Preliminary Study Results Suggest that New HIV/AIDS
Drug, Sustiva(TM) (efavirenz), is Effective When Used with ZERIT(R) (stavudine)and Epivir(R) (lamivudine) BERLIN (ots-PRNewswire) - First-Line Combination Containing Established Brands and New Agent Offers Convenient and Generally Well Tolerated Option Initial 24 week clinical data presented today show that Sustiva(TM) , the new, once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI), when taken with the two nucleoside analogues ZERIT(R), also known as d4T, and Epivir(R), reduced viral load to less than 400 copies/mL in 100 percent of patients using an as treated data analysis. These data were presented at the 9th Annual European Conference of Clinical Microbiology and Infectious Diseases. "These preliminary study results suggest that proven and established drugs, like ZERIT(R), when combined with newer agents give patients very potent and tolerable first line options to fight HIV disease," says Cal Cohen, M.D., Director, Community Research Initiative of New England. "In addition to the potent antiviral effects of this drug combination, the convenient dosing schedule of Sustiva once-daily and ZERIT, one pill taken twice- daily with no food restrictions, will make it easier for patients to adhere to this regimen. This convenient regimen allows patients minimal disruptions to their everyday lives." The study, a 48-week open-label multicenter trial, combined Sustiva(TM) (efavirenz) with ZERIT(R) (stavudine) and Epivir(R) (lamivudine) as first-line therapy. The data presented analyzed the first 42 men and women to reach 24 weeks of therapy. These patients had average baseline viral loads of 75,858 copies/mL and CD4 counts of 380 cells/mm3 . Of the patients who were on therapy at 24 weeks (as treated analysis), 100 percent achieved viral loads of less than 400 copies/mL and 97 percent of patients achieved less than 50 copies/mL using an ultrasensitive HIV test. Using one of the most stringent statistical analyses (intent to treat: non completer = failure), 92 percent of the patients who entered the trial achieved viral loads of less than 400 copies/mL, and 89 percent of patients achieved less than 50 copies/mL. A mean increase in CD4 cells of 169 cells/mm3 was reported. Viral load and CD4 cell counts are key indicators of how well HIV disease is being controlled. This study is the first of many on going trials investigating Sustiva and ZERIT. A companion study, 044, will investigate Sustiva (efavirenz), ZERIT (stavudine) and VIDEX (didanosine) dosed once daily in a 48 week, open-label, multicenter study. These trials are designed to evaluate the efficacy, tolerability and durability of these drug therapies in diverse combinations in various stages of HIV disease. Since the discovery of the HIV in the early 1980s, the epidemic has grown to global proportions and the field of HIV/AIDS research has moved into a new era of therapeutic advances. In this ever-changing arena, Bristol-Myers Squibb Company has made a strong commitment to extending the survival and enhancing the lives of people with HIV/AIDS. As a leader in this field, Bristol-Myers Squibb will continue its efforts in the areas of patient education, clinical research, health provider training, and collaboration with government, academic and non- governmental organizations (NGOs) to bring the benefits of medical research to HIV-infected patients worldwide. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal business are pharmaceuticals, consumer products, nutritionals and medical devises. It is a leading maker of innovative therapies for cardiovascular and metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin products. For full prescribing information on ZERIT(R) (stavudine) and VIDEX(R) (didanosine), please contact Felicitas Zorn at 49-89- 1214-2267 or Patti Doykos Duquette at 609-897-3077. For full prescribing information on Sustiva TM (efavirenz), contact Sandra James at 302-892-1306. ots Original Text Service: Bristol-Myers Squibb Internet: http://www.newsaktuell.de Contact: Felicitas Zorn of BMS Germany, 49-89-1214-2267, or Patti Doykos Duquette of Bristol-Myers Squibb, International Public Affairs, 609-897-3077
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