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| |  FDA Recommends Full Approval for Hivid(r) Combination Therapy NUTLEY, N.J., Feb. 28, 1996 -- The Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended the full approval of HIVID(R) (zalcitabine), also known as ddC, for use in combination with AZT (zidovudine) for the treatment of HIV infection. This decision was based upon review of two landmark studies which provided clinical endpoint data to support this indication. In commenting on the benefit of combination of HIVID(R) and AZT, the committee concluded that the benefit for this combination is seen predominately in patients without a prior history of AZT use. HIVID(R) was cleared by the FDA for use as a monotherapy in 1994 and has been available for combination use with AZT since June 1992 when accelerated approval was originally granted. The data from ACTG 175 and the Delta trial indicated that patients had slowed progression of their disease and improved survival by using HIVID(R) with AZT as their first AIDS therapy. These studies compared either AZT or ddI monotherapy to combinations of AZT with HIVID(R) or ddI. Preliminary results from the Delta trial virology substudy presented at the 3rd Conference on Retroviruses show that patients taking HIVID(R) and AZT do not develop resistance to HIVID(R) after 112 weeks. The major serious side effects of HIVID(R), when taken alone or in combination with AZT, are peripheral neuropathy and, much less frequently, pancreatitis. Some patients also experience less serious side effects, including oral ulcers and rash "With this new, substantial clinical data, the advantages of combination therapy become abundantly clear," says Dr. Gabriel Torres, Medical Director of the AIDS Center at St. Vincent's Hospital in New York. "Further, as resistance to antiretroviral compounds is known to limit the effectiveness of a drug, it makes sense to use combination therapy with AZT and ddC as a first-line treatment, especially considering ddC's favorable resistance and tolerability profiles." Recent Research Findings ACTG 175 was a randomized, double-blind trial of 2,467 HIV infected individuals with CD4 cell counts between 200 and 500 cells/mm3 and no history of AIDS-defining events. Of the total, 1,067 patients had no prior therapy with AZT. Trial participants, who were followed for 147 weeks, were given AZT or ddI alone, or AZT in combination with either HIVID(R) or ddI. In addition to delaying disease progression and death, the study found that combination therapy with HIVID(R) and, AZT had a positive effect on CD4 cell count and viral load. The Delta trial, based on data from over 3,000 European and Australian patients with either ARC, AIDS or a CD4 cell count of less than 350, confirmed the ACTG 175 findings in the AZT naive population. Combined Therapy and INVIRASE(R) INVIRASE(R) in combination with nucleoside analogues is indicated for the treatment of advanced HIV infection in selected patients. This indication is based on changes in surrogate markers in patients who initiated INVIRASE(R) concomitantly with either HIVID(R) (in patients previously treated with prolonged AZT therapy) or AZT (in previously untreated patients). In clinical studies, INVIRASE(TM) was well-tolerated by most patients and reported adverse events were mostly of mild intensity. The most frequently reported adverse events, at least possibly related to INVIRASE(R) treatment, and of at least moderate intensity, included diarrhea (3.8 percent), abdominal discomfort (1.3 percent) and nausea (1.9 percent). About Roche Roche Laboratories of Nutley, N.J., is the pharmaceutical sales and marketing division of Hoffmann-La Roche Inc., and has a long history in the area of HIV that includes HIVID(R), INVIRASE(R), Cytovene(R), Roferon-A(R) and Bactrim(TM). Roche is also active in the development of diagnostic tests such as Polymerase Chain Reaction (PCR) technology, that quantifies levels of HIV in blood. Hoffmann-La Roche, a research-based health care company, is a member of the Roche Group headquartered in Basel, Switzerland. A world leader in health care, the Roche Group is dedicated to research and the development and delivery of diagnostic tests, treatment and services for people with life-threatening diseases.
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