Pre-Exposure 5 8 Prophylaxis (PrEP) by the Numbers $3 Efficacy, regulatory 7 1 approval and more AUGUST 2016 %6 avac.org PrEP is the use of ARVs to reduce HIV risk in people who are HIV-negative. Daily oral PrEP, the one form of PrEP proven to work today, is recommended by the World Health Pre-Exposure Prophylaxis Organization as an additional option for all people at substantial risk of HIV. In spite of this endorsement and the need for new tools, different countries are moving at different speeds. Many are looking to demonstration projects—small-scale pilots (PrEP) by the Numbers that provide information on how to deliver oral PrEP in real-world settings. Advocates will look to countries to develop policies and plans to expand PrEP access. Now is the time to take regulatory action, learn from demonstration projects and fast-track Efficacy, regulatory status and more plans for scale-up. Other formulations of ARV-based prevention are also being evaluated and could provide additional options in the future. PrEP ors i ou ae t Eectiveess a herece i rials o ral a opical eoovir-ase Prevetio 100 CAPRISA 004 (tenofovir Trials of oral and topical gel, BAT-24 dosing) 80 tenofovir-based PrEP show FEM-PrEP that these strategies reduce 60 IPERGAY (TDF/FTC) risk of HIV infection if they ) 40 iPrEx are used correctly and ss (% Partners PrEP (TDF) 20 consistently. Higher adherence ene iv Partners PrEP (TDF/FTC) ect is directly linked to greater f 0 PROUD (TDF/FTC) levels of protection. Ef -20 TDF2 VOICE (TDF) -40 Calculations based on VOICE (TDF/FTC) analyses involving a subset -60 VOICE (tenofovir gel, of total trial participants. 10 20 30 40 50 60 70 80 90 daily dosing) Percentage of participants' samples that had detectable drug levels A Global Look at PrEP Introduction The numbers in the large circles represent global 11 totals, many of which took 16 years to achieve, while the smaller circles represent 12 changes in just under a year Regulatory approvals (since Oct '15). In sub- 52 13 Implementation studies Saharan Africa, many of planned, ongoing, the implementation studies completed globally are in female sex workers— 30 Implementation leaving gaps in research on studies in Africa men who have sex with men, adolescent girls and young 5 2 + National women, and other groups Global 2In strategies in need. 1 recommendations development ARV-Based PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV Prevention Pipeline The pipeline of ARV-based IPM Pop IPM CHAARM IPM TaiMed CONRAD HPTN/ACTG IPM Gilead Council CONRAD prevention products includes oral pills, vaginal rings, ACTIVE DRUG vaginal and rectal gels, TFV Tenofovir DAR Darunavir IPCP IPM IPM Pop IPM IPM CONRAD GSK/ViiV Janssen vaginal films, long-acting NIAID Council Tenofovir TFV DAP Dapivirine injectable ARVs. Not pictured prodrug TDF Tenofovir disoproxil are a range of multipurpose fumarate GRF Griffithsin Albert IPM TFV/ Tenofovir/ DS DS003 CONRAD ImQuest CHAARM ImQuest CONRAD emtricitabine technologies in development Einstein DELIVERY SYSTEM FTC 003 (BMS793) that aim to reduce women’s TDF/ Tenofovir disoproxil Oral pills Vaginal FTC fumarate/emtricitabine IQP IQP -0528 tablet risk of HIV and STIs, and MIV MIV 150 5P12 5P12-RANTES Vaginal gel Rectal gel 150 provide effective contraception. CDC IPM RTI Pop Pop IPM IPM TMC GSK 744 Council Council Long-acting 278 Ripilvirine 744 Vaginal ring injectable Monoclonal MVA Maraviroc MAb antibody Vaginal film Thin film For up-to-date information on the polymer MK- MK-2048 ARV-based prevention pipeline, visit the Mintaka Pop RAL Raltegravir 2048 Council Phosphate HIV Prevention Research Database at Nano-fiber No drug tested buffered saline MK- Vicriviroc www.avac.org/pxrd. 4176 currently PrEP PrEP Watch PrEP Facts My PrEP Experience PrEP Online Resources www.prepwatch.org www.prepfacts.org www.myexperience.blogspot.com www.avac.org/prep AUGUST 2016 Founded in 1995, AVAC is an international, non-profit organization that uses education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of biomedical HIV prevention options as part of a comprehensive response to the pandemic. AVAC is based in the US, and focuses on issues and priorities in countries where prevention research and www.avac.org implementation are ongoing. Specifically, we seek to deliver proven HIV prevention tools for immediate impact; demonstrate and roll out new HIV prevention options; and develop long-term solutions needed to end the epidemic..