The studies compared APRETUDE vs a daily PrEP pill* and were designed with diversity in mind
2 double-blind clinical studies
Approximately 8,000 participants
Included at-risk HIV-1–negative status cisgender men, transgender women, and cisgender women
Study 1:
4,566 cisgender men and transgender women at risk for getting HIV
APRETUDE–12 people became HIV-positive
A daily oral PrEP–39 people became HIV-positive
50% of US participants identified as Black/African American men
12% of global participants identified as transgender women
18% of US participants identified as Hispanic/Latino
Nearly three-quarters of participants were under 30. The average age was 26
Study 2:
3,224 cisgender women
at risk for getting HIV
APRETUDE–3 people became HIV-positive
A daily oral PrEP–36 people became HIV-positive
Participants were on the product for an average of 1.2 years.
*Daily oral PrEP studied was tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC).
3,224 women in Sub-Saharan Africa
Nearly half were younger than 25
Were there side effects?
Across both studies, the most common side effect was injection-site reactions.
- Injection-site reactions were reported by 82% of participants who received APRETUDE in Study 1 and 38% of participants who received APRETUDE in Study 2
- Injection-site reactions included pain, tenderness, hardened mass or lump, swelling, bruising, redness, itching, warmth, loss of sensation at the injection site, abscess, and discoloration
- In Study 1, 41% of participants reported a mild injection-site reaction, 56% of participants reported a moderate injection-site reaction, and 3% of participants reported a severe injection-site reaction
- In Study 2, 66% of participants reported a mild injection-site reaction, 34% of participants reported a moderate injection-site reaction, and <1% of participants reported a severe injection-site reaction
- 3% of participants in Study 1 and no participants in Study 2 discontinued taking APRETUDE due to injection-site reactions
Aside from injection-site reactions, common side effects reported in ≥1% of patients treated with APRETUDE or a daily PrEP pill* were:
- In Study 1, 6% of participants receiving APRETUDE and 4% of participants receiving a daily PrEP pill* discontinued due to adverse events.
- In Study 2, 1% of participants receiving APRETUDE and 1% of participants receiving a daily PrEP pill* discontinued due to adverse events.
- These are not the only side effects of APRETUDE. For more information, see the Risks and Side Effects page. Always tell your doctor if you experience any side effect.
*Daily oral PrEP studied was tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC).
