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| |  Once a Day Combination Therapy Achieves Undetectable HIV Levels LAUSANNE, Switzerland, May 28, 1997 -- Forty-two week data of DuPont Merck's investigational antiretroviral therapy DMP 266 in combination with Crixivan(R) (indinavir) found 80 percent of patients achieved HIV-RNA below level of quantification and CD4 cell count elevation averaging 140 cells/mm3. In addition, the combination attained a 99.99 percent (4.3 log 10 using values as reported) average reduction in HIV-RNA among patients studied. In truncated analysis, this represented a 2.5 log 10 average reduction in HIV- RNA. The findings from an initial, ongoing phase II study were presented today at the Eighth European Congress of Clinical Microbiology and Infectious Diseases. In the study, 21 patients received indinavir (800 mg, every eight hours) for two weeks followed by combination therapy with DMP 266, a non-nucleoside reverse transcriptase inhibitor (200 mg, once daily). Additional studies using higher doses of DMP 266 with indinavir are underway and will be reported on in the future. Another group of nine patients received the protease inhibitor indinavir alone for 26 weeks followed by the addition of Zerit(R) (stavudine) and DMP 266. In combination use, indinavir dosing was 1,000 mg every eight hours. At 26 weeks, approximately 40 percent of the patients receiving indinavir alone had plasma levels below 400 copies/mL of HIV-RNA. After stavudine and DMP 266 were added and following 16 weeks of the triple combination, 83 percent of the patients had plasma levels below 400 copies/mL. "DMP 266's apparent ability to significantly drop viral load in HIV-infected patients is good news," said Kenneth Wagner, M.D., Associate Professor of Medicine, Division of Infectious Diseases, Uniformed Services University of the Health Sciences, Bethesda, Maryland. "These promising results, coupled with DMP 266's once-a-day dosing, demonstrate strong potential for treatment success and patient compliance with DMP 266 combination therapy." Patients enrolled in the study groups had CD4 counts of 100-500 cells and more than 20,000 copies of HIV-RNA in the bloodstream at the time of entry into the study. In both study groups, DMP 266 was well-tolerated; two patients were discontinued from treatment due to an adverse clinical event. The most commonly reported adverse events for the indinavir monotherapy and DMP 266-indinavir groups were rash, sinusitis, upper respiratory infection and diarrhea, with no difference in incidence between the two treatment groups. "In clinical trials, we are finding DMP 266 is emerging as a potent weapon in combating HIV," said Henry Pan, M.D., Ph.D., Executive Vice President of Clinical Development, DuPont Merck. "We look forward to continuing evaluation of studies to measure DMP 266's ability to sustain undetectable viral loads in different HIV patient populations." The DuPont Merck Pharmaceutical Company is a worldwide, research-based pharmaceutical company focused on research, development and delivery of pharmaceuticals to treat unmet needs in the fight against HIV, cardiovascular disease, central nervous system disorders, cancer and arthritis-related disorders. The company is also a leader in radiopharmaceuticals.
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