GILD Data on Once-Yearly Lenacapavir for HIV Prevention Positive

Gilead Sciences, Inc. GILD announced positive data from its ongoing phase I study evaluating pipeline candidate, lenacapavir.

Lenacapavir is a novel, once-yearly injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention as pre-exposure prophylaxis (PrEP).

Gilead presented data on two novel, once-yearly formulations of lenacapavir for PrEP during an oral abstract session at the Conference on Retroviruses and Opportunistic Infections (CROI 2025). Data was also published in The Lancet.

The data presented support the further development of once-yearly lenacapavir for PrEP.

Gilead’s shares have surged 56.8% in the past year against the industry's decline of 8.6%.

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More on Gilead’s Lenacapavir

The phase I study evaluated the pharmacokinetics, safety and tolerability of two intramuscular single-dose 5000mg lenacapavir formulations. The study included 40 healthy adults at low risk of HIV acquisition, between 18 and 55 years of age, with a body mass index of less than or equal to 35.0 kg/m2.

The data from the phase I study showed that the two different formulations of once-yearly lenacapavir (administered via intramuscular injection) achieved and maintained plasma concentrations exceeding those associated with HIV prevention efficacy observed in the late-stage PURPOSE 1 and PURPOSE 2 studies.

Gilead plans to launch a phase III study on once-yearly lenacapavir for PrEP in the second half of 2025.

The company had earlier reported data from the late-stage PURPOSE 1 and PURPOSE 2 studies that showed that twice-yearly subcutaneous lenacapavir demonstrated superiority at reducing HIV infections when compared to background HIV incidence (bHIV) and once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in a broad and geographically diverse range of people.

Gilead is evaluating once-yearly lenacapavir as an intramuscular injection, which is different from the subcutaneous formulation of lenacapavir, which is being investigated for twice-yearly dosing. The most commonly reported adverse event for both intramuscular formulations studied was injection site pain, which was reduced by pretreatment with an ice pack. Medication-emergent adverse events were similar between the two cohorts and mostly mild to moderate in severity.

GILD also presented data from the PURPOSE 1 study at the CROI 2025 that showed preference for twice-yearly lenacapavir versus once-daily orals.

A Potential Approval of Lenacapavir Should Boost GILD

Gilead is a dominant player in the HIV market.  Biktarvy is the number one prescribed regimen for both treatment-naïve and switch patients.  It continues to maintain its dominant position with an increasing market share for treatment and prevention.

Lenacapavir is already approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals.  

At present, there are two FDA-approved daily oral medications for PrEP — Truvada and Descovy.

Please note that Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex.

Truvada is a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, approved for the treatment of HIV-1 infection and PrEP.

The strong results from the PURPOSE increase the probability of lenacapavir’s approval, which should further solidify GILD’s HIV franchise. Lenacapavir has a competitive advantage as it needs to be taken only twice yearly, unlike daily oral pills, and addresses a broad population.

A long-acting injectable form of PrEP was also approved by the FDA. In 2021, the regulatory body approved ViiV Healthcare’s Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms for PrEP to reduce the risk of sexually acquired HIV.

ViiV Healthcare is a global specialist HIV company, majorly owned by GSK plc GSK, with Pfizer PFE and Shionogi as shareholders. The company was formed by GSK and Pfizer in 2009.

Apretude is given first as two initiation injections, administered a month apart and then every two months. Patients in need can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to understand how well they can tolerate the drug.

Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK.

GSK posted 13% growth in HIV sales in 2024, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.

GILD’s Zacks Rank

Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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