Experience with the implementation of PrEP in France
•
3 likes•2,108 views
Fast-track the end of AIDS in the EU - practical evidence-based interventions. Presentation by: Jean-Michel Molina, Assistance Publique Hôpitaux de Paris In a two-day meeting under the auspices of the Maltese Presidency of the Council of the European Union (30-31 January 2017), HIV experts from across the European Union discussed how to reverse this trend and how to prepare Europe to achieve the set target of ending AIDS by 2030.
Recommended
More Related Content
What's hot
What's hot (20)
Viewers also liked
Viewers also liked (11)
Similar to Experience with the implementation of PrEP in France
Similar to Experience with the implementation of PrEP in France (20)
More from European Centre for Disease Prevention and Control
More from European Centre for Disease Prevention and Control (20)
Recently uploaded
Recently uploaded (20)
Experience with the implementation of PrEP in France
- 1. Experience with the Implementation of PrEP in France Jean-Michel Molina Saint-Louis Hospital, University of Paris Diderot, Inserm U941, Paris, France Fast-track the end of AIDS in the EU St Julians, Malta, January 2017
- 2. 11/2015 Approval for PrEP in France
- 3. Reasons for PrEP Deferral in France 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. 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year of Diagnosis 0 500 1000 1500 2500 2000 3000 43% MSM 23% Foreign Heterosexual women 15% Foreign Heterosexual men 9% French heterosexual men 7% French heterosexual women 2% UDI 6000 new HIV-infections in France in 2015 Public Health France, December 2016 Increase in Newly Diagnosed Infections among MSM in France
- 5. 5 1. Adapted from Karim SS and Karim QA. Lancet 2011;378:e23–25; 2. Weller S and Davis K. Cochrane Database Syst Rev 2002:CD003255; 3. Smith DK et al. JAIDS 2015;68:337–344; 4. Baeten et al NEJM 2016; 5. van Damme L et al. NEJM 2012;367:411–422; 6. Marrazzo JM et al. NEJM 2014, Rees H, CROI 2015, Abs. 26LB FEM-PrEP in women,5 VOICE (TDF/FTC, TDF vaginal gel), FACTS (TDF gel) in women6 0 10 20 30 40 50 60 70 80 90 100 Efficacy (%) Studies Reduction of HIV Transmission Non significant* Condoms in heterosexuals2 80% Partners PrEP in discordant couples1 75% Condoms in US MSM3 70% Bangkok PrEP in IDU 49% TDF2 in men & women1 63% Medical male circumcision1 54% CAPRISA 004 (1% TDF vaginal gel) in women1 39% iPrEx in MSM1 44% Aspire / MTN 020 (Dapivirine ring)4 27% Relative Efficacy of Prevention Strategies
- 6. Efficacy of Daily PrEP in MSM in the UK Group No. of infections Follow- up (PY) Incidence (per 100 PY) 90% CI Overall 23 465 5.0 3.5–6.9 Immediate 3 243 1.2 0.4–2.9 Deferred 20 222 9.0 6.1–12.8 Efficacy = 86% (90% CI: 64-96%) P-value =0.0001 Number Needed to Treat =13 (90% CI: 9 – 23) S. McCormack et al Lancet 2015
- 7. HIV Incidence (mITT Analysis) 97% relative reduction vs. placebo Median Follow-up in Open-Label Phase 18.4 months (17.5-19.1) Treatment Follow-Up Pts-years HIV Incidence per 100 Pts-years (95% CI) Placebo 212 6.60 (3.60-11.1) TDF/FTC (double-blind) 219 0.91 (0.11-3.30) TDF/FTC (open-label) 515 0.19 (0.01-1.08) Molina et al AIDS 2016, July 20, Durban, South Africa
- 8. Lobbying for PrEP in France • ANRS (leadership and communication) • Community groups (AIDES and others) • HIV specialists (clinicians, epidemiologists, virologists, social sciences) • ANSM (French Medicine Agency) group of experts • National AIDS Council • French group of experts • International guidelines • Media and social media
- 9. Temporary Recommendation for Use (RTU) for Truvada for PrEP • Specific French procedure to secure and regulate off-label indication of a medicine for unmet medical needs • ASM and Gilead set up an RTU to allow the use of TDF/FTC for PrEP on January 4, 2016 • Adults (> 18 years) at high risk of sexual HIV acquisition • Daily or On Demand PrEP (for MSM) • Subject registration mandatory – Data collected by physicians on a Gilead website – PrEP initiation, HIV seroconversion, AEs, pregancy – Data analyzed by Gilead and reported to ANSM every 3 months – Prescription for 1 month then 3 months
- 10. Who is Eligible for the Truvada RTU • 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
- 11. Places where PrEP can be Prescribed and Delivered in France • Hospitals (80%) HIV specialists • STI clinics (21%) • GP will be able renew prescriptions in 03/2017 • Drugs are delivered in hospital and private pharmacies.
- 12. Cumulative Nb of Individuals Enrolled Jan 2016 - Jan 2017
- 13. Number of Subjects Registered per Region Haute Normandie Basse Normandie Bretagne Pays de la Loire Poitou- Charentes Aquitaine Midi-Pyrénées Languedoc- Roussillon Provence Alpes Côte d’Azur Centre Ile-de- France Bourgogne Picardie Nord Pas-de-Calais Champagn e Ardenne Lorraine Alsace Franche- Comté Rhône AlpesAuvergne Limousin > 1000 > 50 > 1 > 300
- 14. Subjects Registered up to January 2017 Patients (Median, range) or (%) N= 2998 Age 37 (18-84) French 88.9% Men 97.8% Women 0.7% (n=20) Transgender 0.7% (n=19) MSM 97.4% Chemsex 19.9% STIs in prior 12 months 30.6% PEP in prior 12 months 10.9% PrEP on demand 59% 2 HIV seroconversion with 1100 person-years of FU: HIV Incidence of 0.17/100 PY
- 15. Lessons Learned in France Close partnership with the community and has led to PrEP approval Increase PrEP awareness among doctors and people at risk (MSM, transgender, and heterosexual migrants) Adapt available resources and provide comprehensive sexual health care 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 Demonstrate the public health benefit of PrEP implementation: ANRS « PREVENIR » project
- 16. National Prevention Campaign for MSM
- 17. Acknowledgments • Europe should get PrEPared for the PrEP revolution • PrEP is an additional tool to prevent HIV- infection, and people at risk of HIV- acquisition should have access to PrEP • PrEP is a unique opportunity to change the course of the HIV epidemic • Europe should unite make PrEP available at an affordable price Summary
Editor's Notes
- 86% reduction is greater than seen in placebo-controlled HIV prevention trials. The 90% confidence interval gives us 95% confidence around the lower bound of 58% reduction. The 95% lower bound is 52% - both exceed the 50% reduction we considered would make a useful impact on our epidemic. Rate difference is important for public health as it informs the number who would need to be treated. The number of gay men who need to be treated for one year to avert one infection is very low – only 13.
- Figure 2. Kaplan–Meier Estimates of Time to HIV Infection (Modified Intention-to-Treat Population). The cumulative probability of HIV acquisition is shown for the two study groups. The efficacy of preexposure prophylaxis with emtricitabine and tenofovir disoproxil fumarate (FTC–TDF) was 44%, as compared with placebo (P=0.005). The inset graph shows a more detailed version of the overall graph up to a probability of 0.10.