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PrEP implementation strategies across
Europe – an overview
Teymur Noori, ECDC
25 October, 2016
HIV Drug Therapy Glasgow 2016
Outline
 Context and ECDC opinion on PrEP
 ECDC meeting on PrEP in April 2016
 Informal use of PrEP in Europe (Hornet/ECDC survey)
 Status of PrEP implementation in Europe
Injecting drug use
Heterosexual contact
(women)
Heterosexual contact
(men)
Sex between men
Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014
+44%
-28%
-33%
-19%
HIV diagnoses, by mode of transmission
2005-2014, EU/EEA
Data is adjusted for reporting delay. Cases from Estonia and Poland excluded due to incomplete reporting on transmission mode during the
period; cases from Italy and Spain excluded due to increasing national coverage over the period.
Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014
Percentage of HIV diagnoses, by route of
transmission, 2014, EU/EEA
Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014
Which
interventions
work?
Hepatitis A
and B
vaccination
Condoms
and
lubricants
HIV and STI
testing
Treatment
for HIV,
viral
hepatitis
and STI
Health
promotion
MSM-
competent
health
services
Targeted
care for
MSM living
with HIV
ECDC guidance on HIV/STI
prevention among MSM (2015)
The evidence indicates
that these 7 services and
interventions, can:
 Effectively prevent and
reduce HIV/STI transmission
among MSM
 Address the needs of MSM
who are living with HIV
 Promote sexual health among
all MSM
 Have most impact when
when provided in
combination
Which
interventions
work?
Hepatitis A
and B
vaccination
Condoms
and
lubricants
HIV and STI
testing
Treatment
for HIV,
viral
hepatitis
and STI
Health
promotion
MSM-
competent
health
services
Targeted
care for
MSM living
with HIV
ECDC guidance on HIV/STI
prevention among MSM (2015)
The evidence indicates
that these 7 services and
interventions, can:
 Effectively prevent and
reduce HIV/STI transmission
among MSM
 Address the needs of MSM
who are living with HIV
 Promote sexual health among
all MSM
 Have synergistic effects when
provided in combination
 Evidence review and grading were performed prior to
release of the PROUD and IPERGAY studies
 The scientific panel viewed the lack of European
evidence (at the time) and the EMA not having
approved PrEP as sizeable barriers to strongly
recommending PrEP as part of comprehensive
programmes
ECDC opinion on PrEP April 2015
 Countries should give consideration to
integrating PrEP into their existing HIV
prevention package for those most at-
risk, starting with MSM
 Issues related to PrEP implementation
will need to be addressed in the context
of each Member State's health system
 ECDC will provide support to Member
States and the European Commission
with regards to PrEP implementation
ECDC meeting on PrEP
27-28 April, 2016
Objectives:
 Discuss key issues related to PrEP in
the EU/EEA setting
 Assess whether ECDC has a role to
play in supporting countries who are
considering PrEP implementation
Participants:
 Public health/policy makers
 Clinicians
 Community representatives
 Agency representatives
Key issues discussed
Session 1
Eligibility criteria for
PrEP in Europe
(Elske Hoornenborg)
Session 2
Appropriate models of
service delivery
(Sheena McCormack)
Session 3
Cost and cost-
effectiveness
(Valentina Cambiano & Nigel Field)
Session 4
Clinical and public
health monitoring
(Pep Coll, Robert Grant, Sheena
McCormack)
Options for delivering PrEP
Options Pros Cons
Clinic-based services  Used to discussing sexual health
 See people with STIs and at risk of HIV
 HIV/STI testing is in place
 Dispense TDF/FTC as part of PEP
 Confidential
 May not be walk-in and/or free
 Under-resourced and under-staffed
 Too few clinics
Community-based
services
 See people at risk of HIV – often peers
 May be the only provider seeing migrants
and minority ethnicities
 Confidential
 HIV testing in place
 Walk-in and free
 Referral pathways to prescribers of ARV
 May not be able to screen for STIs
 May need referral pathways for PrEP
 May not have sustainable funding
HIV specialists  Familiar with ARV
 HIV/STI testing available
 May depend on referrals to reach the
target population
 Notes available throughout hospital
 Appointments required
 Co-payments for some or all STI tests
Primary care
physicians
 If seeing the target population, will be
discussing sexual health, screening for
HIV/STIs, and familiar with ARV
 Set up for short appointments
 Co-payments
 Notes available to practice staff
 Very few primary care physicians are
likely to have the necessary experience
and interest
Peers and online  Peer discussion and support
 Signposting to services for HIV/STIs and
renal monitoring
 Convenient
 Can reach a large population quickly
 Co-payment for drug (could also be a
good thing)
 Not confidential (could also be a good
thing)
 Outside surveillance systems
Adapted from Sheena McCormack's presentation at the ECDC meeting on PrEP (27 April 2016)
 Whichever model is chosen, consideration must be
given to how best to integrate PrEP into existing
services
 Each country will need to consider where HIV/STI
testing and treatment are best delivered
 Given differences in country contexts, it is not feasible
or helpful to make Europe-wide recommendations
Meeting outputs
https://www.researchgate.net/publication/303438065_Pre-Exposure_Prophylaxis_in_the_EUEEA_Challenges_and_Opportunities
Hornet/ECDC survey
on PrEP
Hornet/ECDC survey (23-25 April 2016)
8,543 persons responded (48h)
France
United Kingdom (UK)
Russia
Italy
Germany
Belgium
Turkey
Spain
Netherlands
Denmark
Ukraine
Switzerland
Sweden
Portugal
Other
26%
22%
10%
13%
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
Are you HIV-positive?
No
Unsure
Yes
79%
10%
11%
n= 4392 persons responding to this question (51%)
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
Are you currently taking PrEP?
98%90%
69% of those on PrEP said their sexual health provider was aware that they were taking PrEP
No
Yes
10%
90%
n= 8048 (excludes HIV-positive respondents)
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
Where did you obtain PrEP?
0%
10%
20%
30%
40%
50%
60%
70%
Research study Friend Internet PEP acquired and split Physician/doctor
France Other
n= 528 persons on PrEP responding to this question
Percentage
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
Intention to use PrEP
(“I am very likely to use PrEP in the next 6 months”)
n= 7159 HIV-negative persons responding
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
Status of PrEP
implementation in
Europe
(Published 16 October)
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
Status of PrEP implementation in Europe
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016. (updated)
Timeframe and setting of PrEP implementation
COUNTRY STATUS OF PrEP TIMEFRAME SETTING
FRANCE Implemented/reimbursed 2016 Health care setting
NORWAY Implemented/reimbursed 2016 Health care setting
BELGIUM Ongoing demonstration project (2015-2018) Health care setting
NETHERLANDS Ongoing demonstration project (2015-2018) Health care setting
ITALY Ongoing demonstration project Health care setting
UNITED KINGDOM Completed demonstration project (2012-2016) Health care setting
CROATIA Planned demonstration project (2016-?) Health care setting
DENMARK Planned demonstration project (2017-2018) Community-based setting
GREECE Planned demonstration project (2016-2017) Health care setting
IRELAND Planned demonstration project (2016-2017) Health care & community setting
LUXEMBOURG Planned demonstration project (2016-2017) Health care setting
MALTA Planned demonstration project -- TBD
PORTUGAL Planned demonstration project (2016-2017) Community-based setting
ROMANIA Planned demonstration project -- TBD
SPAIN Planned demonstration project (2016-2017) Community-based setting/STI clinic
SWEDEN Planned demonstration project (2016-2017) Health care setting
AZERBAIJAN Planned demonstration project (TBD) TBD
GEORGIA Planned demonstration project (2017-2018) TBD
ISRAEL Planned demonstration project (2017-2018) Health care setting
UKRAINE Planned demonstration project (2017-2018) Community-based setting
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
What issues are limiting or preventing the
implementation of PrEP in your country?
ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
0 5 10 15 20 25 30 35
Drug resistance
Eligibility
Lower condom use
Other/Not licensed
Adherence
Increases in STIs
Feasibility
Cost of service delivery
Cost of PrEP
Number of countries (n=36)
High importance Medium importance Low importance
European discourse on PrEP: from a policy
maker/public health perspective
Is PrEP
efficacious?
2014-15
What about
STIs, drug
resistance,
condom
use?
Is PrEP
efficacious?
2014-15 2015
European discourse on PrEP: from a policy
maker/public health perspective
Can we
afford
PrEP?
What about
STIs, drug
resistance,
condom
use?
Is PrEP
efficacious?
20162014-15 2015
European discourse on PrEP: from a policy
maker/public health perspective
How do we
implement
PrEP?
Can we
afford
PrEP?
What about
STIs, drug
resistance,
condom
use?
Is PrEP
efficacious?
20162014-15 2016-172015
European discourse on PrEP: from a policy
maker/public health perspective
Conclusions
 Current efforts to reduce STI/HIV incidence among MSM in Europe
are failing
 While countries figure out whether or not to implement PrEP,
community implementation is in full swing, demand increasing
 An increasing number of countries in Europe and Central Asia are
considering implementing PrEP demonstration projects
 Although the costs of PrEP MUST come down, we need focus on
supporting countries who are considering PrEP
– Bringing clinicians, public health experts, community reps and policy makers
together
– Lay out the options for where and how to deliver PrEP
Thank you!
Gianfranco Spiteri
Anastasia Pharris
Andrew Amato
Sean Howell (CEO Hornet)
Alex Garner (Senior Health Innovation Strategist, Hornet)
Adam Bourne (LSHTM)
Kathy Attawell, Manuel Battegay, Josip Begovac, Torsten Berglund, Anders Blaxhult, Viviane Bremer, Gus
Cairns, Valentina Cambiano, Jordi Casabona, Olivia Castillo Soria, Pep Coll, Susan Cowan, Caroline Daamen,
Silke David, Antonio Diniz, Nigel Field, Robert Grant, Neta Harel, Elske Hoornenborg, Kristina Ingmarsdotter
Persson, Cary James, Marie Laga, Lennie Lindberg, Fiona Lyons, Bruno Maia, Anna Marzec-Bogusławska,
Sheena McCormack, Michael Meulbroek, Jean-Michel Molina, Arild Johan Myrberg, Otilia Mårdh, Brooke
Nichols, Georgios Nikolopoulos, Velina Pendolovska, Ines Perea, Francois Pichon, Ferran Pujol, Daniela Rojas
Castro, Anders Sönnerborg, Judit Takacs, Lara Tavoschi and Marti Vall

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PrEP implementation strategies across Europe – an overview

  • 1. PrEP implementation strategies across Europe – an overview Teymur Noori, ECDC 25 October, 2016 HIV Drug Therapy Glasgow 2016
  • 2. Outline  Context and ECDC opinion on PrEP  ECDC meeting on PrEP in April 2016  Informal use of PrEP in Europe (Hornet/ECDC survey)  Status of PrEP implementation in Europe
  • 3. Injecting drug use Heterosexual contact (women) Heterosexual contact (men) Sex between men Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014 +44% -28% -33% -19% HIV diagnoses, by mode of transmission 2005-2014, EU/EEA Data is adjusted for reporting delay. Cases from Estonia and Poland excluded due to incomplete reporting on transmission mode during the period; cases from Italy and Spain excluded due to increasing national coverage over the period. Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014
  • 4. Percentage of HIV diagnoses, by route of transmission, 2014, EU/EEA Source: ECDC/WHO (2015). HIV/AIDS Surveillance in Europe, 2014
  • 5. Which interventions work? Hepatitis A and B vaccination Condoms and lubricants HIV and STI testing Treatment for HIV, viral hepatitis and STI Health promotion MSM- competent health services Targeted care for MSM living with HIV ECDC guidance on HIV/STI prevention among MSM (2015) The evidence indicates that these 7 services and interventions, can:  Effectively prevent and reduce HIV/STI transmission among MSM  Address the needs of MSM who are living with HIV  Promote sexual health among all MSM  Have most impact when when provided in combination
  • 6. Which interventions work? Hepatitis A and B vaccination Condoms and lubricants HIV and STI testing Treatment for HIV, viral hepatitis and STI Health promotion MSM- competent health services Targeted care for MSM living with HIV ECDC guidance on HIV/STI prevention among MSM (2015) The evidence indicates that these 7 services and interventions, can:  Effectively prevent and reduce HIV/STI transmission among MSM  Address the needs of MSM who are living with HIV  Promote sexual health among all MSM  Have synergistic effects when provided in combination  Evidence review and grading were performed prior to release of the PROUD and IPERGAY studies  The scientific panel viewed the lack of European evidence (at the time) and the EMA not having approved PrEP as sizeable barriers to strongly recommending PrEP as part of comprehensive programmes
  • 7. ECDC opinion on PrEP April 2015  Countries should give consideration to integrating PrEP into their existing HIV prevention package for those most at- risk, starting with MSM  Issues related to PrEP implementation will need to be addressed in the context of each Member State's health system  ECDC will provide support to Member States and the European Commission with regards to PrEP implementation
  • 8. ECDC meeting on PrEP 27-28 April, 2016 Objectives:  Discuss key issues related to PrEP in the EU/EEA setting  Assess whether ECDC has a role to play in supporting countries who are considering PrEP implementation Participants:  Public health/policy makers  Clinicians  Community representatives  Agency representatives
  • 9. Key issues discussed Session 1 Eligibility criteria for PrEP in Europe (Elske Hoornenborg) Session 2 Appropriate models of service delivery (Sheena McCormack) Session 3 Cost and cost- effectiveness (Valentina Cambiano & Nigel Field) Session 4 Clinical and public health monitoring (Pep Coll, Robert Grant, Sheena McCormack)
  • 10. Options for delivering PrEP Options Pros Cons Clinic-based services  Used to discussing sexual health  See people with STIs and at risk of HIV  HIV/STI testing is in place  Dispense TDF/FTC as part of PEP  Confidential  May not be walk-in and/or free  Under-resourced and under-staffed  Too few clinics Community-based services  See people at risk of HIV – often peers  May be the only provider seeing migrants and minority ethnicities  Confidential  HIV testing in place  Walk-in and free  Referral pathways to prescribers of ARV  May not be able to screen for STIs  May need referral pathways for PrEP  May not have sustainable funding HIV specialists  Familiar with ARV  HIV/STI testing available  May depend on referrals to reach the target population  Notes available throughout hospital  Appointments required  Co-payments for some or all STI tests Primary care physicians  If seeing the target population, will be discussing sexual health, screening for HIV/STIs, and familiar with ARV  Set up for short appointments  Co-payments  Notes available to practice staff  Very few primary care physicians are likely to have the necessary experience and interest Peers and online  Peer discussion and support  Signposting to services for HIV/STIs and renal monitoring  Convenient  Can reach a large population quickly  Co-payment for drug (could also be a good thing)  Not confidential (could also be a good thing)  Outside surveillance systems Adapted from Sheena McCormack's presentation at the ECDC meeting on PrEP (27 April 2016)  Whichever model is chosen, consideration must be given to how best to integrate PrEP into existing services  Each country will need to consider where HIV/STI testing and treatment are best delivered  Given differences in country contexts, it is not feasible or helpful to make Europe-wide recommendations
  • 13. Hornet/ECDC survey (23-25 April 2016) 8,543 persons responded (48h) France United Kingdom (UK) Russia Italy Germany Belgium Turkey Spain Netherlands Denmark Ukraine Switzerland Sweden Portugal Other 26% 22% 10% 13% ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
  • 14. Are you HIV-positive? No Unsure Yes 79% 10% 11% n= 4392 persons responding to this question (51%) ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
  • 15. Are you currently taking PrEP? 98%90% 69% of those on PrEP said their sexual health provider was aware that they were taking PrEP No Yes 10% 90% n= 8048 (excludes HIV-positive respondents) ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
  • 16. Where did you obtain PrEP? 0% 10% 20% 30% 40% 50% 60% 70% Research study Friend Internet PEP acquired and split Physician/doctor France Other n= 528 persons on PrEP responding to this question Percentage ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
  • 17. Intention to use PrEP (“I am very likely to use PrEP in the next 6 months”) n= 7159 HIV-negative persons responding ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
  • 18. Status of PrEP implementation in Europe (Published 16 October) ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
  • 19. Status of PrEP implementation in Europe ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016. (updated)
  • 20. Timeframe and setting of PrEP implementation COUNTRY STATUS OF PrEP TIMEFRAME SETTING FRANCE Implemented/reimbursed 2016 Health care setting NORWAY Implemented/reimbursed 2016 Health care setting BELGIUM Ongoing demonstration project (2015-2018) Health care setting NETHERLANDS Ongoing demonstration project (2015-2018) Health care setting ITALY Ongoing demonstration project Health care setting UNITED KINGDOM Completed demonstration project (2012-2016) Health care setting CROATIA Planned demonstration project (2016-?) Health care setting DENMARK Planned demonstration project (2017-2018) Community-based setting GREECE Planned demonstration project (2016-2017) Health care setting IRELAND Planned demonstration project (2016-2017) Health care & community setting LUXEMBOURG Planned demonstration project (2016-2017) Health care setting MALTA Planned demonstration project -- TBD PORTUGAL Planned demonstration project (2016-2017) Community-based setting ROMANIA Planned demonstration project -- TBD SPAIN Planned demonstration project (2016-2017) Community-based setting/STI clinic SWEDEN Planned demonstration project (2016-2017) Health care setting AZERBAIJAN Planned demonstration project (TBD) TBD GEORGIA Planned demonstration project (2017-2018) TBD ISRAEL Planned demonstration project (2017-2018) Health care setting UKRAINE Planned demonstration project (2017-2018) Community-based setting ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016.
  • 21. What issues are limiting or preventing the implementation of PrEP in your country? ECDC. Evidence brief: Pre-exposure prophylaxis for HIV prevention in Europe. Stockholm: ECDC; 2016. 0 5 10 15 20 25 30 35 Drug resistance Eligibility Lower condom use Other/Not licensed Adherence Increases in STIs Feasibility Cost of service delivery Cost of PrEP Number of countries (n=36) High importance Medium importance Low importance
  • 22. European discourse on PrEP: from a policy maker/public health perspective Is PrEP efficacious? 2014-15
  • 23. What about STIs, drug resistance, condom use? Is PrEP efficacious? 2014-15 2015 European discourse on PrEP: from a policy maker/public health perspective
  • 24. Can we afford PrEP? What about STIs, drug resistance, condom use? Is PrEP efficacious? 20162014-15 2015 European discourse on PrEP: from a policy maker/public health perspective
  • 25. How do we implement PrEP? Can we afford PrEP? What about STIs, drug resistance, condom use? Is PrEP efficacious? 20162014-15 2016-172015 European discourse on PrEP: from a policy maker/public health perspective
  • 26. Conclusions  Current efforts to reduce STI/HIV incidence among MSM in Europe are failing  While countries figure out whether or not to implement PrEP, community implementation is in full swing, demand increasing  An increasing number of countries in Europe and Central Asia are considering implementing PrEP demonstration projects  Although the costs of PrEP MUST come down, we need focus on supporting countries who are considering PrEP – Bringing clinicians, public health experts, community reps and policy makers together – Lay out the options for where and how to deliver PrEP
  • 27. Thank you! Gianfranco Spiteri Anastasia Pharris Andrew Amato Sean Howell (CEO Hornet) Alex Garner (Senior Health Innovation Strategist, Hornet) Adam Bourne (LSHTM) Kathy Attawell, Manuel Battegay, Josip Begovac, Torsten Berglund, Anders Blaxhult, Viviane Bremer, Gus Cairns, Valentina Cambiano, Jordi Casabona, Olivia Castillo Soria, Pep Coll, Susan Cowan, Caroline Daamen, Silke David, Antonio Diniz, Nigel Field, Robert Grant, Neta Harel, Elske Hoornenborg, Kristina Ingmarsdotter Persson, Cary James, Marie Laga, Lennie Lindberg, Fiona Lyons, Bruno Maia, Anna Marzec-Bogusławska, Sheena McCormack, Michael Meulbroek, Jean-Michel Molina, Arild Johan Myrberg, Otilia Mårdh, Brooke Nichols, Georgios Nikolopoulos, Velina Pendolovska, Ines Perea, Francois Pichon, Ferran Pujol, Daniela Rojas Castro, Anders Sönnerborg, Judit Takacs, Lara Tavoschi and Marti Vall

Editor's Notes

  1. Based on the inclusion of 7 interventions in public health programmes; these are most effective if delivered in combination.
  2. Based on the inclusion of 7 interventions in public health programmes; these are most effective if delivered in combination.