PURPOSE 1 compared twice-yearly subcutaneous lenacapavir with oral PrEP regimens in adolescent girls and young women. HIV incidence was lower with injected lenacapavir; injection-site reactions were more common. These findings do not directly test weekly oral PrEP.
Program relevance
PURPOSE 1 studies twice-yearly subcutaneous lenacapavir for PrEP, not the catalog once-weekly oral formulation.
Formulation / population: Subcutaneous lenacapavir every 26 weeks for PrEP; not once-weekly oral lenacapavir.
Formulation mismatch: injectable twice-yearly PrEP, not weekly oral PrEP.
Journal Article / Clinical Trial, Phase III / Randomized Controlled Trial / Multicenter Study / Comparative Study
PURPOSE 2 evaluated twice-yearly subcutaneous lenacapavir against an oral PrEP comparator in men and gender-diverse participants. The abstract reports lower HIV incidence, with some discontinuations due to injection-site reactions. The formulation differs from the catalog application.
Program relevance
PURPOSE 2 studies twice-yearly subcutaneous lenacapavir in another PrEP population, not weekly oral PrEP.
Formulation / population: Subcutaneous lenacapavir every 26 weeks for PrEP; not once-weekly oral lenacapavir.
Formulation mismatch: injectable twice-yearly PrEP, not weekly oral PrEP.
Journal Article / Randomized Controlled Trial / Clinical Trial, Phase III / Multicenter Study / Comparative Study
A small open-label phase 2 study compared weekly oral islatravir plus lenacapavir with a daily treatment regimen in virologically suppressed adults with HIV. Suppression was generally maintained; the indication and companion drug differ from weekly oral PrEP.
Program relevance
The weekly oral regimen combines lenacapavir with islatravir for HIV treatment; it is not lenacapavir-only PrEP.
Formulation / population: Once-weekly oral islatravir plus lenacapavir for HIV treatment, not lenacapavir-only PrEP.
Indication and regimen mismatch: HIV treatment with islatravir, not weekly oral PrEP.
Journal Article / Randomized Controlled Trial / Clinical Trial, Phase II / Multicenter Study