MTN-020-ASPIRE A Vaginal Ring Containing Dapivirine for HIV-1 PrEP - - PowerPoint PPT Presentation

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE Study: Background

Source: Baeten JM, et al. N Engl J Med. 2016;375:2121-32.

Placebo Ring

(n = 1,316)

Dapivirine Ring

(n = 1,313)

Study Design: ASPIRE

• Background: Randomized, double-blind, phase 3,

placebo-controlled trial of a dapivirine-containing vaginal ring changed every 4 weeks as compared to a placebo ring for HIV-1 prevention for women at multiple sites in Malawi, South Africa, Uganda and Zimbabwe

• Inclusion Criteria (2,629 enrolled)
• 18-45 years of age
• HIV seronegative
• Sexually active
• Nonpregnant
• Treatment Arms:
• Dapivirine 25 mg vaginal ring, changed monthly
• Placebo vaginal ring, changed monthly

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE Study: Results

Number of New HIV Infections (All Sites)

Source: Baeten JM, et al. N Engl J Med. 2016;375:2121-32.

97 71

25 50 75 100 125 150

Placebo ring Dapivirine ring Number of HIV Infections

P = 0.046

⇓ 27%

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE Study: Results

Number of New HIV Infections (Excluding 2 Sites with Poor Retention)

Source: Baeten JM, et al. N Engl J Med. 2016;375:2121-32.

85 54

25 50 75 100 125 150

Placebo ring Dapivirine ring Number of HIV Infections

P = 0.007

⇓ 37%

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE Study: Results

Incidence Rate for New HIV Infections

Source: Baeten JM, et al. N Engl J Med. 2016;375:2121-32.

4.5 3.3

2 4 6 8 10

Placebo ring Dapivirine ring Incidence per 100 person-years

P = 0.046

⇓ 27%

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE Study: Results

Relative Reduction, by Age Group

Source: Baeten JM, et al. N Engl J Med. 2016;375:2121-32.

27 10 61

20 40 60 80

Overall Age ≤25 Age >25 %Relative Reduction

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE Study: Results

Reduction in HIV Incidence Comparing Age Groups

Source: Baeten JM, et al. N Engl J Med. 2016;375:2121-32.

Reduction in HIV Incidence by Age Groups in ASPIRE HIV Protection (Reduction in Incidence Comparing Dapivirine Ring to Placebo)

Subgroup Analysis

<25 years-old 10% >25 years-old *61%

Post-hoc Analysis

18-21 years-old 27% 21-27 years-old *56% 27-45 years-old *51%

*Improved HIV protection in older age groups correlated with increased markers of adherence

A Vaginal Ring Containing Dapivirine for HIV-1 PrEP

MTN-020-ASPIRE Study: Conclusions

Source: Baeten JM, et al. N Engl J Med. 2016;375:2121-32.

Conclusions: “A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence.“

Acknowledgment

The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $800,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program.

The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.