Apretude (Cabotegravir) for HIV

Apretude (cabotegravir) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents who weigh at least 35 kilograms and are at risk for getting HIV-1.

How Apretude Works and How It’s Taken

Apretude is a type of medicine called an integrase inhibitor. It blocks an HIV enzyme called integrase. HIV needs this enzyme to make more copies of itself.

Apretude is used as pre-exposure prophylaxis, also called PrEP. It helps reduce the risk of sexually acquired HIV-1 infection in adults and adolescents who weigh at least 35 kilograms and are at risk of getting HIV-1.

Apretude is not approved to treat HIV-1. A person must test negative for HIV-1 before starting Apretude and before every injection. If a person becomes infected with HIV-1 while receiving Apretude, they must switch to a complete HIV-1 treatment regimen.

HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).

Apretude is given by a healthcare provider as an injection into the muscle of the buttock. The first two injections are given one month apart. After that, one injection is given every two months.

The oral lead-in is optional. A healthcare provider and person may choose oral cabotegravir before the first injection to check how well cabotegravir is tolerated. Apretude may also be started without an oral lead-in.

Typical Dosing for HIV PrEP

Apretude is used to prevent HIV-1, not to treat HIV-1.

Each Apretude injection contains 600 milligrams of cabotegravir in 3 milliliters.

With an optional oral lead-in:

Take oral cabotegravir 30 milligrams by mouth once daily for at least 28 days.
Give the first Apretude 600-milligrams injection on the last day of the oral lead-in or within three days after it ends.
Give a second Apretude 600-milligrams injection one month later.
Continue with Apretude 600 milligrams every two months.

Without an oral lead-in:

Give the first Apretude 600-milligrams injection at month 1.
Give the second Apretude 600-milligrams injection at month 2.
Continue with Apretude 600 milligrams at month 4 and every two months after that.

A scheduled injection may be given up to seven days before or after the planned injection date.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Apretude Side Effects

In clinical studies of Apretude, the most common side effects occurred in at least 1 percent of people. These include:

Injection site reactions (problems where you get the shot, such as pain, swelling, or a lump)
Diarrhea
Headache
Pyrexia (fever)
Fatigue
Sleep disorders
Nausea
Dizziness
Abdominal flatulence (gas)
Abdominal pain
Vomiting
Rash
Decreased appetite
Back pain
Upper respiratory tract infection
Myalgia (muscle pain)

Serious Side Effects and Warnings

Apretude can cause serious side effects that may require immediate medical attention. These include:

Drug-resistant HIV-1 — If Apretude is started or continued when someone has HIV-1, the virus can become harder to treat.
Severe allergic reactions — Serious reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can cause severe rash, blisters, mouth sores, eye irritation, swelling, trouble breathing, or feeling very ill.
Liver problems — Liver injury may cause symptoms such as yellowing of the skin or eyes, dark urine, nausea, vomiting, stomach pain, or unusual tiredness.
Depression or mood changes — These mood changes can include suicidal thoughts or actions.

Get medical help right away if you think you are having a serious reaction. If you or someone you know needs help, you can contact the 988 Suicide & Crisis Lifeline by calling or texting 988 or by using the online chat.

How To Save on Apretude

ViiV Healthcare, the manufacturer of Apretude, offers the Apretude Savings Program. Eligible people with commercial insurance may pay as little as $0 per injection.

The Apretude Savings Program also offers support through ViiVConnect Access Coordinators, including help understanding insurance coverage, verifying benefits, determining eligibility for savings programs, and appealing denied claims.

To learn more, visit the Apretude Savings Program website or call 844-588-3288.

What To Know Before Taking Apretude

Before starting Apretude, your healthcare provider will test you for HIV-1. You must test negative before starting Apretude and before every injection.

Some HIV-1 tests may miss a very recent infection. Tell your healthcare provider if you may have been exposed to HIV-1 recently or had flu-like symptoms within the past month. These symptoms may include fever, tiredness, muscle or joint pain, headache, sore throat, vomiting, diarrhea, rash, night sweats, or swollen lymph nodes.

Before receiving Apretude, tell your healthcare provider if you:

Have ever had a rash or allergic reaction to cabotegravir
Have or have had liver problems
Have or have had mental health problems
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed

Apretude may remain in your body for 12 months or longer after your last injection. Tell your healthcare provider if you become pregnant while receiving Apretude or after stopping it.

While receiving Apretude for PrEP:

Know your HIV-1 status and your partners’ HIV-1 status.
Ask partners with HIV-1 whether they are taking HIV medicines and have an undetectable viral load.
Get tested for HIV-1 before every Apretude injection.
Get tested for other sexually transmitted infections, such as syphilis, chlamydia, and gonorrhea.
Tell your healthcare provider right away if you think you were exposed to HIV-1.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not receive Apretude if:

Your HIV-1 status is unknown or positive
You have had a previous hypersensitivity reaction to cabotegravir or any ingredients in Apretude
You take carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, or rifapentine

If you miss or plan to miss an injection by more than seven days, contact your healthcare provider right away. Your provider may recommend oral cabotegravir for up to two months to replace one missed every-two-month injection. You may also need to restart the injection schedule based on how much time has passed since your last dose.

Apretude should be used during pregnancy only when the expected benefit is greater than the possible risk to the child. A pregnancy exposure registry monitors pregnancy outcomes in people exposed to Apretude. Healthcare providers can register pregnancies by visiting the Antiretroviral Pregnancy Registry website or calling 800-258-4263.

Do not breastfeed if acute HIV-1 infection is suspected.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Apretude for HIV?

In two large studies, Apretude reduced the risk of getting HIV-1 more than daily Truvada.

In a study of cisgender men and transgender women who have sex with men, Apretude reduced the risk of HIV-1 infection by 66 percent. After further testing, the results showed a 69 percent reduction in new HIV-1 infections.

In a study of cisgender women at risk of getting HIV-1, Apretude reduced the risk by 88 percent. After further testing, the results showed a 90 percent reduction in new HIV-1 infections.

How long does Apretude take to work for HIV?

It is not known how long it takes Apretude to provide its highest level of protection against HIV-1.

It is important to receive every injection on schedule. Apretude should be used as part of a full HIV-1 prevention plan. This includes safer sex practices, such as using condoms. Apretude is not always effective in preventing HIV-1 infection.

What tests or monitoring are needed with Apretude for HIV?

You need an HIV-1 test before starting Apretude and before every injection.

If an antigen/antibody HIV-1 test is negative, the result should be confirmed with an RNA test. Apretude may still be given before the RNA result is available.

You should also be tested for HIV-1 if you are diagnosed with another sexually transmitted infection.

Your healthcare provider may use blood tests and other monitoring to check your liver. Apretude should be stopped if liver injury is suspected.