The current status of PrEP in Europe Pep Coll AIDS Research Institute-IrsiCaixa Fight AIDS Foundation BCN Checkpoint
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
4 2016 What are we waiting for?
4 2018 What are we waiting for?
Estimated new HIV infections are decreasing globally 2.600.000 2.400.000 2.200.000 2.000.000 Global 1.800.000 1.600.000 1.400.000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Source: UNAIDS/WHO global estimates.
Estimated new HIV infections are decreasing globally, but increasing in the WHO European Region 2.600.000 180.000 160.000 2.400.000 2.200.000 140.000 120.000 100.000 Global 2.000.000 80.000 1.800.000 1.600.000 60.000 40.000 20.000 WHO European Region 1.400.000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 0 Source: ECDC/WHO (2016). HIV/AIDS Surveillance in Europe, 2015. UNAIDS/WHO global estimates.
Estimated new HIV infections are decreasing globally, but increasing in the WHO European Region 180.000 2.600.000 2.400.000 160.000 140.000 Global 2.200.000 120.000 100.000 WHO European Region 2.000.000 80.000 East 1.800.000 1.600.000 60.000 40.000 20.000 West Centre 1.400.000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 0 Source: ECDC/WHO (2016). HIV/AIDS Surveillance in Europe, 2015. UNAIDS/WHO global estimates.
WHO European Region >160 000 persons were diagnosed with HIV in 2016 80% 17% 4% 8 Source: ECDC/WHO (2017). HIV/AIDS Surveillance in Europe 2017 2016 data
Percentage of HIV diagnoses, by route of transmission, 2014, EU/EEA Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014
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, 2014-2015 100% 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
Guidelines on PrEP National Guidelines
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
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
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; 2016. (updated)
PrEP scenarios in Europe: Available through the National Health System And the winner is!
November 2015 Approval for PrEP in France Jean-Michel Molina
Places where PrEP can be prescribed and delivered in France Hospitals (80%) HIV specialists STI clinics (20%) GP are able to renew prescriptions 10000 people on PrEP Drugs are delivered in hospital and private pharmacies
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)
Demonstration or implementation studies Netherlands daily vs intermittent PrEP N= 370 Ending by December 2018 But available at pharmacies Source: www.ggd.amsterdam.nl/infectieziekten/soa-hiv-sense/prep/amprep
England Demonstration or implementation studies Source: www.prepimpacttrial.org.uk
Demonstration or implementation studies Wales 36 months Source: www.friskywales.org/wales-prep-project.html
Demonstration or implementation studies Spain Feasibility study Sponsored by: Spanish Ministry of Health Planned N= 400 12 months PrEP-ara Sponsored by: Health Department of Catalonia N= 70 24 months
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= 5400 36 months Austria, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom Sponsored by: Gilead Sciences
PrEP scenarios in Europe: Informal PrEP
Germany 50-Euro-PrEP-program Source: www.lovelazers.org/en/germany-prep-available-in-pharmacies
Italy Generic (70 Euros) Source: www.prepinfo.it/chi-siamo
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
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
To be updated http://www.prepineurope.org/en
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
Challenges Monitor and evaluate PrEP implementation Development of new formulas (Long Acting drugs, implants, neutralizing antibodies) Reduce cost of drugs for PrEP
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 0 5 10 15 20 25 30 35 Number of countries (n=36) ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
Acknowledgements Teymur Noori Jean-Michael Molina Giulio Corbelli Ricardo Fuentes