FDA Approves Rilpivirine for Treatment of HIV for Pediatric Patients 2 and Older

The FDA has approved rilpivirine (Edurant Ped; Johnson and Johnson) for the treatment of HIV in combination with other antiretroviral therapies in treatment-naïve pediatric patients at least 2 years and older with a weight of at least 14 kg and less than 25 kg, according to a press release from the company.¹

“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,” Penny Heaton, MD, global therapeutic area head of Infectious Diseases and Vaccines at Johnson & Johnson, said 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.”¹

The approval was based on data from the PAINT (NCT00799864) and PICTURE (NCT04012931) studies in pediatric populations, according to the press release. The drug is indicated for children aged 2 and older weighing at least 25 kg for the 2.5 mg oral tablet. The drug was previously approved in the 25 mg oral tablet (Edurant), according to the press release. Treatment naïve is considered HIV-1 RNA of less than 100,000 copies/mL.¹

The PICTURE trial evaluated the drug for individuals weighing 10 kg or more and were treatment naïve with HIV RNA less than or equivalent to 100,000 copies/mL, according to an article on Pharmacy Times. The PAINT trial evaluated long-acting rilpivirine with other antiviral agents for those weighing 10 kg or more who are virologically suppressed and treatment experienced with HIV-1 RNA below 50 copies/mL, according to the article.²

Both trials showed that the drug maintained or suppressed HIV, however the efficacy was limited to patients who had 100,00 copies/mL or less compared those who had above 100,000 copies/mL. In the PAINT trial, investigators reported that virological response of less than 50 copies/mL was observed in 72.2% of patients at week 48 and 43.8% at week 240. The results also showed that when virological response was 400 copies/mL or less, the percentage was 75% and 50%, respectively. For treatment adherence of over 95%, investigators found that 48% of patients had virological responses compared with 28.6% of those with less than 95% adherence.^2,3

Further, they found at the 240 week analysis, 50% of patients were considered virological failure, with 4 individuals never being suppressed and the remaining 12 rebounding, according to the results of the study.3 Virological failure was observed in 48% of individuals with treatment adherence of greater than 95% compared to 57.1% with less than 95% adherence.³

The most common adverse events included depression, headache, insomnia, and rash. Further, severe AEs included rash, allergic reaction, fever, tiredness, difficulty breathing, skin swelling, joint ache, and redness, according to the article.²

In August 2023, Janssen submitted the supplemental new drug application.²

References

1. U.S. FDA Approves Edurant Ped (rilpivirine) for Certain Pediatric Patients Living with HIV-1. News release. Johnson and Johnson. March 19, 2024. Accessed March 21, 2024. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-edurant-ped-rilpivirine-for-certain-pediatric-patients-living-with-hiv-1

2. Hunter E. Janssen Seeks to Expand Indication for Rilpivirine to Include Children Weighing 10 Kg or More With HIV. Pharmacy Times. August 1, 2023. Accessed March 21, 2024. https://www.pharmacytimes.com/view/janssen-seeks-to-expand-indication-for-rilpivirine-to-include-children-weighing-10-kg-or-more-with-hiv-1

3. Lombaard J, Ssali F, Thanyawee P, et al. Phase 2 Open-Label Study of Long-Term Safety, Tolerability, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive Adolescents Living with HIV-1. Antimicrob Agents Chemother. 2022;66(2):e0091621. doi:10.1128/AAC.00916-21