What the studies showed

What the
studies showed

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

Among the most diverse PrEP studies ever conducted.

Three APRETUDE patients
Three APRETUDE patients

Among the most diverse PrEP studies ever conducted.

APRETUDE was proven superior at reducing the risk of getting HIV vs a daily oral PrEP.*

*Daily oral PrEP studied was tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC).

APRETUDE was proven superior at reducing the risk of getting HIV vs a daily oral PrEP.*

*Daily oral PrEP studied was tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC).

Study 1:
4,566 cisgender men and transgender women at risk for getting HIV

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APRETUDE–12 people became HIV-positive

A daily oral PrEP–39 people became HIV-positive

Participants were on the product for an average of 1.3 years.

*Daily oral PrEP studied was tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC).

Participants were on the product for an average of 1.3 years.

*Daily oral PrEP studied was tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC).

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

Women and HIV image
Women and HIV image

Study 2:
3,224 cisgender women
at risk for getting HIV

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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:

Common Side Effects reported in ≥ 3% of patients treated with APRETUDE or TRUVADA
Common Side Effects reported in ≥ 3% of patients treated with APRETUDE or TRUVADA
  • 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).

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