Atlantic Study Positions ZERIT(R) (d4T, Stavudine) and Once-Daily VIDEX(R) (ddI, didanosine) as Flexible, First-Line Foundation of HIV 'Cocktails'

SAN FRANCISCO (PROTEXT) - Landmark International Treatment 'Strategy' Trial Results Provide Patients and Doctors Important News on Customizing Treatment With Three Types of Anti- HIV Cocktails According to preliminary 48-week data from the ATLANTIC study, the nucleoside analogue foundation of ZERIT(R) (d4T, stavudine) and once-daily VIDEX(R) (ddI, didanosine) with the addition of a drug from any one of three commonly used classes of drugs has produced highly potent results. In August, the U.S. Food and Drug Administration (FDA) approved ZERIT and VIDEX for use as a first- line component of a triple combination antiretroviral therapy regimen. In June, once-daily VIDEX received mutual recognition by the member states of the European Union. Results of the ATLANTIC study, the first international study to determine how to best start and sequence HIV drug regimens, show that the third drug -- a non-nucleoside reverse transcriptase inhibitor (nevirapine), a protease-inhibitor (indinavir) or another nucleoside analogue (lamivudine) -- can be tailored to meet patients' specific medical needs, allowing physicians and patients to preserve future treatment options. "The ATLANTIC study results clearly suggest that physicians and patients can safely start anti-HIV therapy with a variety of three-drug combinations, " said Robert Murphy, MD, professor of medicine, medical director of the AIDS Clinic Treatment Unit, Northwestern University Medical School and a leading investigator of the ATLANTIC study. "These 48 week results reaffirm the ability of physicians to customize therapy for individual patients and save certain treatment options for future use -- an important consideration as treatment guidelines continue to evolve." Preliminary (48 week) results from the ATLANTIC trial show that the addition of nevirapine, indinavir or lamivudine to the ZERIT(R) (d4T, stavudine) / VIDEX(R) (ddI, didanosine) foundation produced sustained reductions in viral load (a measure of the amount of HIV in the blood) and increases in CD4+ cell counts. Previous studies, notably the ALBI study and the START II trials, have shown that the ZERIT/VIDEX foundation is at least as potent and tolerable as the dualnucleoside combination of AZT/3TC, and associated with greater increases in CD4 cell counts. Additionally, ZERIT/VIDEX foundation has a more favorable resistance profile. The median increase of CD4 cells at week 48 was 146 for d4T/ddI/IDV, 134 for d4T/ddI/NVP, and 166 for d4T/ddI/3TC. The majority of patients on all three arms were able to sustain viral reductions of <50 copies/ml through week 48. d4T/ddI/3TC d4T/ddI/NVP d4T/ddI/IDV Intention-to-treat 49% 51% 57% As-treated 78% 82% 90% "Intention-to-treat" analyses all patients who entered the trial. "As treated" analyses only those patients who were currently on the study's therapies at 48 weeks. ATLANTIC is a randomized, open-label, strategy study designed to evaluate the safety and efficacy of three available triple combination regimens in patients who have not previously received treatment. The study includes over 300 patients at 17 sites in Europe and the United States treated with the combination of ZERIT (40 mg) and once daily VIDEX (400 mg) combined with nevirapine, indinavir or lamivudine. Patients will be followed for up to 144 weeks, making ATLANTIC the longest trial ever to measure efficacy of triple combination regimens. Patients with a moderately increased viral load (between 500 and 5,000 copies/ml) will intensify their treatment with the addition to the anti-cancer agent hydroxyurea to their regimen. It is anticipated that this approach may delay the need for patients to switch to a new combination regimen. Strategy trials are studies designed to evaluate realistic treatment regimens as a means to determine what drugs to start with, when to switch regimens and what drugs to switch to. Such trials view HIV as a chronic disease that requires optimal management over the long term. Historically, HIV clinical trials have been designed to measure the efficacy of specific drug combinations, comparing single agents to double combinations, or double combinations to triple combinations. Such trials did not address the differences between commonly used triple combinations. "Patients beginning HIV-therapy need to get the best start they can and they need therapies that continue to work over time," said Steve Schnittman, MD, Group Director, HIV Clinical Research, Bristol-Myers Squibb. "These updated results from the ATLANTIC study demonstrate the treatment options that are possible with ZERIT and VIDEX and the durability of combinations based on ZERIT and VIDEX." Patients in each of the ATLANTIC study arms received a once- daily dose of VIDEX(R) (ddI, didanosine) (400 mg), which is currently in clinical trials worldwide. Once daily dosing is thought to make it easier for patients to adhere to their drug regimens, as incomplete adherence may lead to the development of drug resistance, thereby reducing the ability of treatment regimens to keep HIV at bay. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals, and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com. For full prescribing information on ZERIT and VIDEX, please contact Patti Duquette at 1-609-897-3077. ots Original Text Service: Bristol-Myers Squibb International Limited Internet: http://www.newsaktuell.de Contact: Patricia Doykos Duquette of Bristol-Myers Squibb, International Public Affairs, 415-284-8043, e-mail: patricia.duquette@bms.com; or Glenn Mursell of Countrywide Porter Novelli, +44-171-584-0122 email: glenn.mursell@cpn.co.uk Web site: http://bms.com Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT