1. Setting the Stage for PrEP Where are we now, and where should we go?
Mitchell Warren, Executive Director
PrEP in Practice AIDS 2018
25 July 2018

2. To Think About Where is the greatest unmet need for prevention?
What products will people want AND use?
How can we best deliver PrEP for impact AND build platforms to deliver next generation PrEP?

3. Oral PrEP Timeline US FDA approval & WHO guidance
iPrEx results
US FDA approval & WHO guidance
Gates demo projects start in Kenya, Uganda, South Africa, Senegal, Benin, India, Nigeria enrolling avg. 700 participants per project
Gates Planning & Feasibility Studies
Partners OLE results
PROUD & IPERGAY results
WHO recommends PrEP as option for all at substantial risk
~24 countries have approved PrEP
Partners PrEP & TDF2 results
Kenya approves PrEP
Bridge to Scale Implementation Project (Jilinde Project) in Kenya aiming to enroll 20,000
Research (clinical trials; OLE)
VOICE & FEM-PrEP oral arms stop early
Regulatory/country approvals
South Africa approves PrEP
DREAMS starts to implement PrEP in 5 countries
Implementation/demo
Selection of implementation and demo projects, 152 projects in total.
For full list see

4. Where Are We Now 43 regulatory approvals 2 global guidelines
13 national guidelines
141 discrete oral PrEP projects worldwide – demo projects, national rollout, DREAMS Initiative implementers
Approximately 340,000 oral PrEP initiations
Of which 220,000 are in the US
As of July 2018, from

5. What We’ve Learned 131 68 54 Oral PrEP Implementation Studies
Key Takeaways from early Oral PrEP rollout
Distinct post-approval oral PrEP implementation projects and studies; most were small-scale
131
Post-approval studies and projects
Post-approval studies were not all designed to address decision-maker questions
Different countries conducted projects including multiple in the same country (e.g. 25 in one country) 68
Countries
Data from research was not well timed to inform decision making at global or country level
Different organizations involved in oral PrEP implementation research 54
Stakeholders
Complex, fragmented stakeholder landscape

6. Why It Matters Different Strokes for Different Folks Method
Contraception
HIV Prevention
Behaviour ✓
Barrier Methods
Gels
✓– not registered
Rings
✓– with regulatory body
Oral pill
Injectables
? – 1 ARV, 1 bNAb, 2 vax in phase 3; others in development
Implants
? – multiple in preclinical
Surgical procedures
Treatment

8. Key Questions about Users (& Influencers)
Personal
Programmatic
Policy
Who needs what?
Who wants what?
Who gets what?
How to deliver it?
How to support adherence?
Who pays?
Who decides?
Those who use
Those who choose
Those who pay the dues

9. Product Considerations
For each product, understand and balance:
Biologic efficacy
Product cost
User effectiveness
Program cost
Dosing
User preference
Side effect profile
Provider training
User burden
Systemic/Topical
Health system burden
Reversibility
Delivery channel(s)
Discretion of use/ contribution of stigma
User vs. provider initiated

10. Bottom line(s) Oral TDF/FTC is the PrEP we have now
Oral F/TAF results due in 2020 – BUT currently only being studied for efficacy in men and transgender women who have sex with men
Dapivirine ring could enter the market by 2020 – possible multi-purpose product could follow
Fast Track targets ( ) due in 2020
Earliest injectable px to market in 2022 – one possible product
Earliest vax or bNAb to market in 2024 – multiple products
Earliest implant px to market in 2025 – multiple devices; two active drugs
Fast Track targets ( ) due in 2030

11. Acknowledgements