FDA approves formulations of tenofovir for HIV-infected children

The FDA has approved updated labeling for tenofovir disoproxil fumarate to include dosing information for the treatment of HIV-1 infection in pediatric patients aged 2 to 18 years.

The FDA has also approved a supplemental New Drug Application for three lower-strength, once-daily tablets of tenofovir (Viread; Gilead Sciences) in doses of 150 mg, 200 mg and 250 mg for children aged 6 to 12 years, as well as an oral powder formulation to support dosing in pediatric patients aged 2 to 5 years.

For the treatment of HIV-1 in pediatric patients aged at least 2 years, 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.

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 of tenofovir. The updated labeling recommends that the oral powder should be mixed with 2 oz to 4 oz of soft food that does not require chewing, such as applesauce or yogurt, but should not be administered in a liquid because the powder may float atop the liquid after stirring. Tenofovir is available as tablets in 150 mg, 200 mg, 250 mg and 300 mg strengths for pediatric patients who weigh at least 17 kg and who are able to reliably swallow intact tablets.

The pediatric regulatory applications for tenofovir were supported by clinical data from two randomized trials of 184 HIV-1 infected patients who either received tenofovir treatment (n=93) or a placebo/active comparator (n=91) combined with other antiretroviral agents for 48 weeks. The adverse reactions observed in patients who received tenofovir were consistent with those observed in adult trials and included rash, diarrhea, headache, pain, depression, asthenia and nausea.

“Prenatal HIV testing and antiretroviral interventions during pregnancy have contributed to a dramatic decline in the number of children born with HIV in the United States. However, there remains an unmet need for heat-stable, taste-neutral pediatric formulations that do not require cold storage, particularly in resource-limited settings, where mother-to-child transmission remains a significant challenge,” Norbert Bischofberger, PhD, chief scientific officer at Gilead Sciences, said in a press release. “We are very pleased to provide an important new therapeutic option for younger HIV patients and will work to make the pediatric formulations of Viread available as quickly as possible.”

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