Preliminary Study Results Suggest that New HIV/AIDS

Drug, Sustiva(TM) (efavirenz), is Effective When Used withZERIT(R) (stavudine)and Epivir(R) (lamivudine) BERLIN (ots-PRNewswire) - First-Line Combination Containing Established Brands and NewAgent Offers Convenient and Generally Well Tolerated Option Initial 24 week clinical data presented today show thatSustiva(TM) , the new, once-daily non-nucleoside reversetranscriptase inhibitor (NNRTI), when taken with the twonucleoside analogues ZERIT(R), also known as d4T, and Epivir(R),reduced viral load to less than 400 copies/mL in 100 percent ofpatients using an as treated data analysis. These data werepresented at the 9th Annual European Conference of ClinicalMicrobiology and Infectious Diseases. "These preliminary study results suggest that proven andestablished drugs, like ZERIT(R), when combined with newer agentsgive patients very potent and tolerable first line options tofight HIV disease," says Cal Cohen, M.D., Director, CommunityResearch Initiative of New England. "In addition to the potentantiviral effects of this drug combination, the convenient dosingschedule of Sustiva once-daily and ZERIT, one pill taken twice-daily with no food restrictions, will make it easier for patientsto adhere to this regimen. This convenient regimen allowspatients minimal disruptions to their everyday lives." The study, a 48-week open-label multicenter trial, combinedSustiva(TM) (efavirenz) with ZERIT(R) (stavudine) and Epivir(R)(lamivudine) as first-line therapy. The data presented analyzedthe first 42 men and women to reach 24 weeks of therapy. Thesepatients had average baseline viral loads of 75,858 copies/mL andCD4 counts of 380 cells/mm3 . Of the patients who were on therapyat 24 weeks (as treated analysis), 100 percent achieved viralloads of less than 400 copies/mL and 97 percent of patientsachieved less than 50 copies/mL using an ultrasensitive HIV test.Using one of the most stringent statistical analyses (intent totreat: non completer = failure), 92 percent of the patients whoentered the trial achieved viral loads of less than 400copies/mL, and 89 percent of patients achieved less than 50copies/mL. A mean increase in CD4 cells of 169 cells/mm3 wasreported. Viral load and CD4 cell counts are key indicators ofhow well HIV disease is being controlled. This study is the first of many on going trials investigatingSustiva and ZERIT. A companion study, 044, will investigateSustiva (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, tolerabilityand durability of these drug therapies in diverse combinations invarious stages of HIV disease. Since the discovery of the HIV in the early 1980s, theepidemic has grown to global proportions and the field ofHIV/AIDS research has moved into a new era of therapeuticadvances. In this ever-changing arena, Bristol-Myers SquibbCompany has made a strong commitment to extending the survivaland enhancing the lives of people with HIV/AIDS. As a leader inthis field, Bristol-Myers Squibb will continue its efforts in theareas of patient education, clinical research, health providertraining, and collaboration with government, academic and non-governmental organizations (NGOs) to bring the benefits ofmedical research to HIV-infected patients worldwide. Bristol-Myers Squibb is a diversified worldwide health andpersonal care company whose principal business arepharmaceuticals, consumer products, nutritionals and medicaldevises. It is a leading maker of innovative therapies forcardiovascular and metabolic and infectious diseases, centralnervous system and dermatological disorders, and cancer. Thecompany is a leader in consumer medicines, orthopaedic devices,ostomy care, wound management, nutritional supplements, infantformulas, and hair and skin products. For full prescribing information on ZERIT(R) (stavudine) andVIDEX(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.deContact: Felicitas Zorn of BMS Germany, 49-89-1214-2267, or PattiDoykos Duquette of Bristol-Myers Squibb, International PublicAffairs, 609-897-3077

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