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Incidence of HIV-Infection with Daily or On Demand PrEP with TDF/FTC in the Paris Area: An Update of the Prevenir Study.

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Disclosures

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  1. Incidence of HIV-Infection with Daily or On Demand PrEP with TDF/FTC in the Paris Area: An Update of the Prevenir Study JM. Molina, J. Ghosn, M. Algarte-Genin, D. Rojas -Castro, L. Beniguel, G. Pialoux, C. Delaugerre, J-P. Viard, C. Katlama, C. Segouin, C. Pintado, P-M. Girard, J. Lourenco, M. Ohayon, S. Le Mestre, B. Spire, V. Doré, L. Assoumou, and D. Costagliola for the ANRS PrevenirStudy Group Assistance Publique Hôpitaux de Paris, INSERM, Université de Paris, IPLESP, Coalition PLUS, AIDES, ANRS, SESSTIM, ORS PACA, France

  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 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 in Paris like in San Francisco and Australia Molina et al. NEJM 2015, Lancet HIV 2017

  4. Study Design TDF/FTC Daily • HIV-negative high risk adults • Inconsistent Condom use • eGFR > 50 mL/mn • HbS Ag negative if On Demand 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 regimen • Follow-up every 3 months with 4th Gen ELISA HIV test and plasma creatinine • STI screening at physician’s 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 at 3 years > 15% reduction of new HIV diagnoses among MSM in Paris region in comparison with the numbers provided by the National Surveillance network in 2016 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 social disparities and 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% May 2, 2019: 3,057 pts enrolled across 26 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 7685 times people had sex assessed in 2134 participants > M3 * According to the protocol, or at least one pill before (<24h) and one pill after sex (<24h)

  10. HIV Incidence (mITT Analysis) Global HIV Incidence: 0.09/100 PY (95% CI: 0.01-0.33) (2 cases) Mean Follow-up of 8.7 months and 2208 Person-Years Rate of study discontinuation: 8.9/100 PY 143 HIV-infections averted* * assuming an incidence of 6.6/100 PY as observed in the Placebo group of the ANRS Ipergay study

  11. HIV-Infected individuals

  12. Sexual Behavior Increase of +43% at 3-month (P <0.001) Increase of +21% at 3-month (P <0.001) Decrease of -20% at 3-month (P <0.001) Increase of +15% at 3-month (P <0.001)

  13. Viral Hepatitis Infections 23 cases of viral hepatitis were diagnosed in 23 participants Overall incidence rate of viral hepatitis 1.04 per 100 PY (0.66–1.56)

  14. Incidence of BacterialSTIs 674 2146 1001 1701 1359 N=3026 3026 Increase in incidence of +38% per year (P <0.001) Trends assessed in piecewise exponential survival models

  15. Incidence of BacterialSTIsAccording to the PrEP Regimen Overall incidence rate of 86 per 100 PY (95% CI 82-90) Trends assessed in piecewise exponential survival models

  16. Incidence of Anal CT/GC Incidence of Anal CT/GC Incidence of Anal Gonorrhoea Increase of +48% per year (P <0.001) Increase of +47% per year (P <0.001) Overall incidence of 27 per 100 PY (95% CI 24-29) Overall incidence of 51 per 100 PY (95% CI 48-54) Trends assessed in piecewise exponential survival models

  17. Adverse Events *Vomiting (grade 3); Diarrhea (grade 1); Nausea/Headache/Dizziness (grade 1)

  18. Lab Abnormalities

  19. Summary Interim report of an open-label cohort study enrolling mostly MSM: 50% use Daily, 50% On demand PrEP Pts using Daily TDF/FTC have more partners, more condomless sex and a higher incidence of bacterial STIs High efficacy of Daily and On Demand PrEP in MSM: Only 2 HIV-infection in persons who have discontinued PrEP High and correct use of PrEP Good safety profile with both dosing regimens and only three participants with drug discontinuation due to gastro-intestinal AEs High retention rate High incidence of bacterial and viral STIs

  20. Acknowledgments The Participants The Sites Investigators and Counselors The Trial Scientific Committee The Community Advisory Board The ANRS Staff INSERM IPLESP Paris Hospitals (APHP) University of Paris http://prevenir.anrs.fr/

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