PURPOSE 1 (lenacapavir vs. F/TDF)
Trial question
What is the role of pre-exposure prophylaxis with twice-yearly lenacapavir in HIV-negative women?
Study design
Multi-center
Double blinded
RCT
Population
3208 female patients.
Inclusion criteria: adolescent girls and young women who were sexually active with male partners, who had unknown HIV status and no HIV testing within the previous 3 months.
Key exclusion criteria: prior receipt of a HIV vaccine; prior use of long-acting systemic HIV pre-exposure prophylaxis or HIV post-exposure prophylaxis.
Interventions
N=2138 lenacapavir (subcutaneous lenacapavir every 26 weeks plus daily oral placebo).
N=1070 emtricitabine/tenofovir disoproxil fumarate (daily oral emtricitabine/tenofovir disoproxil fumarate plus subcutaneous placebo).
Primary outcome
Incidence of incidence of human immunodeficiency virus infection
0
1.69
-0.4/100 py
-0.8/100 py
-1.3/100 py
-1.7/100 py
Lenacapavir
Emtricitabine/tenofovir disoproxil
fumarate
Significant
decrease ▼
Significant decrease in the incidence of incidence of HIV infection (0/100 py vs. 1.69/100 py).
Safety outcomes
No significant difference in adverse and serious adverse events.
Significant difference in injection site reaction (68.8% vs. 33.9%).
Conclusion
In adolescent girls and young women who were sexually active with male partners, who had unknown HIV status and no HIV testing within the previous 3 months, lenacapavir was superior to emtricitabine/tenofovir disoproxil fumarate with respect to the incidence of incidence of HIV infection.
Reference
Linda-Gail Bekker, Moupali Das, Quarraisha Abdool Karim et al. Twice-Yearly Lenacapavir or Daily F / TAF for HIV Prevention in Cisgender Women. N Engl J Med. 2024 Jul 24. Online ahead of print.
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