The figures below show the relationship between PrEP efficacy and adherence, and the status of regulatory action on PrEP worldwide. Different countries are moving at Pre-Exposure Prophylaxis different speeds. Many are looking to demonstration projects—small-scale pilots that provide information on how to deliver PrEP in real-world settings. Unfortunately, the vast majority of the projects that are currently delivering PrEP are outside of sub- (PrEP) by the Numbers Saharan Africa. This despite the fact that sub-Saharan Africa is where many new HIV acquisitions, particularly via sexual transmission, are taking place today. Now is the time to take regulatory action and to move ahead with demonstration projects linked Efficacy, regulatory approval and more to plans for scale-up. Other formulations of ARV-based prevention are also being evaluated and could provide additional options in the future. PrEP Works if You Take It — Effectiveness and Adherence in Trials of Oral and Topical Tenofovir-Based Prevention 100 Trials of oral and topical CAPRISA 004 (tenofovir gel, BAT-24 dosing) tenofovir-based PrEP show 80 iPrEx that these strategies reduce 60 TDF2 risk of HIV infection if they ) 40 Partners PrEP (TDF) are used correctly and ss (% 20 consistently. Higher adherence ene Partners PrEP (TDV/FTC) iv ect is directly linked to greater f 0 FEM-PrEP levels of protection. Ef -20 VOICE (TDF) VOICE (TDF/FTC) Calculations based on -40 VOICE (tenofovir gel, analyses involving a subset -60 daily dosing) of total trial participants. 10 20 30 40 50 60 70 80 90 Percentage of participants' samples that had detectable drug levels Pearson correlation = 0.86, p=0.003 Source: Salim S. Abdool Karim, CAPRISA Regulatory Approval in Trial Host Countries for Daily TDF/FTC The TDF/FTC combination pill TDF/FTC approved (brand-name Truvada) that for prevention has shown efficacy for PrEP is United States already used for treatment in HIV-positive people, and so Regulatory application filed for a prevention is approved and licensed in indication for TDF/FTC many countries. One key step Australia for this PrEP strategy is to Brazil South Africa ensure that the drug is licensed Thailand (and therefore available) and that it is approved for use for Trial host countries with both prevention and treatment no regulatory application filed for prevention in each country. So far, the Botswana Kenya US is the only place where this Canada Peru has taken place. National Ecuador Tanzania France Uganda guidelines for PrEP use are Germany United Kingdom another key step. ARV-Based PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV Prevention Pipeline The pipeline of ARV-based IPM Pop IPM IPM IPM GSK CONRAD HPTN/ACTG IPM Gilead Council CONRAD prevention products includes oral pills, vaginal rings, vaginal and rectal gels, ACTIVE DRUG IPM IPM IPM IPCP IPM Jansen CONRAD vaginal films, long-acting NIAID TFV Tenofovir DAR Darunavir injectable ARVs. Not pictured Tenofovir DAP Dapivirine TFV prodrug are a range of multipurpose TDF Tenofovir disoproxil fumarate GRF Griffithsin IPM IPM Pop ImQuest Albert TaiMed CONRAD technologies in development Council Einstein DELIVERY SYSTEM TFV/ Tenofovir/ DS DS003 that aim to reduce women’s FTC emtricitabine 003 (BMS793) Oral pills Vaginal tablet TDF/ Tenofovir disoproxil risk of HIV and STIs, and FTC fumarate/emtricitabine IQP IQP -0528 Vaginal gel Rectal gel provide effective contraception. IPM MIV ImQuest IPM RTI CDC Pop MIV 150 5P12 5P12-RANTES Council Long-acting 150 Vaginal ring injectable TMC GSK 744 278 Ripilvirine 744 Thin film For up-to-date information on the Vaginal film Monoclonal polymer MVA Maraviroc MAb antibody ARV-based prevention pipeline, visit the Mintaka Pop IPM Pop HIV Prevention Research Database at Council Council Phosphate Nano-fiber No drug tested buffered saline RAL Raltegravir currently www.avac.org/pxrd. PrEP PrEP Online PrEP Watch PrEP Facts My PrEP Experience Resources www.avac.org/prep www.prepwatch.org www.prepfacts.org www.myexperience.blogspot.com MARCH 2015 March 2015.