A Daily Pill to Prevent HIV: Oral Pre-exposure Prophylaxis (PrEP) Delivette Castor, PhD USAID Jason Reed, MD, MPH Jhpiego Timothy Mah, DSc USAID Global Health Mini-University September 14, 2017
Presentation Overview Oral PrEP Basics What is it? How does it prevent HIV? Who might benefit from Oral PrEP? PrEP Policy and Guidance PrEP introduction and scaleup in SSA What s next? 2
What is oral PrEP? A pill taken daily by HIV-negative individuals to reduce their risk of HIV Contains anti-hiv medicine(s) that have been widely used to treat HIV infection Comprised of Tenofovir (TDF) alone or in combination with Emtricitabine (FTC) or Lamivudine (3TC) Brand name (non-generic name) of TDF/FTC combination is Truvada
How does oral PrEP prevent HIV? When HIV-negative people take oral PrEP, concentration of anti-hiv medicine(s) gradually builds in their bodies (if they take as prescribed) Should they subsequently be exposed to HIV, the medicine prevents the virus from infecting their body s cells This is similar to the way in which oral contraceptives work to prevent pregnancy and malaria prophylaxis works to prevent malaria
How does oral PrEP prevent HIV? HIV Transmitted
How does oral PrEP prevent HIV? HIV Not Transmitted
What is the evidence that oral PrEP works? Scientific data from a large number of clinical trials and demonstration projects have proven that PrEP is effective at preventing HIV infection On-demand Truvada MSM- France (IPERGA Y) Daily Truvada MSM- UK (PROUD ) Daily Truvada Discordant Couples- Uganda, Kenya (Partners PrEP) Daily Tenofov ir Discordant Couples- Uganda, Kenya (Partners PrEP) Daily Truvada Heterosexu al M & F- Botswana (TDF2) Daily Truvada MSM- America s, Thailand, South Africa (iprex) Daily Truvada Women- Kenya, South Africa, Tanzania (FEMPr EP) Daily Truvada Women- South Africa, Uganda, Zimbabwe (MTN003/ VOICE) Daily Viread Women- South Africa, Uganda, Zimbabwe (MTN003/ VOICE)
Consistent protective effect across 5 studies 4 of the 5 studies show >80% protection Evidence in men is compelling (MSM > discordant couples > general heterosexual men) 9/22/2017 8
Oral PrEP inconsistent effectiveness across 4 studies Topical PrEP inconsistent effectiveness across 3 studies Effectiveness consistent in those with detectable drug levels 9/22/2017 FOOTER GOES HERE 9
PrEP is Over 90% Effective Results indicated that oral PrEP when taken as prescribed over 90% effective at protecting HIV-negative people against HIV In the FTC TDF group, among subjects with a detectable study-drug level, as compared with those without a detectable level, the odds of HIV infection were lower by a factor of 12.9 (95% CI, 1.7 to 99.3; P<0.001), corresponding to a relative reduction in HIV risk of 92% (95% CI, 40 to 99; P<0.001). After adjustment for reported unprotected receptive anal intercourse, the relative risk reduction was 95% (95% CI, 70 to 99; P<0.001). Citation: Grant, Robert M., et al. "Preexposure chemoprophylaxis for HIV prevention in men who have sex with men." New England Journal of Medicine 363.27 (2010): 2587-2599.
PrEP Guidance 11
WHO Guidance & Support In response to the evidence, WHO issued series of guidance documents, culminating in their 2016 recommendation: oral PrEP be made available to anyone at substantial risk of becoming infected with HIV Added Oral PrEP to the WHO Essential Medicines List in 2017 Released the WHO Oral PrEP Implementation Tool in July 2017 http://www.who.int/hiv/pub/prep/prep-implementation-tool/en/
PrEP Trajectory in PEPFAR 2015 - PEPFAR SAB recommends PrEP implementation Pre-2015 - USAID supported Partner s PrEP OLE, Partner s Demo, FEM-PrEP & several demonstration studies 2016 - COP Guidance encouraged stakeholder coordination and PrEP readiness activities. - Drug procured w/ non-pepfar funds - DREAMS sites can initiate PrEP - PrEP interagency TF formed 2017 - Guidance allows for procurement of PrEP ARVs when Test & START policy initiated VL testing in place multi-month scripting for stable ART clients 2018 - COP guidance Forthcoming 13
PEPFAR FY18 PrEP Targets 5 150 500 530 1,000 1,300 1,550 1,680 1,700 1,700 2,769 4,496 11,757 12,815 16,150 23,993 Oct 2017 - Sept 2018 Total = 82, 096 UNAIDS 2020: 3 Million 14
Country Progress on Oral PrEP South Africa PrEP rollout at Sex Worker sites (Mar 2016) Kenya National Oral PrEP Rollout (May 2017) Namibia PrEP Guidelines (WAD 2016) 15
PrEP Introduction and Scale-up 16
Who might benefit from PrEP? High and medium incidence comprise 95% of HIV infections 17
Who might benefit from PrEP? 18
Cost and Impact of Potential Roll Out Scenarios 19
Framework for Scaling up PrEP OPTIONS project: www.prepwatch.org 20
Countries with Demonstration Projects 21
CAPRISA 084: PrEP Demonstration Project Objectives: To assess the feasibility, acceptability, uptake and patterns of use of daily, oral tenofovir diproxyl fumarate + emtricitabine provided as part of SRH services to young women (and men) at risk of acquiring HIV in urban and rural KwaZulu-Natal Determine contraceptive use patterns; STIs and pregnancy rates among female PrEP clients Develop a critical mass of trained health care workers skilled to provide PrEP and integrate HIV services into SRH services Characterize PrEP seekers and succesful users Monitor safety of PrEP use in routine services Describe patterns of PrEP use including adherence Determine factors that influence use patterns and adherence What client and provider support is needed for PrEP use? 5
CAPRISA 084: Study Sites & Population Enroll + 2000 clients on oral PrEP Total RURAL Vulindlela n=1200 ANC + FP Clinics + School SRH services URBAN ethekwini n=500 STI clinic + FP clinic + Tertiary institutions PERI-URBAN Umlazi n=300 Pregnant + postpartum Men Age (years) (Range) # enrolled & offered PrEP # (%) initiating PrEP 23.3 (18-30) 429 264 (61%) # Still on PrEP after 6 months 166 (64%) # Still on PrEP after 12 months As of July 2017 68 (52%) 6
CAPRISA 084: Reasons for non-use of PrEP Reasons for not initiating PrEP Not interested / willing / ready to take PrEP HIV test positive, abnormal ALT/AST, medical condition No self-perceived HIV risk Concerned about objection from partner Reasons for stopping PrEP Bad allergic reaction/ rash and swelling of the upper body, Not willing to take ARV medication, Unavailable because of work, No money for transport to get to the clinic, or No longer interested due to lower HIV risk perception
Bridge to Scale: Program Overview
Overall Project Goal To demonstrate and document an effective model for how oral Pre-exposure Prophylaxis (PrEP) can be scaled up as an HIV-prevention intervention in low-resource settings
Priority Population for PrEP Female sex workers (FSWs) Men who have sex with other men (MSM), including male sex workers Adolescent girls and young women (AGYW)
Geographic Locations
Kenya s PrEP Scale-up Milestones
Key Bridge to Scale Milestones
Sub Goal 1: Demonstrate Effectiveness of Population Level PrEP Interventions Supply Integrate PrEP into existing combination prevention services Demand Human Centered Design Behavioral Economics
Bridge to Scale Service Delivery Points Bridge to Scale Service Delivery Points PrEP is delivered using facility-based and community-based models Drop in Centers - 18 Public Health Facilities - 26 Private Health Facilities - 7 Outreach 32
Demand Creation Framework
National PrEP Campaign Identity
Sub Goal 2: Develop and document an acceptable, affordable, and replicable approach to launch and scale-up the use of oral PrEP Learning laboratory Costing, impact, and affordability (Modeled) Replicability Implementation toolkit
Sub Goal 3: Country level & International advocacy Implementation guidelines Domestic and international financing Systems to enable scale up Ensure political, donor, and community support for the scale-up of oral PrEP
Media Engagement
Planned Activities Service Delivery Capacity building of health providers Provision of job aids for providers Commodity quantification based on actual consumption Strengthen supply chain and commodity reporting
Demand Creation Less Mass Media and increased Interpersonal Communication
Crisis Communications Risk mapping Political, cultural, religious resistance Anti-PrEP activism Risk compensation leading to infection Crisis committee formed Interim crisis strategy in place
What is next? 42
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/near phase 3; others in pre. Implants? multiple in preclinical Surgical procedures Treatment Prevention Paradigm 2017 and Beyond Source: AVAC.org
USAID Microbicide Product Introduction Initiative (MPii) Product R&D Antibodies Long Acting Injectables Films Rings Pre-Clinical T1 - Translation to Human (Move a molecule into product ) T2 - Translation to Patients/Practice (Generate the real world evidence) T3 - Translation to Program (Introduce in existing health systems and scale-up) Minimize delays in introducing HIV/AIDS prevention Better prepare national health systems to deliver new HIV prevention products to Women 9/22/2017 44
THANK YOU! Delivette Castor dcastor@usaid.gov Jason Reed Jason.reed@jhpiego.org Timothy Mah tmah@usaid.gov 46