Apretude is a medicine approved by the FDA in 2021 to reduce the risk of contracting HIV through sexual contact, also known as pre-exposure prophylaxis (PrEP). PrEP is used to prevent the transmission of HIV in people who do not have the virus but may be at risk of getting it through sexual activity. Apretude, which is given via long-acting injection, can be used as a form of PrEP. It is important to note that Apretude does not offer protection against other sexually transmitted infections (STIs) such as herpes, gonorrhea, or chlamydia.
How Was It Studied for the Prevention of HIV?
Two large studies were conducted to see if Apretude is safe and effective as a PrEP regimen in people at risk of getting HIV.
In both studies, Apretude was compared to Truvada, an HIV PrEP regimen recommended by the CDC and the United States Public Health Service. Each trial lasted 153 weeks. At the end of each trial, Apretude was found to be more effective than Truvada for preventing HIV.
The main side effects reported by patients receiving Apretude were pain, itching, swelling, and redness near the injection site.
Both trials are being continued to see the long-term effects of Apretude.
Who Was Included in These Studies?
- Adults
- Males and females
- Asian, Black, Hispanic/Latino, and White people
How Strong Is the Evidence for Apretude?
Based on the current studies, Apretude is safe and effective for preventing HIV in those who may be at risk of getting it. The CDC and the United States Public Health Service recommend Apretude as one of several PrEP regimens.
How Do I Use Apretude?
Apretude is a long-acting injection that is given by a health care provider, usually at a hospital or clinic. Prior to starting Apretude injections, your health care provider may first prescribe you cabotegravir tablets, also known as Vocabria, for approximately one month to determine if you can tolerate the medication. After two initial injections one month apart, Apretude is typically given every two months. Your health care provider will make sure you are receiving Apretude as scheduled. Missing doses of Apretude can cause it to not work as well over time. It is important not to miss or skip doses.
Do not stop Apretude without talking to your health care provider first.
What Can I Do to Prevent or Manage Side Effects?
The most common side effects seen with Apretude are pain, itching, swelling, and redness near the injection site; nausea; and headache.
If you have pain, itching, swelling, or redness near the injection site, applying a cold compress may help. If you have diarrhea, make sure to drink plenty of fluids to stay hydrated. Getting plenty of rest and drinking enough water can help with headaches.
Over-the-counter (OTC) or prescription medicine can be used to help with side effects of Apretude. Talk to your health care provider for specific recommendations.
These are not all of the side effects of Apretude. Talk with your health care provider if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088.
What Types of Drug Interactions Can Happen?
Some other medicines may alter the blood levels of Apretude, causing there to be too much or too little medicine in your body. This could lead to serious side effects or the medicine not working well.
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you use or have recently taken. This will help make sure your medicines work well together.
How Do I Know If It Is Working?
Your health care provider will order several routine tests while you are on Apretude. One of those tests is an HIV test. This looks for the presence of the virus in your blood, and the test should be negative if you are using Apretude as prescribed. If you ever test positive for HIV, you will need to start treatment for HIV.
What Special Considerations Should I Be Aware Of?
Because Apretude is a long-acting injection, it can remain in your body for up to 12 months or longer after the last dose. Tell your health care provider if you are or plan to become pregnant or to breastfeed.
Is There Any Cost Assistance Available?
There is a copay program from the manufacturer that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have.
You can find out more at www.apretudecopayprogram.com. If you have questions about cost, insurance coverage, or any other financial support issue, you can also contact ViiV Healthcare at 877‑844‑8872.
