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@JVLazarus1 - Dec 2018
Prof Jeffrey V. Lazarus [[email protected]]
Vice-chair, EASL International Liver Foundation
Affiliated Professor, CHIP, Rigshospitalet, University of Copenhagen,
WHO Collaborating Centre on HIV and Viral Hepatitis
Associate Researcher, Miguel Servet Scholar, ISGlobal, Hospital Clínic -
University of Barcelona
Associate Professor, Faculty of Medicine, University of Barcelona
Integrated health systems
approaches for viral hepatitis
elimination
@JVLazarus2 - Dec 2018
A couple of questions as we close the meeting…
1. Do you believe that the elimination of hepatitis C as a major public health threat by 2030 is possible globally? In your country?
2. In which populations do you feel HCV elimination is most feasible in now?
@JVLazarus3 - Dec 2018
HCV treatment timeline
Sources: Pawlotsky JM, et al. J Hepatol 2016; 62: S87–99; Manns M, et al. Nat Rev Dis Primers 2017;3:1–19.
Early era of DAA’s
TVR
BOC
SMV
SOF
Identificationof HCV
IFN + RBV
The IFN era
IFN Peg-IFN + RBV
Pan-genotypic era
SOF/VEL G/P
SOF/VEL/VOX
DCVLDV/SOF
OBV/PTV/r + DSV
EBR/GZR
“DAA revolution”
“non-A, non-B”
hepatitis
1984 1989 1998 2001 2013 2014 2015 2016 2017…2011 Elimination?
@JVLazarus4 - Dec 2018
WHO Global Health Sector Strategy on Viral Hepatitis 2016–2021
Source: WHO Global Health Sector Strategy on viral hepatitis. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_32-en.pdf?ua=1 (Accessed August 2016)
28 May 2016: The first of
its kind, WHO publishes a
global strategy aiming for
elimination of viral
hepatitis as a public health
threat by 2030
@JVLazarus5 - Dec 2018
Source: WHO GHSS. http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_32-en.pdf?ua=1 (Accessed August 2016).
▪ Increase in sterile needle and syringes provided per PWID/year from 20
in 2015 to:
▪ 200 by 2020
▪ 300 by 2030
Harm reduction
▪ 90% of people aware of HCV infection by 2030
Testing targets
▪ 80% of people treated by 2030
Treatment targets
Incidence targets
▪ 30% reduction in new HCV infections by 2020
▪ 80% reduction in new HCV infections by 2030
Mortality targets
▪ 10% reduction in mortality by 2020
▪ 65% reduction in mortality by 2030
Global Health Sector Strategy HCV targets at a glance
@JVLazarus6 - Dec 2018
The continuum of viral hepatitis services and the retention cascade
Source: WHO Global Hepatitis Report, 2017. Available at www.who.int/hepatitis/publications/global-hepatitis-report2017/en/ (accessed May 2017).
@JVLazarus7 - Dec 2018
A paradigm change to eliminate viral hepatitis:The central role of people and communication
Source: Lazarus and France. A new era for the WHO health system building blocks? 2014.
@JVLazarus8 - Dec 2018
People-centred, well integrated health systems
See: http://www.who.int/servicedeliverysafety/areas/people-centred-care/en/
@JVLazarus9 - Dec 2018
• Widespread disagreement was reported between stakeholders respondents
• Results showed gaps in policies for harm reduction both within and outside
prisons
• Strategies/policies for responding to hepatitis C still lacking in the Nordic
countries
• Need for scaling up guidelines for prevention, testing, treatment, and goals for
elimination
Results
Source: Safreed-Harmon et al. PLOS One 2018
@JVLazarus10 - Dec 2018
Towards Meeting WHO Elimination Targets: Expanding the Treater Pool
Marshall AD, et al. Lancet Gastroenterol Hepatol 2018; 3:125–133.
94% of countries and jurisdictions (33/35) required a specialist to prescribe
reimbursed DAAs for HCV
• Gastroenterologist• Hepatologist• Internal medicine specialist• Infectious diseases specialist
General practitioners in England (with specialist input) and Germany can
prescribe reimbursed DAAs
Prescriber type restrictions for DAA reimbursement in Europe,
as of August 2017
@JVLazarus11 - Dec 2018
Testing/screening of HCV in non-hospital settings according to patient groups
Of the 20 countries that reported HCV testing/screening in
non-hospital settings the distribution was as below:
Other:
•NGOs (3)
•Centres for HIV/sexual
health (3)
•Mobile clinics (1)
•Outreach programmes
(2)
•Local health houses (1)
•Prisons (2)
•Anonymous screening
office (2)
•Social health care
institutes (1)
•Private laboratories (2)
•Private clinics (1)
•“Substance misuse
services” (1)Source: Lazarus et al. JIAS 2018
@JVLazarus12 - Dec 2018
Different models of HCV care are needed for different HCV subpopulations
GP: general practitionerBruggmann P, Litwin AH. Clin Infect Dis 2013;57(Suppl 2):S56–61
Models of HCV care
General population
PWID
Prison
Migrant
Drug and alcohol clinics
Primary healthcare/GP centres
Prisons
Community health centre
Harm reduction drop-in centres
Tertiary care
Multiple models essential
@JVLazarus13 - Dec 2018
Case 1. Where Would You Want To Be Treated?
Shared Addiction Care Copenhagen (SACC) Report 2017. Available at: http://www.chip.dk/Collaborations/SACC (accessed July 2018).
Former Organization Future Organization
Drug Treatment Unit
Lab
Specialized Care
Test and Treat
Drug Treatment Unit Specialized Care
Lab
@JVLazarus14 - Dec 2018
Case 2. Background: HCV testing at pharmacies project
• Based on original model of community pharmacy testing piloted by the London Joint Working Group.
• 8 machines based in the top 8 needle exchange pharmacies in Birmingham and Manchester (not all sites yet active in the two locations).
• Live from mid-July 2018
Source: Ahmed Elsharkawy, Birmingham, UK. Personal communication, Oct 2018.
@JVLazarus15 - Dec 2018
The Technology – Pin Prick Based
Can a pharmacist do this in Denmark?
@JVLazarus16 - Dec 2018
The care pathway
@JVLazarus17 - Dec 2018
Micro-elimination approach
Generally speaking, micro-elimination approaches should meet the following criteria, although these criteria may need to be adapted to different epidemiologic situations and geographic settings:
▪ There is a plan for how to tailor health resources and services to overcome known barriers and achieve high levels of HCV diagnosis and treatment in one or more clearly definable populations of interest within a specified timeframe.
▪ The plan sets forth achievable annual targets, basing these on mathematical modeling when relevant to determine the levels of diagnosis and treatment required to progress to the plan’s ultimate elimination targets.
▪ The plan is developed and implemented through a multi-stakeholder process, with essential participants including government officials, health service providers, and civil society representatives.
▪ Progress and outcomes are monitored and publicly reported using indicators selected at the outset of the process.
Sources: Lazarus JV et al. The micro-elimination approach to eliminating hepatitis C: strategic and operational considerations. Seminars in Liver Disease, July 2018.
@JVLazarus18 - Dec 2018
Case 3. Micro-elimination in action: Tayside region of Scotland
• In the United Kingdom, the Tayside region of Scotland is being used as a test bed of regional micro-elimination, using an integrated combination of pathways to target all groups infected with HCV, especially focusing on treatment of PWID in needle and syringe programs, to prove the concept of “treatment as prevention.”
• The complementary service pathways include:• conventional nurse-led outreach programmes• pharmacist-led treatment of patients on opioid substitution therapy in• community pharmacies• treatment in prisons• treatment by embedded hepatitis specialist nurses in addiction treatment
centres.
• It is anticipated that all of these services will deliver the volume of treatment modelled to reduce prevalence to below 10% and incidence to below 1% over 3 years, thereby achieving elimination.
Source: ClinicalTrials.gov. Evaluating treatment as prevention among people who inject drugs in Dundee for HCV (ERAPID HCV). Available at: https://clinicaltrials.gov/ct2/show/record/NCT03356405?view=record. Accessed 27 June 2018.-Radley A, Melville K, Tait J, Stephens B, Evans JMM, Dillon JF. A quasi-experimental evaluation of dried blood spot testing through community pharmacies in the Tayside region of Scotland. Frontline Gastroenterol 2017;8(03):221–228.-Radley A, Tait J, Dillon JF. DOT-C: a cluster randomised feasibility trial evaluating directly observed anti-HCV therapy in a population receiving opioid substitute therapy from community pharmacy. Int J Drug Policy 2017;47:126–136
@JVLazarus19 - Dec 2018
Case 4. HCV infection in Spanish prisons: JAILFREE-C
1. Cabezas J. Personal communication; 2. Cuadrado A, et al. Am J Gastroenterol 2018;DOI: 10.1038/s41395-018-0157-x; 3. Larney S, et al. Hepatology 2013;58(4):1215‒24; 4. Saiz de la Hoya P, et al. Eur J Clin Microbiol Infect Dis 2011;30(7):857‒62
▪ General and penitentiary populations in Cantabria in 2016
∼600,000 inhabitants1
431inmates in El Dueso2
▪ HCV prevalence in penitentiary population3,4
~10x higher than in
general population
22.7%in 2011
▪ Features of prison1
– Concentration of disease (infectious, psychiatric, addictions)
– Opportunities for health care
– Population at risk of infection and for spread new infections
– Release to community ‒ more transmission risk
@JVLazarus20 - Dec 2018
Efficacy outcomes1
All inmates received tx for 8‒12 weeks under direct observed therapy
Sources: Cuadrado A, et al. Am J Gastroenterol 2018; DOI: 10.1038/s41395-018-0157-xStrategic Plan for Tackling Hepatitis C in the Spanish National Health System. Ministry of Health, Social Servicesand Equality. 2015. Available at: http:// www.easl.eu/medias/files/eu/PEAHC_v2_eng.pdf https://www.msssi.gob. es/en/ciudadanos/enfLesiones/enfTransmisibles/hepatitisC/PlanEstrategi-coHEPATITISC/docs/PEAHC_eng.pdf (accesssed August 2018)
*Following current guidelines at that time. Studyperiod: May 2016 to July 2017; EOT: end of treatment;
LDV: Ledipasvir; SOF: sofosbuvir
100
92,4 95,3
0
20
40
60
80
100
EOT SVR12 (ITT) SVR12 (PP)
Pati
ents
(%
)
Evolution of prevalence
12,9
0,10
5
10
15
Baseline End of study
66/66 61/66 61/64
@JVLazarus21 - Dec 2018
12 Countries on Track to Achieve WHO HCV Elimination Targets
2017 data. CDA Foundation. POLARIS Observatory. Available at: http://cdafound.org/Polaris/ (accessed July 2018);
Not on track: elimination unachievable given present policy
Working towards elimination
On track for WHO elimination targets
UKJapan
Australia
France
Spain
Mongolia
Italy
Georgia
Egypt
The Netherlands
Switzerland
Iceland
@JVLazarus22 - Dec 2018
Acknowledgements
Contact: [email protected]
http://pathtozero.eiu.com/
All authors of all cited studies
