Multipurpose Prevention Technologies (MPTs) for Sexual & Reproductive Health

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1 Multipurpose Prevention Technologies (MPTs) for Sexual & Reproductive Health

2 Session Objectives This session is designed to help you: Define multipurpose prevention technologies (MPTs) Describe 3 benefits of MPTs for women Describe 2 existing MPTs in use globally Describe at least 3 delivery systems in development Describe 2 major challenges for MPTs development Describe the general MPTs development timeline

3 Multipurpose Prevention Technologies Prevent at least 2 of the following: unintended pregnancy, STIs, HIV/AIDS Should be safe & easily available Are designed with key input from women for their specific needs & preferences

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5 Global need, regional priorities

6 Case Study #1: HIV in Women Age 33, married Already has 6 children Husband spends a significant amount of time out of the village and she accepts he is unfaithful Husband will not wear a condom Every 60 seconds a young woman is infected with HIV.

7 Global Need Each year 1.7 million people die from AIDS and 2.5 million become infected. 1 million people contract a sexually transmitted infection every day. 222 million women have an unmet need for modern contraception. Each day, close to 800 women in developing countries die from complications related to pregnancy and childbirth.

8 Case Study #2: Unintended Pregnancy Age 30, married Has delivered 2 children in 3 years Husband wants more children Sister died birthing her 5 th baby in 7 years 222 million women have an unmet need for modern contraception.

9 In the United States Nearly half of all pregnancies among American women are unintended. STIs are the most commonly reported communicable diseases in the US. There are18.9 million new cases of STIs each year in the US. 14

10 Case Study #3: STIs Age 27 Not in a committed relationship Currently taking oral contraception Doesn t always use a condom 1 million people contract a sexually transmitted infection everyday.

11 MPTs: Historical Precedents H2O + flouride The pill + iron Grains + folic acid

12 Currently Available MPTs Male Condom Female Condom ADVANTAGES: Available now DISADVANTAGE: Use rates are low, difficult to negotiate

13 Complex Factors = Many Possibilities Conditions Pregnancy, HSV, HPV, HIV, BV, Chlamydia, Gonorrhea, Syphilis, Candida, Trich Product Types Vaginal film, Vaginal tablet, Oral tablet, Vaginal ring, Non-IVR device, Vaginal gel, Injectable, Implantable MPT Product Possibilities Delivery Methods Topical daily, Topical pericoital, Systemic sustained, Topical sustained, Oral daily, Oral pericoital Actions HC, Non-HC, Barrier, Pro-biotic, Antimicrobial, Antifungal, Antiviral

14 Why do women need MPTs? Healthy timing & spacing of intended pregnancies Protection against HIV Protection against other STIs

15 On-Demand Products: Tenofovir Gel (CONRAD) Electrospun Nanofibers 1 st proof-of-concept vaginal microbicide Coitally-dependent Confirmation trial underway for 2014 Novel formulation of active drugs in thin film-type configuration Combination via film layering Vaginally administered w/o applicator

16 Sustained Release Devices: Combination Intravaginal Rings 60-day Dapivirine + LNG (IPM) Nuvaring Type MPT Technology DPV + LNG Early development underway, clinical studies 2015? Pregnancy, HIV Novel polymer/co-extrusion IVR Multiple API delivery Established scale-up manufacturing system

17 Long Acting Injectables: TMC278LA (rilpivirine; PATH) GSK 744 (II; ViiV) Injectable nano-suspension of approved NNRTI Long acting: 2-3 mos (?) Multiple trials: P1 dose ranging PK; SD/MD PK/PD P2 planning Experimental integrase inhibitor Dose ranging human safety P1 NHP model efficacy studies complete

18 MPTs in the Pipeline Small Organic Molecules Broad Spectrum Natural Products Proteins/Peptides Non-Hormonal Contraceptives

19 Single & Multipurpose Vaccines Today: Single purpose vaccines (HPV & HBV) 20 years: Multivalent vaccines (HSV, HIV, Gonorrhea, Chlamydia, Trichomonas, other STIs) Contraceptive vaccines are not likely

20 MPT Product Profile: Working Group Recommendations MPT PRODUCTS HIV/STI Prevention Unintended Pregnancy

21 MPT Product Development Timeline PRE-CLINICAL CLINICAL

22 MPTs roadmap is not linear

23 Collaboration, advocacy, & research to advance MPTs

24 Initiative for Multipurpose Prevention Technologies

25 Barriers to progress on MPTs

26 The time for MPTs is now

27 What you can do? SHARE Spread the news about life saving MPTs with your colleagues and networks. COLLABORATE If you work in a related field, join the IMPT and move research, policy, funding and education efforts forward to save lives. CONTRIBUTE Your financial and in-kind support can accelerate MPT education, research and introduction. TELL YOUR STORY- Make the case for MPTs with your stories, experiences and anecdotes by ing stories@cami-health.org.

28 Learn more about MPTs

29 Questions?

30 Thank you! Support for this project is made possible by the generous support of the American people through the United States Agency for International Development (USAID) under the terms of the HealthTech Cooperative Agreement #AID-OAA-A , managed by PATH. The contents are the responsibility of CAMI/PHI and its partners and do not necessarily reflect the views of USAID or the US Government.