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FIRST COMBINATION REGIMEN OF HIV DRUGS CLEARED BY FDA

 FIRST COMBINATION REGIMEN OF HIV DRUGS CLEARED BY FDA
 RESEARCH TRIANGLE PARK, N.C., June 22 /PRNewswire/ -- The Food and Drug Administration (FDA) today announced that Hivid(R) brand zalcitabine (formerly dideoxycytidine(ddC)) has been cleared for marketing when used in conjunction with Retrovir(R) brand zidovudine (AZT), the most widely prescribed antiretroviral drug for people with AIDS. The availability of combination therapy is significant in that it may offer some patients in late stage disease some improvement of their immune system.
 Retrovir, marketed by Burroughs Wellcome Co. since 1987, remains first-line therapy for the treatment of various stages of HIV infection. Hivid, a product of Hoffmann-La Roche, is not a substitute for Retrovir, but rather is indicated for use in combination with Retrovir for the treatment of adult patients with advanced HIV infection (less than 300 CD4 cells/mm3) who have demonstrated significant clinical or immunologic deterioration. When used in combination with Hivid, Retrovir is dosed at 600 mgs per day, as indicated in the Hivid labeling.
 The indication for combination use of Retrovir and Hivid is based on limited data from a phase I/II National Institute of Allergies and Infectious Diseases (NIAID) study (ACTG 106) of patients with CD4 helper cell counts below 300. This study compared patient groups given combination therapy with Retrovir and Hivid to patient groups treated with Retrovir alone. In addition to the combination study by the NIAID, pivotal data provided by Burroughs Wellcome produced consistent results.
 "Using the two drugs together at full doses may have benefit in some patients. We are optimistic that when the improvement we've seen in patients' CD4 cell counts is supplemented by clinical efficacy data we will have even a better idea of the impact that this regimen will have on the disease," said study investigator, Robert T. Schooley, M.D., head of the division of infectious diseases at the University of Colorado Health Sciences Center, Denver.
 Burroughs Wellcome has filed a supplemental New Drug Application with the FDA to amend labeling for Retrovir to include the new combination regimen.
 -0- 6/22/92
 /CONTACT: Sharon Bickus, 919-248-8611, or Kathy S. Bartlett, 919-248-4302, both of Burroughs Wellcome Co./ CO: Burroughs Wellcome Co.; Food and Drug Administration ST: North Carolina IN: MTC SU: PDT


JM -- CH006 -- 2516 06/22/92 15:40 EDT
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Publication:PR Newswire
Date:Jun 22, 1992
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