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Incidence of HIV infection in the ANRS Prevenir Study in the Paris Region with Daily or On Demand PrEP with TDF/FTC

This study examines the incidence of HIV infection in the ANRS Prevenir Study in the Paris Region using daily or on-demand pre-exposure prophylaxis (PrEP) with TDF/FTC. The study aims to show a reduction in new HIV diagnoses among men who have sex with men (MSM) and evaluate PrEP adherence, sexual behavior, and safety.

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Incidence of HIV infection in the ANRS Prevenir Study in the Paris Region with Daily or On Demand PrEP with TDF/FTC

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  1. Incidence of HIV-infection in the ANRS Prevenir Study in the Paris Region with Daily or On Demand PrEP with TDF/FTC J.-M. Molina, J. Ghosn, L. Béniguel, D. Rojas-Castro, M. Algarte-Genin, G. Pialoux, C. Delaugerre, Y. Yazdanpanah, C. Katlama, C. Ségouin, S. Morel, C. Pintado, B. Loze, S. Le Mestre, S. Gibowski, V. Doré, L. Assoumou, B. Spire, D. Costagliola, and the Prevenir ANRS study group Assistance Publique Hôpitaux de Paris, INSERM, Sorbonne University, IPLESP, Coalition PLUS, AIDES, ANRS, SESSTIM, ORS PACA, France 22th International AIDS Conference Amsterdam, July 25, 2018

  2. Disclosures Research grants: Gilead Advisory Boards : Merck, Gilead, ViiV, Teva Shareholder: none

  3. Background ANRS IPERGAY: high effectiveness of PrEP with oral TDF/FTC taken « On Demand » in high risk MSM. 86% relative reduction in HIV-incidence in the TDF/FTC arm vs placebo (95% CI: 40-98, P=0.002) 97% relative reduction in HIV-incidence in the TDF/FTC arm vs placebo during the open-label extension (95% CI: 81-100) Limited data on real-world experience with On demand PrEP Confirm public health impact of PrEP on the HIV epidemic like in San Francisco and New South Wales Molina et al. NEJM 2015, Lancet HIV 2017

  4. Study Design • HIV-negative high risk adults • Inconsistent Condom use • Creat. Clearance > 50 mL/mn • HbS Ag negative if On Demand TDF/FTC Daily TDF/FTC On Demand http://prevenir.anrs.fr/ Open-Label Prospective Cohort Study in the Paris Region May 31st 2020 May 3rd 2017 n = 3,000 Show 15% reduction in new HIV diagnoses among MSM in the Paris Region • Participants opted for either Daily or On Demand PrEP and could switch regimens • Follow-up every 3 months with 4th Gen ELISA HIV test and plasma creatinine • STI screening at physicians’ discretion (Guidelines recommend every 3 months in MSM) • Condoms, gels, risk reduction and adherence counseling, Q on sexual behavior

  5. Study Objectives Primary Objective To show > 15% reduction of new HIV diagnoses among MSM in the Paris region in comparison with the numbers provided by the National Surveillance network in 2016 (mandatory notification of HIV diagnoses in France) Secondary Objectives Participants characteristics Overall HIV incidence and by dosing regimen (Daily or On Demand) PrEP adherence and coverage of sex events (self-report, dried blood spots) Impact of peer counseling on adherence and retention Sexual behavior (condom use, Nb of sexual acts, Nb of partners, STIs) Safety, tolerability 3,000 pts to be enrolled (85% MSM) with the hypothesis of PrEP efficacy: 80% July 2, 2018: 1628 pts enrolled across 22 sites

  6. Baseline Characteristics * at last sexual intercourse : cocaine, GHB, MDMA, mephedrone

  7. Baseline Characteristics * at last sexual intercourse : cocaine, GHB, MDMA, mephedrone..

  8. DosingRegimen over Time

  9. Adherence to PrEP / Condoms PrEP / Condom use at last sexual intercourse 2279 sex acts assessed in 1102 participants > M3 * According to the protocol, or at least one pill before (<24h) and one pill after sex (<24h)

  10. HIV Incidence (ITT Analysis) Mean Follow-up in this Open-Label Study: 7 months (SD: 4) Incidence of study discontinuation: 3.3/100 PY including 1.5/100 PY who discontinued PrEP 85 HIV-infections averted* * assuming an incidence of 9.17/100 PY as observed in the ANRS Ipergay study in Paris

  11. Sexual Behavior On Demand Daily

  12. Viral Hepatitis Infections 11 cases of viral hepatitis were diagnosed in 11 participants Incidence rate of first Viral Hepatitis 1.1 vs 1.2 per 100 PY in the Daily and On Demand groups

  13. Adverse Events

  14. Lab Abnormalities

  15. Summary Interim report of an open-label cohort study enrolling mostly MSM High efficacy of Daily and On Demand PrEP in MSM: No breakthrough HIV-infection and 85 HIV-infections averted Pts using Daily TDF/FTC have more partners and more frequent sex High and correct use of PrEP Good safety profile with both dosing regimens and no drug discontinuation for AEs High retention rate Trend toward some increase in risk compensation Data on STIs rates and HIV epidemic are pending

  16. PrEP “On Demand”

  17. Acknowledgments The Participants The Sites Investigators and Counselors The Trial Scientific Committee The Community Advisory Board The ANRS Staff INSERM IPLESP http://prevenir.anrs.fr/

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