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| |  ROI CONFERENCE: Sustiva Combination Can Suppress HIV To Undetectable Levels WILMINGTON, DE -- February 5, 1998 -- The DuPont Merck Pharmaceutical Co. announced that HIV-infected patients taking a two-drug combination, including the investigational drug Sustiva(TM) (efavirenz), are maintaining HIV-RNA levels below quantifiable levels (BQL) in their blood for more than one year (60 weeks). The study of this anti-HIV drug, Sustiva, given once-daily in combination with the protease inhibitor, Crixivan(R) (indinavir), to treatment-naive and to nucleoside analogue reverse transcriptase inhibitor-experienced patients, was presented today at the Fifth Conference on Retroviruses and Opportunistic Infections. In addition, the company presented data showing that 600 mg of Sustiva given to treatment-naive patients, in combination with Retrovir(R) (zidovudine, AZT) and Epivir(R) (lamivudine, 3TC), reduced HIV-RNA to BQL in 100 percent of patients after 24 weeks of treatment. "We are encouraged that these two studies show that Sustiva in combination provides patients potential for long-lasting viral load suppression with new choices for drug regimens; it is particularly noteworthy that such a high percentage of patients have gone below the limit of quantification using regimens with and without a protease inhibitor," said Paul Friedman, M.D., President, DuPont Merck Research Laboratories. In the two drug combination study of 101 patients, 59 received Sustiva, a non-nucleoside reverse transcriptase inhibitor (NNTRI) in combination with the protease inhibitor Crixivan. Results at 60 weeks revealed that 89 percent of patients receiving the two-drug combination therapy achieved and maintained suppression of HIV-RNA to below quantifiable levels (BQL, less than 400 copies/mL). Patients achieved a 2.45 log10 average reduction in HIV-RNA levels out of a possible 2.48 log10. Patients also experienced an average CD4 cell count increase of 264 cells/mm3. In the three-drug combination study of another 137 patients, patients received Sustiva at doses of 200, 400 or 600 mg, once daily in combination with zidovudine (AZT, 300 mg twice daily) and lamivudine (3TC, 150 mg twice daily). After 24 weeks of treatment, 100 percent of the 21 patients randomised to the 600 mg dose of Sustiva in combination with AZT and 3TC achieved HIV-RNA levels below the level of quantification (BQL, less than 400 copies/mL). Sustiva is generally well-tolerated. In these two studies, the most commonly reported side effects from the regimens containing Sustiva included headache, rash, fatigue, insomnia, diarrhea, dizziness, sinusitis, influenza-like symptoms and nausea. Severe rashes have been reported in fewer than one percent of cases. Only three patients were discontinued due to rash. Out of the 42 patients who achieved HIV-RNA BQL in the Sustiva/Crixivan study, 38 patients (90 percent) also achieved HIV-RNA levels that were undetectable at 60 weeks. In the study, BQL was defined as a viral load reading of less than 400 copies/mL and undetectable was defined as a viral load reading giving no signal (both using the standard Amplicor(TM) assay). Patients from any arm of the study who achieved undetectable levels had significantly better long-term results than those whose viral load was only BQL. Over time, only eight percent of all patients who achieved undetectable levels experienced viral load rebounds while 42 percent of these patients who achieved only BQL had a viral load rebound. "These data suggest that reaching an undetectable viral load of less than one copy may be a better indicator of a sustained treatment response than the traditional BQL of 400 copies," said Joel. Gallant, M.D., M.P.H., director of Johns Hopkins Moore HIV Clinic. "These data indicate that Sustiva, given in combination with a protease inhibitor, can suppress HIV to undetectable levels over a long period of time." Clinical trials also are being conducted to determine the potential benefit of Sustiva in combination with other antiretroviral agents and the therapeutic compatibility of Sustiva when given with other drugs commonly used in the HIV patient population. Data presented at the conference revealed: -- No dosing change is needed when Sustiva is taken in combination with the protease inhibitor Viracept(R) (nelfinavir). Data previously presented at the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy showed measurable levels of Sustiva in CSF samples from three HIV patients taking 200 mg of Sustiva once daily. Additional studies in humans are underway to confirm and extend these findings. More information on: Merck, and DuPont
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