The current status of PrEP in Europe. Pep Coll AIDS Research Institute-IrsiCaixa Fight AIDS Foundation BCN Checkpoint

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1 The current status of PrEP in Europe Pep Coll AIDS Research Institute-IrsiCaixa Fight AIDS Foundation BCN Checkpoint

2 DISCLOSURES I have received a research grant from Gilead Sciences awarded to my institution I have participated in Advisory Boards of Merck, Gilead and ViiV Healthcare I am a Principal Investigator of the DISCOVER study

3 What are we waiting for?

4 What are we waiting for?

5 Estimated new HIV infections are decreasing globally Global Source: UNAIDS/WHO global estimates.

6 Estimated new HIV infections are decreasing globally, but increasing in the WHO European Region Global WHO European Region Source: ECDC/WHO (2016). HIV/AIDS Surveillance in Europe, UNAIDS/WHO global estimates.

7 Estimated new HIV infections are decreasing globally, but increasing in the WHO European Region Global WHO European Region East West Centre Source: ECDC/WHO (2016). HIV/AIDS Surveillance in Europe, UNAIDS/WHO global estimates.

8 WHO European Region > persons were diagnosed with HIV in % 17% 4% 8 Source: ECDC/WHO (2017). HIV/AIDS Surveillance in Europe data

9 Percentage of HIV diagnoses, by route of transmission, 2014, EU/EEA Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014

10 MSM are disproportionately at risk for and affected by HIV, STI and viral hepatitis 100% 90% 80% Proportion of new diagnoses attributed to sex between men, EU/EEA, % 100% 70% 60% 72% 50% 40% 30% 47% 53% 20% 10% 0% 12% 20% Acute HBV Acute HCV Gonorrhea HIV Syphilis LGV MSM Heterosexual Other Source: ECDC, Sexually transmitted infections in Europe, 2014; Hepatitis B and C in Europe, 2015 (forthcoming 2017); ECDC/WHO HIV Surveillance in Europe, 2015

11 Guidelines on PrEP National Guidelines

12 WHO guidelines on PrEP (2015) Oral PrEP should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination HIV prevention approaches Substantial risk of HIV infection is provisionally defined as HIV incidence greater than 3 per 100 person years

13 EACS guidelines PrEP can be used in adults at high-risk of acquiring HIV infection Recommended in HIV-negative MSM and transgender individuals who are inconsistent in their use of condoms with casual partners or with HIV-positive partners who are not on treatment May be considered in HIV-negative heterosexual women and men who are inconsistent in their use of condoms and likely to have HIV positive partners who are not on treatment

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15 Status of formal PrEP implementation in Europe (as of 26 October 2017) ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; (updated)

16 PrEP scenarios in Europe: Available through the National Health System And the winner is!

17 November 2015 Approval for PrEP in France Jean-Michel Molina

18 Places where PrEP can be prescribed and delivered in France Hospitals (80%) HIV specialists STI clinics (20%) GP are able to renew prescriptions people on PrEP Drugs are delivered in hospital and private pharmacies

19 Available through the National Health System in: Belgium (previous implementation study: Be-PrEP-ared) a small co-pay fee is required (also in France) Norway Scotland Portugal (limited to 100 people)

20 Demonstration or implementation studies Netherlands daily vs intermittent PrEP N= 370 Ending by December 2018 But available at pharmacies Source:

21 England Demonstration or implementation studies Source:

22 Demonstration or implementation studies Wales 36 months Source:

23 Demonstration or implementation studies Spain Feasibility study Sponsored by: Spanish Ministry of Health Planned N= months PrEP-ara Sponsored by: Health Department of Catalonia N= months

24 Clinical Trials DISCOVER study A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection N= months Austria, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom Sponsored by: Gilead Sciences

25 PrEP scenarios in Europe: Informal PrEP

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27 Germany 50-Euro-PrEP-program Source:

28 Italy Generic (70 Euros) Source:

29 BCN Checkpoint was the first community based organizations implementing the HIV rapid test in Spain BCN PrEP Point (created in November 2017) is the first community centre providing PrEP in Spain > 600 MSM and transgender women on PrEP

30 Hornet/ECDC survey on PrEP Survey included 17 questions Using inbox messages for users of the Hornet application in 55 countries in Europe and Central Asia Period between 17 June and 16 August 2017

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32 To be updated

33 Challenges PrEP being approved and available within National Health Services Close partnership with the community and strong political support Increase PrEP awareness among health professionals and people at risk (MSM, transgender and heterosexual migrants) Define appropriate models of care and access points (hospitals, sexual health clinics, primary care, community-based organizations) How best to integrate PrEP into existing services

34 Challenges Monitor and evaluate PrEP implementation Development of new formulas (Long Acting drugs, implants, neutralizing antibodies) Reduce cost of drugs for PrEP

35 What issues are limiting or preventing the implementation of PrEP in your country? High importance Medium importance Low importance Cost of PrEP Cost of service delivery Feasibility Increases in STIs Adherence Other/Not licensed Lower condom use Eligibility Drug resistance Number of countries (n=36) ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.

36 Acknowledgements Teymur Noori Jean-Michael Molina Giulio Corbelli Ricardo Fuentes