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| |  FDA Approves Pediatric Viramune For HIV Treatment COLUMBUS, OH – Nov. 23, 1998 – The United States Food and Drug Administration has approved a pediatric formulation of Roxane Laboratories’ AIDS drug Viramune(R) (nevirapine) to treat infants and children infected with HIV. Viramune is the seventh AIDS medication to be cleared by the FDA for use in the treatment of pediatric HIV/AIDS. Fourteen agents are currently available for adults. "The availability of Viramune's pediatric formulation represents a great advance for the treatment of HIV-positive children, particularly for those children who are in need of new treatment options," said John Sullivan, MD, professor of pediatrics at the University of Massachusetts Medical School, Worcester. "Some of the currently available agents are very effective, but taste terrible. Getting kids to swallow such drugs is very difficult. Viramune, in comparison, is a pleasant-tasting liquid suspension taken twice daily. We have found that Viramune is easy for children to take and is generally well tolerated." Viramune is the first agent belonging to the class of drugs called NNRTIs or non-nucleoside reverse transcriptase inhibitors to be approved for use in children. The FDA's decision was based on clinical trials that provide safety, tolerability and pharmacokinetic data supporting Viramune's use in children. To date, more than 360 children have been treated with Viramune in clinical trials. Some have remained on therapy for as long as six years. Viramune has been shown to suppress HIV-1 in adults when used in combination with other antiretrovirals. In AIDS Clinical Trial Group (ACTG) 180, a multicentre, open-label study, pediatric patients with six weeks or less of prior nucleoside therapy were treated with Viramune monotherapy, double therapy with Viramune/AZT (Retrovir(R), zidovudine, ZDV), or triple therapy with Viramune/AZT/ddI (Videx(R), didanosine) for 28 to 32 weeks. The study findings were published in The New England Journal of Medicine in May 1997. Viramune continues to be studied in ongoing pediatric clinical trials. Preliminary results of ACTG 356, in which patients took a combination of Viramune/AZT/3TC (Epivir(R), lamivudine) and ACTG 245, a double-blind, randomised, placebo-controlled trial of 431 children with advanced HIV disease, were presented at the fifth Conference on Retroviruses and Opportunistic Infections in February 1998. Viramune is generally well tolerated. The most commonly reported adverse events associated with Viramune use are rash, fever, nausea, headache and abnormal liver function tests. Severe and life-threatening skin reactions and hepatotoxicity, including fatal cases of each, have occurred in patients treated with Viramune. In ACTG 180, rash considered by investigators to be related to Viramune occurred in 16 percent of patients (aged two months to 19 years). The most frequently reported adverse events related to Viramune in pediatric patients were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children. The safety profile of Viramune in neonates has not been established. Recommended pediatric dosing for Viramune is 4 mg/kg once-daily for two weeks, followed by 7 mg/kg twice-daily for children between two months and eight years of age and 4 mg/kg twice daily for children eight years and older. The total daily dose should not exceed 400 mg (200 mg twice-daily) for any patient. Viramune tablets have been available since August 1996 and have been used in more than 50,000 adult patients. Viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points. At present, there are no results from controlled clinical trials evaluating the effect of Viramune in combination with other antiretroviral agents on the clinical progression of HIV-1 infection, such as the incidence of opportunistic infections or survival. Viramune should always be administered in combination with at least one additional antiretroviral agent. Related Links: Viramune, Roxane Laboratories
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