He Hepati patitis tis C Dia iagn gnosti ostics cs the Bott - - PowerPoint PPT Presentation

Meeting at the Occasion of AASLD 2014 and 13th HCV DrAG Meeting Boston, November 11, 2014

He Hepati patitis tis C Dia iagn gnosti

• stics

cs – the Bott

• ttleneck

leneck to

• Unloc

lockin king g a Gl a Glob

• bal

al Mark arket

Peter Dailey, FIND Cami Graham, FIND Barbara Bulc, Global Development / FIND

2

Agend nda:

1.

• 1. FIND

D – an innovati tive e partner er in diagn gnost

• stics

cs for r limited ed-res resou

• urce

ce set etti tings ngs

• - Peter Dailey
• 2. Hepati

titi tis s C diagn gnost

• stic

c tests ts - strategy egy and visi sion

• n to address

ss glob

• bal market
• - Peter Dailey, Cami Graham

3.

• 3. New opportu

tuni nities ties for cross-sect sector

• r partners

ership ips

• - Barbara Bulc

4.

• 4. Q&A and Disc

scussi ssion

• n

Moderated by Veronica Miller, Forum for Collaborative HIV Research

Sum ummar ary

3

Objecti ectives es: DRIVE VE ACCESS ESS What

t is pot

• tent

ntial ial of new diagnos nostic tic tests ts to drive ve access ess to care and treatme tment nt of HCV in limited ed-resou esource ce set etti tings ngs, and beyond

• nd

CONV NVERGE PER ERSPEC ECTIVES TIVES Converg

erge divers erse perspecti pectives es to enable e new partne nershi ships ps and innovat ation

• n in suppor

port t of HCV diagnosti nostics cs and treatme tment nt

CATALYZE YZE COL OLLABOR ABORATIONS TIONS Share

re opportuni tuniti ties es for r collaborati

• ration

n with FIND D as a catal alyst st to unlock ck a glob

• bal market

et for HCV diagnosis nosis and treatme tment nt

Object ectiv ives es

FIND – an inno novativ ative partn tner r in diag agnos nostic tics for limit ited-reso resour urce ce sett etting ings

4

Diagn agnos

• sis

s equ quals s knowledge: To enable accura rate treatment, to target t hea ealt lthcare e in interventions, and to measu sure e prog

• gres

ess.

• s. This is the

he basis to:

..... fulfill the patient’s right to know and promote health

... eliminate diseases ... prevent antimicrobial resistance ... improve the efficiency of healthcare spending

Why y diag iagno nost stics ics mat atter er

5

PA TIENTS SCIENCE PRODUCTS SOLUTIONS

Toward rd a worl rld d wh where re di diagnosi nosis s guide des the way to health for for all pe peopl ple

6

Mission : T urning complex diagnostic challenges into simple solutions to transform lives and overcome diseases of poverty

• I. Catalyze

development

• Lead dynamic

needs definition

• Support program

for manufacturers

• Scout technology
• Match-make
• Provide specimens

III. Accelerate access

• Facilitate national

policy and develop- ment of rollout plans

• Help MoHs identify

gaps, coordinate solutions, and deploy experts

• Develop QA tools

& strategies

• II. Guide use

& policy

• Lead clinical trials
• Define evidence

needs

• Support WHO

development

• f guidelines

IV. Shape agenda

• Measure and communicate impact of Dx
• Shape Dx ecosystem to foster willingness to invest/pay
• Lead global discussion on emerging Dx topics

FIND

Partnering for the right solutions

7

With partnerships and opportunities growing, we are determined to keep our role simple: ask the right questions, team up for the right answers. That is, after all, the root of diagnostic success.

Swiss Partners WHO, TDR, UNITAID, Global Fund, Stop TB Partnership, GLI, GDF, MMV, DNDi, SDC, Swiss TPH, EPFL, Canton of Geneva, HUG, and others

FIND

Geneva Switzerland FIND R&D, Industry and Academic partners Implementing partners

How we are structured

Note: locations of expert network and country offices / nodes are examples only

• Currently in India, South Africa, Uganda,

and the Dominican Republic with likely expansion pending

• Responsible for FIND implementation

activities in a country/region, trial support, & coordination with local partners

FIND Country offices / nodes

Network of experts provides expertise to enable development & access work

• IVD industry experts provide developers

mentorship, support

• Access experts across multiple countries

support implementation

Global expert network

• Hub for all FIND activity
• Home to leadership, programme, and

support staff

• Geneva center of global health with 50+

international organization in global helath

FIND Geneva headquarters

Signif ific icant ant pro rogress ess achieved ed in the last st 10 y years

9

TB Sleeping sickness

Patients can now get drug susceptibility testing in 2 hours at a district

• hospital. This used to take

up to 120 days and was only available at national reference labs. The development

• f

a rapid diagnostic test has helped make disease elimination a reality . Joint FIND-WHO efforts to assure the quality of rapid tests have increased the % of quality products in use from 15% to 75%.

Malaria

FIND’s new Support for Success programme eases the way to u uptak ake for pro romising ising pro roducts cts

FIND’s unique global biorepository and feasibility studies

• The FIND biorepository currently counts over 60,000

aliquots among sputum, serum, EDTA plasma, P800 plasma and urine.

• Samples have been provided to more than 40

developers all over the world

• Also serving as the main provider of specimens for the

BMGF TB Biomarkers Discovery project

• Technical feasibility and proof-of concept studies for the

assessment of new TB diagnostic technologies are integrated into collections

Diagnostic trials are a centerpiece of every step in the value chain

12 Acces ess Scaling ling up & conti tinu nued ed adoption ion into to nation ional al polic icy Demons

• nstr

trati ation

• n

Eva valuat luation ion Adop

• pti

tion

• n

into to global al polic icy Registrat tratio ion

• Test and resour

urce e utiliz lizati ation

• n
• Patient

ient impac act

• Epidem

demiologic iological impac act

• Econom

nomic ic impact

• Health

th system impact

• Test accuracy

racy

• Ease of use
• Surrogat
• gate patien

ent t impor

• rta

tant nt outcom

• mes

es

• Basic cost-

comparis risons

• ns
• Comparat

arativ ive e effec ecti tiven enes ess (patient ient importa tant nt outcomes es, , case detec ecti tion

• n);

;

• Cost of diagn

gnos

• sti

tic proces ess and treatm tmen ent, t, incl.

• l. for patien

ients ts

• Operati

ation

• nal

al requir uirem emen ents for implem lemen entat tatio ion n (infra frastruct ructure re and human) n)

• Provide an open platform and ensure adequate firewalls to avoid conflicts of interest
• Combining specimen banks and strong trial infrastructure to streamline the

pathway

• Trial design, planning and coordination optimized to inform policy review

FIND’s Access team accelerates uptake through a multi-pronged approach

Ensure that holistic solutions tailored to specific country needs are in place Support development of country implementation plans for solutions Strengthen country capabilities to implement and capture benefit of solutions

2 1 3

Political commitment Process & managerial efficiency Strong lab / health systems

Countr ntry y adopti tion

From tests to comprehensive diagnostic solutions

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Easy to use diagnostic

Connectivity and IT Training packages Quality assurance Impact measurement Policy & Regulatory guidance Support and supply chain

Hepati titis tis C diagnos nostic ic tests ts - Strategy gy and vision

• n to addre

ress ss globa bal l mark rket

15

16

• Hepatitis C virus causes an estimated 350,000 deaths/year
• The majority of infections and deaths occurs in low/middle-income

countries

• A large proportion of the burden of infections and also co-

infections (with HIV and TB) occurs in vulnerable populations

Sta State of the HCV disease ease

All Hepatitis C chronic carriers Patients who know their status On Treatment 170-250M

Living in LMIC Actual Ideal Actual Ideal

8% Unknown

Likely close to zero in LMICs

Global Burden of Disease Report AALSD 2013

17

Today, , HCV infect ectio ion n is severel erely y un under-diagnosed diagnosed

<8% of cases diagnosed in MICs, even less in LICs Roots of under-diagnosis include lack

• f appropriate tools & delivery issues

5 50 10

MM people

• 94%

Italy Germany France US

4

Brazil

5

Russia

3

India

12

China

48

Cases diagnosed Estimated prevalence

• 1. Low & Middle Income Countries

Source: Decision resources; UNITAID: Hepatitis C Medicines and Diagnostics in the Context of HIV/HCV Co-Infection: A Scoping Report (October 2013)

Current diagnostic algorithm is complex

• 6 different diagnostic tests needed for a total cost
• f $250-2500 per patient
• RDT screening tests are expensive (~$10) and of

highly variable quality, esp in sub-Saharan Africa NAAT-based Dx tools that are currently needed to confirm infection and & for treatment monitoring can only be performed at centralized labs

• Most low-income countries lack capacity to

conduct viral load testing

• Complicates medical management of hepatitis C

and blood-banking Current treatment regimens are complex and expensive – LMICs 1 unable to implement at scale

• Injectable IFN-based treatment can cost up to

$20k per patient plus costs of monitoring and AEs Lack of reliable data for LMICs. Available data suggests a major problem of under-diagnosis Impossible for low-income countries to diagnose and treat patients at scale

IFN-free ee treatme ment nt regime mens ns are revolut lutioniz ionizin ing g HCV care

• 1. First approval and market entry

Note: DAA: Direct Acting Antiviral; FDV: Faldaprevir; HCP: Health care professional; I-based: Interferon based; I-free: Interferon free; IFN: Interferon; NSOC: New Standard Of Care; RBV: Ribaverin; SOC: Standard Of Care; SVR: Sustained Viological Response (measure for cure effectiveness) Source: BCG

Standard of Care (SOC) IFN + RBV

SVR: 38–52%

Revolution: I-free 2 DAA +/- RBV

Better safety and efficacy – Decreased risk for discontinuation – IFN ineligibles can be treated

SVR: >90%

Evolution: Fast follower I-free 2-3 DAA

Higher efficacy – Broad cross-GT labels

SVR: >90%

> 20111 20151 20181 Oral, affordable, IFN-free regimens will allow for the first time the treatment of patients in the developing world at scale

Year of est. launch in LMICs

Sept 16, 2014 – Gilead signs licensing agreements for sofusbivir with 7 Indian generics for 91 countries November 3, 2014 – Bristol- Myers Squibb announces intention to work with licensed generic manufacturers for 90 countries

FIND’s strategy is focused on addressing challenges aro round d diagnosis nosis to meet et globa bal l goals ls

Enable a world free

• f

Hepatitis C To support the Global Hepatitis Programme in its goals: to reduce transmission, reduce the morbidity and mortality, and reduce the socio-economic impact of viral hepatitis at individual, community and population levels Long-term vision 5-year goal Strategy objectives Enable affordable and fit-for-purpose diagnosis Enable access to diagnosis Support the prevention

• f infection

Demonstrate the need and benefit of interventions for HCV

4 1 2 3

20

Detail etail: : pot

• tentia

ential for dramatic matic simpli lific ication tion of HCV diagno gnosis sis in the mid- to long ng-term erm

Current Long term Mid-term

Screening – RDT/ELISA Quantitative molecular – for confirmation of active infection Genotype Biomarker/Imaging/Biopsy – for staging +/- IL28B - for prognosis Quantitative molecular - Test

• f treatment response

Quantitative molecular - Test

• f cure

Screening – RDT/ELISA Quantitative molecular – for confirmation of active infection Biomarker/Imaging/Biopsy – for staging Quantitative molecular - Test

• f treatment response

Quantitative molecular - Test

• f cure

Screening – RDT/ELISA Qualitative– for confirmation of active infection Biomarker – Cirrhosis versus no cirrhosis Qualitative molecular - Test of cure

Cost $17-55 $20-478 $100-1,625 $17-80 TBD $17-320 $17-80

FIND wi will l prioritize itize needs s in develop elopment ment based ed on pot

• tential

tial impac act and likelih elihood

• od of FIND success

ess

Likelihood of FIND success

Core antigen test Core FIND focus FIND supports/coordinates No explicit FIND work

Key

Transform- ational Critical Moderate Low Very high High Moderate Low

• Technical feasibility
• Availability of funding
• Fit with FIND

capabilities/strategy

Impact

• Public health

impact

• Individual

impact

Improved serology tests Qualitative molecular test Improved staging test

New oppor

• rtunities

tunities for cross-sec ector

• r

collaborations aborations

22

Global bal health alth stak akeho eholder ers s are begin ginnin ning g to address ss need eds s

WHO Global Hepatitis Program, CDC Medecins Sans Frontieres Coalition Internationale SIDA and CHAI Treatment action group IVD & pharma industries UNITAID, The Global Fund Examples of stakeholders supporting increased global work on HCV

• Coordination and leadership of global efforts
• Agenda shaping and policy definition
• Monitoring and surveillance
• Provision of care & evaluation of new approaches / tools
• Advocacy for increased prioritization of HCV
• Advocacy for increased prioritization of HCV
• Price negotiations to lower cost of HCV care (early stages)
• Advocacy for increased prioritization of HCV
• Development of diagnostic platforms and drugs that could

have impact in low resource settings

• Exploring increased funding through relationship of HCV

with comorbid diseases (HIV and TB)

• Potential support for HCV via polyvalent viral load testing

24

Catalyze cross-sector partnerships Transform HCV diagnostics in developing markets Turn HCV into treatable disease globally

FIND’s objective : Unlocking a global market for HCV

WHA HAT? T? HOW?

25

Catal alyz yze product uct developme pment nt: :

Develop new partnerships with developers of diagnostics

• Build on two TPPs (Technical Product Profiles)
• Products developed and launched in 3-5 years

Develop partnerships with pharmaceutical manufacturers

• Build on business case and win-win for collaboration
• Expand access to treatment through diagnostics

Conceptualize and develop a “Public-Private Funding Consortium”

• Develop an investment case
• Increase investments in development of cost-effective HCV diagnostics

Opportu tunit nities ies for collabo aborations rations 2014/ 14/15

26

Guide de use and policy cy Accelerate access

Ensure early inclusion of key partners (e.g. WHO, CDC, MoH)

• Catalyze development of target product profiles (TPPs)
• Ensure engagement in WHO processes

Shape the agenda

Advocacy to raise awareness for HCV solutions & investments

• Convene 1-2 meetings in 2014/15 with experts, industry and influencers
• Strengthen HCV initiative (movement) with partners and patients
• Develop strong advocacy story based on existing technical knowledge

Opportu tunit nities ies for collabo aborations rations 2014/ 14/15 (Cont.)

• nt.)

27

Shape the agenda

2014

• AASLD, Boston, 7-11 Nov’14
• Pre-meeting at the 13th DrAG meeting, Boston, 11 Nov’14
• The Global Fund Board Meeting, 20-21 Nov’ 14
• UNAIDS Program Coordinating Board (PCB), 9-11 Dec’14

2015

• WHO Executive Board, Geneva, Jan’15
• World Economic Forum (WEF), Davos 21-24 Jan ‘15
• World Innovation Summit for Health (WISH), Doha, 17-18 Feb ’15
• FIND Board meeting, Geneva, Mar’15
• The Global Fund Board Meting, 31 Mar’15 - 1 Apr’15
• EASL Meeting (EU Assoc. for the Study of Liver Disease), Vienna, 22-26 April
• WHO World Health Assembly (WHA), Geneva, May‘15
• The Forum’s 2015 National Summit on HCV and HIV Diagnosis, Prevention and Access to Care,

Washin ington,

• n, 4-6 June ‘15
• UN General Assembly (UNGA), New York, Sep t’15
• World

d Hepatitis s Summ mmit, , Glasgo gow, 2-4 September ‘15

Opportu tunit nities ies to c contin inue ue dialog

• gue

e in 2014/ 14/15

28

Drama matic tic imp mproveme ements nts in Hepatitis titis C trea eatm tment ent hold ld the e pot

• tential

ential for cur uring ng this s deadl adly y diseas ease e imp mpact acting ng est. . 170-250M 250M peopl ple e global bally ly New w diagnos nostics tics are neede eeded d to ful ully y bene nefit t from m these ese trea eatm tmen ents ts especia ecially lly in develop eloping ing coun untr tries ies FIND IND is dedi s dedica cated d to working king with th partne ners to Catalyze lyze diagnos

• sti

tic developme elopment nt, , Guide de use e and policy cy, , Impro prove e access ss and d Sh Shape pe the e agend nda a Today y is an imp mpor

• rtan

tant t step towar ards ds bui uilding ding the e cross ss-sect sector

• r

partne nershi hips neede eeded d for r inno novat ative e diagnost gnostics ics so solutions utions Our ur goal is to conti ntinue nue to collabo abora rate e with h ur urgenc ency y to bene nefit t Hepatitis titis C patients ents in need ed aroun und the e worl rld d

Summar ary y --

• - and going

g forward

29

Tha hank nk you!

Q & & A : Unloc locking king a global al mark rket et for Hepatitis titis C

30

Simila ilar r Peak k in HCV Prevalen alence ce at Age 55 (Glo lobally) bally)

2005

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Mohd Hanafiah; Hepatology 2013; 57:1333