INDICATIONS

FORMS

*Prices represent cost per unit specified, are representative of "Average Wholesale Price" (AWP).
^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

• Cabotegravir 600 mg injection x1 dose monthly for 2 months followed by every other month thereafter.
• If oral lead-in cabotegravir is used (28 days), initiate the first dose on the last day or within 3 days of oral-lead in phase.
• Individuals may be given the subsequent cabotegravir injections up to 7 days before or after the date the individual is scheduled to receive the injection.

Missed Injections

• If second injection is missed and time since first injection is:
  • ≤2 months: administer intramuscular cabotegravir 600 mg injection as soon as possible, then continue to follow the every other month injection schedule.
  • >2 months: restart intramuscular cabotegravir 600 mg injection monthly x2 doses, followed by every every month injection thereafter.
• If third or subsequent injection is missed and time since prior injection is:
  • ≤3 months: administer intramuscular cabotegravir 600 mg injection as soon as possible, then continue to follow the every other month injection schedule.
  • >3 months: restart intramuscular cabotegravir 600 mg injection monthly x2 doses, followed by every every month injection thereafter.

RENAL DOSING

ADVERSE DRUG REACTIONS

DRUG INTERACTIONS

• Cabotegravir is contraindicated in patients receiving concurrent medications that may significantly decrease the plasma concentration through UGT1A1 that results in increased risk for loss of virologic response.

*Table includes potentially significant interactions but is not all inclusive.

SPECTRUM

• HIV

RESISTANCE

• In the HPTN 083 trial[3], INSTI resistance-associated substitutions were detected from 5 subjects who achieved target plasma concentrations of cabotegravir and included R263K, E138A+Q148R, E138K+Q148K, G140A+Q148R, E138K+Q148K, L74I+E138E/K+G140G/S+Q148R+R157Q.

PHARMACOLOGY

COMMENTS

• Intramuscular cabotegravir injection must be administered by a healthcare provider.

Basis for recommendation

1. FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf Accessed February 27, 2025

   Comment:
   
   
   
   

References

2. Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022;399(10337):1779-1789.  [PMID:35378077]

   Comment: In this phase 3, randomized, double-blind, double-dummy, active controlled, superiority trial (The HPTN 084 trial), the incidence of HIV-1 infection was compared in female adults at risk for HIV-1 infection who received either daily oral tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg or every other month intramuscular cabotegravir 600 mg injection. Those randomized to intramuscular cabotegravir injection group received 5 weeks of daily oral cabotegravir 30 mg lead-in followed by monthly intramuscular cabotegravir 600 mg injection for 2 months prior to transitoning to every other month injection. Eligible participants had at least two episodes of vaginal intercourse in the previous 30 days, nonreactive test results with at least one HIV rapid antibody test, a laboratory-based atnigen-antibody test, and an undetectable HIV RNA up to 14 days before enrollement. The incidence of HIV-1 infection was higher in the dialy oral tenofovir disoproxil fumarate compared to the every other month intramuscular cabotegravir injection groups (1.85% vs 0.20%, HR 0.12 (95% Cl 0.05-0.31, p< 0.001)).
   

3. Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. N Engl J Med. 2021;385(7):595-608.  [PMID:34379922]

   Comment: In this phase 2b-3, randomized, double-blind, double-dummy, multicenter, active controlled, noninferiority trial (The HPTN 083 trial), the incidence of HIV-1 infection was compared in adult cisgender MSM and transgender women at risk for HIV infection who received either daily oral tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg or every other month intramuscular cabotegravir 600 mg injection. Those randomized to every other month intramuscular cabotegravir injection received 4 weeks of daily oral lead-in cabotegravir 30 mg followed by monthly intramuscular cabotegravir 600 mg injection for 2 months prior to transitioning to every other month injection schedule. Eligible participants had a negative HIV serologic test at enrollment, an undetectable blood HIV RNA viral load within 14 days before trial entry, and CrCl >60 ml/min. The cohort consisted primarily MSM (87.4%). At week 161, the incidence of HIV-1 infection was higher in the daily oral tenofovir disoproxil fumarate/emtricitabine than every other month intramuscular cabotegravir injection groups (1.22/100 person-years vs 0.41/100 person -years respectively, HR 0.34 (95% Cl 0.18-0.62, p< 0.001). 81.4% of the intrasmuscular cabotegravir injection group experienced injection-site reactions.