Direct-Acting Antivirals Drastically Simplify HCV Diagnosis and Monitoring

38 Pages·2015·6.56 MB·English

by  Lei Chou

HCV Webinar Series
Webinar #2:
Direct-Acting Antivirals Drastically
Simplify HCV Diagnosis and
Monitoring
Senior Scientific Officer, Hepatitis and HIV,
Presenter: Dr. Teri Roberts,
FIND (Foundation for Innovative New Diagnostics), Geneva
FIND
TAG HCV Webinar Series:
Direct Acting Antivirals Drastically Simplify HCV
Diagnostics and Monitoring
Teri Roberts
Scientific Officer for HCV & HIV
[email protected]
10 December 2015
Introduction to FIND
Why Diagnostics Matter

Diagnosis equals knowledge:
To enable accurate treatment, to target
healthcare interventions, and to measure
progress.
Enable control, elimination and eradication of diseases.
•  The global community needs diagnostics to target interventions,
identify outbreaks, and monitor progress towards goals.
Turning Complex Diagnostic Challenges
Turning Complex Diagnostic Challenges
Into Simple Solutions To Transform Lives
Into Simple Solutions To Transform Lives
FIND
Catalyze Guide use Accelerate
development access
& policy
• Dynamic needs • National policy
• Clinical trials
definition
• Define evidence
• Rollout plans
• Support program
needs
for manufacturers
• Support WHO • Gaps analysis and
• Scout technology
development solutions
• Match-make of guidelines
• Specimen • QA tools
and strategies
repository
Shape • Measure and communicate impact of Dx
agenda • Shape Dx ecosystem to foster willingness to invest
• Lead global discussion on emerging Dx topics

SCIENCE PRODUCTS SOLUTIONS PATIENTS
Working With 185 Partners Globally And
Forming Coalitions, Always With The End In Mind
Universities and Government/
Implementing
Research Industry multilateral Advocacy Clinical Trial Sites
partners
Institutes agencies
•  44 partners •  46 partners •  35 partners •  2 partners •  32 partners •  26 partners
Significant Progress Achieved In The
Last 10 Years
TB Sleeping sickness Malaria

Patients can now get drug The development of a Join t FIND-WHO efforts to

susceptibility testing rapid diagnostic test has assure the quality of rapid
High-priority target product profile for
hepatitis C diagnosis in decentralized
in 2 hours at a district helped make disease tests have increased the
settings:
hospital. This used to take elimination a reality. % of quality products in
Report of a consensus meeting
up to 120 days and was only use from 15% to 75%.

22 April 2015
available at national reference Vienna, Austria

labs.

High-priority target product profile for

hepatitis C diagnosis in decentralized
HCV: High-priority target product profile for hepatitis C
settings:
diagnosis in decentralized settings: Combined TPP for
Report of a consensus meeting

HCV diagnostics following consensus process

22 April 2015
V ienna, Austria
Why HCV diagnostics matters
HCV a significant global health problem with an
opportunity to intervene
•  185M HCV-infected people worldwide; 130-150M of them are living in resource-
limiting settings.
HCV therapy evolution
•  Up to 85% of HCV-infected will
DAA:
develop chronic disease that leads sofosbuvir,
daclatasvir,
to severe liver damages (such as
simeprevir
PI: boceprevir,
liver cirrhosis and HCC).
etc
telaprevir 2014
Peginterferon-
•  HCV causes an estimated 2011
alpha 2a
DAA
350,000-500,000 deaths/year.
2001 12 weeks
PI + PEG-IFN + SVR>90%
•  New highly efficient pan-genotypic, RBV
PEG-IFN + RBV
24-48 weeks
all-oral, IFN-free direct acting 24-48 weeks
SVR = 38-52% SVR = 63-75%
antiviral (DAA) drugs eliminate the

virus in 12-weeks course.
Lack of simple and affordable HCV diagnostic solutions
is a major barrier to large treatment access in LMIC
130-150M 1% Unknown
Likely close Actual
Actual

to zero in
Ideal
Ideal
LMICs
Living in LMIC
All Hepatitis C chronic Patients who know their
On Treatment
carriers status
•  World Health Assembly (WHA) resolution in 2014 specifically highlights the importance to
improve HCV screening worldwide.
•  WHO has HCV elimination as a goal.
India: “We need to tackle our Mozambique: “As we are Indonesia: “HCV is wiping out a
hepatitis problem, both HBV and getting our HIV problem under whole generation of people who
HCV, and this is the time to do it. better control, we see the at some point in their lives used
India will drive the treatment impact of HCV that is drugs or were unlucky to get a
availability like it did for HIV but threatening our achievements contaminated injection or blood
we need to make diagnosis but it is a silent killer and product. We can and need to
available on a larger scale to people don’t know they have it urgently intervene and
identify the patients to treat.” until it’s too late.” diagnostics are the first step!”