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.”