What is Apretude®? Everything you need to know

Written on May 22, 2023 by Lori Mulligan, MPH. To give you technically accurate, evidence-based information, content published on the Everlywell blog is reviewed by credentialed professionals with expertise in medical and bioscience fields.

Table of contents

• Why is it important to add Apretude® to your HIV prevention toolbox?
• How often is Apretude® administered?
• Who is eligible to take Apretude®?
• Is Apretude® safe?
• Is Apretude® effective?
• Everlywell offers HIV resources
• Related content

You may be asking, "What is Apretude®?"

On December 20, 2021, the U.S. Food and Drug Administration (FDA) approved Apretude® which is the first long-acting injection of cabotegravir, for use in at-risk adults and adolescents weighing at least 77 pounds for pre-exposure prophylaxis (PrEP). The purpose of PrEP is to prevent the transmission of HIV either through two oral pills–Truvada® and Descovy®–or now through this injection of Apretude®.

“This approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.

She further adds that “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”[1]

To understand what Apretude® is, we will explore how it’s administered, who is eligible, how safe it is, and how effective it has been so far.

First, we will consider some of the promising, as well as sobering, HIV statistics regarding infection rates in the U.S. and globally.

Why is it important to add Apretude® to your HIV prevention toolbox?

Promising statistics

In 2020 in the U.S., PrEP was prescribed for 25% of the 1.2 million people for whom it is recommended. This is a significant increase from the 3% in 2015, but there is still room for much more improvement. It will be interesting to see how Apretude® moves the needle on this statistic.

The growth in PrEP use, along with increased testing and treatment, has played a part in recent decreases in new HIV infections in the U.S. CDC estimated new HIV infections fell 8% from 2015 to 2019 after a period of general stability. The impact of COVID-19-related disruptions in HIV prevention services on these trends is not yet known.[2]

Sobering statistics

African Americans in the U.S. continue to face rates of infection that are more than eight times as high as whites, and Hispanics/Latinos face rates that are almost four times as high, in large part because they experience the greatest barriers to accessing prevention and care services.[3]

According to the United Nations, globally, the number of new infections dropped only 3.6% between 2020 and 2021, the smallest annual decline in new HIV infections since 2016.

Every year, around 1.5 million people around the world are infected with HIV. This number is falling, although not fast enough to reach a United Nations target of fewer than 370,000 new infections a year by 2025.[4]

How often is Apretude® administered?

Apretude® is given first as two initiation intramuscular injections administered one month apart and then every two months thereafter. There may be temporary soreness or irritation at the injection site.

Before receiving your first injection, your care team may have you take oral cabotegravir tablets once daily for one month to see how well you will tolerate the injection.[5]

Who is eligible to take Apretude®?

Injectable Apretude® is for people of all genders and identities at risk of HIV infection.

Currently, the injectable method of PrEP is recommended for adults and adolescents who have a bad reaction to oral medications or have trouble adhering to the daily pill schedule.[6]

Is Apretude® safe?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Flu-like symptoms—fever, chills, muscle pain, cough, headache, fatigue
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Headache
• Nausea
• Pain, redness, or irritation at injection site
• Trouble sleeping[7]

Is Apretude® effective?

The World Health Organization (WHO) recommended that Apretude® is a “safe and highly effective HIV prevention tool” that opens the way to including it in worldwide HIV-prevention programs.[8]

In a Nature article, authors cited the results of a randomized clinical trial that showed that Apretude®, taken as an injection six times a year, is more effective at preventing infection than the standard means of PrEP—a daily oral dose of tenofovir disoproxil fumarate and emtricitabine—that is in use around the world.[9]

Everlywell offers HIV resources

STD treatment online

If you think you may have been exposed to HIV or have questions about your sexual health, book a video appointment with a clinician who can start you on your path to a diagnosis and treatment. (Age 18+)

At-home HIV lab test

This at-home HIV lab test will check for exposure to HIV. In the event that your test results are abnormal, you’ll have the opportunity to connect with our independent physician network at no additional cost to discuss your particular case.

You can also speak with a healthcare provider about HIV prevention and/or treatment by booking an appointment via Everlywell's option for STD treatment online.

Related content

HIV PrEP with Apretude®: how does Apretude® work?

PrEP for HIV prevention: how it works and more

How does Truvada® work?

References

1. FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention. Published December 2021. Accessed on May 15, 2023.
2. PrEP for HIV Prevention in the U.S. CDC. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/hiv/PrEP-for-hiv-prevention-in-the-US-factsheet.html. Accessed on May 18, 2023.
3. 2019 National HIV Surveillance System Reports. CDC. https://www.cdc.gov/nchhstp/newsroom/2021/2019-national-hiv-surveillance-system-reports.html. Accessed on May 17, 2023.
4. Millions of lives at risk as progress against AIDS falters. UNAIDS. https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2022/july/20220727_global-aids-update. Accessed on May 17, 2023
5. Proschan K. What You Need To Know About Injectable PrEP (Apretude®) San Fransisco AIDS Foundation. https://www.sfaf.org/collections/beta/what-you-need-to-know-about-injectable-prep-apretude/. Published December 2021. Accessed on May 16, 2023.
6. Cabotegravir Suspension for Injection. Cleveland Clinic. https://my.clevelandclinic.org/health/drugs/23675-cabotegravir-suspension-for-injection. Accessed on May 17, 2023.
7. PrEP for HIV Prevention in the U.S. CDC. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/hiv/PrEP-for-hiv-prevention-in-the-US-factsheet.html. Accessed on May 17, 2023.
8. WHO recommends long-acting cabotegravir for HIV prevention. World Health Organization. https://www.who.int/news/item/28-07-2022-who-recommends-long-acting-cabotegravir-for-hiv-prevention. Accessed May 17, 2023
9. Preventive HIV drug shows urgent need for transparency on pricing. Nature. 2022 Aug;608(7922):239. doi: 10.1038/d41586-022-02136-6. PMID: 35945377. https://pubmed.ncbi.nlm.nih.gov/35945377/.