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| |  ZERIT, an Important New Option for Treating HIV-Infected Children PRINCETON, N.J., Jan. 16, 1997 -- Until recently, there were very few options for infants and children infected with the human immunodeficiency virus (HIV), which causes AIDS. Despite the development of many promising new AIDS treatments, few have been studied extensively in pediatric populations. According to the Pediatric AIDS Foundation, an estimated 20,000 children nationwide are infected with HIV. More than 7,000 of these children, under age 13, have AIDS, according to the U.S. Centers for Disease Control and Prevention. However, the availability of a new oral solution formulation of Bristol-Myers Squibb's ZERIT(R) (stavudine, d4T) represents a significant addition to the limited therapeutic options available to treat HIV-infected infants and children. A number of clinical trials are underway to determine the safety and efficacy of ZERIT(R) in combination with other HIV/AIDS treatments, including nucleoside analogues and protease inhibitors. ZERIT for Oral Solution is a fruit-flavored powder in bottles providing 2OOmL of a 1 mg/mL stavudine solution upon constitution with water. ZERIT is a nucleoside analogue that inhibits the action of reverse transcriptase, a vital enzyme the AIDS virus uses to reproduce itself. "The entire pediatric AIDS community welcomes the availability of a liquid formulation of d4T," commented Arthur Ammann, M.D., a pediatric immunologist and AIDS specialist who is also president of the American Foundation for AIDS Research (AmFAR). "Pediatricians and parents need approved drugs in a properly formulated liquid, as this is the only safe and reliable way to give medication to very sick children, particularly infants, in whom infection begins at birth. "At this point in the epidemic, when there is increasing evidence of the efficacy of combination therapy in controlling HIV and preventing viral resistance, the availability of d4T in liquid form will provide additional therapeutic options," Dr. Ammann added. In a recently completed AIDS Clinical Trials Group Study (ACTG 240), ZERIT was compared with AZT for initial treatment of HIV-infected children. "Children receiving stavudine experienced better weight gain, and their absolute CD4+ lymphocyte counts were better maintained than children taking AZT," said Mark Kline, M.D., Associate Professor, Department of Pediatrics, Baylor College of Medicine, Houston. "Patients in the d4T group encountered significantly fewer episodes of low white blood cell counts compared to the AZT group. "Stavudine demonstrates excellent safety and efficacy results compared to other nucleoside analogues -- specifically AZT. It is a valuable new treatment option for children with HIV," continued Dr. Kline, who will present final results from this multicenter study at the Fourth Conference on Retroviruses and Opportunistic Infections in Washington, D.C. on January 24. "The availability of ZERIT(R) Oral Solution demonstrates Bristol-Myers Squibb's commitment to providing safe, effective and manageable treatments for pediatric HIV/AIDS patients," said Laurie Smaldone, M.D., vice president, infectious disease, clinical research at the Bristol-Myers Squibb Pharmaceutical Research Institute. "In making VIDEX(R) (didanosine/ddI) and ZERIT available in pediatric formulations, we have expanded the range of options for management of HIV/AIDS in children." VIDEX is indicated for the treatment of HIV infection in adults and children when antiretroviral therapy is warranted. The VIDEX pediatric indication is based on striking results from the ACTG 152 pediatric study, a landmark large-scale clinical trial, in which VIDEX, whether administered alone or in combination with AZT, demonstrated superior efficacy and safety over AZT monotherapy in previously untreated children infected with HIV. Bristol-Myers Squibb (NYSE: BMY) is one of the leading companies in the research and development of HIV treatments. VIDEX has been on the market in the U.S. since 1991 and is available worldwide. The most common side effects associated with VIDEX are diarrhea and peripheral neuropathy. ZERIT, the company's second contribution to antiviral therapy, has been available in the U.S. since June 1994, in Europe since May 1996, and in several other countries worldwide. The only notable clinical toxicity of ZERIT is peripheral neuropathy, which usually resolves if treatment is withdrawn. Resumption of treatment may be considered at a reduced dose. Both drugs are now available for the treatment of pediatric AIDS. Bristol-Myers Squibb also markets Megace(R) Oral Suspension for HIV anorexia/cachexia and Fungizone(R) Oral Suspension for oral candidiasis in HIV-infected patients. Bristol-Myers Squibb 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 a leader in consumer medicines, orthopedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin products. Visit Bristol-Myers Squibb on the World Wide Web at: http://www.bms.com
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