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Lenacapavir 5 PrEP Global Studies
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The PURPOSE trials will evaluate the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV-also known as pre-exposure prophylaxis (PrEP).
Lenacapavir is a first-in-class HIV capsid inhibitor that can be administered as a twice-yearly subcutaneous injection. It is currently approved, in combination with other antiretrovirals, for HIV treatment in persons with multidrug-resistant HIV-1 infection. It is also under investigation for HIV prevention. If approved, lenacapavir with its twice-yearly dosing could offer a potential long-acting option to help address the differing needs and preferences of individuals who could benefit from PrEP. The safety and efficacy of lenacapavir for HIV prevention has not been established.
More information about the PURPOSE program can be found at www.purposestudies.com.
5 Purpose Studies for Lanacapavir PrEP: Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program - (01/10/24)
Lenacapavir Protects Against Rectal SHIV Acquisition in Macaque Model
Long-acting lenacapavir acts as an effective preexposure prophylaxis in a rectal SHIV challenge macaque model In macaques, a single subcutaneous administration of LEN demonstrated dose proportional increases in and durability of drug plasma levels. A high-dose SHIV inoculum for the PrEP efficacy evaluation was identified via virus titration in untreated macaques. LEN-treated macaques were challenged with high-dose SHIV 7 weeks after drug administration, and the majority remained protected from infection, as confirmed by plasma PCR, cell-associated proviral DNA, and serology testing. Complete protection and superiority to the untreated group was observed among animals whose LEN plasma exposure exceeded its model-adjusted clinical efficacy target at the time of challenge. All infected animals had subprotective LEN concentrations and showed no emergent resistance.
Long-acting lenacapavir protects macaques against intravenous challenge with simian-tropic HIV.....Here, we show that a single SC administration of LEN, a first-in-class, long-acting inhibitor of HIV-1 CA function, protected PTMs from infection with a stringent, high-dose IV challenge of minimally chimeric HIV-1 (stHIV-A19).Here, we first defined both the in vitro susceptibility of stHIV-A19 replication to LEN inhibition and the PK of a long-acting formulation of LEN in PTMs. We then evaluated LEN PrEP in PTMs against a stringent high-dose stHIV-A19 challenge via the intravenous (IV) route, a transmission route estimated to account for approximately 10% of new HIV-1 infections. Finally, in light of recent reports of emergent HIV-1 infection characterized by drug-resistant virus in the setting of waning drug levels in a rare subset of individuals that received CAB-LA PrEP, we utilized experimental depletion of CD8+ cells, performed after LEN washout, to definitively confirm prevention of infection in animals that received LEN PrEP.
5 Purpose Trials
About PURPOSE 1
• Phase 3 study of an investigational drug, lenacapavir, for PrEP and emtricitabine/tenofovir alafenamide (F/TAF) for PrEP in cisgender Adolescent Girls and Young Women ages 16-25
• This study will be conducted in South Africa and Uganda
• Actual Study start date: August 30, 2021
• this pivotal registrational trial completed full enrolment in September 2023 with more than 5,300 participants enrolled.
About PURPOSE 2
• Phase 3 study of an investigational drug, lenacapavir, MSM- for PrEP for Cisgender Men, Transgender Women, Transgender Men, and Gender Non-Binary individuals Who Have Sex With Partners Assigned Male at Birth
• This study will be conducted in the United States, South Africa, Peru, Brazil, Argentina, Mexico, and Thailand.
• Actual Study start Date: June 28 2021
• actual enrollment: 3300
About Purpose 3 (Recruiting)
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN-102), who are disproportionately affected by HIV, with a focus on Black women and other women of color,. Actual start Date: November 17, 2023. Phase 2 Open Label. 250 participants. The primary objectives of this study are:
• To characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women.
• To evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women.
• To evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.
About Purpose 4 (Recruiting)
The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada) (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US). Actual Start date: December 13, 2023. 250 participants.
The primary objectives of this study are:
• To characterize the pharmacokinetics (PK) of LEN.
• To evaluate the safety of LEN and F/TDF for PrEP in US PWID.
About PURPOSE 5
The first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention option in Europe. The study will assess the persistence-defined as consistent and continuous use-of lenacapavir compared with emtricitabine/tenofovir disoproxil fumarate (F/TDF) in people who may benefit from pre-exposure prophylaxis (PrEP) and who are not currently taking PrEP. The study has an intentional focus on recruiting participants from groups across France and the United Kingdom that are disproportionally affected by HIV and often underrepresented in clinical trials.
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