Everything you need to know about the new HIV prevention shot approved in the US

Experts hope it could simplify prevention

While PrEP tablets are already prescribed around the world to prevent people from contracting HIV, experts in the US hope a newly approved jab could improve rates of protection.

Millions of people are already prescribed pre-exposure prophylaxis (PrEP) to lower their chance of contracting HIV.

But a possible alternative to daily tablets has been approved in the US, in the form of a biannual jab. 

The Food and Drug Administration (FDA) has approved Gilead’s lenacapavir, a capsid inhibitor that stops a protein coating from forming to protect the material HIV needs to replicate in the body.

Lenacapavir has not been approved for prescription by Australia’s Therapeutic Goods Administration (TGA).

HIV infects 1.3 million people each year, and the company believes “that lenacapavir is the most important tool we have yet to bend the arc of the epidemic and move this epidemic into the history books," Gilead’s CEO, Daniel O'Day said.

How effective was Lenacapavir in trials?

During two randomised trials, the drug proved close to 100 per cent effective at preventing HIV.

Sciencejournal named lenacapavir its 2024 Breakthrough of the Year after the results of these trials were released, noting that the shot targets “a new understanding of the structure and function of HIV’s capsid protein”.

Common side effects include pain, swelling or redness at the injection site.

Who can be prescribed Lenacapavir in the US?

Gilead said in a press release that patients will need to be tested for HIV prior to every injection, and only HIV-negative individuals should be prescribed the jab, as infection prior to injection could result in drug resistance. 

Adults and adolescents need to weigh at least 35kg to be eligible for the shot.

Common side effects include pain, swelling or redness at the injection site, associate professor of medicine at Johns Hopkins School of Medicine, Eileen Scully told The Washington Post.

But some are concerned about the accessibility of the drug, with the jab costing $43,924 per year in the US. Image: Pexels

Experts are concerned about barriers to access

Many PrEP drugs need to be taken consistently every day to be fully effective, so some experts believe the long-acting injections could be an easier mode of protection. 

But some are concerned about the accessibility of the drug, with the jab costing $43,924 per year in the US. 

The company has said it will offer co-pay assistance for eligible people, though CEO of the Foundation for AIDS Research, Kevin Robert Frost said the drug "will only be as effective as it is accessible and affordable".

Scully said, as well as the treatments that are already available, “the more people who know about (the injection), the better, because this is a really empowering step for people to take”. Image: Pexels

According to a 2019 review, “limited PrEP awareness, medical mistrust, HIV stigma, and low perceived personal risk” can prevent at-risk heterosexuals from accessing PrEP currently, while “structural barriers impeding PrEP use include poverty impeding access to health insurance and care, limiting mobility and health literacy”.

Scully said, as well as the treatments that are already available, “the more people who know about (the injection), the better, because this is a really empowering step for people to take”.

Originally published as Everything you need to know about the new HIV prevention shot approved in the US