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| |  Videx/Zerit Combination Therapy for HIV Radically Reduces Vital Load GALVESTON, Texas, Jan. 30, 1996 -- The University of Texas Medical Branch at Galveston (UTMB) announced today the results of an ongoing multi-center trial of the combination of two leading therapies for human immunodeficiency virus (HIV), the virus that causes AIDS. Early data from AL 460-001 suggest that the combination of ZERIT(R) (stavudine, d4T) and VIDEX(R) (didanosine, ddl) in HIV-infected adults may offer significant benefit. The study, a double-blind, randomized, pilot dose comparison trial of 75 HIV-infected patients, is showing that the combination of ZERIT and VIDEX produces significant effects on key indicators of HIV therapy effectiveness, including antiviral activity and CD4 count. "We are extremely optimistic about the potential benefits of this combination,'' said Richard Pollards, MD, Professor of Internal Medicine, Microbiology and Immunology, and Pathology. "Study AL 460-001 suggests that two products that have proven their clinical effectiveness individually -- ZERIT and VIDEX -- can be combined to produce antiviral benefits rivaling those seen with other combinations of nucleoside agents.'' Preliminary data show that the combination of ZERIT and VIDEX had a significant antiviral effect, producing a substantial (multi-log) drop which appears to be prolonged. The combination also produced an increase in CD4 cells, with a mean increase of 60 to 100+ cells maintained for as long as one year. Changes in the count of CD4 cells, an immune response market, and antiviral activity are widely considered to be early indicators of HIV therapy effectiveness. The combination has been very well tolerated to date. Patients enrolled in the study had initial CD4 cell counts of 200-500 and had no prior antiretroviral experience. Study Al 460-001 is ongoing, and additional data will be available in future months. ZERIT, a nucleoside analogue, was cleared for marketing under the U.S. Food and Drug Administration's accelerated approval program in June 1994, and was granted full approval on December 21, 1995. ZERIT is indicated for the treatment of adults with HIV infection who have received prolonged prior treatment with AZT. VIDEX, also a nucleoside analogue, was cleared for marketing by the FDA in October 1991. VIDEX is indicated in patients with HIV who have had prolonged prior AZT (zidovudine) therapy who have demonstrated significant clinical or immunologic deterioration during AZT therapy. Both products are marketed by Bristol-Myers Squibb Company. "This study is an important step forward in our efforts to evaluate available AIDS therapies,'' said Dr. Pollard. ``We will continue to research the relative benefits of different treatments, including combination therapies, and to bring the results of this urgently needed information to patients, physicians and the public at large.'' With the results of Study AL 460-001, the strength of VIDEX as a component in combination therapy is further demonstrated. In September 1995, the results of AIDS Clinical Trial Group (ACTG) 175 found that VIDEX alone (monotherapy) and in combination with AZT (zidovudine) was superior to AZT monotherapy when examining the study's primary endpoints: slowing CD4 cell decline, progression to AIDS and death. ACTG 175 also showed that the treatments had a favorable effect on the clinical endpoints of death due to AIDS or death alone. Study AL 460-001 was funded by Bristol-Myers Squibb, a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. Other institutions participating in the study include Houston Clinical Research Network; Northwestern; Rush Medical College; Southwestern Medical Center; and UCLA. Texas' only state-owned-multicategorical hospital, the University of Texas Medical Branch's John Sealy Hospital is designed to treat any and all patients and varieties of illness. Home of the state's first medical school, founded in 1891, UTMB today consists of four schools, two institutes, seven hospitals and 144 hospital and outpatient clinics. Occupying 88 acres on Galveston Island's east end, UTMB currently enrolls more than 2,800 students, employs 9,750 faculty and staff members, has awarded more than 19,000 degrees in the health science professions, and lists physical assets in excess of $1 billion. For further information: Stephen T. Harris of University of Texas Medical Branch at Galveston, (409) 772-2618
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