PrEP Overview in Light of Lenacapavir Licensing Agreements

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Gilead Sciences’s decision to distribute HIV prevention drug lenacapavir made the news this month when they signed noninclusive, royalty free voluntary licensing agreements with six pharmaceutical manufacturers in Asia and North Africa.

Gilead currently charges lenacapavir patients in the United States $42,250 yearly. There is currently no information about how much it will cost as part of a prophylaxis preexposure (PrEP) regimen.

The agreement will benefit 120 countries,18 of which account for 70% of total HIV cases worldwide. However, Mohga Kamal-Yanni, M.D., policy co-lead for the People’s Medicines Alliance shook her head, saying that while impressive, the decision leaves out middle- and high- income countries including Brazil, Colombia, Mexico, China and Russia that, when combined, account for about 20% of global HIV infections.

Lenacapavir treatment begins with a combination of tablets and one injection, followed by a single injection every six months. There were no HIV incidences in more than 2,000 cisgender women given lenacapavir in the PURPOSE 1 trial, when compared with placebo. The ongoing PURPOSE 2 trial is researching lenacapavir’s effectiveness in men, transgender women and non-binary people. If the results are positive, Gilead expects to file applications with the FDA approval when the trial finishes late this year.

The International AIDS Society argues that this decision is a step in the right direction toward satisfying the United Nations Programme on HIV/AIDS (UNAIDS) goal to have 95% of people worldwide (roughly 10 million people) at risk for HIV to have access to PrEP.

In 2023, only 3.5 million at-risk people were receiving PrEP worldwide, according to clinical insight published today in JAMA Insights. The paper, authored by Matthew A. Spinelli, M.D., and Monica Gandhi, M.D., M.P.H. of the University of California in San Francisco and Kenneth Ngure, M.P.H., Ph.D.,from Jomo Kenyatta University of Agriculture and Technology in Juja, Keny, presents a review of approved PrEP regimens.

The UNAIDS 2024 global AIDS update reported no decreases in HIV cases since 2021. In 2023, there were an estimated 1.3 million additional HIV cases recorded.

Several PrEP regimens are available, including:

• daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (FDA approved in 2012).
• daily tenofovir alafenamide (TAF/FTC) (FDA approved in 2019).
• monthly vaginal dapivirine ring (approved by the European Medicines Agency in 2020).
• intramuscular long-acting injectable cabotegravir administered bimonthly (FDA approved in 2021).

In a 2024 study comparing the effectiveness of daily TDF/FTC and daily TAF/FTC showed no difference in HIV incidence and both were deemed effective.

The vaginal dapivirine ring is the first effective microbicide for HIV prevention. A randomized trial of 2,629 women in sub-Sahara Africa showed that women given dapivirine had 3.3 HIV infections per 100 person-year's when compared to placebo which resulted in 4.5 infections per 100 person-years

Intramuscular long-acting injectable cabotegravir is administered every eight weeks and costs $22,000 per patient per year, both of which are significant barriers to care.

On-demand PrEP is another HIV prevention option. A double dose of the pill must be taken at least 1.3 hours before sex, followed by another dose taken 24 and 48 hours after sex.

“PrEP is effective for HIV prevention and PrEP options are expanding, although newer agents, such as cabotegravir, have had limited utilization,” the authors of the review conclude. “Clinicians should offer PrEP to all HIV-negative adolescents and adults at risk of HIV infection through sexual activity or injection drug use, discuss the importance of adherence, and offer PrEP adherence support interventions if needed.”