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Injectable PrEP approved for use in the United States

Hester Phillips

12 January 2022

Urgent action is now needed so that people most at risk of HIV across the world can benefit

Close up of a syringe being held
Photo credit: iStock/Enes Evren

What is this latest PrEP development about?

An injectable PrEP for adults at risk of getting HIV through sex has been approved for use in the United States.

PrEP (pre-exposure prophylaxis) contains antiretroviral drugs that stop people who are HIV negative from getting HIV. If someone is exposed to HIV during sex but has been taking PrEP correctly there will be a high enough level of antiretrovirals in their blood to prevent infection.

Before now, PrEP has only been available in tablet form, which people normally take once a day. This is the first time injectable PrEP has been available anywhere in the world – and it could be a gamechanger for HIV prevention.

How does a PrEP injectable work?

Only trained healthcare workers can provide a PrEP injection. To start, two injections (in the buttocks) are given one month apart. After that, an injection is needed once every two months. The injection contains the antiretroviral drug cabotegravir.

If someone misses an injection, they can take PrEP tablets for up to two months before starting injections again.

Someone who wants to have an injection will need to take an HIV test before. This is because only people who do not have HIV can use injectable PrEP.

What are the benefits of having a PrEP injection?

Many people will find it easier to have an injection every other month than taking a pill every day.

People may also feel that getting an injection protects their privacy better because others won’t see them taking a pill each day or find their supply of PrEP medication.

Two large trials have assessed the effectiveness of injectable PrEP. The first involved gay men, men who have sex with men and transgender women, the other involved cisgender women. In both trials, people were more likely to keep having injections than they were to take daily pills. This made injectable PrEP between 69-89% more effective at preventing HIV than PrEP tablets.

Is injectable PrEP safe?

The trials mentioned above found cabotegravir injections were safe for cisgender and transgender men and women.

The most common side-effects were mild or moderate swelling or pain caused by the injection itself, which went after a few days.

What does this mean for HIV prevention where I am?

Currently injectable PrEP is only available in the United States.

But UNAIDS is calling for injectable PrEP to “quickly be made available and affordable to people who need it most, not just in the United States of America but everywhere in the world”. It has urged the pharmaceutical companies behind injectable PrEP to share the formula with generic producers in low and middle-income countries.

For injectable PrEP to become widely available, regional and national drug regulators will need to approve it. The South African drug regulator is already considering approval, for example, and a decision is due in the next few months. The price of injectable PrEP must also come down.

Once these things have happened, national HIV prevention programmes must be ready to roll out injectable PrEP. Advocating to ensure communities most affected by HIV are involved in the design of these plans is essential for ensuring injectable PrEP reaches the people who need it the most.

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