PURPOSE 2 Study
A Phase 3 Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Long-Acting Subcutaneous Lenacapavir and Daily Oral Emtricitabine/Tenofovir Alafenamide for HIV Prevention.
Rationale
Daily oral PrEP options such as F/TDF (Truvada) and F/TAF (Descovy) are highly effective in preventing HIV infection. However, adherence to a daily pill remains a key barrier to widespread uptake and sustained use, particularly in populations at highest risk. Lenacapavir (LEN), with its novel mechanism of action and pharmacokinetic profile supporting twice-yearly dosing, offers a promising long-acting alternative that can reduce reliance on daily pill-taking and mitigate associated stigma and disclosure concerns.
The PURPOSE 2 study explores whether subcutaneous LEN, administered every six months, can significantly enhance uptake and adherence to PrEP especially among disproportionately affected and historically underrepresented populations such as Black MSM, transgender women, and gender-diverse individuals
Primary Objective
To evaluate the efficacy of long-acting LEN in preventing HIV-1 infection among participants aged ≥16 who engage in condomless receptive anal sex with partners assigned male at birth and are at risk for HIV-1.
Investigators
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Prof Thesla Palanee-Phillips, Co-Principal Investigator
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Dr Nkosiphile Ndlovu, Co-Investigator
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Dr L. Kew, Co-Investigator
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Dr L. Kgoa, Co-Investigator
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Dr H. Ismail, Co-Investigator
Publications
Published November 27, 2024: Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons
Media Coverage
- News Release, 13 November 2024: Gilead Presents Full PURPOSE 2 Data Results for Twice-Yearly Lenacapavir for HIV Prevention at HIV Glasgow.
Latest Update
November 2024
For more details about the PURPOSE 2 Study please email rhicomms@wrhi.ac.za
Click here for further details regarding the PURPOSE 2 Study.
