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May 8, 2013

FDA Approves Sustiva for Children 3 Months to 3 Years Old

Broadening pediatric treatment options, the U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Sustiva (efavirenz) for use in HIV-positive children 3 months to 3 years old and weighing at least 7.7 pounds (3.5 kilograms). The approval of the antiretroviral’s expanded pediatric use (ARV) also came with dosing recommendations, including a “capsule sprinkle” administration meant for those who cannot swallow capsules or tablets.

Sustiva, which is a non-nucleotide reverse transcriptase inhibitor, was approved in 1998 for HIV-positive children 3 years of age or older and weighing at least 22 pounds (10 kg).

The expanded approval was based upon three open-label trials evaluating the pharmacokinetics, safety and ARV activity of Sustiva in combination with other ARVs in 182 treatment-naive and treatment-experienced HIV-positive pediatric study participants between 3 months and 21 years old. With a median observation of 123 weeks, investigators found that the drug lowered viral load and led to a rise in CD4 counts across all ages.

Rates of adverse reactions were similar to those found in studies of adults taking Sustiva, with the exception of an increase in rash, experienced by 32 percent of the participants, and which was more likely to be severe. Five of the children (2.7 percent) dropped out of the study because of the rash.

To read a Bristol-Myers Squibb release, click here.

To read the FDA labeling update, click here.

Search: Sustiva, efavirenz, pediatric, U.S. Food and Drug Administration, FDA, Bristol-Myers Squibb, capsule sprinkle.

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