US approves twice-yearly injection for HIV prevention – what you need to know about lenacapavir
The US Food and Drug Administration (FDA) has approved lenacapavir, an injectable drug that offers long-lasting protection against HIV infection. Administered once every six months, this new treatment marks a major advancement in expanding prevention options for people at risk of HIV infection.
Most HIV prevention drugs are daily pills (known as PrEP), which many people struggle to take regularly for various reasons, including inconvenience, price, stigma and side-effects. Lenacapavir works differently. It’s a new type of drug that attacks HIV’s protective shell, stopping the virus from copying itself at multiple stages.
In recent years, two other long-acting medicines have been developed for HIV, but neither of them offers protection for a full six months like lenacapavir.
People using the long-acting lenacapavir injection take pills for a short time – either two weeks before the shot or for the first days after – to ensure they are protected while the injection starts working.
After that, just one injection under the skin keeps the drug working and protects people for six months. This makes a big difference for those who find it hard to take a pill every day because of a busy life, forgetting or because of the stigma they face. Discretion can sometimes be an important factor, and people receiving long-acting medicines don’t need to carry pills or explain them to others.
Even though lenacapavir is highly effective at preventing HIV, it doesn’t offer protection from other sexually transmitted infections, so using condoms and getting regular screening for sexually transmitted diseases remains important.
Two breakthrough HIV cases in the second pivotal study of lenacapavir were linked to a virus mutation that made it resistant to the drug. That is rare, but it demonstrates why regular check-ups remain important to ensure the drug continues working effectively.
Most people don’t experience serious side-effects when using long-acting lenacapavir for prevention. The most common side-effect is mild discomfort at the injection site – things like redness, swelling or soreness – which usually resolves quickly on its own.
A few people have reported feeling nauseous, but this is uncommon. The drug can interact with some other medicines, so it must only be used under medical supervision.
Global roll out? Price will be a big factor
Regulatory agencies in different regions work independently to scrutinise medicines and so approval by one is not a guarantee of approval by another. However, it could be approved for use in the UK later in 2025, and the UK National Institute for Health and Care Excellence is already evaluating lenacapavir.
The price of lenacapavir will be a big factor in how widely it is used globally. In the US, it’s currently priced at around US$28,000 per year (£22,000), but the cost of medicines often differs in different countries.
Since the overwhelming majority of people affected by HIV live in low- and middle-income countries, a twice-yearly prevention could have a profound effect and it is contingent on everyone working in global health to help ensure that happens quickly.
Some researchers have estimated that generic manufacturers supplying low- and middle-income countries could make lenacapavir for as little as US$25 a year if it were made in large enough quantities. But achieving this will require major investment and coordination to ensure the drug reaches the regions where HIV is still a major public health challenge.
Earlier this year, Gilead, the pharmaceutical company behind lenacapavir, also presented data on a once-yearly version of the drug, so even longer protection may become available in the future.
Lenacapavir is a major step forward in HIV prevention. With just two injections a year, it is a simple and highly effective option for people who need protection but find daily pills difficult. It’s not a replacement for other forms of protection – condoms and regular testing are still important – but it could be life changing for many people.
If it becomes widely available around the globe, it could help make HIV prevention more accessible, more adaptable and easier to deliver for a wide range of people.
Read more: HIV prevention: why a new injectable drug could be such a breakthrough – podcast
Andrew Owen is a Director and CSO for Tandem Nano Ltd. and a co-inventor of patents relating to long-acting medicines. He has consulted Gilead Sciences. Shionogi and Assembly Biosciences, and has been an investigator on grant income received by his institutions from from Tandem Nano Ltd., Gilead Sciences, ViiV Healthcare, and Bicycle Therapeutics.