Twice-yearly HIV injection demonstrates 100% efficacy

HIV cell

Interim analysis of the Phase III PURPOSE 1 trial indicates that Gilead Sciences twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrates 100% efficacy for the investigational use of HIV prevention in cisgender women.

PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).

Based on these results, the independent Data Monitoring Committee (DMC) has recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, Chief Medical Officer, Gilead Sciences. “We look forward to additional results from the ongoing PURPOSE clinical programme and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”

A critical new choice for HIV prevention

These are the first data generated from Gilead’s landmark PURPOSE programme, which is the most comprehensive and diverse HIV prevention trial programme ever conducted.

According to the trial data, there were 0 incident cases of HIV infection among 2,134 women in the lenacapavir group, compared to 16 incident cases among 1,068 women in the Truvada group.

“Twice-yearly lenacapavir for PrEP, if approved, could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world – especially cisgender women,” said Linda-Gail Bekker, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and past President of the International AIDS Society.

“While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule.”

Gilead expects results in late 2024/early 2025 from the programme’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth.

Diana Spencer, Senior Digital Content Editor, DDW

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