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Gilead Sciences has announced the progression of subject enrolment in two Phase II collaborative studies to assess lenacapavir, an investigational long-acting HIV prevention option.

Named PURPOSE 3 (HPTN-102) and PURPOSE 4 (HPTN-103), these studies are targeting cisgender women and people who inject drugs in the US.

PURPOSE 3/HPTN-102 is focusing on the enrolment of cisgender women, particularly black women and other women of colour who are disproportionately affected by HIV.

PURPOSE 4/HPTN-103 is targeting people in the US who inject drugs.

These studies are sponsored and funded by Gilead and are being implemented through the HIV Prevention Trials Network (HPTN).

The HPTN’s efforts are supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH).

These trials will assess the safety, acceptability, and pharmacokinetics of lenacapavir administered via injection every six months as a pre-exposure prophylaxis (PrEP) option.

The first participants for PURPOSE 3/HPTN-102 were enrolled at a site at the University of California, San Diego.

Gilead Sciences HIV clinical development vice-president Jared Baeten said: “HIV prevention is only effective when people are able to access and adhere to the prevention methods that fit within their lives, and a twice-yearly subcutaneous injectable could be an important option for some people for whom existing PrEP modalities, for varying reasons, are not feasible.

“Gilead is proud to partner with NIH, HPTN, and members of communities across the US on these important studies, recognising that lenacapavir for PrEP, if deemed safe and effective, could potentially help more people, in more populations, prevent HIV.”

In April this year, Gilead received FDA approval for the label expansion of its HIV-1 fixed dose combination therapy, Biktarvy, in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1.

Clinical Trials Arena
Populations & Programmes
Long-acting PrEP, HIV prevention, lenacapavir