Could a new combined PrEP and contraception pill be a gamechanger?

What is the dual prevention pill?

A daily pill for women that prevents both pregnancy and HIV. It contains PrEP and a combination contraceptive.

How does it work?

The dual prevention pill (DPP) will be packaged in a blister pack, similar to birth control pills.

Each pack will contain 28 tablets. Of these, 21 will contain contraception and PrEP, while 7 tablets will contain PrEP only. Combination contraception is only taken for 21 out of 28 days of the menstrual cycle. The PrEP-only tablets should be taken during this seven-day break to stay protected from HIV.

Packs will be colour-coded and numbered to show when to take which pills.

Is the dual prevention pill safe?

The World Health Organization has confirmed that oral PrEP and a combination contraceptive can be taken together safely.

Because the DPP combines two approved medications, a clinical trial is not needed for regulatory approval. Instead, the DPP will be tested this year in something known as a ‘bioequivalence’ study. If this shows the DPP is absorbed in the body at a similar rate to taking PrEP and contraceptive pills separately, developers will ask the US Food and Drug Administration for regulatory approval. This decision is expected in 2024, after which national regulators will conduct their own approval processes.

What are the benefits of the dual prevention pill?

Because the DPP is just one pill, it is more convenient than taking PrEP and birth control pills separately. It also expands choice for women who want to reduce their risk of unintended pregnancy and HIV.

PrEP can be stigmatised, but there is more acceptance of the contraceptive pill. So the DPP could reduce the stigma that women might feel when using this form of HIV prevention.

Are there any drawbacks?

Like combined oral contraception, the DPP should not be taken until six months after giving birth.

Users of longer-acting hormonal contraception, such as contraceptive injections, will still need to use another type of HIV prevention, such as oral PrEP or condoms.

As the DPP contains PrEP, it is likely that women will need to go to a health facility to get it. This is less convenient than accessing standard birth control pills, which tend to be available in pharmacies and community-based settings.

What does this mean for HIV and family planning services where I live?

Kenya, South Africa and Zimbabwe are likely to be the first countries to introduce the DPP. This year, government-backed implementation studies will begin in these countries to assess what women and their partners think of taking the DPP, the DPP’s cost-effectiveness and other factors.

The DPP will then need national regulatory approval, which is expected to happen in 2024. If approved, the DPP is likely to be recommended for women of reproductive age. But early DPP introduction will probably be targeted towards women aged 20+ because they are more likely to use both birth control pills and oral PrEP than younger women and girls. Feedback suggests that prioritising adolescent girls and young women when the DPP is first introduced could lead to it being stigmatised.

If the DPP becomes widely available, it should be offered as an option for women interested in preventing pregnancy and HIV. But it should be clear that this is one of a range of contraceptive and HIV prevention products. Women should be supported to make an informed choice about what will work best for them.