What is Apretude? The First FDA Approved Injectable PrEP Medication
The First FDA Approved Injectable PrEP Medication
Despite a significant improvement in the treatment and survival of HIV, it is still not a curable condition. It is therefore critical to take the necessary precautions to prevent infection. Preventative measures include condoms and other barriers methods. However, recent research has led to several pre-exposure prophylactic (PrEP) medications to reduce the risk of contracting HIV.
After being recently approved, Apretude is the first form of injectable PrEP on the market. The drug is expected to become available in early 2022. It is a groundbreaking innovation. Of the approval, Dr Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said, “Today’s 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.”
This article will discuss what Apretude is, how it works, and what benefits you can expect from it.
What is Apretude?
Apretude, or cabotegravir, was approved by the U.S. Food and Drug Administration (FDA) on December 20, 2021. It is the first injectable, long-acting medication designed to reduce the risk of contracting HIV-1. Apretude is now a suitable alternative to other pre-exposure prophylaxis (PrEP) like Truvada and Descovy. These pills need to be taken daily to be effective – and missing a dose could lead to infection.
In contrast, as Apretude is an injectable PrEP, it is significantly longer-lasting. You only need to receive an injection once a month for the first two months, and then subsequently, once every other month.
Who should take Apretude?
According to the FDA approval, Apretude is suitable for adults and adolescents who weigh at least 77 pounds (35 kilograms) and do not have HIV but are at risk of contracting the virus.
Apretude was pioneered by the pharmaceutical company Viiv. In the company’s approval announcement, CEO Deborah Waterhouse said, “People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the U.S., may want options beyond daily oral pills. With Apretude, people can reduce the risk of acquiring HIV with as few as six injections a year.”
Currently, only a quarter of those who would benefit from HIV prevention are taking it. As Dr David Rosenthal, medical director of the Center for Young Adult Adolescent and Pediatric HIV at Northwell Health in New York State, explained, “Often this is because patients don’t want to take medications daily.”
The result is a rising trend of HIV in 25- to 39-year-olds. For such people, Apretude is a revolutionary solution that may save their lives.
How does Apretude differ from prior PrEP options?
Previously, the only two PrEP options were Truvada (emtricitabine-tenofovir) and Descovy (emtricitabine-tenofovir alafenamide). Both pills needed to be taken daily to be effective. Such adherence is difficult, however. And a single missed dose can increase your risk of contracting HIV.
In comparison, Apretude does not require remembering to take a pill every day. Rather, with injections reduced to bi-monthly after the first two months, Apretude significantly increases your protection without you needing to remember anything.
That’s a pretty substantial benefit.
How effective is Apretude?
Before receiving FDA approval, Apretude underwent two clinical trials.
In the first trial, HIV-free men and transgender women (who have sex with men and have a high-risk behavior of HIV infection) were the study group. Those who took Apretude in this trial had a 69% lower risk of HIV infection compared to Truvada.
In the second trial, the study group was HIV-free women at risk of HIV infection. Apretude lowered the risk of HIV infection by 90% compared to Truvada
There were some side effects reported, however.
Participants in the trial were more likely to experience injection site reactions, headaches, fever, fatigue, back pain, muscle pain, and rash compared to people who took Truvada. Other potential side effects include:
Nausea and vomiting
Diarrhea
Loss of appetite
Breathing difficulties
Blisters or sores
Red or swollen eyes
Swollen faces, lips, mouth, or tongue
Mood changes
Sleep problems
Liver damage
However, most side effects go away with time or are mild enough to be manageable. Nevertheless, according to the FDA, people wishing to take Apretude can first take it orally as a pill for four weeks to assess how well they tolerate the drug.
How is Apretude administered?
Being an injectable PrEP, Apretude is injected into the muscle of your buttock. As mentioned, you will receive an injection for the first two months, then every two months thereafter. Due to its long-lasting effect, Apretude can stay in your body for 12 months or longer after your last injection.
Suppose you miss an injection by more than seven days. In that case, you should contact your healthcare provider immediately to discuss alternate PrEP options.
How can you get Apretude?
If you wish to begin using Apretude as an injectable PrEP, contact your healthcare provider. Still, the drug was only approved recently, so it may not be covered under your health insurance plan. The FDA did announce in 2021 that all insurers must cover the cost of all forms of PrEP, so it may not be long before Apretude is also included in your coverage. The drug has a list price of $3,700 per dose as it stands. This is likely to limit uptake in the short- to medium-term.
For further information about Apretude, read the new FDA approval available at the FDA website.
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