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| |  ECCMID: Sustiva Effective In Combination With d4T And 3TC For HIV BERLIN, GERMANY -- March 22, 1999 -- Data presented today show that DuPont Pharmaceuticals’ Sustiva(TM) (efavirenz), a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI), when taken in combination with Zerit(R) (stavudine, d4T) and Epivir(R) (lamivudine, 3TC) reduced viral load to below quantifiable levels (BQL, less than 400 copies/mL) in 100 percent of patients using observed data analysis. A second study showed that Sustiva as part of combination drug therapy suppressed HIV to below quantifiable levels in the female genital tract and cerebrospinal fluid (CSF). These data were presented at the ninth European Conference of Clinical Microbiology and Infectious Diseases. The first study, an ongoing 48-week open-label multicentre trial, evaluated Sustiva in combination with d4T (30-40 mg, twice daily) and 3TC (150 mg, twice daily). Looking at the observed data analysis at 24 weeks, 100 percent of patients achieved viral loads BQL (less than 400 copies/mL) and 97 percent of patients achieved BQL using the ultrasensitive assay (less than 50 copies/mL). There were only three discontinuations out of 42 patients studied. None of the discontinuations were related to adverse events. Looking at the non-completer equals failure analysis after 24 weeks of treatment, 92 percent of patients achieved viral loads BQL (less than 400 copies/mL) and 89 percent achieved viral load BQL (50 copies/mL). A mean increase in CD4 cells of 169 cells/mm3 was observed. The average baseline viral load was 75,858 copies/mL and the average CD4 cell count was 380 + 302 cells/mm3. "These data show that non-protease combinations including Sustiva continue to provide effective treatment options for people with HIV that are relatively simple to take," said Cal Cohen, M.D., director, Community Research Initiative of New England. "This confirms recommendations from the DHHS treatment guidelines that Sustiva be included as an option for first-line therapy." 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 the Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents as the first member of its class among the preferred antiretroviral agents to be used in combination treatment of HIV-infected individuals. Safety data from this study at 24 weeks show that when Sustiva was combined with d4T and 3TC, the most commonly reported side effects greater than or equal to Grade 2, regardless of relationship, were: rash generalised (five percent), rash maculopapular (five percent), headache (five percent), abnormal dreaming (five percent) and nausea (five percent). No severe rashes were reported (Grade III or IV). Data from the second study show that Sustiva in combination with AZT/3TC or indinavir lowered viral load in both vaginal and cerebrospinal fluid to BQL (less than 400 copies/mL) in two groups of patients. In the first group of eight patients, 100 percent of the women achieved virus BQL in their genital tract after 12 weeks of therapy. In the second group of nine patients, 100 percent achieved virus BQL in their cerebrospinal fluid after 16 weeks of therapy that included Sustiva. "The Sustiva combination not only suppressed levels of virus in the blood, but also in these viral sanctuaries," said Dr. Karen Tashima, assistant professor of medicine, Brown University at the Miriam Hospital in Providence, R.I. "These data may help us learn more about the neurological implications of HIV and transmission of the disease itself." There are currently no data demonstrating that Sustiva therapy can reduce the risk of transmitting HIV to others through sexual contact or blood contamination. The FDA granted accelerated approval for Sustiva, a non-nucleoside reverse transcriptase inhibitor, on Sept. 17, 1998 based on analyses 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 evaluating long term suppression of HIV-RNA with Sustiva. Sustiva product labelling states that the most significant adverse events associated with Sustiva therapy are nervous system symptoms, which are reported in 52 percent of patients (such as dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming). These symptoms occur early in treatment and generally resolve within two to four weeks. The discontinuation rate for nervous system symptoms was 2.6 percent. Rarely, patients experience more serious side effects that may affect mood or the ability to think clearly. Patients should be cautioned not to operate hazardous machinery or drive if they experience nervous system symptoms. Skin rash, usually mild-to-moderate, was reported in 27 percent of adults and 40 percent of children. Rash usually occurs in the first two weeks of therapy and resolves with continued treatment within one month. The incidence of severe rash was less than one percent in adults and seven percent in children. The discontinuation rate for any grade rash was 1.7 percent. Sustiva product labelling also states that 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. Women should not become pregnant while taking Sustiva because birth defects have been seen in animals given Sustiva.
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