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Gilead small molecule demonstrates strong capability for HIV prevention

According to Gilead, the study is the first Phase III HIV prevention trial to demonstrate a zero-infection rate.

HIV Lenacapavir Gilead

Gilead Sciences’ twice-yearly injectable HIV-1 capsid inhibitor enabled 100 percent efficacy for investigational use of HIV prevention in cisgender women. This is according to interim analysis topline results of the Phase III PURPOSE 1 trial. Lenacapavir showed superiority to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).

Potential for HIV prevention

“With zero infections and 100 percent efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections”

“With zero infections and 100 percent efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” remarked Dr Merdad Parsey, PhD, Chief Medical Officer, Gilead Sciences. “We look forward to additional results from the ongoing PURPOSE clinical programme.”

These are the first data generated from the programme, which comprise of five HIV prevention trials worldwide.

Efficacy data for lenacapavir

There were zero incident cases of HIV infection among 2,134 women in the lenacapavir group, the interim analysis found. Comparatively, 16 incident cases were reported among 1,068 women in given Truvada.

Furthermore, superiority of twice-yearly lenacapavir over bHIV (incidence 2.41 per 100 person-years) was observed.

Gilead noted that HIV incidence was found to be numerically similar, (incidence 2.02 per 100 person-years) in 2,136 women, when compared to the Truvada group and was not statistically superior to bHIV.

Gilead shared that based on these findings, the independent Data Monitoring Committee (DMC) recommended that the blinded phase of the trial is stopped and to offer open-label lenacapavir to all participants with the infection.

PURPOSE 1 is evaluating the safety and efficacy of twice-yearly, subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) and once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF) in over 5,300 cisgender women and adolescent girls aged 16-25 in South Africa and Uganda.

“While we know traditional HIV prevention options are highly effective when taken as prescribed, twice-yearly lenacapavir for PrEP could help…increase PrEP adherence and persistence given its twice-yearly dosing schedule,” commented Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and past President of the International AIDS Society.

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