Edurant and Vocabria Now Approved for Pediatric Patients

Cabenuva Approved for Children, No Longer Requires Lead-In Therapy
March 30, 2022
Triumeq PD Approved to Treat HIV
April 1, 2022
Cabenuva Approved for Children, No Longer Requires Lead-In Therapy
March 30, 2022
Triumeq PD Approved to Treat HIV
April 1, 2022

March 30, 2022 – Janssen’s Edurant® (rilpivirine) and ViiV Healthcare’s Vocabria® (cabotegravir) have received expanded indications for the short-term treatment of HIV-1 infection.

  • Previously approved for short-term treatment of HIV in adults only, the drugs are now indicated for short-term treatment of HIV in patients who are at least 12 years old and weigh at least 35kg (77 pounds). Under this indication, Edurant and Vocabria must be used together.
  • Before switching to Edurant and Vocabria, patients must already be virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no suspected resistance to either drug.
  • Recommended dosing for short-term treatment is one 30mg tablet of Vocabria and one 25mg tablet of Edurant taken once daily by mouth with a meal. Recommended treatment duration is based on whether the medications are being used as an oral lead-in therapy or as a missed dose replacement for a long-acting injectable HIV treatment.
  • Vocabria, which received initial FDA approval in 2021, is also indicated in at-risk adults and adolescents (weighing at least 35kg) for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
  • First FDA approved in 2011, Edurant is also approved for use in combination with other antiretroviral agents to treat HIV in treatment-naïve patients at least 12 years old (weighing at least 35kg) with HIV-1 RNA less than or equal to 100,000 copies/mL.