MAY 15, 2024
Health Canada approves Apretude, the first long-acting injectable for HIV prevention
- A long-acting formulation of cabotegravir (Apretude) has been approved for HIV prevention
- This drug has been highly effective in clinical trials at significantly reducing the risk of HIV
- Apretude proved superior to daily oral HIV prevention and was generally well tolerated in trials
A long-acting injectable formulation of the HIV drug cabotegravir has been developed for the prevention of HIV. In well-designed clinical trials, long-acting cabotegravir has been found to be highly effective at reducing the risk of HIV infection. Furthermore, this drug has been found to be superior to daily oral tenofovir DF + FTC (a combination sold as Truvada and available in generic formulations). One factor that may be driving this superiority is the reduced adherence requirements associated with injectable cabotegravir (an injection every two months vs. daily pill taking). The formulation of long-acting cabotegravir meant for HIV prevention is called Apretude.
HIV prevention
When HIV drugs are used prior to exposure to prevent infection, this is called pre-exposure prophylaxis (PrEP). Apretude represents the first long-acting formulation of PrEP that has been found to be highly effective.
In Canada, Apretude has been approved for “at-risk adults and adolescents aged 12 and older and weighing at least 35 kg for PrEP […].” Once Apretude becomes available in Canada, people who are interested in and medically eligible for getting Apretude injections (and after discussion with their healthcare provider) have two options:
- They can start a course of pills (cabotegravir 30 mg daily) for up to a month then switch to injections.
- If doctor and patient agree, they can begin an injection of Apretude and skip the use of the oral formulation.
Initially, patients receive one injection of Apretude once monthly for two consecutive months. Injections are given deep into the buttocks. After this initial injectable dosing, LA cab is given once every two months.
Due to its infrequent dosing, Apretude has the potential to change the way PrEP is used. Some people do not wish to use daily oral PrEP or have difficulty taking pills or remembering to take pills. In such cases, injectable long-acting PrEP in the form of Apretude could meet their HIV prevention needs. For prevention of HIV, Apretude will be available in 3-mL vials containing 600 mg of cabotegravir for injection.
Side effects
Common side effects of Apretude (tablets and solution for injection) include the following:
- headache
- diarrhea
- feeling hot
In clinical trials these tended to be mild to moderate, temporary and resolve without treatment.
People who receive injections of Apretude can develop the following side effects on the skin where the drug was injected:
In clinical trials these tended to be mostly mild to moderate and resolve within a few days.
HIV treatment
A long-acting formulation of cabotegravir has also been developed (and approved) for HIV treatment. When cabotegravir is used by people with HIV, it has to be used in combination with another drug, rilpivirine. A long-acting formulation of rilpivirine has also been developed. This dual therapy is meant for patients whose HIV is already suppressed due to another combination of HIV treatments.
Depending on discussion with their doctor, some patients begin treatment with the oral formulations of these drugs and then subsequently switch to the injectable formulations. Alternatively, also after discussion with their doctors, some patients switch from other oral regimens directly to injectable cabotegravir and injectable rilpivirine. Results from clinical trials support either way of initiating treatment with cabotegravir + rilpivirine. For initiation of treatment, cabotegravir is available in 3-mL vials (containing 600 mg). Subsequent injections consist of cabotegravir in a 2-mL vial (containing 400 mg). Injectable cabotegravir for treatment comes as a kit, bundled with liquid rilpivirine for injection. Even though the kit is covered by most provincial and other formularies for treatment of HIV, this kit contains two drugs and is not approved for use as HIV prevention.
Access
The manufacturer of Apretude, ViiV Healthcare, is negotiating with private insurance formularies; the drug should receive coverage from them within two to three months.
In the weeks and months ahead, ViiV will make supplies of Apretude available to wholesalers so they can supply pharmacies with the drug.
Canada’s provinces and territories as well as the federal government keep lists of drugs that they subsidize. These lists are called formularies. ViiV is negotiating with federal, provincial and territorial formularies about a price for Apretude. If the price is one that governments can afford, they will agree to subsidize the drug. Negotiations over drug pricing can sometimes be lengthy, taking a year, sometimes longer. Your pharmacist will know if and when Apretude becomes available on your region’s formulary.
For the future
Apretude has already been approved in the U.S. and European Union. There will be much to learn from the deployment of Apretude in those places to ensure an equitable distribution of the drug in Canada.
—Sean R. Hosein
Resources
TreatmentUpdate 250 – CATIE
REFERENCES:
- ViiV Healthcare. Apretude — cabotegravir tablets and extended release injectable suspension. Product Monograph. 10 May 2024.
- ViiV Healthcare Canada. ViiV Healthcare Announces Health Canada Approval for APRETUDE (Cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Press Release. 13 May, 2024.
- Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. New England Journal of Medicine. 2021 Aug 12;385(7):595-608.
- 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 May 7;399(10337):1779-1789
- Flexner C. The future of long-acting agents for preexposure prophylaxis. Current Opinion in HIV/AIDS. 2022 Jul 1;17(4):192-198.
- Mitchell KM, Boily MC, Hanscom B, et al. Estimating the impact of HIV PrEP regimens containing long-acting injectable cabotegravir or daily oral tenofovir disoproxil fumarate/emtricitabine among men who have sex with men in the United States: a mathematical modelling study for HPTN 083. Lancet Regional Health: Americas. 2023 Jan 17;18:100416.
- Han K, Patel P, McCallister S, et al. Long-acting cabotegravir pharmacokinetics with and without oral lead-in for HIV PrEP. Antimicrobial Agents and Chemotherapy. 2024 May 6:e0147523.
- Irie WC, Mayer K. Avoiding Shots in the Dark: Learning from the Past To Inform the Implementation of Long-Acting Injectable Pre-Exposure Prophylaxis for Black American Cisgender Women. AIDS and Behavior. 2024; in press.
From Canadian AIDS Treatment Information Exchange (CATIE).
This content was originally published by CATIE, Canada’s source for HIV and hepatitis C information.
Source: CATIE:
https://www.catie.ca/catie-news/health-canada-approves-apretude-the-first-long-acting-injectable-for-hiv-prevention
For more information visit CATIE's Information Network at www.catie.ca
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