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 mameletezisi@who.int #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

mameletzisi@who.int