Gilead has unveiled positive topline results from an interim analysis of its Phase III PURPOSE 2 trial showing that its twice-yearly HIV drug lenacapavir outperformed once-daily Truvada (emtricitabine + tenofovir disoproxil fumarate).
The trial (NCT04925752) enrolled cis- and transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth. Half the patients received lenacapavir, and half received Truvada, a once-daily oral HIV medication. There were two HIV cases out of the 2,180 enrolled patients, meaning 99.9% of patients did not acquire HIV. Lenacapavir was 89% more effective than Truvada, and it reduced HIV infections by 96% compared to background HIV incidence (bHIV).
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Based on these results, the independent Data Monitoring Committee recommended that Gilead stop the blinded phase of the trial and offer open label lenacapavir to all participants.
Gilead previously touted positive data from the Phase III PURPOSE 1 trial (NCT04994509), where lenacapavir – a HIV-1 capsid inhibitor – prevented 100% of HIV cases in cisgender women. The trial met its primary endpoint, showing the superiority of lenacapavir to Truvada for HIV prevention.
Lenacapavir is already approved as an HIV treatment for patients resistant to other medication options. It gained US Food and Drug Administration (FDA) approval backed by findings from the Phase II/III CAPELLA clinical trial of the drug plus an optimised background regimen, in December 2022. The drug is now being trialled as a type of pre-exposure prophylaxis (PrEP) medication, a group of drugs that HIV-negative people can take to minimise the risk of contracting HIV.
Lenacapavir’s twice-yearly dosing schedule could be a major breakthrough in the HIV space, where patients can find it challenging to stick to daily pills due to stigma and low adherence. In May 2024, several public figures and celebrities – who described the drug as a “gamechanger” – wrote an open letter to Gilead urging them to provide fair access to lenacapavir in low- and middle-income countries.
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By GlobalDataIn the announcement accompanying the study results, PURPOSE 2 principal investigator and professor of medicine at Emory University Dr. Colleen Kelley said: “In the United States, the stubbornly high rate of HIV diagnoses—especially in the US South, and particularly among gay and bisexual men of colour and transgender people—demands novel approaches to help people prevent HIV acquisition.
“Because adherence to oral products can be challenging for some people, twice-yearly injectable lenacapavir for PrEP has the potential to be one of the most impactful interventions we could have to drive down new infections and bring us closer to ending the HIV epidemic in the United States.”
