What's New in the Guidelines?

Updated
Reviewed
Feb. 24, 2021

Panel’s Recommendation for Long-Acting Injectable Cabotegravir and Rilpivirine in Persons with HIV

On January 21, 2021, the U.S. Food and Drug Administration (FDA) approved the first complete long-acting injectable antiretroviral (ARV) regimen, cabotegravir and rilpivirine, as an option to replace the current ARV regimen in adults with HIV.

Based on the clinical trial results from two large randomized controlled trials, the Panel recommends that once monthly cabotegravir and rilpivirine intramuscular (IM) injections can be used as an optimization strategy for people with HIV currently on oral antiretroviral therapy (ART) with documented viral suppression for at least 3 months (although optimal duration is not defined) (AI), who—

  • have no baseline resistance to either medication,
  • have no prior virologic failures,
  • do not have active hepatitis B virus (HBV) infection (unless also receiving an oral HBV active regimen),
  • are not pregnant and are not planning on becoming pregnant, and
  • are not receiving medications with significant drug interactions with cabotegravir and rilpivirine.

Before initiation of the IM injection, patients should receive oral cabotegravir and oral rilpivirine for 28 days as an oral lead-in period to assess tolerance to these drugs. Clinicians should refer to the product label for information regarding IM dose administrations as well as management strategies for planned or unplanned missed doses.

Read the full Recommendation for the Long-Acting Injectable Antiretroviral Regimen of Cabotegravir and Rilpivirine.

Panel’s Recommendation for Long-Acting Injectable Cabotegravir and Rilpivirine in Persons with HIV

On January 21, 2021, the U.S. Food and Drug Administration (FDA) approved the first complete long-acting injectable antiretroviral (ARV) regimen, cabotegravir and rilpivirine, as an option to replace the current ARV regimen in adults with HIV.

Based on the clinical trial results from two large randomized controlled trials, the Panel recommends that once monthly cabotegravir and rilpivirine intramuscular (IM) injections can be used as an optimization strategy for people with HIV currently on oral antiretroviral therapy (ART) with documented viral suppression for at least 3 months (although optimal duration is not defined) (AI), who—

  • have no baseline resistance to either medication,
  • have no prior virologic failures,
  • do not have active hepatitis B virus (HBV) infection (unless also receiving an oral HBV active regimen),
  • are not pregnant and are not planning on becoming pregnant, and
  • are not receiving medications with significant drug interactions with cabotegravir and rilpivirine.

Before initiation of the IM injection, patients should receive oral cabotegravir and oral rilpivirine for 28 days as an oral lead-in period to assess tolerance to these drugs. Clinicians should refer to the product label for information regarding IM dose administrations as well as management strategies for planned or unplanned missed doses.

Read the full Recommendation for the Long-Acting Injectable Antiretroviral Regimen of Cabotegravir and Rilpivirine.

Download Guidelines