Антиретровирусное лечение – перспективы Европейского клинического общества по СПИДу (EACS)/Antiretroviral Treatment.The European AIDS Clinical Society (EACS) Perspective.2017

1. Antiretroviral Treatment
the European AIDS Clinical Society (EACS) Perspective
Manuel Battegay
European AIDS Clinical Society, Brussels
Division of Infectious Diseases & Hospital Epidemiology, Basel

2. Conflict of Interest
None
– No participation in Speakers Bureau at any time ever
– No stocks or stock options of pharmaceutical or biotech
companies at any time ever
– No participation in Satellite Meetings since 2011
– No participation in Advisory Boards since 2014

3. Thank you
for valuable discussions and slides
Dominique Braun, Zürich
Jens D Lundgren, Copenhagen
Cristina Mussini, Modena
Marco Vitoria, Geneva
Stéphane de Wit, Brussels

4. EACS
The European AIDS Clinical Society is a not-for-profit organisation
whose mission is to promote:
• Excellence in Standards of Care
• Research and Education in HIV infection and related Co-infections
• Formulation of Public Health Policy
with the aim of increasing the quality of care and reducing HIV disease
burden across Europe (WHO Europe region with 53 countries).
www.eacsociety.org
Working
Groups
Guidelines
Training &
Education
WAVE
Conference &
Collaborative
Meetings
EACS Award Public Health
Funding &
Grants
Women Against
Viruses in Europe
 HIV Online Courses
 Summer School
 Young Invest. Conf.
 Medical Exch. Progr.
 EACS Conference
 Standard of Care
 ECMID
 ECDC
 WHO Europe
 HIV Glasgow
 and others

5. – The Guidelines Perspective
– The clinical view of the Cascade of Care
– Standard of Care
Antiretroviral Treatment
the European AIDS Clinical Society (EACS) Perspective

6. Aims of ART
Suppression of HIV viral load!
Close to normal immunological function
Close to normal life expectancy with unprecedented
reduction of HIV morbidity and mortality
(Close to) complete reduction of transmission (TASP)
http://www.eacsociety.org
HIV Medicine, 2016, updated

7. Trickey et al, The ART CC-Collaboration, The Lancet HIV 2017
Survival of HIV-positive patients starting ART
between 1996-2013: The Art CC Collaboration
18 European and North American HIV-1 cohorts: 88’504 patients
2106 died in the 1st year of ART and 2302 died in the 2nd or 3rd year of ART
Expected ages at death for
Europeans aged 20y starting ART in
08–10, on the basis of mortality
during the first 3y of ART: 67·6y (95%
CI 66·7–68·5) for men, 67·9y (67·2–
68·7) for women; lower than in the
French population (79y men, 85y
women). Estimates based on
mortality during the 2nd and 3rd y of
ART: Ages at death 10y higher.
The expected age at death of a 20-
y-old patient starting ART during
08–10, CD4>350, 1y after starting
ART, was 78·0y (77·7–78·3).

8. START: 57% Reduced Risk of Serious
Events or Death with Immediate ART
4.1% vs 1.8% in deferred vs immediate arms experienced serious AIDS or
non-AIDS–related event or death (HR: 0.43; 95% CI: 0.30-0.62; P < .001)
10
8
6
4
2
0
CumulativePercentWithEvent
0 6 12 18 24 30 36 42 48 54 60
Mo
Deferred ART
Immediate ART
INSIGHT START Study Group, Lundgren JD et al., N Engl J Med. 2015
RCT, 35 countries, 215 sites, n = 4’685 patients
n = 2’326
n = 2’359
initiated immediately
following randomization
Deferred until CD4+ cell count ≤ 350 cells/mm3,
AIDS, or event requiring ART

9. Impact on Guidelines
the lower the CD4 count,
the greater the urgency to start ART immediately
ART recommended in all adults with HIV-infection
irrespective of the CD4 count

10. Policy on ART initiation in the EU/EEA,
2014 and 2016 (as of November 2016)
ECDC (European Centre for Disease Prevention and Control): The status of the HIV
response in the European Union/European Economic Area, 2016
* At the time of validation

11. High Fraction of Transmissions
during Primary HIV infection
• Phylogenetic tree >100’000
Swiss- and non-Swiss
background sequences
• Seroconversion dates >4’000
patients
Marzel et al, CID 2015; Slide Courtesy Dominique Braun, Zürich
33% transmissions during
PHI (range 30%–42%)

12. ART recommended in the
setting of Primary HIV infection
Treatment of PHI recommended for all HIV-positive persons
Where immediate ART (= same day) is advised
• Neurological disease, in particular meningo-encephalitis
(within hours)
• Acute infection
• Severe or prolonged symptoms
• Age ≥ 50 years
• CD4 count < 350 cells/μL
Superior Outcomes with Same-Day HIV Testing and ART Initiation in
different settings for: ART uptake, improved retention with viral
suppression and reduced risk of mortality
Koenig et al, AIDS 2016, Durban

13. Perception versus Reality

14. Assessing HIV-positive Persons'
Readiness to Start and Maintain ART
www.eacsociety.org
Goal: to help persons start and/or maintain ART
Successful ART requires a person's readiness to start and adhere to the regimen over time.
Open question: “I would like to talk about HIV medicines.” “What do you think about them?”
Precontemplation:
“I don’t need it, I feel good.”
“I don’t want to think about it.”
Contemplation:
“I am weighing things up and feel
torn about what to do about it.”
Preparation:
“I want to start, I think the drugs
will allow me to live a normal life.”
Action: “I will start now.”
Support: Show respect for the person's
attitude / health and therapy beliefs / establish
trust / individualised information
Support: Allow ambivalence / support the
person in weighing pros and cons
Support: Reinforce decision / educate the
person on adherence, resistance and side
effects / assess self-efficacy
Consider aids: e.g. mobile, partner, DOT
Stages of readiness to start ART

15. ART Panel Chair: Anton Pozniak, London
ART Panel Vice-Chair: Jose Arribas, Madrid
Young scientist: Margherita Bracchi, London
Guidelines Chair and Coordinator: Manuel Battegay, Basel
Assistant Coordinator: Lene Ryom, Copenhagen
http://www.eacsociety.org
Dolutegravir
Elvitegravir
Raltegravir
Rilpivirine
Darunavir/boost.
STR
STR
STR

16. ART Panel Chair: Anton Pozniak, London
ART Panel Vice-Chair: Jose Arribas, Madrid
Young scientist: Margherita Bracchi, London
Guidelines Chair and Coordinator: Manuel Battegay, Basel
Assistant Coordinator: Lene Ryom, Copenhagen
http://www.eacsociety.org
Raltegravir
Efavirenz
Darunavir/boost.
Lopinavir/r
Atazanvir/boost.
STR

17. • 75 clinical sites,14 European countries
• 888: 548 heterosexual, 340 MSM,
• 1238 eligible couple-years of follow-up (1.3 yrs)
• MSM 22 000 sex acts
• heterosexuals 36 000 sex acts
A. Rodger et al and JD Lundgren for the PARTNER Study Group, JAMA 2016
11 HIV-negative partners became HIV-positive (10 MSM; 1 heterosexual)
No phylogenetically linked transmissions = Within-couple HIV transmission = 0
Upper 95%confidence limit of 0.30/100 couple-yrs of follow-up
(condomless anal sex 0.71 per 100 couple-yrs of fup)
More robust data for risk of condom-less anal sex available by early 2018.

18. Effects of Various Levels of Adherence on
the Individual and Community
Gandhi M, Gandhi RT. N Engl J Med 2014

19. EACS Guidelines
1. ART
2. Co-morbidities
3. Co-infections
4. Opportunistic infections
Drug-drug interactions

20. – The Guidelines Perspective
– The clinical view of the Cascade of Care
– Standard of Care
Antiretroviral Treatment
the European AIDS Clinical Society (EACS) Perspective

21. Number of people on antiretroviral
therapy in Europe and Central Asia, 2015
ECDC (European Centre for Disease Prevention and Control): Special Report: HIV treatment and care
New HIV-infections
n = 153’407 in 2015 (Nov. 2016)

22. HIV-infected people diagnosed late
in the EU/EEA, 2015
ECDC (European Centre for Disease Prevention and Control): The status of the HIV
response in the European Union/ European Economic Area, 2016

23. Countries reporting barriers to getting people
diagnosed with HIV onto ART (n = 48), 2016
ECDC (European Centre for Disease Prevention and Control): Special Report: HIV treatment and care
Barrier Number of countries
Legal and policy issues
Laws and policies 16
System and service delivery issues
Knowledge and skills of health professionals 9
Referral to treatment programes 23
Availability of treatment programmes 16
Availability of drugs 12
Confidentiality 18
Integration with other health services 16
Integration with support services 12
Social and cultural issues
Stigma and discrimination among health professionals 18
Stigma and discrimination within key populations 24
Language and culture (migrants) 20

24. People living with HIV who know their status, are on
ART and are virally suppressed in 29 Countries
across Europe and Central Asia 2016 *
ECDC (European Centre for Disease Prevention and Control): Special Report: Continuum of HIV care
* Latest data availabe reported by countries in March 2016

25. Viral suppression among HIV-infected persons in the 29
countries with data on all four stages of the continuum of
care, EU/EEA and non-EU/EEA countries, 2016*
*Latest data available reported by countries in March 2016
ECDC (European Centre for Disease Prevention and Control): Special Report: Continuum of HIV care

26. – The Guidelines Perspective
– The clinical view of the Cascade of Care
– Standard of Care
Antiretroviral Treatment
the European AIDS Clinical Society (EACS) Perspective

27. 1st Standard of care meeting
2014, Rome Italy
2nd Standard of care meeting
2016, Brussels, Belgium
European AIDS Clinical Society Standard of Care meeting on HIV and related coinfections: The Rome
Statements. Mussini C, Antinori A, Bhagani S, Branco T, Brostrom M, Dedes N, Bereczky T, Girardi E,
Gökengin D, Horban A, Lacombe K, Lundgren JD, Mendao L, Mocroft A, Oprea C, Porter K, Podlekareva D,
Battegay M, d'Arminio Monforte A; European Aids Clinical Society. HIV Med. 2016

28. Access to HIV drugs
• Registration and reimbursement; including speed of
registration and reimbursement of new drugs, new
formulations etc.
• Access to fixed dose combinations
• Access to new drugs
• Use of generics
Slide Courtesy Stéphane de Wit, Brussels

29. Access to HIV monitoring
• Viral load
• CD4
• Resistance testing
• HLA testing
• Therapeutic drug monitoring (TDM)
Slide Courtesy Stéphane de Wit, Brussels

30. Comparing ART monitoring strategies in
adults/adolescents with HIV in 2016
(IAS, DHHS, EACS and WHO ART guidelines)
GUIDELINES
Time point /frequency of
VL testing
Time point /frequency of
CD4 testing
At ART
initiation
After ART
initiation
After VL
suppressio
n
VL threshold
(treatment failure
criteria)
At ART
initiation
After ART
initiation
After VL consistently
suppressed and
clinically stable on
ART
IAS (2016) yes 1-2 months Every 3-6
months
>200 copies/ml yes Every 3-6
months
If clinically indicated
DHHS (2016) yes 1-2 months
Every 3-6
months
>200 copies/ml yes
Every 3-6
months
Every 12 months
EACS (2016) yes 3-6 months Every 3-6
months
>50 copies/ml yes Every 3-6
months
Every 12 months
WHO (2016) no 6 and 12
months
Every 12
months
> 1000 copies/ml yes Every 6-12
months
If clinically indicated
Marco Vitoria, WHO Nov, 2016

31. Maintenance in Care
• Assess adherence (ask open questions)
• Use support by digital help (e.g. Guidelines, DDI)
• Assess barriers
• Integrate health and community services:
TB, Hepatitis, STI, Co-morbidities, Vaccines
Community groups, Antenatal clinics, Mental health services,
Prison
Testing programs
• Identify high-risk populations and provide easy access to care:
Women, People living with drugs, Migrants
• Eliminate stigma, support patients, support health care providers

32. Challenges and Opportunities
• Share best practice and upbuild networking platforms
• Use the EACS e-learning platform
• Define criteria for sites of excellence in HIV Medicine in a region
• Upbuild research collaborations on projects of mutual interest
• Promote access to registries/databases/reporting systems at local,
national, European level
• Intensify working with Community (platforms)
• Collaborate/engage with efforts lead by WHO Collaborative Centre
on HIV, TB in HIV and viral hepatitis in the region
Jens D Lundgen, Copenhagen, Stéphane de Wit, Brussels

33. E-learning Online courses
Clinical Management of HIV Online Course
In-depth training on the clinical management of HIV
for clinicians via a flexible and resource-saving online
platform. Available in both Russian and
English. Special emphasis will be placed on co-
infections and co-morbidities as well as state-of-the-
art treatment of HIV according to international
guidelines from EACS and WHO.
Pre-Exposure Prophylaxis Online Course
Newly added
Contact
Ms. Anne Grevsen
HIVonlinecourse@eacsociety.org
www.eacsociety.org

34. Summary and Perspective
• The effects of HIV-ART for lowering morbidity, mortality and HIV-
transmission are unprecedented in medical history.
• EACS aims to increase the quality of care and research by:
• Issuing patient focused guidelines and standards of care
• Training and educating clinicians and care providers by e-
learning, teaching courses and the EACS Conference
• Collaborating with Community, WHO Europe, ECDC and other
medical societies such as ESCMID.

35. Summary and Perspectives
• Collaboration is paramount to enable a better Cascade of Care
with integration of Public Health and services from testing to
maintenance of ART.
• Across Europe inequalities exist which must be approached with
fully shared and coordinated committment.
• The very high new HIV infection rate requires to place HIV/AIDS,
ART and the Cascade of Care at highest European priority.