Cabotegravir + Rilpivirine

Y. Vivian Tsai, Pharm.D.

INDICATIONS

FDA

  • For the treatment of HIV-1 infection in adults and adolescents ≥12 years of age and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpirivine.
    • The initial FDA approval in 2021 was based on two phase 3 clinical studies, FLAIR[10]and ATLAS[9], which provided an indication for monthly injection of cabotegravir/rilpivirine.
    • In 2022, the FDA updated its approval extending the dosing interval to every other month based on ATLAS-2M trial[7]. Additionally, the FDA also made oral-lead in phase with oral cabotegravir + rilpivirine optional based on the long-term outcomes from FLAIR trial at 124 weeks that showed no differences in virologic suppression when participants underwent direct-to-injection switch[8]. Lastly it also extended approval to adolescents at least 12 years of age and weighing at least 35 kg to receive either monthly or every other month injection based on MOCHA trial[2].

NON-FDA APPROVED USES

  • The International Antiviral Soceity-USA (IAS-USA) treatment guidelines support the use of intramuscular cabotegravir/rilpivirine injection for adults with HIV-1 viremia who are unable to take oral antiretroviral regimen consistently despite extensive efforts and clinical support, have high risk of HIV disease progression (CD4 cell count < 200/μL or history of AIDS-defining complications), or virus susceptible to both cabotegravir and rilpivirine. This recommendation is supported by limited clinical evidence that demonstrated positive outcomes in adult with HIV-1 viremia who had adherence challenges[3][6].

There's more to see -- the rest of this topic is available only to subscribers.

Last updated: March 15, 2025