Lenacapavir Offers Future Method of HIV Prevention After Stellar Trial Results

Jared Baeten, MD, PhD, vice president of HIV clinical development at Gilead Sciences, spoke with The American Journal of Managed Care^® about the significance of lenacapavir, the twice yearly pre-exposure prophylaxis (PrEP) injection, preventing all participants in the clinical trial, all of whom were cisgender women, from contracting HIV.

This transcript was lightly edited for clarity.

Transcript

How significant is it to find that lenacapavir is so effective in preventing HIV?

I think the findings of the PURPOSE 1 [NCT04994509] study stand pretty clearly. There's no clearer number, I think, that we could have expected than ZERO infections. It does take one's breath away; it certainly knocked me back a little bit to see something that was so, so, so clear as a finding in big clinical trials, and I've done PrEP clinical trials for approaching 2 decades now. So it's really, really a striking result, And obviously one that's that's highly statistically significant. And I think, more importantly, it's been sometimes seen, some of the actions are quite meaningful around the world to be able to see a finding like this.

Lenacapavir's investigational for PrEP, but we've worked hard in the PURPOSE program to gather as expeditiously and rigorously as possible information on the efficacy and safety across populations around the world. The PURPOSE 1 results are the first, obviously a big piece of that information.

How beneficial is it that lenacapavir is only taken twice a year?

So the PURPOSE 1 trial evaluated lenacapavir in comparison to the expected background HIV incidence in the population, as well as to Truvada [emtricitabine/tenofovir disoproxil fumarate], a daily oral pill which has been proven and used around the world for PrEP. And lenacapavir's findings were superior both to that background HIV incidence and to the incidence seen in Truvada. That likely for Truvada, of course, reflects that taking a daily pill for HIV prevention requires both that pill to work if it's taken, but also for it to be taken.

And I think what's a clear finding that's been seen around the world in the decade-plus that daily oral PrEP has been studied and used has been that not all individuals who are offered or receive a prescription or pills for PrEP are able to successfully take it and successfully take it for the long haul. So lenacapavir as twice yearly removes a lot of that challenge of taking a pill every day, both the action of taking a pill but also everything around that.

It could potentially remove some of the stigma and discrimination of taking medicines for HIV prevention. It certainly removes having to have a pill bottle in your purse or your medicine cabinet or your bedside table that someone could find. And that really could allow people to be able to take potentially effective HIV prevention on a more regular basis and with greater persistence.