With Gilead Sciences sprinting to a likely approval next year for its long-acting pre-exposure prophylaxis (PrEP) drug for HIV, the California company has a chance to one-up GSK. While the British company’s long-acting Apretude is injected every two months, Gilead’s answer is dosed just twice a year.
Later this decade, GSK hopes to launch PrEP options that have four and six months of staying power. But, until then, it will do battle with Apretude (cabotegravir long-acting), which has just excelled in several real-world studies.
In two real-world evidence studies of nearly 1,300 people, Apretude has shown better than 99% effectiveness in preventing HIV infections. GSK’s ViiV Healthcare unit also presented findings from the PILLAR implementation study, which show reductions in stigma and anxiety among users of the treatment. The new results are being presented Wednesday through Saturday in Los Angeles during IDWeek 2024.
The results add to the positive momentum for Apretude, which was approved in December 2021 as the first long-acting PrEP option for HIV. The drug offers an alternative to daily pills such as Gilead’s Truvada and its follow-on Descovy.
In the Trio Health cohort being presented at IDWeek 2024, there were zero HIV diagnoses among people who received Apretude. The real-world study included a diverse population of 474 cis- and transgender male and female subjects who initiated use of Apretude in the U.S. between December 2021 and January 2024. At the time of the analysis, 83% of those in the study were still on Apretude. Of those 396 participants, only 3% had missed an injection.
In the OPERA study, which evaluated a diverse cohort of 764 individuals, including 29% Black and 29% Hispanic participants, there were just two cases of HIV. In one of the cases, the participant had discontinued treatment. In the other, there was “inconsistent testing,” according to ViiV.
The findings “support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial,” Harmony Garges, M.D., chief medical officer at ViiV, said in a release.
“We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic,” Garges added.
In the PILLAR study, which included 200 transgender men and men who have sex with men who initiated Apretude after previously using daily pills for PrEP, participants identified a variety of quality-of-life advantages.
In the study, which also included 23% Black and 39% Hispanic subjects, 15% of the participants entered the program reporting privacy worries about taking oral PrEP medicines. Additionally, 24% said they felt they had to hide their oral PrEP use from others, and 29% expressed worry about stigma from taking oral PrEP. Six months after initiation of Apretude, fewer than 1% of the participants reported privacy concerns while 1% expressed worry about the stigma of using the new drug.
Additionally, participants noted reduced stress over missing a PrEP dose and added confidence that they were still protected from HIV.
In its push to gain approval for its long-acting answer lenacapavir, Gilead also has reported stellar results from two phase 3 trials including the PURPOSE 1 study, which flashed 100% efficacy, with no infections among more than 2,000 cisgender women and adolescent girls ages 16 to 25 in Africa.
Gilead plans to submit applications for the approval of lenacapavir early next year and to launch by the end of 2025. Lenacapavir first hit the market in 2022 under the brand name Sunlenca for use alongside other agents in patients with multidrug-resistant HIV.
While GSK was first to introduce a long-acting PrEP option, it trails Gilead on the ultralong-acting front. GSK plans to launch an every-four-month version of Apretude in 2026 and start a registrational study for a twice-yearly option in 2027.
In the first half of this year, GSK reported sales of Apretude at 126 million pounds sterling ($164 million), which more than doubled the figure from the first half of 2023. Meanwhile, sales of GSK’s long-acting injected HIV treatment Cabenuva were at 458 million pounds ($596 million), which were up 51% year over year. The company has projected sales of its HIV drugs to reach 7 billion pounds ($9.1 billion) by 2026.
Wall Street’s consensus estimate has put lenacapavir’s global peak sales at around $3 billion across HIV prevention and treatment. Gilead raked in $18.2 billion in sales of its HIV drugs in 2023, which was up 6% from 2022.