To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Videx Prolongs Lives and Dramatically Delays Progression of AIDS URL: http://www.pslgroup.com/dg/617E.htm Doctor's Guide February 28, 1996
PRINCETON, N.J., Feb. 28, 1996 -- Striking new results from the largest controlled pediatric trial to date show that Bristol-Myers Squibb's VIDEX (didanosine; ddI) delays progression of AIDS and may be superior to AZT (zidovudine) monotherapy, Bristol-Myers Squibb announced today. The new data from the AIDS Clinical Trials Group (ACTG) 152 pediatric study was presented today at the U.S. Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee Meeting as one of three large-scale clinical trials which identify VIDEX, alone or in combination, as an important drug that should be considered as part of initial treatment for the human immunodeficiency virus (HIV), the virus that causes AIDS. "The proven survival benefit of VIDEX shows that the drug can be considered an important component of future combinations, including those with the protease inhibitors," said Paul A. Volberding, M.D., Director, AIDS Program, University of California, San Francisco. ACTG 152 compared three treatments for children with symptomatic HIV infection or AIDS: VIDEX taken alone, VIDEX plus AZT and AZT monotherapy. The study found that children who were given VIDEX alone or in combination were less likely to develop serious infections associated with HIV or suffer serious side effects than did those receiving AZT monotherapy. In fact, based upon significant differences seen in disease progression and deaths, the AZT monotherapy portion of the trial was discontinued by the ACTG. Children receiving VIDEX alone or in combination with AZT were allowed to complete the study. The children who received VIDEX alone and those who received AZT in combination with VIDEX benefitted similarly from the therapy. Two additional studies presented today that further demonstrate the survival benefit of VIDEX include the European and Australian Delta Trial and U.S. ACTG 175 trial, which together studied over 5,000 patients. The ACTG 175 study found that VIDEX, alone or in combination with AZT, was superior to AZT monotherapy in slowing CD4 cell decline, or delaying progression to AIDS and death. The results of the Delta Trial were consistent with the results of ACTG 175, although the patients in the Delta trial entered with more advanced disease than those patients in ACTG 175. "The results of ACTG 175 are extremely important and will change the way that HIV infected adults are initially treated," said Martin Hirsch, M.D., Professor of Medicine, Harvard University. "ddI (VIDEX), either as monotherapy or in combination with AZT, was superior to AZT monotherapy in substantially reducing the risk of disease progression among patients with intermediate stage disease." The Delta Trial showed that VIDEX plus AZT significantly prolonged survival compared to AZT monotherapy in patients with more advanced HIV infection just starting therapy. In these patients, the combination of VIDEX plus AZT significantly reduced the risk of death by 42%, which is superior to AZT monotherapy. In addition, VIDEX plus AZT significantly slowed progression to AIDS or death as compared to AZT plus ddC (zalcitabine). "We are extremely gratified by the results of these three trials," said Laurie Smaldone, M.D., Vice President, Infectious Disease, Clinical Research, Bristol-Myers Squibb Pharmaceutical Research Institute. "Both VIDEX and the combination of VIDEX and AZT have proven their survival benefit and should assume an important role as initial therapy for the treatment of HIV infection." VIDEX belongs to the nucleoside analogue family of compounds, which also includes Bristol-Myers Squibb's ZERIT(R) (stavudine, d4T). "Interim results of another study, AI 460-001, show that the combination of VIDEX and ZERIT dramatically reduces the amount of virus in the blood. Preliminary data recently presented suggest the combination of VIDEX plus ZERIT may be one of the most potent and long lasting of the nucleoside combinations. Although there have been no direct comparisons, the combination of VIDEX plus ZERIT may surpass the effects reported for other combination therapies," said Dr. Smaldone. "In addition to its proven clinical benefit, VIDEX therapy is significantly less expensive," said Michael Loberg, Ph.D., President, Bristol-Myers Squibb Oncology/Immunology. "The annual cost of VIDEX is significantly less than all the other antiretroviral drugs, including AZT. As the increasing use of multiple-drug combination therapies raises the overall cost of treating HIV, this advantage is becoming more important to the patient and the health care provider," he added. In response to patient requests, VIDEX will soon be available as a smaller tablet which is easier to chew, quicker to dissolve in water, and orange flavored. These improvements are expected to further increase the use of VIDEX by both patients with HIV and the physicians who care for them. In ACTG 175 and the Delta trial, therapy with VIDEX was well tolerated and clinical adverse events such as pancreatitis were rare in all treatment regimens. VIDEX is currently indicated for the treatment of adults and children with advanced HIV infection and prolonged prior treatment with AZT, or for those who are intolerant of or failing AZT therapy. ZERIT, which has been marketed in the U.S. since 1994, is available in other countries and has been recommended for marketing approval in the fifteen countries of the European Union. ZERIT is indicated for the treatment of HIV-infected adults who have received prolonged prior zidovudine therapy. Please see complete prescribing information for VIDEX and ZERIT. Bristol-Myers Squibb (NYSE: BMY) 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, orthopedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin products. CONTACT: Jennifer True of Bristol-Myers Squibb, 609-252-6540 / Bristol-Myers Squibb press releases available through Company News On-Call by fax, 800-758-5804, ext. BMYFAX (269329) or at http://www.prnewswire.com/cnoc/exec/menu?269329 (BMY) --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.