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| |  Norvir is Cleared for Use in Children with HIV and AIDS ABBOTT PARK, Ill., March 14, 1997 -- Abbott Laboratories (NYSE: ABT) has received clearance from the U.S. Food and Drug Administration (FDA) for the use of NorvirTM (ritonavir), a protease inhibitor, in children with HIV and AIDS. Norvir is one of the first of currently marketed protease inhibitors to receive FDA clearance for use in children with HIV and AIDS. The drug is one of the first-generation protease inhibitors that has been shown to have a positive impact in the lives of AIDS patients. Norvir was cleared for marketing for adult use on March 1, 1996. "We are pleased that now children, too, may benefit from a protease inhibitor," says Susan DeLaurentis, co-founder, Pediatric AIDS Foundation. "This has been urgently needed." The dosing recommendation for Norvir in children (age 2-16) is based primarily on pharmacokinetic and safety data from an ongoing Phase I/II study being conducted by a team of scientists at the HIV and AIDS Malignancy Branch of the National Cancer Institute, in collaboration with Abbott Laboratories. Currently, researchers have enrolled 51 HIV-infected children with either no prior therapy, progressive disease, or toxicity to another antiretroviral regimen. The use of Norvir was evaluated in the 44 children who had completed at least four weeks of treatment as of Sep. 30, 1996. Norvir was given alone for the first 12 weeks, then in combination with zidovudine and/or didanosine. The recommended dosage of Norvir in children, in combination with nucleoside analogues, is 400 mg/m2, twice daily, and should not exceed 600 mg, twice daily. The starting dose is 250 mg/m2, twice daily, which should be titrated to 400 mg/m2. The evaluation of the antiviral effect of Norvir in children is ongoing. In HIV-infected patients age 2-16 years, the adverse event profile was similar to that seen during clinical trials and post-marketing experience in adults. The most common adverse events in adults include nausea, diarrhea, vomiting, asthenia and taste disturbance. Safety of Norvir in children below age two has not been established. Norvir should not be used in combination with highly metabolized medications known to cause serious or life-threatening adverse events. Norvir is currently indicated in adults in combination with nucleoside analogues or as monotherapy for the treatment of HIV infection when therapy is warranted. For patients with advanced HIV disease, this indication is based on the results from a study that showed a reduction in both mortality and AIDS-defining clinical events for patients who received Norvir. Median duration of follow-up in this study was six months. The clinical benefit from Norvir therapy for longer periods of treatment is unknown. For patients with less advanced disease, this indication is based on changes in surrogate markers in studies evaluating patients who received Norvir alone or in combination with other antiretroviral agents. Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products.
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