Gilead's twice-yearly HIV prevention shot hits bullseye, trial stopped early

20 Jun 2024
firstwordpharma.com
Phase 3Clinical Result
Gilead Sciences announced Thursday that the Phase III PURPOSE 1 trial evaluating its biannual injection lenacapavir for pre-exposure prophylaxis (PrEP) has been stopped early after it was found to be 100% effective at preventing HIV infection in women. Company shares climbed more than 8% on the news, boosting Gilead’s market valuation by $6.6 billion.
This is the first readout from Gilead's PURPOSE programme, which consists of five HIV prevention trials around the world.
The randomised PURPOSE 1 study enrolled more than 5300 women and adolescent girls aged 16 to 25 years old in South Africa and Uganda. One group received twice-yearly subcutaneous lenacapavir while another took Gilead's once-daily oral drug Descovy (emtricitabine/tenofovir alafenamide). A third group was assigned Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets, also taken once a day.
Outperformed daily Truvada pills
The study compared lenacapavir to the expected background rate of HIV infection as well as to Truvada, with Gilead's injectable HIV-1 capsid inhibitorHIV-1 capsid inhibitor proving superior on both counts.
Out of 2134 women who received lenacapavir, not a single one contracted HIV, whereas among 1068 women taking daily Truvada pills, 16 became infected. Specifically, lenacapavir outperformed the background HIV rate of 2.41 infections per 100 person-years, meeting the primary endpoint, and also beat Truvada's rate of 1.69 infections per 100 person-years. Truvada was used as a secondary comparator in the trial.
Among 2136 women taking Descovy, 39 contracted HIV, translating to an infection rate of 2.02 per 100 person-years. Gilead said Descovy's performance was numerically similar to Truvada's and not significantly better than the background HIV rate.
The decision to stop PURPOSE 1 comes after the study's independent data monitoring committee (DMC) recommended that Gilead halt the blinded phase of the trial and offer open-label lenacapavir to all participants based on the interim analysis results.
Lenacapavir was also generally well-tolerated and no significant or new safety concerns were identified. Detailed results will be presented at a future conference.
$1.7 billion-plus opportunity
Industry analysts are optimistic. "Our market research had suggested potential for high receptivity to a twice-yearly subcutaneous injectable among uninfected, higher-risk individuals," remarked Brian Abrahams of RBC Capital Markets. "We have estimated subcutaneous lenacapavir for PrEP could grow the market considerably and have sales of $1.7 billion-plus in the out years."
Gilead now awaits results from PURPOSE 2, another pivotal trial assessing lenacapavir for PrEP among men who have sex with men, transgender men and women, and gender non-binary people. Participants will be recruited in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US. Those results are due in late 2024 or early 2025 and, along with PURPOSE 1, will be key when Gilead seeks approval for lenacapavir as a PrEP option.
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