Lenacapavir, a twice-yearly injectable antiretroviral, reduced the risk of HIV infection by 96% in a large study of gay and bisexual men and gender diverse people, according to a Gilead Sciences announcement.
Along with recent data from a parallel study of cisgender women, these results position lenacapavir for federal Food and Drug Administration approval for HIV prevention, possibly next year. Advocates are already pressuring Gilead to ensure that lenacapavir PrEP is made available at an affordable cost to those who need it most.
"I think this will add an additional option of choice that will really empower key communities," Daniel Driffin, DrPH, of the HIV Vaccines Trials Network told the Bay Area Reporter after his remarks at the recent U.S. Conference on HIV/AIDS in New Orleans. "The conversation should already be started on what a successful rollout will look like, especially for Black and Brown communities, folks across the South and folks on Medicaid and Medicare."
Jorge Roman, senior director of clinical services at the San Francisco AIDS Foundation, is eager to start offering twice-yearly PrEP as an additional prevention option.
"We hope that the path to FDA approval for lenacapavir goes quickly and smoothly," Roman told the B.A.R. "We still need more tools and resources to end HIV transmission in this country and globally. Long-acting injectable versions of PrEP could do a lot to help us end the HIV epidemic. A key here is that new PrEP options must be affordable and accessible."
PURPOSE-2 study results
As the B.A.R. reported this week, the San Francisco Department of Public Health's latest HIV epidemiology annual report shows an encouraging decline in new cases, but twice-yearly PrEP could further move the needle.
While the daily PrEP pills Truvada and Descovy (both from Gilead) are around 99% effective when taken consistently, additional options are still needed. Some people have trouble remembering to take a pill every day and some are hesitant to have pill bottles that could be lost or stolen or reveal they are at risk for HIV. Currently, ViiV Healthcare's Apretude (injectable cabotegravir), which is administered every other month, is the longest-acting PrEP option.
White gay and bisexual men in San Francisco and other cities have eagerly embraced oral PrEP, but uptake has been slower for other groups. The federal Centers for Disease Control and Prevention estimates that only about a third of the 1.2 million people in the United States who could benefit from PrEP are using it. Having multiple options available helps ensure that everyone can find a prevention method that works for them.
The PURPOSE 2 trial enrolled more than 3,000 cisgender men, transgender women and men, and nonbinary people who have sex with men at more than 80 sites in the United States and six other countries. They were randomly assigned to receive either lenacapavir injections once every six months or daily Truvada pills.
There were two new HIV diagnoses among the 2,180 study participants in the lenacapavir group compared with nine cases among the 1,087 people assigned to Truvada, according to Gilead. Lenacapavir reduced the risk of HIV acquisition by 96% relative to the expected background incidence among people not on PrEP and by 89% compared to daily Truvada. Lenacapavir and Truvada were both generally safe and well tolerated with no new safety concerns.
As the B.A.R. reported in June, the parallel PURPOSE 1 trial showed that twice-yearly lenacapavir PrEP was 100% effective for preventing HIV acquisition among more than 5,000 young cisgender women in South Africa and Uganda. Further results were presented at the International AIDS Conference in Munich in July.
The new data "really means the labeling can be inclusive of just about all populations who could benefit from this wonderful prevention innovation," PURPOSE 1 lead investigator Dr. Linda-Gail Bekker of the University of Cape Town told the B.A.R. "Oral PrEP still remains a terrific option for those who prefer it and can use it, but for those who have struggled, this is just amazing. We remain very excited about seeing regulatory and generic company engagement happening urgently now so people can benefit as soon as possible."
Pricing and access
Advocates and researchers lauded the new findings but expressed concerns about cost and access.
Lenacapavir (sold as Sunlenca) is currently approved only as part of a combination treatment regimen for people with multidrug-resistant HIV, at a cost of around $4,000 per month. Generic versions of Truvada pills can cost as little as $20 per month. A study presented at the International AIDS Conference showed that the price of lenacapavir could potentially be brought down to around $40 per year with voluntary licensing and competition between generic suppliers.
"This is the second impressive result for this new HIV prevention option, opening up more possibilities for choice for even more people to find an option that is right for them," AVAC Executive Director Mitchell Warren said in a statement. "Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most. ... But these data only matter if the field moves with speed, scale, and equity."
Gilead said it has committed to making lenacapavir available in the countries where the need is greatest, including expediting voluntary licensing to supply low-cost versions of the drug.
"Gilead will work urgently with regulatory, government, public health, and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide for all those who want or need PrEP," chairman and CEO Daniel O'Day said in the company news release.
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