FDA expands Intelence label to include young children with HIV

The FDA has approved labeling changes for Intelence to expand treatment for HIV-infected patents aged 2 to 6 years and weighing at least 10 kg.

The dose for Intelence (etravrine, Janssen) for patients weighing 10 kg to 20 kg is 100 mg twice daily, which should be swallowed with water or mixed with water, the agency said.

Etravrine had previously been approved for patients with HIV aged 6 years and older. It is used with other HIV medicines to treat HIV infection, according to the company.

The FDA’s approval of the labeling expansion was based on studies of etravrine in adults, as well as two phase 2 trials in treatment-experienced pediatric patients. The first trial included 101 patients aged 6 to 18 years (TMC125-C213), and the second trial included 20 patients aged 2 to 6 years (TMC125-c234/IMPAACT P1090). Patients in the open-label studies received weight-based dosages of etravrine plus an optimized background regimen of antiretroviral drugs. Researchers found that the safety, pharmacokinetics and efficacy were comparable to those observed in adults who received etravrine 200 mg twice daily.

The FDA noted that etravrine is not recommended for children aged younger than 2 years.

Reference:

Janssen. Intelence (etravrine). http://www.intelence.com. Accessed July 19, 2018.