PURPOSE 1 (F/TAF vs. F/TDF)
Trial question
What is the role of pre-exposure prophylaxis with daily emtricitabine-tenofovir alafenamide in HIV-negative women?
Study design
Multi-center
Double blinded
RCT
Population
3207 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=2137 emtricitabine/tenofovir alafenamide (daily oral emtricitabine/tenofovir alafenamide plus daily oral placebo).
N=1070 emtricitabine/tenofovir disoproxil fumarate (daily oral emtricitabine/tenofovir disoproxil fumarate plus daily oral placebo).
Primary outcome
Incidence of incidence of human immunodeficiency virus infection
2.02
1.69
2.0/100 py
1.5/100 py
1.0/100 py
0.5/100 py
0.0/100 py
Emtricitabine/tenofovir
alafenamide
Emtricitabine/tenofovir disoproxil
fumarate
No significant
difference ↔
No significant difference in the incidence of incidence of HIV infection (2.02/100 py vs. 1.69/100 py; IRR 1.2, 95% CI 0.67 to 2.14).
Safety outcomes
No significant difference in adverse and serious adverse events.
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, emtricitabine/tenofovir alafenamide was not 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 Oct 3;391(13):1179-1192.
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