ATLANTIC STUDY POSITIONS ZERIT(R) (D4T, STAVUDINE) AND ONCE-DAILY VIDEX(R) (DDI, DIDANOSINE) AS FLEXIBLE, FIRST-LINE FOUNDATION OF HIV 'COCKTAILS'

Landmark International Treatment 'Strategy' Trial ResultsProvide Patients and Doctors Important News on CustomizingTreatment With Three Types of Anti-HIV Cocktails

San Francisco, September 28 (PROTEXT) - According topreliminary 48-week data from the Atlantic study, the nucleosideanalogue foundation of ZERIT(R) (d4T, stavudine) and once-dailyVIDEX(R) (ddI, didanosine) with the addition of a drug from anyone of three commonly used classes of drugs has producedhighly potent results. In August, the U.S. Food and DrugAdministration (FDA) approved ZERIT and VIDEX for use as a first-line component of a triple combination antiretroviral therapyregimen. In June, once-daily VIDEX received mutual recognition bythe member states of the European Union.

Results of the ATLANTIC study, the first international studyto determine how to best start and sequence HIV drug regimens,show that the third drug -- a non-nucleoside reversetranscriptase 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 treatmentoptions.

''The ATLANTIC study results clearly suggest that physiciansand patients can safely start anti-HIV therapy with a variety ofthree-drug combinations, '' said Robert Murphy, MD, professor ofmedicine, medical director of the AIDS Clinic Treatment Unit,Northwestern University Medical School and a leadinginvestigator of the ATLANTIC study. ''These 48 week resultsreaffirm the ability of physicians to customize therapy forindividual patients and save certain treatment options for futureuse -- an important consideration as treatment guidelinescontinue to evolve.'' Preliminary (48 week) results from theATLANTIC trial show that the addition of nevirapine, indinavir orlamivudine to the ZERIT(R) (d4T, stavudine) / VIDEX(R) (ddI,didanosine) foundation produced sustained reductions in viralload (a measure of the amount of HIV in the blood) and increasesin CD4+ cell counts. Previous studies, notably the ALBI study andthe START II trials, have shown that the ZERIT/VIDEX foundationis at least as potent and tolerable as the dualnucleosidecombination of AZT/3TC, and associated with greater increases inCD4 cell counts. Additionally, ZERIT/VIDEX foundation has amore favorable resistance profile.

The median increase of CD4 cells at week 48 was 146 ford4T/ddI/IDV, 134 for d4T/ddI/NVP, and 166 for d4T/ddI/3TC. Themajority of patients on all three arms were able to sustain viralreductions 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 thetrial. ''As treated'' analyses only those patients who werecurrently on the study's therapies at 48 weeks.ATLANTIC is a randomized, open-label, strategy study designed toevaluate the safety and efficacy of three available triplecombination regimens in patients who have not previously receivedtreatment. The study includes over 300 patients at 17 sites inEurope and the United States treated with the combination ofZERIT (40 mg) and once daily VIDEX (400 mg) combined withnevirapine, indinavir or lamivudine.

Patients will be followed for up to 144 weeks, makingATLANTIC the longest trial ever to measure efficacy of triplecombination regimens. Patients with a moderately increased viralload (between 500 and 5,000 copies/ml) will intensify theirtreatment with the addition to the anti-cancer agenthydroxyurea to their regimen. It is anticipated that thisapproach may delay the need for patients to switch to a newcombination regimen.

Strategy trials are studies designed to evaluate realistictreatment regimens as a means to determine what drugs to startwith, when to switch regimens and what drugs to switch to. Suchtrials view HIV as a chronic disease that requires optimalmanagement over the long term. Historically, HIV clinicaltrials have been designed to measure the efficacy of specificdrug combinations, comparing single agents to doublecombinations, or double combinations to triple combinations. Suchtrials did not address the differences between commonly usedtriple combinations.

''Patients beginning HIV-therapy need to get the best startthey can and they need therapies that continue to work overtime,'' said Steve Schnittman, MD, Group Director, HIV ClinicalResearch, Bristol-Myers Squibb. ''These updated results from theATLANTIC study demonstrate the treatment options that arepossible with ZERIT and VIDEX and the durability of combinationsbased 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 iscurrently in clinical trials worldwide. Once daily dosing isthought to make it easier for patients to adhere to their drugregimens, as incomplete adherence may lead to the development ofdrug resistance, thereby reducing the ability of treatmentregimens to keep HIV at bay.

Bristol-Myers Squibb is a diversified worldwide health andpersonal care company whose principal businesses arepharmaceuticals, consumer products, nutritionals, and medicaldevices. It is a leading maker of innovative therapies forcardiovascular, metabolic and infectious diseases, centralnervous system and dermatological disorders, and cancer. Thecompany is also a leader in consumer medicines, orthopaedicdevices, ostomy care, wound management, nutritional supplements,infant formulas, and hair and skin care products.

Visit Bristol-Myers Squibb on the World Wide Web athttp://www.bms.com. For full prescribing information on ZERIT andVIDEX, please contact Patti Duquette at +1-609-897-3077.UNS Contact: Patricia Doykos Duquette of Bristol-Myers Squibb,International Public Affairs, +1 284-8043, e-mail:patricia.duquette@bms.com; or Glenn Mursell of Countrywide PorterNovelli, +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 bepublished under the "CTK" slug. Protext is a commercial serviceproviding distribution of press releases from clients, who areidentified in the text of Protext reports and who bear fullresponsibility for their contents.

PROTEXT