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| |  Sustiva Approved In U.S. As Part Of HIV Combination Therapy WILMINGTON, DE -- Sept. 18, 1998 -- The United States Food and Drug Administration has approved DuPont Pharmaceuticals’ Sustiva(TM) (efavirenz), a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) for treatment of HIV-1 infected individuals. Sustiva is the first anti-HIV drug to be approved by the FDA for once-daily dosing and will be used in combination with other anti-HIV drugs in both adult and pediatric patients. Results from more than a dozen clinical trials involving more than 2,000 patients demonstrate the efficacy, safety and flexibility of Sustiva. These results indicate that Sustiva reduces plasma viral RNA to below quantifiable levels (less than 400 copies/mL using the standard Amplicor(TM) assay) in a majority of HIV-1-infected naive and treatment-experienced individuals in two-, three- and four-drug combinations. Studies have shown that efavirenz penetrates into the cerebrospinal fluid, a common viral sanctuary. Sustiva can be taken only once a day with or without food. However, a high fat meal may increase the absorption of Sustiva and should be avoided. Sustiva will be available in 200 mg capsules for adult dosing of 600 mg per day and in 100 mg capsules and 50 mg capsules for pediatric dosing. The accelerated approval of Sustiva is based on analysis of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, there are no results from controlled trials evaluating long-term suppression of HIV-RNA with Sustiva. In one study, Sustiva in combination with two nucleoside analogues (AZT and 3TC) suppressed HIV-RNA to below quantifiable levels in a greater proportion of patients than did the control arm consisting of a current standard of care regimen containing indinavir, AZT and 3TC. More subjects from the indinavir, AZT and 3TC control arm discontinued therapy because of adverse events and this accounted for a substantial fraction of the difference between the treatment regimens. The open label design of the study makes it difficult to assess the relative efficacy of the treatment arms. In a second study of patients with extensive prior use of nucleoside analogues, the combination of Sustiva, the protease inhibitor nelfinavir and nucleoside analogues suppressed HIV-RNA to below quantifiable levels in a higher percentage of patients than did a control arm consisting of nelfinavir and nucleoside analogues. 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. Sustiva therapy should always be initiated in combination with at least one other antiretroviral agent to which the patient has not been previously exposed. Safety data from clinical trials show Sustiva is generally well tolerated. The most significant adverse events associated with Sustiva therapy are nervous system symptoms, which are reported in approximately half of patients (dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming). The discontinuation rate for nervous system symptoms was 2.6 percent. These symptoms occur early in treatment and generally resolve within a few weeks. Rarely, patients have more serious side effects that may affect mood or ability to think clearly. Mild to moderate skin rash was reported in approximately one out of four patients. The incidence of severe rash was less than one percent. The discontinuation rate for rash in clinical trials was 1.7 percent. Women should not become pregnant while taking Sustiva because birth defects have been seen in animals given Sustiva.
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