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| |  ICAAC: Sustiva (Efavirenz) Effective, Well Tolerated In Combination Therapy For HIV Positive Patients TORONTO, ON -- September 18, 2000 -- Data presented at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy indicate that the combination of DuPont Pharmaceuticals' Sustiva™ (efavirenz), d4T (stavudine) and 3TC (lamivudine) provides durable viral suppression and may be used in important first-line treatment of HIV-positive treatment-naïve patients. These findings, from Study DMP 266-043, further demonstrate the antiviral activity of Sustiva in combination treatment in patients infected with HIV. Using the rigorous method of reporting data called intent-to-treat: non- completer=failure analysis, the results from the 68 people enrolled in the study indicate that after 84 weeks of treatment with Sustiva+d4t+3TC, 78 percent (n=50) of patients achieved HIV-RNA suppression to less than 400 copies/mL and 73 percent (n=47) were below 50 copies/mL. Additionally, using the same method of analysis, 74 percent (n=17) of patients with viral loads greater than or equal to 100,000 copies/mL were less than 400 copies/mL and 70 percent (n=16) were less than 50 copies/mL. The mean increase in CD4 cell count for all patients from baseline at 84 weeks was 318 cells/mm3 (+34.5) -- these data were statistically significant. "The combination of Sustiva with d4T and 3TC offers patients starting their first antiretroviral regimen a potentially potent and durable treatment option," says Calvin Cohen, M.D., Research Director, Community Research Initiative of New England. "The extended data from this study indicate that this combination could be effective for patients with high viral load and low CD4 cell counts, which makes it attractive to a wide range of patients we've seen who are starting therapy." Safety data from Study 043 indicate that adverse events greater than or equal to grade 2 were experienced by 44 percent (n=30) of patients with only three patients discontinuing due to adverse events. The most frequently reported grade 2 or higher adverse events were abdominal pain, dizziness, headache and nausea. Study 043 was a single-arm, open-label, multicenter study of 68 antiretroviral-naive patients. Mean HIV-1 RNA and CD4 counts of patients included in the study were 4.82 (+0.63) log10 copies/mL (65,623 copies/mL) and 376 + 278 cells/mm3 respectively. 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 "strongly recommended" for use in first-line combination with NRTIs for the treatment of HIV-infected individuals. Sustiva 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. 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, where the frequency of each of these events was approximately one percent. 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® (astemizole), Propulsid® (cisapride), Versed® (midazolam), Halcion® (triazolam) or ergot derivatives. Current treatment guidelines recommend against the use of any antiretroviral agent 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. Related Links: Sustiva (efavirenz) and DuPont Pharmaceuticals.
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