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| |  Sustiva, First Once-Daily Anti-HIV Drug, Approved In Canada WILMINGTON, DE -- March 23, 1999 -- The Health Protection Branch of Health Canada has approved DuPont Pharmaceuticals’ anti-HIV drug, Sustiva(TM) (efavirenz), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for the treatment of HIV-1 infection in combination with other antiretroviral agents. Sustiva was also recommended for full marketing authorisation in Europe by the Committee for Proprietary Medicinal Products (CPMP). The Canadian indication is based on analyses of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. Sustiva is also the first once-daily anti-HIV drug to be recommended for full marketing authorisation in Europe. "The approval of Sustiva in Canada provides physicians here with access to a much-needed once-daily anti-HIV drug," said William Cameron, M.D., director, Ontario Region of the Canadian HIV Trials Network. "The clinical trial results suggest that Sustiva, when used in combination with other antiretroviral agents, may not only simplify dosing, but its potency and tolerability may also offer physicians and patients new treatment options." To date, more than 35,000 patients in the U.S. are using Sustiva as part of their treatment regimens. The U.S. Department of Health and Human Services' (DHHS) Panel on Clinical Practices for Treatment of HIV Infection recently recommended that Sustiva be included in new AIDS Treatment Guidelines as the first non-protease inhibitor among the preferred antiretroviral agents to be used in first-line treatment of HIV-infected individuals who are naive to antiretroviral treatment. Results reported in the U.S. Sustiva package insert indicate that 60 percent to 80 percent of patients treated with regimens containing Sustiva (dosed at three 200 mg capsules) maintain viral load below 400 copies/ml at 24 weeks based on the conservative non-completer equals failure method of analysis. Studies have shown that efavirenz penetrates into the cerebrospinal fluid, a common viral sanctuary. The clinical significance of the presence of Sustiva in the cerebrospinal fluid is not known. 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 (such as dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming). The discontinuation rate for nervous system symptoms was 2.6 percent. These symptoms occur early intreatment 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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