Apretude, First Injectable PrEP, Gets FDA Approval

In mid-December 2021, the U.S. Food and Drug Administration (FDA) approved Apretude (cabotegravir) as the first injectable HIV preventive drug.

Apretude is approved for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and teens. This is the first alternative to taking a daily pill for PrEP.¹

PrEP in pill form is 99 percent effective if someone can keep up with the daily regimen. However, doctors have found some groups of people have trouble taking a daily pill.²

The groups found to have trouble taking a daily PrEP pill include:²

• Young men who have sex with men
• Those with substance use disorders
• People with depression
• Those who live in poverty

The active ingredient in Apretude

The active ingredient in Apretude is cabotegravir extended-release injectable suspension.³

How does Apretude work?

Apretude is an integrase strand inhibitor (INSTI). This class of drugs blocks HIV from replicating and infecting new cells.^1,3

Evidence for Apretude

Apretude was studied in 2 randomized, double-blind clinical trials. Trial 1 included 4,566 HIV-negative men and transgender women who have sex with men and have high-risk behavior for acquiring HIV. Trial 2 included 3,224 HIV-negative cisgender women at risk of acquiring HIV.¹

In both clinical trials, Apretude was more effective than PrEP pills for these groups. The hope is that an injectable medicine will be easier to manage and help more people avoid HIV.¹

Possible side effects

The most common side effects of Apretude include:1,3²

• Injection site reactions
• Headache
• Fever
• Fatigue
• Back pain
• Muscle aches and pains
• Rash

Some people taking Apretude in clinical trials also developed liver damage and depression.¹

Apretude comes with a boxed warning, the strictest warning given by the FDA. It has this warning because you must test negative for HIV before taking it. In clinical trials, drug-resistant HIV was found in people who had undiagnosed HIV while taking Apretude.¹

These are not all the possible side effects of Apretude. Talk to your doctor about what to expect when taking this drug. You also should call your doctor if you have any changes that concern you when taking Apretude.

Things to know

You must weigh at least 77 pounds (35 kilograms) to take this drug.^1,3

In the first month, Apretude is given 2 times 1 month apart. After that, it is given once every 2 months.^1,3

You must test negative for HIV before beginning Apretude and each follow-up injection. This testing reduces the chance of developing resistance to HIV treatment.^1,3

If you acquire HIV while taking Apretude, you must transition to an HIV treatment plan.^1,3

You and your doctor will need to weigh the risks and benefits of taking Apretude if you are breastfeeding. Traces of the drug remain in the body for a year or more after you stop taking it so it may affect your baby.^1,3

Before beginning treatment with Apretude, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.

For more information, read the full prescribing information of Apretude.