A man receives a vaccine shot
Posed by model (Photo: Shutterstock)

The likelihood of a twice-yearly PrEP injection moved closer this week. Gilead released the results of a new trial into its HIV drug: lenacapavir. 

The medication is already used as an HIV treatment. However, the pharma giant is testing whether it might work as a long-acting injectable form of PrEP. Currently, only one form of long-acting PrEP, taken every two months, has FDA approval. 

On Friday, Gilead said its first lenacapavir study showed it to be 100% effective. That’s a rare result for any clinical trial. In this instance, researchers studied over 2,000 young women in South Africa and Uganda. Both countries have high infection rates. 

Current PrEP doesn’t work as well in women as it does in gay men. This is because the medication’s efficiency is tied to maintaining a sufficient concentration in crucial body tissues. For example, higher concentrations of Truvada accumulate in rectal tissue compared to the vagina. 

Throughout the lenacapavir study, none of the female, African trial participants contracted HIV. 

This makes the twice-yearly injection more effective than a daily pill of Truvada or Descovy for women. 

We hasten to add that daily tablets remain highly effective when taken correctly by gay and bisexual men. However, not everyone takes them every day as advised — which is why there’s so much interest in long-acting injectables. 

Trial halted early because of startling result

Because of lenacapavir’s efficiency, the study’s data monitoring committee stopped the trial early. The results were not expected until September. Clinical trials can be halted early if it’s obvious a drug is not working, or if it is clearly working much better than current options. It’s unethical not to proceed with development as quickly as possible in the latter case.

This is just Gilead’s first study results into long-acting lenacapavir. It’s also conducting a similar trial using gay and bisexual men in the Americas, South Africa and Thailand. Those results are due early next year.

Ever since AIDS first appeared in the early 1980s, medical researchers have tried to create a vaccine. This is not a vaccine, but as Dr Andrew Hill of the University of Liverpool told aidsmap, “This is the closest we have ever been to a vaccine against HIV” – even if you’ll need to get it twice a year. 

Making it affordable and available

Even before this results announcement, excitement was building around lenacapavir’s possibilities. So much so that last month, around 300 advocates and healthcare experts wrote an open letter to Gilead urging it to make lenacapavir—if it passes its medical trials—available to low-income and middle-income countries at an affordable cost. 

Signatories of the letter included celebrities such as Karamo Brown, Stephen Fry, Gillian Anderson, and Alan Cummings.

“We commend Gilead Sciences, Inc. for your work developing the new long-acting HIV medicine Lenacapavir. Requiring only two injections a year, it could be a real game-changer worldwide for the people most excluded from high-quality healthcare,” said the letter.

“We urge Gilead to ensure that people in the Global South living with or at risk of HIV can access this groundbreaking medicine at the same time as people in the Global North can.”

Gilead responded with a statement saying it’s developing a strategy, “to deliver lenacapavir swiftly, sustainably and in sufficient volumes, if approved, to high-incidence, resource-limited countries.

“[We will ensure] supply in the countries where the need is greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir, and will develop a robust direct voluntary licensing program to expedite access to those versions of lenacapavir in high-incidence, resource-limited countries. We are moving with urgency to negotiate these contracts.”

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