PURPOSE Program Could Prove Efficacy of Lenacapavir for Multiple Demographics

Jared Baeten, MD, PhD, vice president of HIV clinical development at Gilead Sciences, spoke with The American Journal of Managed Care^® about all of the trials included in the PURPOSE program, as well as when patients can expect to see lenacapavir offered as a new form of HIV prevention.

This transcript has been lightly edited for clarity.

Transcript

How soon can we expect to see lenacapavir made available for prevention of HIV?

The PURPOSE 1 [NCT04994509] results are, as I said before, the first but a big step in figuring out [and] fully defining the efficacy and safety of lenacapavir for PrEP, and puts us on a pathway toward really important next steps of regulatory review and aiming toward regulatory approval.

PURPOSE 1 is complemented by another study called PURPOSE 2 [NCT04925752]. That is a trial that is ongoing among cisgender men and transgender populations, women and men, as well as gender nonbinary individuals. That is a global trial, it's fully enrolled, and we anticipate that its results will come end of this year or beginning of next.

Together, those 2 trials would form the regulatory package for review by drug regulatory agencies around the world to be able to formally assess the safety and efficacy. We think that given the timelines now that we know from PURPOSE 1 and what we are anticipating for PURPOSE 2, that regulatory filings and potentially the first regulatory approval could be by the end of next year.

What are other trials in the PURPOSE program that we can look forward to seeing?

Yhe PURPOSE program is a is a collection of studies grounded, of course, in the 2 pivotal phase 3 trials: PURPOSE 1, we now have at least the top line results, and PURPOSE 2 ongoing among cisgender men and gender nonbinary and transgender individuals around the world. Those 2 are complemented by additional trials, [PURPOSE] 3 [NCT06101329], 4 [NCT06101342], and 5 that are studying lenacapavir acceptability, safety, and pharmacology in dedicated populations that, for various logistical or scientific reasons, couldn't be included in the initial PURPOSE trials. Those include women in the United States, persons who inject drugs, and individuals who live in Europe.

It's also really important to emphasize that within the entire PURPOSE program, particularly PURPOSE 1 and 2, and then across 3, 4, and 5, we've worked really hard to represent the diversity of the needs of people who want or need PrEP [pre-exposure prophylaxis]. So in the PURPOSE 1 and 2 studies that included adolescents, and both trials included adolescents down to age 16, as well as individuals who have the potential to become or who did become pregnant. And we will have information, particularly from the PURPOSE 1 program, safety and efficacy, information looking at the use of lenacapavir through pregnancy. Both of the trials work to have geographically and then, as PURPOSE 2 especially, racial, ethnic, and gender diversity. Because we really want in the PURPOSE program to be able to speak to as broad of the needs of people who want or need PrEP as we could.