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Transcript of How do we scale up oral PrEP containing TDF? · Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1...
How do we scale up oral PrEP containing TDF?
The need for and availability of PrEP in Europe and globally
Ioannis Hodges-Mameletzis WHO Geneva February 9, 2018 [email protected] #offerPrEP
Disclosure
• I have no financial conflict of interest
1988
1st Case study: Odysseus
• From a village in Crete
• 18 years old, feels repressed
• Moves to the big city in 1988 to study (Thessaloniki)
• He doesn’t know much about HIV prevention
• He is diagnosed with HIV in 1992
2018
2nd case study: Konstantinos (aka. Kostas)
• From a village in Crete
• 19 years old, like Odysseus, also repressed
• He moves to the big city in 2018 (Athens), knows a little bit about HIV prevention
• Condoms are available, but he struggles with them – He has multiple partners
• Uses an iPhone, and has heard about PrEP through Yellow Pages (aka. Grindr)
• Goes to the doctor and asks to learn more about it
• He is told to just use a condom
A month later
• Gus goes back to the doctor
• He has a bottle of generic PrEP from
Thailand
• Kostas goes back to the doctor
• He has a bottle of generic PrEP from Thailand
Kostas shows the doctor all the WHO guidance on oral PrEP (dating back to 2012)
WHO PrEP Implementation Tool (2017)
In summary, Kostas
• Is well-informed
• Wants to keep himself HIV-negative
• Has ‘alternative’ PrEP access
• But he doesn’t have an informed health care provider
BIG QUESTION
If we have global evidence-based
guidance, why the hesitation?
Bottlenecks
Barriers
Barriers? Myths? Excuses?
• Cost
• Uncertainty over clinical outcomes – STIs
– HIV drug resistance
• Lack of awareness amongst providers
• Lack of awareness amongst policy makers
• Misinformation in people who could benefit
• Treatment gaps (not a myth)
• Moralization – ‘It’s not a vote winner to stand up for key populations’
‘Challenge to motivate governments’
Cost of originator vs generic in LMICs
https://www.msfaccess.org/sites/default/files/MSF_assets/HIV_AIDS/Docs/UTW_Drug_Profiles_TDF_FTC.pdf
BAD NEWS
• What is the epidemiology telling us in Europe?
Rate of new HIV diagnoses per 100000 population, by year of diagnosis and
adjusted for reporting delay, in the EU/EEA and the WHO European Region*,
1985–2016
New HIV diagnoses per 100,000 population, 2016
Characteristics of new HIV diagnoses reported in the WHO
European Region, the EU/EEA, and West, Centre and East of
the WHO European Region, 2016
Facilitators
1. Civil society
2. Generic and originator
competition
Generic tenofovir-FTC products which are
registered in France
1. Mylan
2. Biogaran
3. EG
4. TEVA
5. Zentiva
http://base-donnees-publique.medicaments.gouv.fr/afficheGroupeGene.php?idGrp=1371
Gilead filing of Truvada for a PrEP indication in ‘access’ countries
Country Status Date Brazil approved May-17 Chile approved May-17 Kenya approved Nov-15 Malawi approved Feb-17 Peru approved Mar-16 South Africa approved Nov-15 Thailand approved Aug-16 Tanzania approved Dec-16 Zambia approved Apr-17 Zimbabwe approved Mar-17
Updated January 2018
High income countries where Truvada has been registered for PrEP
• FDA, USA (2012)
• ANSM, France
• Health Canada
• TGA, Australia
• EMA (2016)
• FDA, Taiwan China
• Israel
• New Zealand
Updated February 2018
WHO PQ generic manufacturers of TDF + FTC
Generic manufacturers registered-providing PrEP to countries based on WHO-UNAIDS intelligence
1. Adcock Ingram Healthcare 2. Aspen Pharmacare 3. Aurobindo 4. Cipla 5. Emcure 6. Hetero Drugs 7. Macleods Pharmaceuticals 8. Matrix 9. Mylan 10. Strides
1. Mylan (supplying to France, Greece, and other countries)
2. Biogaran (France) 3. EG (France) 4. Elpen (Greece) 5. Cipla (India approved TDF-FTC for PrEP) 6. Teva (USA, Israel) 7. Sandoz (Norway, Sweden) 8. Hexal (Germany, generic arm of Novartis) 9. KrKA 10. Zentiva 11. Dr. Reddy's Laboratories (Indian Company
providing PrEP to Scotland) 12. Government Pharmaceutical Organization
(Thailand) (TENO-EM) 13. Lupin?
Source: WHO GPRM: http://www.who.int/hiv/amds/gprm/en/
Source: WHO-UNAIDS country intelligence
2. Clinical guidance
3. Regional action plan prioritizing PrEP
(2017): http://www.euro.who.int/__data/assets/pdf_file/0007/357478/HIV-action-plan-en.pdf?ua=1
Starting to see real-life success of PrEP implementation
New HIV diagnoses, deaths, and prevalence, 2006-2016, San Francisco
Australia: real-life, public health impact of combination
prevention
Newly diagnosed HIV cases in New South Wales (including
Sydney)
Source: http://www.health.nsw.gov.au/endinghiv/Documents/q2-2017-nsw-hiv-data-report.pdf
• Educated community
and built demand for
PrEP among MSM
• PrEP demonstration
project at scale
• 25% reduction in the
average number of new
cases compared to the
previous five years.
PrEP starts March 2016
UK data comes up later
Global PrEP Coalition (GPC)
• WHO-led, established in 2017
• Core group of members
• ‘Platform’ for sharing lessons – Country-to-country (region-to-region)
– ‘Let’s not re-invent the wheel’
• What is being planned for 2018? – Webinar series
– Technical assistance to countries
– Implement the WHO PrEP implementation tool
The 3 ’s
• Concept generated at IAS 2017 in Paris
• If you want public health impact, need to ‘influence’ three key ‘actors’
PROVIDERS
Pocket card for clinicians
Early adopters (the providers)
POLICY MAKERS
PrEP users (potential and current)
Oral PrEP scale-up is a reality
• February 2018 – Over 19 countries have approved TDF-FTC for oral PrEP
• Gilead Sciences, Mylan, Cipla, Teva, and other manufacturers in the PrEP market space
• Implementation largely focused in MSM – (e.g. USA, France, Australia, UK, Thailand, Brazil)
• Large scale-up for women underway in SSA (SA, Kenya, Lesotho national programmes, AGYW, SW, SDC, others)
Some outstanding questions on
implementation?
• How do we integrate (and where do we integrate) PrEP?
• Move beyond HIV prevention: Can we realistically position PrEP as part of sexual health?
• How can we make PrEP service delivery simple, safe, and effective? – This is what we should learn from one setting to the
next as we implement over the next few years
STIs are on our radar
Marrazzo et al, PLOS Medicine, 2018
It takes time
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3
Unique Individuals Starting FTC/TDF for PrEP in US, 2012 to 2016 (by quarter)
58
2015 2014 2013 2012 2012 2013 2014 2015 2016
98,732 Unique Individuals Starting FTC/TDF
for PrEP:
1,715 in Q3 2012 → 11,827 in Q3 2016
6.9 times increase 2012 - 2016
Men and Women Starting FTC/TDF for PrEP in US, 2012 to 3rd Quarter 2016
59
2,826 2,768 2,467 3,409 3,590 3,028 3,779
13,650
30,074
33,141
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
2012 2013 2014 2015 2016
4-YearTotal: 98,732
5,853
Women: 15,060
Men: 83,672
6,547
16,117
33,483 33,731
Proportion Women
VMMC uptake in Africa
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)
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
My challenge
• Advocate to all those 3 P’s
• How?
– Be constructive with your ministries and your providers
– Frame it in a different context
• eMTCT, PEP, sexual health
Where do we go on from here?
• Big take-home message:
– Constructive rapport between CBOs and public health officials
• Practical note: National PrEP Task Force in each of your countries
• 1st step: Put PrEP in your guidelines
Odysseus
• Is adhering really well to his ART
• But we don’t know if he’s virally suppressed
• He has anxiety over the fact the Greek public health system has not been able to cover a VL test for past 16 months
Kostas
• Has found a very nice doctor who’s non-judgmental, and is ensuring he is getting HIV test, STI screening, and is checking to make sure his kidneys are OK.
• He’s still buying his drug online while the Greek state decides what to do with PrEP
• He has been emailing his Ministry that France went for 5 generic options for PrEP in its national system in July 2017
Acknowledgments
• WHO team – Rachel Baggaley (leads HIV
prevention work) – Michelle Rodolph – Shona Dalal – Antons Mozalevskis
• Global PrEP Coalition • ECDC
– Teymur Noori
• UNAIDS – Peter Godfrey-Faussett – Rosalind Coleman
• Peer reviewers of WHO PrEP implementation tool
• Gus Cairns • PrEP in Europe • Jhpiego • AVAC • Civil society partners • Unitaid • BMGF