FDA Adds Children to HIV Drug Indication

The FDA has expanded the indication for etravirine (Intelence) to include treatment of HIV-1 in pediatric patients ages 6 and older in combination with other anti-retroviral medication.

The expansion means that the drug is now also indicated for pediatric patients who are experiencing virologic failure with HIV-1 strains resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and other anti-retroviral medications, a statement from manufacturer Janssen Therapeutics said.

The approval adds a new, 25-mg dose of the drug, which allows weight-based treatment for pediatric patients.

Etravirine was approved in January 2008 as a treatment for adults with resistance to NNRTIs and other anti-retroviral treatments.

Approval for the pediatric indication was based on data from the Pediatric trial with Intelence as an Active NNRTI Option (PIANO) study, which measured safety, tolerability, and efficacy of the drug in combination with other anti-retroviral treatment in 101 treatment-experienced HIV-1 pediatric patients ages 6 to under 18 who weighed at least 35.2 lbs.

At baseline, patients' plasma HIV-1 RNA and CD4 cell counts were measured, with a median of 3.9 log10 RNA copies/mL and median CD4 cell count of 385 x 10⁶ cells/mm³.

Patients were measured for achievement of undetectable viral load (defined as <50 HIV-1 RNA copies/mL) at week 24 of the study. Of those receiving drug treatment, 52% had an undetectable viral load at week 24, with 67% achieving <400 HIV-1 RNA copies/mL. Mean CD4 cell count increase from baseline was 112 x 10⁶ cells/mm³.

Adverse events include severe skin rash, allergic reactions, change in shape or body fat, immune system change (including tingling, numbness, or pain in hands and feet in adult patients), and diarrhea, which was more common in children.

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By Cole Petrochko