New research suggests that Gilead Sciences Inc.’s GILD lenacapavir, sold as Sunlenca in the U.S. for HIV prevention, could cost patients just $40 annually.
Currently priced at $42,250 for the first year, campaigners urge the company to significantly reduce costs globally.
In December 2022, the FDA approved Lenacapavir in combination with other antiretrovirals to treat HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
At the International AIDS Conference in Munich, experts presented a study estimating that a generic version of lenacapavir could be produced for $40 a year, assuming 10 million people used it annually.
The Guardian report added that slashed prices would also allow profit of around 30%.
Dr. Andrew Hill of Liverpool University, who led the research, emphasized the significance of a biannual injection in preventing HIV, calling it the closest we’ve come to an HIV vaccine.
Campaigners are advocating for Gilead to permit generic licensing through the UN-backed Medicines Patent Pool in all low-and middle-income countries (LMICs), which account for 95% of HIV infections.
Gilead has stated that it is “too early” to price lenacapavir for prevention as it awaits clinical trial data and potential regulatory approvals.
On Wednesday, Gilead revealed full efficacy and safety results from its Phase 3 PURPOSE 1 trial.
Detailed data from the trial’s interim analysis announced in June showed that lenacapavir, the company’s twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women (women assigned female at birth).
Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).
The independent Data Monitoring Committee recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
As of July 23, more than 840 trial participants have opted to switch to lenacapavir.
Adherence to lenacapavir and placebo injections included in the oral PrEP study groups was high: 91.5% of all trial participants received on-time injections at week 26, and 92.8% received on-time injections at one year.
On-time injection rates (within 28 weeks of prior injection) were similar across all study groups, whether receiving lenacapavir or placebo injections.
Sixteen incident HIV cases among 1,068 women were observed in the Truvada group (1.69/100 person-years), and 39 incident HIV cases among 2,136 women were observed in the Descovy group (2.02/100 person-years).
In the primary efficacy analysis, HIV incidence with Descovy was not different from bHIV, and no evidence of difference was observed compared to Truvada in the secondary efficacy analysis.
Adherence to once-daily oral Descovy and Truvada, measured by detecting tenofovir diphosphate in blood samples from a subset of patients, was low and declined over time.
No new safety concerns were identified, and lenacapavir, Descovy, and Truvada were generally well tolerated.
Gilead expects results from the program’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP, in late 2024/early 2025.
If positive, the regulatory filing for lenacapavir for PrEP will include PURPOSE 1 and PURPOSE 2 results.
The use of lenacapavir and Descovy for the prevention of HIV in cisgender women is investigational.
Price Action: GILD stock was trading higher by 2.80 at $73.20 at the last check on Wednesday.
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