What Is the Dapivirine Ring?

Transcription

1 What Is the Dapivirine Ring? Dr. Zeda Rosenberg, CEO Beyond Phase III: 2014 Civil Society Consultation

2 What Are Microbicides? Products being developed to help prevent sexually transmitted HIV infection Most contain ARVs, already used successfully to treat HIV Could come in many forms to meet women s varying needs: Vaginal gel applicator Long-acting vaginal ring Vaginal tablet, soft gel, film Ideally safe, effective, low cost, user-friendly 2

3 Who Is IPM? Nonprofit organization working to protect women s sexual and reproductive health Developing products like the dapivirine ring to reduce the risk of HIV transmission to women safely and effectively Funded by governments and foundations Work with local research centres and trial networks like MTN to conduct clinical trials of our products Offices in South Africa and US 3

4 Microbicide Vaginal Rings Long-acting: monthly or longer o Could potentially improve adherence o Better adherence better effectiveness Easy to use, comfortable o Flexible ring, can be self-inserted o Rarely felt by women or male partners o Little or no impact on sexual activity Suitable for developing world o Relatively low manufacturing cost o Good safety and acceptability data Potential for contraceptive/arv combinations Important potential new option for women 4

5 What is Dapivirine? Highly potent ARV (NNRTI) Developed by Janssen o Evaluated in preclinical and clinical studies as oral therapeutic Licensed to IPM in 2004 o Royalty-free license to develop as topical microbicide for HIV prevention in developing countries Acts inside cells in the vagina to block the ability of HIV to multiply 5

6 Dapivirine Vaginal Ring Off-white flexible silicone ring Made by mixing dapivirine into liquid silicone The mixture is put into a ring mold and heated The solid ring can slowly release drug into vaginal tissue Now in late-stage clinical trials: The Ring Study and ASPIRE 6

7 7 How the Dapivirine Ring is Used

8 Prior Research Vaginal rings used safely and effectively for other medical uses in Europe and US for almost 20 years Dapivirine found to be safe and welltolerated in over 20 clinical trials by IPM and partners since IPM clinical trials to date show dapivirine ring is safe and welltolerated (6 clinical trials ongoing) IPM clinical trials also show steady drug release and low systemic absorption 8

9 What we know about dapivirine ring acceptability Among women Very comfortable Not felt during daily activities Willing to use if effective Among men Most did not feel during sex No impact on sexual pleasure and no side effects Most favorable characteristics to women Potential for HIV prevention Does not alter sexual experience Worn every day Involving male partners Important partner accepts ring 9

10 10 Dapivirine Ring Licensure Program

11 Dapivirine Ring Licensure Program IPM 027 Long-term safety and efficacy 1950 participants, ongoing ( ) in Africa MTN-020 Additional safety and PK clinical trials Safety and effectiveness 2629 participants enrolled, ongoing ( ) in Africa Drug-drug interactions Condom functionality (male and female) Safety in adolescents (15-17 years) and post-menopausal women (>45 years) Effect of menses/tampon use 11

12 Why Two Parallel Phase III Trials? Regulatory approval usually requires results from at least two Phase III clinical trials One Phase III trial can take 4-6 years, from design to data analysis Running two clinical trials in parallel saves time enabling rapid regulatory submission if the dapivirine ring shows safety and efficacy 12

13 Thank you! Questions? A microbicide could mean the difference between life and death for millions of women. Let us do everything in our power to accelerate its development. Mrs. Graça Machel 13