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Nevirapine receives pediatric indication for treating HIV/AIDS

Nevirapine is the seventh AIDS drug for pediatric HIV/AIDS; 14 medications are currently FDA-approved for use in adults.

[First of its kind]

[Your turn]

December 1998

COLUMBUS, Ohio - The Food and Drug Administration (FDA) recently approved a pediatric formulation of nevirapine (Viramune, Roxane Laboratories) to treat infants and children infected with HIV, according to a statement from Roxane.

Nevirapine has been shown to rapidly suppress levels of HIV in adults. Studies in more than 360 infants and children found it to be safe and well tolerated for use as treatment for pediatric HIV infection.

The recommended pediatric dosing for nevirapine is 4 mg/kg once daily for two weeks, followed by 7 mg/kg twice daily for children between 2 months and 8 years of age; 4 mg/kg twice daily for children 8 years and older. The total daily dosage should not exceed 400 mg (200 mg twice daily) for any patient.

Viramune is the seventh AIDS medication cleared by the FDA for the treatment of pediatric HIV/AIDS; 14 medications are currently FDA-approved for use in adults.

"The availability of nevirapine'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 L. Sullivan, MD, professor of pediatrics, University of Massachusetts Medical School, Worcester, Mass. "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."

First of its kind

The antiretroviral AIDS drug is the first in the class of non-nucleoside reverse transcriptase inhibitors to be approved for pediatric use. The FDA's decision was based on clinical trials that provide safety, tolerability and pharmacokinetic data supporting the drug's use in children. To date, more than 360 children have been treated with nevirapine in clinical trials. Some have remained on therapy for as long as six years.

In the AIDS Clinical Trial Group (ACTG) 180, a multicenter, open-label study, pediatric patients with six weeks or less of prior nucleoside therapy were treated with nevirapine monotherapy, double therapy with nevirapine- zidovudine (AZT, Retrovir, Glaxo Wellcome), or triple therapy with nevirapine, AZT, and didanosine (ddI, Videx, Bristol-Myers Squibb) for 28-32 weeks.

Viramune tablets have been available since August 1996 and have been used in more than 50,000 adult patients. Nevirapine is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection. This indication is based on analysis of changes in surrogate end-points.

There are currently no results from controlled clinical trials evaluating the effect of nevirapine in combination with other antiretroviral agents on the clinical progression of HIV infection, such as the incidence of opportunistic infections or survival. Nevirapine should always be administered in combination with at least one additional antiretroviral agent.

Your turn

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Copyright 2000, SLACK Incorporated. Revised 15 September 2000.