FDA approves rilpivirine for pediatric patients with HIV-1, weighing 14 kg to 25 kg
Administration of the HIV-1 specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) to the indicated population can be done via 25 mg oral tablets or new 2.5 mg oral tablets, developed to help administration and weight-adjusted dosing for children.
FDA approves rilpivirine for pediatric patients with HIV-1, weighing 14 kg to 25 kg | Image Credit: © Calin - © Calin - stock.adobe.com.
The FDA has approved rilpivirine (EDURANT PED; Johnson & Johnson) to treat HIV-1 in combination with other antiretroviral therapies (ARVs) for treatment-naïve children aged at least 2 years who weigh at least 14 kg (30.86 lbs) and less than 25 kg (55.11 lbs), according to a press release from Johnson & Johnson.
The approval is based on results from the PAINT and PICTURE studies (NCT00799864 and NCT04012931) that demonstrated rilpivirine effectively suppressed the virus in treatment-naïve pediatric patients with HIV-1 RNA <100,000 copies/mL.
Administration of the HIV-1 specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) to the indicated population can be done via 25 mg oral tablets or new 2.5 mg oral tablets, developed to help administration and weight-adjusted dosing for children.
“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, Johnson & Johnson, in the press release.
"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,” added Heaton.
According to Johnson & Johnson, rilpivirine-treated individuals with HIV-1 RNA greater than 100,000 copies / mL at therapy start experienced virologic failure (HIV-1 RNA ≥50 copies / mL) compared to individuals treated with HIV-1 RNA less than or equal to 100,000 copies / mL.
Rilpivirine, in combination with cabotegravir (VOCABRIA), is indicated for short-term treatment of HIV-1 infection in adults and adolescents aged 12 years and up who weigh at least 35 kg (77.16 lbs) who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, stated Johnson & Johnson.
If individuals are taking any of the following medicines, they should not take rilpivirine:
- carbamazepine
- oxcarbazepine
- phenobarbital
- phenytoin
- rifampin
- rifapentine
- dexamethasone (more than a single dose)
- St. John’s wort (Hypericum perforatum)
- esomeprazole
- lansoprazole
- omeprazole
- pantoprazole
- rabeprazole
The most common side effects of rilpivirine include depression, headache, trouble sleeping, and rash.
Reference:
US FDA approves EDURANT PED (rilpivirine) for certain pediatric patients living with HIV-1. Johnson & Johnson. Press release. March 19, 2024. Accessed March 20, 2024. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-edurant-ped-rilpivirine-for-certain-pediatric-patients-living-with-hiv-1
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