Edurant PED Approved for Pediatric Patients With HIV-1

The Food and Drug Administration (FDA) has expanded the approval of Edurant^® (rilpivirine) to include treatment of HIV-1 in combination with other antiretroviral agents in treatment-naïve children 2 years of age and older, weighing at least 14kg with HIV-1 RNA less than or equal to 100,000 copies/mL. The approval also includes a new formulation of the drug, Edurant^® PED (rilpivirine), a 2.5mg tablet for oral suspension indicated for pediatric patients weighing at least 14kg to less than 25kg.

The pediatric approval was based on data from the phase 2 PAINT study (ClinicalTrials.gov Identifier: NCT00799864), which evaluated the pharmacokinetics, safety, tolerability and efficacy of Edurant and Edurant PED weight-adjusted doses administered once daily in combination with an investigator-selected background regimen containing 2 nucleoside reverse transcriptase inhibitors. 

Cohort 2 included antiretroviral treatment-naïve HIV-1 infected pediatric patients 6 to less than 12 years of age weighing at least 17kg (n=18). At week 48, findings showed 72% (13/18) of patients had HIV-1 RNA less than 50 copies/mL, while 17% (3/18) had HIV-1 RNA of at least 50 copies/mL. 

The safety and efficacy of Edurant and Edurant PED in treatment-naïve pediatric patients 2 to less than 6 years of age were supported by evidence from adult studies with additional population pharmacokinetic data from pediatric patients 6 years and older.

Due to differing pharmacokinetic profiles, Edurant 25mg film-coated tablets and Edurant PED 2.5mg tablets for oral suspension should not be substituted on a mg-per-mg basis. The recommended dosage in pediatric patients is based on body weight. Both formulations should be taken orally once daily with a meal. Edurant PED must be dispersed in drinking water prior to administration; it should not be chewed or swallowed whole. When a pediatric patient reaches a weight of 25kg or more, they should be switched to Edurant tablets.

“Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their treatment journey,” said Penny Heaton, MD, Global Therapeutic Area Head, Infectious Diseases and Vaccines at Johnson & Johnson. “While the population of young children living with HIV is small, additional treatment options remain key to ensuring that each person living with HIV can be matched to a treatment regimen that is right for them.”