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MYCOBUTIN PREVENTS ONSET OF AIDS-RELATED INFECTION

 /ADVANCE/ DUBLIN, Ohio, Sept. 16 /PRNewswire/ -- An article published in today's (Sept. 16) issue of the New England Journal of Medicine reports that Mycobacterium avium complex (MAC), a life- threatening bacterial opportunistic infection in people with AIDS (PWAs), can be prevented through the use of a prophylactic treatment. The article describes the results of two studies which showed that Mycobutin(R) (rifabutin capsules) reduces the frequency of MAC bacteremia in PWAs by half.
 The two randomized, double-blind trials were conducted from 1990 to 1992 at 73 research sites throughout the United States and Canada and evaluated 556 patients in the U.S./Canadian study and 590 patients in the U.S. study. The trials compared Mycobutin to placebo in preventing disseminated MAC infection in PWAs who have CD4 counts of 200 or less.
 Disseminated MAC is the fastest growing bacterial opportunistic infection that occurs in as many as 40 percent of patients with advanced HIV disease. Symptoms include weight loss, fever, abdominal pain, diarrhea, fatigue, night sweats, nausea and weakness. It is a major cause of illness among people with AIDS and appears to decrease survival.
 Clinical Trial Results
 In each study, patients were randomly assigned to receive either 300 mg of Mycobutin once a day or placebo. All patients enrolled in the studies had a previous AIDS defining event, CD4 counts of 200 or less and were receiving antiretroviral therapy and prophylaxis for Pneumocystis carinil pneumonia. Patients were excluded from the studies if they tested positive for MAC at the time of entry, had prior mycobacterial infection or a history of allergy to rifamycin drugs.
 The primary end-point for the studies was the development of MAC bacteremia as determined through a positive blood culture. Secondary end-points included MAC-related signs and symptoms, adverse events and survival.
 In the U.S./Canadian study, 18 percent of placebo patients develop MAC compared to 9 percent taking Mycobutin. Results were similar in the U.S. study, where MAC developed in 17 percent of placebo compared to 8 percent in the Mycobutin patients. Patients receiving Mycobutin also experienced a significant reduction in MAC-related fever and fatigue, both of which contribute substantially to morbidity.
 "As people with AIDS live longer, the prevalence of disseminated MAC is increasing," said Fred Gordin, M.D., chief, infectious diseases, Veterans Affairs Medical Center. "Rifabutin can prevent the onset of MAC and reduce the symptoms associated with this infection."
 Overall, the most common side effects were discolored urine, rash and nausea. Other reported side effects were neutropenia, abdominal pain and diarrhea.
 The studies were supported by a grant from Adria Laboratories, since May 1, 1993, part of the European pharmaceutical company Kabi Pharmacia.
 Mycobutin was cleared for marketing in December 1992 for the prevention of disseminated MAC disease in patients with advanced HIV infection. To date, it remains the only approved therapy for the prevention of MAC. Mycobutin was developed in North America by Adria Laboratories, Columbus, Ohio.
 Adria Laboratories is devoted to research and development in he areas of oncology and immunology. Mycobutin is marketed through a co- promotional agreement between Adria and SmithKline Beecham.
 -0- 9/15/93/1800
 /CONTACT: Karin Leuffgen of Porter/Novelli, 212-315-8231/


CO: Adria Laboratories ST: Ohio IN: MTC SU:

CK-SM -- NY059 -- 2297 09/15/93 14:04 EDT
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Publication:PR Newswire
Date:Sep 15, 1993
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