirenz), a non-nucleoside reverse transcriptase inhibitor (NNRTI), in February versus Crixivan(R) (indinavir), part of the current "standard" of care, according to the market data firm IMS Health(1), which tracks weekly and monthly prescription sales. This change in treatment approach indicates a movement by physicians toward the increased use of Sustiva in potent and durable protease inhibitor-sparing regimens for their HIV-infected patients. "We're measuring our success against the benchmark set by protease inhibitors, which have played a tremendously important role in creating and developing the science of combination therapy," said Nicholas L. Teti, President and Chief Operating Officer of DuPont Pharmaceuticals. "We're proud to have developed the only drug of this stature in the NNRTI class that gives patients and physicians a long-awaited potent and durable therapeutic option. As the leading NNRTI, Sustiva is rapidly moving toward becoming the standard of care across the entire HIV market." Sustiva was developed by DuPont Pharmaceuticals and received accelerated approval by the US Food and Drug administration (FDA) in September 1998. Traditional (or full) approval was granted by the FDA on February 9, 2000. Sustiva is the first antiretroviral to receive traditional approval based on a new FDA standard that measures the long-term efficacy of anti-HIV drugs called time-to-treatment failure (TTF). Well-known and long used as a measurement of a drug's clinical efficacy in oncology, time-to-treatment failure analysis measures the efficacy of a drug as a function of the durability of its action over time. Sustiva was granted traditional approval based on this method using results of studies 006 and the AIDS Clinical Trials Group (ACTG) study 364. In study 006, the data demonstrated that patients taking Sustiva+AZT+3TC experienced greater duration of response (i.e., longer TTF) through 112 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 either with or without nelfinavir achieved better virologic suppression than patients taking nelfinavir plus two NRTIs after 48-weeks of treatment. "The availability of the potent non-nucleoside Sustiva gives physicians more options for treating their patients," said Calvin Cohen, M.D., Research Director, Community Research Initiative of New England. "The clinical data available show that combination therapy with Sustiva is more than capable of reducing patients' viral loads to below detectable levels and keeping viral loads there for a long period of time. Sustiva can help physicians achieve the results they typically see with protease inhibitors, and remains a critically important treatment option for all patients, including those who cannot tolerate other medications." In January 2000, the U.S. Department of Health and Human Services (DHHS) named Sustiva as the only non-nucleoside reverse transcriptase inhibitor 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(R) (astemizole), Propulsid(R) (cisapride), Versed(R) (midazolam), Halcion(R) (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. DuPont Pharmaceuticals is a worldwide business that focuses on research, development, and delivery of pharmaceuticals to treat unmet medical needs in the fights against HIV, cardiovascular disease, central nervous system disorders, cancer and arthritis-related disorders. DuPont Pharmaceuticals is also a leader in medical imaging. DuPont is a science company, delivering science-based solutions that make a difference in people's lives in food and nutrition; health care; apparel; home and construction; electronics; and transportation. Founded in 1802, the company operates in 65 countries and has 94,000 employees. Crixivan(R) is a registered trademark of Merck & Company The brands listed are the registered trademarks of their respective owners Notes: Related Links: Sustiva (efavirenz), DuPont Pharmaceuticals, Crixivan (indinavir) and Merck & Company.
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