The Food and Drug Administration (FDA) has approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35kg for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV infection.
Apretude contains an extended-release formulation of cabotegravir, an HIV integrase strand transfer inhibitor. Prior to initiating Apretude, patients must have a negative HIV-1 test. Patients may then proceed directly to injection of Apretude or start with oral cabotegravir for approximately 1 month to assess tolerability first.
The approval of Apretude was based on data from the phase 2b/3 HPTN 083 (ClinicalTrials.gov Identifier: NCT02720094) and HPTN 084 (ClinicalTrials.gov Identifier: NCT03164564) trials, which evaluated the efficacy and safety of Apretude for HIV PrEP. HPTN 083 included men who have sex with men and transgender women who have sex with men (N=4566). HPTN 084 enrolled women who were at increased risk of HIV acquisition (N=3223). In both trials, patients received either Apretude every 8 weeks or daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) 200mg/300mg.
Results from the HPTN 083 trial showed that Apretude was 69% more effective than FTC/TDF in preventing HIV acquisition among the study population (incidence rate per 100 person-years: 0.37% in the Apretude group vs 1.22% in the FTC/TDF group; hazard ratio [HR], 0.31 [95% CI, 0.16-0.58]; P =.0003).
In the HPTN 084 trial, Apretude was found to be 90% more effective than FTC/TDF in preventing HIV acquisition among the study population (incidence rate per 100 person-years: 0.15% in the Apretude group vs 1.85% in the FTC/TDF group; HR, 0.10 [95% CI, 0.04-0.27]; P <.0001).
The most common adverse reactions reported were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
Apretude is supplied in a kit containing one 600mg/3mL single-dose vial of cabotegravir extended-release injectable suspension, 1 syringe, 1 vial adapter, and 1 needle for injection.
Apretude is administered initially as a single intramuscular injection given 1 month apart for 2 consecutive months, then every 2 months thereafter.
The product is expected to be available in early 2022.
- FDA approves first injectable treatment for HIV pre-exposure prevention. News release. US Food and Drug Administration. Accessed December 21, 2021. https://www.prnewswire.com/news-releases/fda-approves-first-injectable-treatment-for-hiv-pre-exposure-prevention-301448538.html.
- ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention. News release. ViiV Healthcare. Accessed December 21, 2021. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-us-fda-approval-of-apretude-cabotegravir-extended-release-injectable-suspension-the-first-and-only-long-acting-injectable-option-for-hiv-prevention/.
- Apretude. Package Insert. ViiV Healthcare; 2021. Accessed December 21, 2021. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF.