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Two new HIV drugs now available for pediatric patients
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Two new HIV drugs now available for pediatric patients
The FDA recently approved two drugs for treatment of HIV-1 in children and adolescents.
The agency approved raltegravir (Isentress, Merck) for use with other antiretroviral drugs for the treatment of HIV-1 infection in patients aged 2 to 18 years. For tenofovir (Viread, Gilead Sciences), the agency updated labeling to include dosing information for the treatment of patients in the same age group. The FDA also approved a supplemental New Drug Application for three lower-strength, once-daily tablets for children aged 6 to 12 years and an oral powder formulation for those aged 2 to 5 years, according to an FDA press release.
Raltegravir is available in tablet form and can be taken twice daily, with or without food. The tablet is also available in a chewable form. Because the two tablet formulations are not interchangeable, the chewable form is approved only for use in children aged 2 to 11 years.
Tenofovir is a indicated for use combined with other antiretroviral agents. The recommended oral dose of tenofovir is 8 mg/kg of body weight (up to a maximum of 300 mg) administered once daily as oral powder or tablets in patients aged at least 2 years.
According to the FDA, the oral powder should be measured only with the supplied dosing scoop, as one level scoop delivers 1 g of powder that contains 40 mg tenofovir.
For more information, visit the FDA website at www.fda.gov/drugs/default.htm.
Availability of effective antiretroviral agents has dramatically altered the life expectancy and life expectations for HIV-infected individuals. Therapies for children with HIV have at times been limited by a lack of pediatric safety and dosing information or appropriate pediatric dosage forms of some very valuable antiretroviral agents. The recent FDA approval of tenofovir and raltegravir for use in children has provided important new options for treatment of children with HIV.
Each of these antiretroviral agents has been highly effective in management of HIV-infected adults, with safety profiles that are typically better than older medications. Availability of tenofovir for children as young as 2 years of age provides a once-daily nucleoside reverse transcriptase inhibitor (NRTI) that can be paired with once-daily emtricitabine, or when appropriate other NRTIs. The combination of tenofovir and emtricitabine is the preferred initial NRTI backbone for adults (to be combined with a non-nucleoside reverse transcriptase inhibitor (NNRTI), a protease inhibitor (PI) or an integrase inhibitor). With a pediatric indication for tenofovir, this combination may assume a similar role in children. Renal toxicity and decreased bone mineral density are long-term adverse events seen in adults and children who have received tenofovir over long durations. Tenofovir is available in powder for mixing with soft foods that do not require chewing (not to be mixed with liquids) and in tablets that can be used in children with weighing more than 17 kg.
Raltegravir, an HIV integrase inhibitor, provides an entirely new class of drugs for children and has been approved for children older than 2 years. This is particularly valuable if resistance has developed to NNRTIs and PIs. With more experience in children, it may also become an option for treating children with HIV who are antiretroviral naïve. Raltegravir is available in a pediatric weight-appropriate tablets. A chewable tablet will be available in mid-year 2012.
– Michael T. Brady, MD
Chairman, AAP Committee on Infectious Diseases
Chair, Department of Pediatrics, Ohio State University College of Medicine, Physician-in-Chief, Nationwide Children’s Hospital, Columbus, Ohio
Disclosure: Dr. Brady reports no relevant financial disclosures.
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