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| |  Once-Daily Anti-HIV Drug Sustiva Approved In Europe WILMINGTON, DE -- June 1, 1999 -- The European Commission has approved DuPont Pharmaceuticals' once-daily anti-HIV drug, Sustiva(TM) (efavirenz) in Europe for antiviral combination treatment of HIV-1 infected adults, adolescents and children three years of age and older. "Physicians and patients in Europe now will have access to this much-needed once-daily anti-HIV drug that may help simplify dosing regimens," said professor Brian Gazzard, M.D., clinical research director of the HIV/GUM Unit, Chelsea and Westminster Hospital, London. "Results of clinical trials also suggest that Sustiva, used in combination with other antiretroviral agents, provides new therapeutic options. The potency and tolerability of Sustiva make it a valuable addition to the anti-HIV armament." Currently, more than 35,000 patients in the United States and about 2,000 patients in Canada 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 to be used in preferred first-line combination treatment regimens for HIV-infected individuals who are naive to antiretroviral treatment. The British HIV Association's draft guidelines on antiretroviral therapy recommend regimens based on non-nucleoside reverse transcriptase inhibitors or protease inhibitors in combination with nucleoside reverse transcriptase inhibitors as first-line therapy. The draft guidelines do not make a specific recommendation between the two classes of antiretroviral agents, indicating that initial therapy should be individualized for each patient. Results reported in the U.S. Sustiva package insert indicate that 60 percent to 80 percent of patients treated with regimens containing Sustiva (dosed with 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. Results reported in European labelling from these same studies, show that 46 percent to 58 percent of patients treated with regimens containing Sustiva maintained viral load below 50 copies/ml at 24 weeks, using the non-completer equals failure method of analysis. Approval for use in children was based on data from a pediatric trial, ACTG 382. In this study, 61 percent of 57 pediatric patients who took Sustiva in combination with nelfinavir and nucleoside reverse transcriptase inhibitors, achieved HIV-RNA greater than 400 copies/ml after 20 weeks of treatment. European approval for the use in children three years of age and older was based on data from a pediatric trial, ACTG382. In this study, 61 percent of 57 pediatric patients who took Sustiva in combination with nelfinavir and nucleoside reverse transcriptase inhibitors, achieved HIV-RNA less than 400 copies/ml after 20 weeks of treatment. The safety profile of Sustiva in pediatric patients was similar to that seen in adults with the exception of rash which was more frequent in children (40 percent) and more often severe (seven percent). The discontinuation rate for rash in children was 8.8 percent. 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. Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI). 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 in clinical trials 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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