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PrEP Roll-Out In France

PrEP Roll-Out In France. Jean- M ichel Molina Saint-Louis Hospital , University of Paris D iderot , Inserm U941, Paris, France. Disclosures of Interest. Research grants: Merck and Gilead Advisory Boards : BMS, Merck, Gilead, Jassen, ViiV Shareholder: none.

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PrEP Roll-Out In France

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  1. PrEP Roll-Out In France Jean-Michel Molina Saint-Louis Hospital, University of Paris Diderot, Inserm U941, Paris, France

  2. Disclosures of Interest Research grants: Merck and Gilead Advisory Boards : BMS, Merck, Gilead, Jassen, ViiV Shareholder: none

  3. Reasons for PrEP Deferral in Europe PrEP approved in 2012 by US FDA and recommended by US CDC but: Uncertainty about real need Inconsistent efficacy across trials Questions regarding safety in healthy individuals Risk of selection of HIV resistance Impact on sexual behavior with reduction of condom use and increase in STIs Issues of cost and cost-effectiveness Implementation challenges

  4. Increase in New HIV-infections in MSM 6600 new HIV-infections in France in 2014 3000 42% MSM Newlydiagnosed HIV-infections 2500 2000 23% ForeignHeterosexualwomen 1500 16% Foreign Heterosexual men 10% French heterosexual men 7% French heterosexual women 1% UDI 1000 500 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Year of Diagnosis INVS, December 2015

  5. HIV Incidence (mITT Analysis) Median Follow-up in Open-Label Phase 18.4 months (17.5-19.1) 97% relative reduction vs. placebo Molina et al AIDS 2016, July 20, Durban, South Africa

  6. Adverse Events **Decrease in plasma creatinine clearance to 48, 71 and 76 ml/mn

  7. Summary of Findings High incidence of HIV infection in high risk MSM in France, UK and Canada Daily and On Demand PrEP with oral TDF/FTC both highly effective in high risk MSM Low condom use did not undermine efficacy Safety of PrEP was good PrEP improved satisfaction and removed fear during sexual activity

  8. Path to PrEP Access in Europe • eCDC comment on PrEP in Europe (April 30, 2015) : EU Members States should give consideration to integrating PrEP into their existing HIV prevention package for those most at-risk of HIV infection, starting with MSM. • WHO updated guidelines (October 2015): Oral PrEP should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches. • EACS Guidelines (v8, october 2015): PrEP is recommended in HIV-negative MSM and transgender individuals who are inconsistent in their use of condoms. PrEP may be considered in HIV-negative heterosexual women and men. • Gilead submitted an application for TDF/FTC PrEP at EMA early 2016 • Implementation projects in Europe: AMPrEP (Amsterdam) and Be-PrEP-ared (Antwerp) • PrEP was approved in France for temporary use with full coverage by the health care system (November 2015)

  9. Recommendation of Temporary Use(RTU) for Truvada for PrEP • ANSM (National Agency for Drug Safety) canauthorize an RTU for a drugalreadyapproved, to beused for an indication differentfromits initial approval • An RTU isgranted for 3 years and canberenewed. • An RTU for Truvada for PrEP wasgranted in November 2015, and wasfullycovered by the national healthinsurance • Within the RTU, Truvada isindicated for PrEP in adults (> 18 years) at high risk of sexual HIV acquisition • This has been effective sinceJanuary 4, 2016

  10. Who is Eligible for the Truvada RTU • Adults (18 years or older) • Negative HIV serologic assay (4th generation ELISA) • No sign of primary HIV infection • No recent HIV exposure (< 1 month) • High risk of sexual HIV acquisition

  11. High Risk of Sexual HIV Acquisition • MSM or transgender individuals with: • Condomless anal sex with at least two different partners over the last 6 months • Episodes of STIs (syphilis, chlamydiae, gonorrhea, HBV, HCV) over the last 12 months • Multiple PEP treatments in the last 12 months • Use of drugs during sexual intercourse (cocaine, GHB, MDMA, etc…) • Other persons at high risk of HIV acquisition on a case by case basis: • Sex workers exposed to condomless sex • Vulnerable persons exposed to condomless sex with people from a group with a high prevalence of HIV • Person from areas/countries of high HIV prevalence • Person with multiple sexual partners • IVDU • Persons having condomless sex with partners with genital ulcers, STIs, or bleeding that can increase their risk of HIV acquisition • Other high risk situations of HIV acquisition

  12. Who is Not Eligible for Truvada • HIV Serologic assay positive or unknown • Signs or symptoms of primary HIV-infection • Creatinine clairance < 50 ml/mn • Chronic HBV infection if PrEP used On Demand • Breast-feeding • Hypersensitivity to TDF or FTC or excipients

  13. DosingRegimens and Follow-up • Dosing Schedule • Daily (1 pill a day) or On demand (only for MSM – Ipergay dosing regimen) • Patients follow-up • Doctor visit (23 Euros - reimbursed 70%: 8 Euros per visit unless complementary insurance) • Baseline tests: HIV/HBV/HCV, tests for STIs (PCR 3 sites and syphilis), creatinine and ALT (190 Euros - reimbursed 60%: 83 Euros, 23 Euros if complementary insurance and free tests for STIs in STI clinic) • Test at Month 1 and every 3 months: HIV test, ALT and creatinine (23 Euros, 2 Euros to be paid, unless complementary insurance) • Tests for STIs as needed (at least once a year) • Global Sexual Health • Referrals for psychiatry, addictology, proctology, sex therapy,

  14. Requirements for the Truvada RTU • Doctors should tell their patients that Truvada is prescribed through an RTU • At ANSM’s request Gilead has opened a website (https://www.rtutruvada.fr) to collect information on PrEP • Doctors should report on this website • data on patients characteristics at treatment initiation, • modalities of PrEP use (daily or on demand), • incident HIV-infections, • drug-related adverse events, • pregnancies, • Data analyzed by Gilead and reported to ANSM every 3 months.

  15. PrEP Implementation in France in 2016 • > 90 PrEP clinics have opened, initially in ANRS Ipergay sites (Paris, Lyon, Nice, Lille, Nantes) • AIDES Website: http://www.aides.org/info-sante/prep • TDF/FTC can be prescribed by hospital-based HIV specialists and STI clinics since June 2016 • TDF/FTC can be obtained at private and hospital pharmacies Cumulative Nb Nb Patients Nb Doctors

  16. Nord Pas-de-Calais Haute Normandie Picardie Basse Normandie Lorraine Ile-de-France Champagne Ardenne Alsace Bretagne Pays de la Loire Centre Franche-Comté Bourgogne Poitou- Charentes Limousin Rhône Alpes Auvergne Aquitaine Provence Alpes Côte d’Azur Midi-Pyrénées Languedoc- Roussillon Number of SubjectsRegistered per Region > 1 > 10 > 100 > 500

  17. Baseline Characteristics (Jan 2016- June 2016)

  18. PrEP “On Demand”

  19. Two HIV Breakthrough Infections • Patient 1: • Negative HIV serologicassayat PrEP initiation • HIV seroconversion at the nextvisitone monthlater • HIV PCR retrospectivelyfound positive atbaseline • Acute HIV-infection at PrEP initiation • Patient 2: • Negative HIV serologicassayat PrEP initiation • HIV seroconversion at the nextvisitone monthlater • HIV RNA: 500 cp/ml with M184I RAM

  20. PrEP Clinicat Paris St-Louis • 408 patients came for a first visit since November 2015.

  21. Baseline CharacteristicsParis St-Louis (Nov 2015- June 2016)

  22. Baseline Characteristics A High Risk Population 3 with HIV positive tests at screening (0.7%) * past year: ecstasy, crack, cocaine, crystal, speed, GHB/GBL ** NG: Neisseria gonorrhoeae, CT: Chlamydia trachomatis, TP: Treponema pallidum

  23. Two HIV Breakthrough Infections • Patient 1: 30-year old MSM • 45 sexual partners in prior 3 months, 30 condomless sexual intercourses in prior 4 weeks • Chemsex (cocaine, 4MEC, poppers) with STIs (chlamydiae, gonorrhea, HPV) • First visit: Nov 24, 2015: HIV serologic assay and PCR negative on Nov 17 • Ordered generic TDF/FTC online and started daily PrEP Dec 9 • Second visit Dec 28, 2015: • HIV serologic test positive (WB: 4 bands) • HIV RNA: 29,557 cp/ml with M184V RAM (bulk sequencing) • TDF: 171 ng/ml in plasma • Started ART Jan 4, 2016 and fully suppressed 4 months later • Patient 2: 37-year old MSM • 20 sexual partners in prior 3 months, 60 condomless sexual intercourses in prior 4 weeks • Chemsex (cocaine, GHB, poppers), psychiatric follow-up and multiple STIs • First visit: Dec 1st, 2015: HIV serologic assay negative on Nov 27 • Daily TDF/FTC prescribed but too expensive and used TDF/FTC from an HIV-infected friend • Second visit March 17, 2016 to get « free » TDF/FTC through the RTU: • Positive HIV serologic test on March 11 ( 6 bands on WB) HIV RNA: 29,557 cp/ml, no resistance • Inconsistent adherence to TDF/FTC • Started ART March 25 and fully suppressed 2 months later

  24. Challenges with PrEP Roll-Out Dedicated nurses to provide information/appointment by email and tel PrEP guide with prescription for tests for HIV and STIs sent by email Organize outpatient clinic to meet the demand Inform nurses and administrative personnel Identify doctors willing to provide PrEP (> 10 doctors) Increase offer: 10 consultations per week (2 to 3 from 6-10 pm) PrEP can be started at first visit and patients seen at Month 1 and every 3 months Adapt outpatient clinic for STI treatment (injections) Peer-counseling by AIDES (PrEP adherence, risk reduction)

  25. Lessons Learned in France Close partnership with the community and strong political support have led to PrEP approval Increase PrEP awareness among doctors and people at risk (MSM, transgender, and heterosexual migrants) Adapt available resources to provide comprehensive sexual health care and meet the demand Define best models of care and access points (hospitals, sexual health clinics, GP) Monitor and evaluate PrEP implementation High risk people self-select for PrEP: HIV-infection detected at screening or soon after PrEP initiation Demonstratethe public healthbenefit of PrEP implementation: ANRS « PREVENIR » project

  26. Political Support from the City of Paris for HIV Prevention City Hall meeting, February 2016

  27. Acknowledgments

  28. Community Engagement

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