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FDA Approves Wider Indication for Sustiva (Efavirenz) in HIV-Infected Pediatric Patients
The FDA has approved Sustiva (efavirenz; Bristol-Myers Squibb) for human immunodeficiency virus-1 (HIV-1)–infected pediatric patients 3 months to 3 years old and weighing at least 3.5 kg. The approval provides a once-daily option as part of an antiretroviral regimen for this population and includes a “capsule sprinkle” administration method for young patients who cannot swallow capsules or tablets.
Sustiva (efavirenz) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was originally approved in the U.S. in 1998 to treat HIV-1–infected children 3 years of age or older and weighing at least 10 kg.
The new regulatory approval was based on results from three open-label studies that evaluated the pharmacokinetics, safety, and antiretroviral activity of efavirenz in combination with other antiretroviral agents in 182 antiretroviral-naïve and -experienced HIV-1–infected pediatric patients (aged 3 to 21 months) for a median period of 123 weeks. Virologic and immunologic responses were observed across all ages at the end of the studies, as measured by HIV RNA and CD4 cell counts.
The adverse reactions observed in the three pediatric trials were similar to those observed in clinical studies in adults, except that rash was more common in the pediatric patients (32% for all grades, regardless of causality) and more often of a higher grade (i.e., more severe). Five pediatric patients (2.7%) discontinued treatment because of rash.
The use of Sustiva (efavirenz) in patients younger than 3 months of age or with a body weight of less than 3.5 kg is not recommended because the drug’s safety, pharmacokinetics, and antiretroviral activity have not been evaluated in those age and weight groups, and because there is a risk of developing HIV resistance if Sustiva is underdosed.
Source: Bristol-Myers Squibb; May 3, 2013.