For virologically suppressed individuals 12 years or older weighing at least 35 kg with HIV-1. See Full Indication.

DHHS Guidelines:
Once-Monthly CABENUVA

The Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines includes once-monthly CABENUVA as an optimization strategy for patients living with HIV who have sustained viral suppression for 3 to 6 months (optimal duration is not defined) and agree to make the frequent clinic visits needed to receive the injections.1 See the full recommendation and key considerations below.

DHHS Guidelines strongly recommend (AI)* once-monthly CABENUVA for virologically suppressed adults with HIV-11

Strength of recommendation for the statement: A=strong, B=moderate, C=optional.
Quality of evidence for the recommendation: I=one or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II=one or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes; III=expert opinion.

Prior to initiating treatment with CABENUVA, prescribe cabotegravir 30-mg and rilpivirine 25-mg oral tablets, both taken once daily with a meal, for approximately 1 month (at least 28 days) to assess feasibility.2

The Panel’s recommendation

In this update, the DHHS Panel now supports use of once-monthly CABENUVA for people with HIV who have sustained viral suppression for 3 to 6 months (optimal duration is not defined) and who1:

  • have good adherence and engagement in care,
  • have no baseline resistance to cabotegravir or rilpivirine,
  • have no prior virologic failures,
  • do not have active or occult hepatitis B virus (HBV) infection (unless receiving an oral HBV regimen),
  • are not pregnant or planning on becoming pregnant, and
  • are not receiving medications with significant drug interactions with oral therapy (during oral lead-in or when a patient plans to miss an injection visit) or injectable cabotegravir or rilpivirine

*Strength of recommendation for the statement: A=strong, B=moderate, C=optional.
Quality of evidence for the recommendation: I=one or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II=one or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes; III=expert opinion.
†Prior to initiating treatment with CABENUVA, prescribe cabotegravir 30-mg and rilpivirine 25-mg oral tablets, both taken once daily with a meal, for approximately 1 month (at least 28 days) to assess feasibility.2

Key considerations

  • The Guidelines recommend patients be suppressed at least 3 to 6 months prior to switch (although optimal duration is not defined). US Prescribing Information does not mandate any specific duration of viral suppression prior to switch1
  • Guidelines discuss switching to long-acting ARVs, including once-monthly CABENUVA, may be advantageous in appropriate patients for reasons including, but not limited to: reducing pill fatigue and disclosure concerns or stigma with taking daily oral medications1
  • Since CABENUVA can only be administered by a healthcare provider, the Guidelines mention there is potential for strain on clinical systems, pharmacies, and patients. ViiV Healthcare has implementation resources to support your practice

ARV=antiretroviral.

REFERENCES:

  1. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. DHHS Adults and Adolescents Antiretroviral Guidelines Panel Recommendation for the Long-Acting Injectable Antiretroviral Regimen of Cabotegravir and Rilpivirine. US Department of Health and Human Services. Updated June 3, 2021. Accessed June 14, 2021. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf.
  2. CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.

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