Download Hepatitis C and injecting drug use an overview.

Hepatitis C and injecting drug
use an overview.
Vivian Hope,
Centre for Infectious Disease Surveillance and Control,
Public Health England.
National Intelligence Network meeting on the health harms associated
with drug use 04/06/14.
Reported laboratory diagnoses of
hepatitis C infection: England
Total number of reports: All exposures and exposure not known.
Proportion of the reports with exposure data, in which injecting drug use was indicated#
100%
Number of reports
10,000
80%
8,000
60%
6,000
40%
4,000
20%
2,000
0
0%
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Proportion of reports with risk information
associated with IDU#
12,000
# Data on exposure is often incomplete or missing.
HCV in UK report, 2013; Shooting Up, 2013.
Hepatitis C among people who inject
psychoactive drugs
Rate of sharing
Anti-HCV prevalence
100%
80%
60%
40%
20%
0%
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
UAM Survey of PWID Data Tables, 2013.
Risk & Incidence
The number of adults that had ever injected receiving drug treatment
has increased by a third (from 84,216, 2005/06 to 111,939, 2011/12).
The vast majority of PWID asked report recent use of a needle & syringe
programme (NSP) (83% in 2012, UAM Survey).
NSP coverage needs to be improved in England as in 2012:
• Only about half of PWID report that the number of needles they had
received was greater than the number of times that they had injected
(47% during preceding four weeks, UAM Survey).
• One-third of PWID report injecting with a previously used needle that
they had attempted to clean (33% during last 28 days, UAM Survey).
Preliminary data from UAM Survey from 2011-12 indicated that of those
who had potentially been at risk of acquiring hepatitis C, 3.3% (95% CI,
2.6%-4.1%) had been infected. Suggesting an incidence of between
7 and 20 infections per 100 person years of exposure in England,
Wales and Northern Ireland.
HCV in UK report, 2013.
Hepatitis C among people who inject
image & performance enhancing drugs
 Prevalence of hepatitis C is lower
those injecting
 among
psychoactive drugs
 Around one in 20 people who
 image & performance enhancing
have ever been infected
 drugs
with hepatitis C.


 1.5% are living with HIV
 5.5% have been infected with hepatitis C
 8.8% have been infected with hepatitis B
Only 9% of those who inject image and performance enhancing drugs
reported ever sharing injecting equipment.
Shooting Up, 2013.
Uptake of voluntary confidential testing
for hepatitis C: England
Proportion aware of their hepatitis C infection
People who inject
psychoactive drugs
Voluntary confidential testing uptake
Proprtion of those tested, tested during preceding two years
100%
80%
60%
40%
20%
0%
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
Only 22% of those who inject image and performance enhancing drugs
report uptake of voluntary confidential testing for hepatitis C.
HCV in UK report 2013, Shooting Up 2013.
Acknowledgments: Fortune Ncube, Katelyn Cullen, Helen Harris & Sema Mandal at
the Centre for Infectious Disease Surveillance and Control.
Thank you.
Opt-out BBVs testing policy
in prisonspublic health opportunities & challenges.
Dr. Autilia Newton
Deputy Director for Health & Justice, PHE
Prevalence of disease: prison/community
2
PWID, HCV and Prisons
•Injecting drug use continues to be the most
important risk factor for HCV infection in the UK.
•Data from the Unlinked Anonymous
Monitoring (UAM) survey of people who
inject drugs (PWID) suggest that levels of
infection in this group remain high in 2012
(49% in England, 34% in Northern Ireland
and 33% in Wales);
•Two-thirds (69 %) of prisoners have used at
least one drug during the year
•About one third of all people treated for
substance misuse in England are treated in
prisons (60,000 prison clinical drug treatment
episodes p.a./197,110 community treatment
contacts 2011-12);
•So prisons are a good setting to test and treat
people for BBVs, especially HCV.
•Trend in HCV prevalence* among PWID in England
& Wales: 2002-2012
‘Community Dividend’ for public health
interventions in prison populations
•
Underserved populations passing
through prison estate ~160,000 per
year;
•
Often belong to wider social groups
and networks contributing
significantly to health inequalities
generally;
•
Delivering health interventions in
prisons not only benefits prisoners’community dividend’ in addressing
issues in underserved populations
generally.
BBV testing data in prisons
Prison Health Performance Quality Indicators (PHPQIs)
 Collated quarterly by NHS Trust Development Authority
 Collects data on number tested and percentage of hep C tests performed out of total
number of receptions in that year
• PHE Sentinel Surveillance of BBV testing
 Reports on trends in BBV testing across England in the 24 participating laboratories
• Genitourinary Medicine Clinic Activity Dataset (GUMCAD)
 Captures all STI diagnoses & sexual health service use in GUM clinics
 “Z” code introduced in 2011 to capture offender data
• PHiPs reports
 PHiPs Team receive reports on positive cases of hep B and C in prisons
5
What we know …….
Trends in individuals tested and testing positive for HBsAg, anti-HCV and HIV 2008-2012
Source: PHE Sentinel Surveillance of BBV testing (across England in the 24 participating laboratories N:
submitting = Apx 39 prisons)
2008
2010
2011
2012
Total
No.
tested
No. +ve
No.
tested
No. +ve
No.
tested
No. +ve
No.
tested
No. +ve
No.
tested
No. +ve
No.
tested
No.
+ve
HBsAg
2,415
38 (1.5%)
2,992
42 (1.4%)
2,860
31(1%)
3,463
52
(1.5%)
3,441
60
(1.7%)
15,171
223
(1.4%)
AntiHCV
2,902
592 (20%)
3,384
563
(16.6%)
3,171
469
(14.7%)
4,432
523
(11.8%)
4,267
456
(10.6%)
18,156
2,603
(14%)
631
8
915
10
1,156
7
1,946
11
2,131
14
(0.6%)
6,779
50
(0.7%)
HIV
6
2009
PHiPs Team reports (+ve hep B)
7
2010
2011
2012
2013
Hepatitis B
acute
2
2
1
0
Hepatitis B
chronic
22
45
93
94
PHiPs Team reports* (+ve hep C)
* The increase in reports is partly due to the improved reporting system of infectious diseases by HPTs
Hepatitis C
acute
Hepatitis C
Hepatitis C
(PCR –
confirmation of
infection)
8
2010
2011
2012
2013
0
1
0
2
106
289
417
735
9
89
205
670
SOPHID
During 2011:
9
•
196 patients who attended HIV care were resident in a prison at that time
•
481 patients who attended HIV care in 2011 were prisoners at any given
time
•
From 2006-2011, 735 people were resident in prison at the time they
attended HIV care services
PHPQI hepatitis C testing data
10
PHPQI data
2012-13
Total Receptions
Hep C Tests
% Hep C tests performed
England total
196,374
12,322
6.3%
Receptions to English prisons in 2012
who received a hepatitis C test
Hepatitis C test results are
known to be under-reported
Public Health England (2013). Hepatitis C in the UK: 2013 report.
http://www.hpa.org.uk/Publications/InfectiousDiseases/BloodBorneInfections/HepatitisCInTheUK/1307HepatitisCintheUK2013report/
11
Hepatitis C in the UK
12
Care pathways are being developed but we
need to do more…
In the 2011 survey of hepatitis C services in English prisons,* 82/110
responding prisons (74%) had a written pathway in place to describe what
happens following a positive hepatitis C result.
National audit** suggests that the most common model of service delivery
in English prisons is hospital outpatient care (52% of prisons), followed by
hospital in-reach (43%) and GP led care (5%)
*Department of Health, Health Protection Agency. National survey of hepatitis C services in prisons in England, 2012. (2012).
Available at: http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/PrisonInfectionPreventionTeam/Guidelines/
**Humphrey C, Professor Lombard M, Dr Newton A, Dr O'Moore E, Railton C. (2013). Public Health England, Department of Health. An audit
of Hepatitis C services in a representative sample of English prisons, 2013.
Available at: http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317139084753
Hepatitis C in the UK
13
Tripartite Agreement: NOMS, NHS England & PHE
•
Published October 2013:
www.justice.gov.uk/about/noms/working-withpartners/health-and-justice/partnership-agreement
•
•
Sets out the shared strategic intent
and joint corporate commitments in
the commissioning, enabling and
delivery of healthcare services in
adult prisons in England.
The agreement follows the reforms to
the Health System in England from April
2013 and replaces the previous National
Partnership Agreement between the
Department of Health and HM Prison
Service (2007). It will remain a live
document updated as required but
substantively reviewed once a year and
will be overseen by a shared Prison
Healthcare Board (England).
TB Oversight Group Meeting, January 2014
•
The agreement sets out:
•
respective roles and objectives of
each organisation in commissioning,
enabling and delivering prison
healthcare services (including
substance misuse services)
•
shared principles and objectives
•
shared development objectives
•
joint governance arrangements
•
Agreed approaches, shared outcomes
and joint principles;
•
Identified 12 specific developmental
priorities on which to work in 2013/14:
14
Tripartite Agreement: Joint Developmental Priorities for 2013-14
•
Developing core service specifications for
prison health and wellbeing services.
•
Developing Information Sharing Agreements
and processes to drive transparency and
continuous improvement of services.
•
Reducing smoking amongst prisoners and
supporting the development of smoke free
prisons.
•
Reviewing the prescribing and abuse of
prescription medications.
•
Improving continuity of care across
transitions;
•
Reviewing multi-agency approaches to
managing serious risk of harm.
•
Reviewing the current commissioning
arrangements for healthcare services in
private finance initiative (PFI) prisons.
•
Reviewing the current arrangements for the
provision of integrated health and social care
services for prisoners.
•
Reviewing & clarifying future responsibility for
the funding of specific healthcare assets and
enabling services.
•
Improving the detection and management of
tuberculosis among prisoners at or near
reception.
•
Testing ‘through the gate’ substance misuse
services as part of the Transforming
Rehabilitation Strategy.
•
Implementing an ‘opt out’ policy for testing for
blood-borne viruses (BBVs) and developing care
pathways for those found to be infected.
Our objective:
•
To oversee the implementation of the joint development priority number 12
of the tripartite agreement:
NHS England, NOMS and PHE will work together to design and
deliver an appropriate ‘opt out’ model of testing for BBVs by
April 2014
How?
To design a template pathway with accompanying supporting
documents for the prison estate, and provide guidance to
stakeholders, including commissioners and service providers.
15
BBV Opt-out Testing policy
Moving from “at risk selective policy”
Universal offer of testing
16
BBVs in Prisons- Primary Care Conference Birmingham May 22 2014
Opt-out BBVs (Hepatitis B, hepatitis C and
HIV) testing policy
• BBVs testing to be recommended to all prisoners
• Prisoners to “opt-out” (i.e. refuse one/more/all tests) if do not wish to
be tested
• Policy should increase considerably (example of antenatal HIV &
Hep B testing) both offer and up-take of testing (current Hep C
testing up-take in prison at around 6%)
• Policy should result in rationalisation of BBVs testing in prisons,
avoiding repeated, unnecessary testing
• “Getting it right” in the remand prisons, should leave little testing to
do in the training prisons
17
BBVs in Prisons- Primary Care Conference Birmingham May 22 2014
Opt-out BBVs (Hepatitis B, C and HIV)
Testing Algorithm
All new arrivals (within first month of arrival)*
Hepatitis B
*BBV testing should be recommended to all prisoners, including those already in prison
Vaccination status
Recorded: complete
course
Recorded:
incomplete course
Vaccination status
unknown
HBsAG (one off test) + 1 dose
vaccine
HBsAG (one off test)
+ 1 dose vaccine
(if incomplete course)
Negative
(complete
vaccination
course if
necessary)
Unvaccinated
Positive
Positive
Negative
Suspend vaccination & refer
for further testing to specialist
service
Immune
Reassure + harm
minimisation. Complete
course if incomplete
vaccination. No need to
repeat test. Remember 4th
dose at 1 year, ideally a
booster at 5 years
Complete vaccination
course
© Crown copyright
Hepatitis C
HIV
BBV testing should be recommended to all prisoners, including those
already
in prison
HCV
Ab test
BBV testing should be recommended to all prisoners, including those
already
in prison
HIV (Ag
+Ab P24)
test
[screening test- shows exposure]
NEGATIVE
POSITIVE
NEGATIVE
POSITIVE (both/either test)
Confirmed by confirmation
test
Reassure+
Harm minimisation
Refer to specialist service
PCR/Ag test
(same sample)
[confirmation testshows infection]
NEGATIVE
POSITIVE
Reassure + harm
minimisation
Reassure +
harm
minimisation
Acute\chronic
infection
Repeat risk
assessment
(and recommend
test)
after each risk
event or
every 12 months
Repeat risk
assessment
(and
recommend
test)
After each risk
event or every
12 months
Refer to
specialist
service
Repeat risk assessment
(and recommend test)
After each risk event or every
12 months
© Crown copyright
Pathfinder prisons
• We know that there are currently exemplars of good
practice in the prison estate;
• Innovative programmes including use of DBST, in-reach
treatment programmes, opt-out testing protocols etc.;
• Need to ‘learn from doing’- identification of ‘pathfinder
prisons’ by NHS England, NOMS & PHE during 2014-15
on rolling implementation;
• From experiences there, will inform roll-out across entire
prison estate.
20
Pathfinders so far
Y&H – Leeds & Hull
North West (Manchester, Kirkham, Forest Bank , Buckley
Hall)
East Midlands (Nottingham, Ranby, Leicester, Stocken)
South West (Dartmoor, Bristol, Channing Wood, Eastwood
Park, Leyhill, Earlstoke)
21
Access to treatment for HCV
Factors influencing access to treatment
• Access to specialist service & type of service (in-reach/out-reach)
• Waiting time (currently 18 weeks but new service specification
proposal of 6 weeks)
• Suitability of patient for treatment
• Willingness of patient to undertake treatment
• Side effects
• New drugs
22
BBVs in Prisons- Primary Care Conference Birmingham May 22 2014
Treatment demand
Impact assessment being looked at currently – AT level …..
• What will be the demand, hep C as an example:
o Of 100 people tested apx. 70 will have used drugs = 70 people (Ref: Stewart et al
2008, 68% had used an illicit drug in the past year and 40% had injected a drug during the four-week period prior to custody)
o Of the 70 apx. 50% known to be +ve = 35 people
o Of the 35 apx. ¼ clear naturally = 27 people
o Of the 27 apx. half be referred for specialist asst = 14 people
o Of the 14 apx. ½ will be assessed = 7 people
o Of the 7 apx. ½ will commenced treatment = 4 people
o Approximately 4% of people entering prison will go on to access
treatment
23
Monitoring the implementation: H-JIPs
• Pathfinder prisons: Recommend testing for HBV/HCV/HIV to
ALL eligible prisoners within 4 weeks of reception
• HCV PCR test to be requested on ALL HCV ab +ve tests
• All prisoners found to be chronically infected with Hepatitis B
and/or Hepatitis C to be referred to a specialist service and seen
within 18 weeks of referral
• All prisoners found to be HIV +ve to be referred to a specialist
service and seen within 2 weeks of referral
24
Things to consider:
25
•
Many people diagnosed in prison
will not commence treatment in
prisons;
•
Modality of testing : venous blood;
DBST; saliva testing (NOT
recommended)
•
Some prisoners might start
treatment in prisons but finish it in
the community;
•
Training of prison staff-health care
& wing staff:
• Impact of ‘bench-marking’.
•
Link with services in the community •
essential to construct appropriate
care pathway;
•
Complexity of commissioning;
•
Specialist service model provision
(in-reach vs referral out)
•
Promotion materials
(leaflets/posters): no specific fund
available for new material, but
prisons already accessing material
currently available;
Data quality- SystmOne, H-JIPs,
PHE data sources.
Health & Justice Pathway England (April 2013)
Police Custody &
Courts
(Including Liaison and
Diversion)
Prison
(Remand and
Sentenced)
Adult Offender
(Male / Female)
Community Order /
Release on License
Pre or post contact
with CJS
(General Population)
NHS England
(Primary Care – GP Services)
Young Adult
Offender
(Male / Female)
NHS England
(Health and Justice
Commissioner)
Clinical
Commissioning
Group
(Secondary Care incl. Mental
Health services)
Substance
Misusing
Offender
(Male/ Female)
Local Authority
(Public Health including
Substance Misuse Services
and Social Care)
Commissioning Opportunities.
• Reducing health inequalities across most vulnerable patient
groups
• Contributing to the reduction of premature deaths
• Cost savings of BBV care further down the care pathway
through early identification and intervention
• Patient safety management and reducing risk of ongoing
transmission
• Building on improved pathways that exist in some
areas/prisons
27
Commissioning Challenges.
• Impact analysis
• Shaping the money around demand not demand around the
money
• Scoping and developing with a constrained budget
• What do we stop doing?
• Staff skills development
• Workforce availability both within prisons and secondary
care centres: In reach vs outreach
• Continuity of care
28
Conclusions
• Tackling BBVs: share partnership public health priority;
• Prison ideal setting to tackle high prevalence &
inequalities; to enable “ripple” effect in the community at
large
• Opt-out testing policy: milestone in the fight against
BBVs
• Challenges: complexity of intervention; complexity of
mechanisms to enable implementation; complexity of
links with services in the community.
29
Increased uptake and new
therapies urgently needed
Modelling the predicted impact of
treatment under different scenarios
Ross Harris
Dr. Helen Harris
Immunisation, Hepatitis and Blood Safety Department
CIDSC, PHE, London
Modelling the predicted impact of treatment
1
The burden of HCV
• Prevalence of chronic
infection in England:
160,000 adults in 2005
• HCV-related end-stage
liver disease and deaths
have increased steadily
over the last 15 years
(PHE 2013)
–Will disease burden
continue to rise?
–Can this be averted?
Modelling the predicted impact of treatment
End-stage liver disease deaths, 1996-2012
Figure reproduced from Hepatitis C in the UK: 2013
report. Public Health England (2013)
2
Back-calculation
• Basic idea:
– Estimate past incidence and numbers progressing
through a natural history model that would give rise to
the observed endpoint data
• Ingredients:
– Observed end-point data over time
HES data on ESLD, HCC; ONS HCC mortality
– Progression probabilities
Reported estimates from cohort studies
• Result:
– Predicted history of disease-stage structure
– Future predictions of disease burden
Modelling the predicted impact of treatment
3
Natural history model
δ1
Infection
Mild
Chronic
HCV
δ2
Moderate
Chronic
HCV
δ3
Cirrhosis
1-δ1-γ1
γ1
Recovery
Mortality
Non-liver
δ5
δ4
Decomp.
Cirrhosis
γ2
Mortality
liver related
δ6
HCC
γ3
HCC
Mortality
(Liver transplant states omitted for clarity)
PREDICTIONS: Currently infected population progresses toward
disease endpoints unless treated
• Successful treatment (SVR) assumed to halt progression
• Treatment failures not retreated
• Future incidence: approx 5,000 cases per year
Modelling the predicted impact of treatment
4
Key features of PHE model
• Statistical model
Back calculation model in a Bayesian framework
Progression probabilities as informative priors
• Fitted to age-specific ONS/HES data
• Assumptions of past incidence not required
(although estimate of current prevalence is used as a constraint)
 Evidence consistency
– Fits with the overall picture of observed data, current
prevalence and best estimates of disease progression
in UK-based cohort studies
Predictions under different
treatment scenarios
• Levels of treatment
–Maintaining current levels (3% treated annually*)
–100% increase over next 10 years
–Scale up to complete coverage over next 10-15 years
• Types of treatment
–Standard treatment (peg interferon and ribavirin)
37% SVR for genotype 1 and 70% non-1
Worse for older patients/more advanced disease
–Improved treatments over next 5 years
90% SVR rate, 60% in cirrhotics
*sales/dispensing data 2006-2011; Hepatitis C in the UK 2013, PHE
Modelling the predicted impact of treatment
6
Standard treatment
Improved treatment
2500
2000
1500
1000
500
0
2015 2020 2025 2030 2035 2040
2015 2020 2025 2030 2035 2040
Year
Current levels
100% increase
Rapid complete coverage
Previous treatment only
Modelling the predicted impact of treatment
7
Disease burden and treatment
• Disease burden is likely to rise in short term
• Increasing treatment levels will mitigate this, but
short-term rises seem inevitable
• Improved treatment will help to make more
immediate impact
– Currently those at highest risk of severe disease have low
probability of achieving SVR
• Swift action required as the infected population
approaches advanced disease stage
– Modelling indicates greater impact for treating sooner rather
than later
Modelling the predicted impact of treatment
8
Costs
• Existing NICE approved therapies are cost effective
EXAMPLE OF COSTS TO SCALE UP DUAL THERAPY
Total healthcare
costs of infected
population
£4680 million
over next 30 years
3% treated per year
Additional cost
under current costs
£1460 million
over next 30 years
Not as
much as
you might
think..?
Complete coverage
of treatment over
next 10-15 years
• New drugs generate healthcare savings and have greater benefits
but will cost more (cost effectiveness yet to be assessed by NICE)
Modelling the predicted impact of treatment
9
Implementation
• Diagnostic and treatment services need to be
accessible to those who need them
• If NICE recommendation of new drugs takes
place, they are still expensive
– Affordability vs. cost-effectiveness
– Advocacy and local commissioning needs to be
strong, with treatment uptake and outcome data
collected for local and national monitoring
• Oral treatment regimens with good
safety/tolerability profiles that can be rolled-out
in community settings will be key
Modelling the predicted impact of treatment
10
Is elimination feasible?
• High levels of treatment will reduce HCV prevalence as well
as disease burden
• Reduction in incidence likely
– Not modelled in this study, but has been demonstrated1
• What is the level of continued risk from injecting drug use?
– Risk of re-infection?
– To what extent is there a core group driving transmission?2
• Any core groups of transmitters would need to be reached by treatment1
– Support to help behaviour change will be key
1.
2.
Martin et al. Can antiviral therapy for hepatitis C reduce the prevalence of HCV
among injecting drug user populations? Journal of Hepatology 2011
Magiorkinis et al. Integrating Phylodynamics and Epidemiology to Estimate
Transmission Diversity in Viral Epidemics. PLOS Computational Biology 2013
Modelling the predicted impact of treatment
11
Motivation
 Specific government targets to increase healthy
life expectancy and reduce premature deaths
(The NHS & PH Outcomes Frameworks, Department of Health 2012/2013)
 Focus on liver mortality and preventable
communicable disease
 Improve health quality as well as length of life
 Addresses inequalities issues
(Healthy Lives, Healthy People, Department of Health 2010)
 Marginalised groups, current/former injectors,
minority ethnic populations
 Building a healthy future
Long term goals, but attainable and cost-effective
Is it really that hard to think 20 years ahead?
Modelling the predicted impact of treatment
12
Finally, some key questions
to ask locally…
Q Has the PHE commissioning template been used to estimate HCV
prevalence and numbers eligible for treatment in your local area?
Q Is local provision in place to promote and offer testing to people at
risk of hepatitis C infection, as recommended by NICE?
Q Are care pathways in place to ensure that diagnosed individuals
can access NICE recommended treatments and care, particularly
for those BME groups at increased risk of infection and those
diagnosed in drug services and prisons?
Q Do the needle and syringe programmes in your local area provide
an appropriate range of services with sufficient coverage, as
recommended by NICE?
Modelling the predicted impact of treatment
13
Acknowledgements
• Michael Sweeting & Daniela De Angelis
MRC Biostatistics Unit
– Original study concept
• Annastella Costella, Sema Mandal, Mary
Ramsay
Immunisation, Hepatitis and Blood Safety department, Public Health
England
– Updated analysis/study guidance
• ONS/HES data providers
Modelling the predicted impact of treatment
14
Additional slides
Modelling the predicted impact of treatment
15
Available data for England
• Hospital Episode Statistics (HES) 1995-2009
– Episodes of end stage liver disease (ESLD)
• varices, ascites or hepatic encephalopathy
– Episodes of hepatocellular carcinoma (HCC)
• HCC mortality, Office for National Statistics
(ONS) 1996-2009
– primary liver cancer or HCC (155.0 or C22.0) plus
hepatitis C infection
• Prevalence in 2005
– Evidence synthesis estimate of chronic prevalence
Modelling the predicted impact of treatment
16
Progression probabilities
Acute to chronic infection
0.738 (0.698, 0.773)
Various (pooled estimate)
Age 0–29
0.017 (0.010–0.028)
Sweeting 2006
Age 30–39
0.010 (0.005–0.025)
Age 40–49
0.016 (0.007–0.035)
Age 50+
0.054 (0.036–0.080)
Chronic HCV to moderate chronic HCV
Moderate chronic HCV to cirrhosis
Age 0–29
0.008 (0.003–0.026)
Age 30–39
0.005 (0.001–0.020)
Age 40–49
0.008 (0.002–0.029)
Age 50+
0.029 (0.010–0.079)
Cirrhosis to HCC
0.035 (0.024–0.046)
Hutchinson 2005
Cirrhosis to decompensated cirrhosis
0.065 (0.040–0.092)
Hutchinson 2005
Decompensated cirrhosis to HCC
0.068 (0.041–0.099)
Planas 2004
Decompensated cirrhosis to liverrelated mortality (not HCC)
0.186 (0.137–0.250)
Hutchinson 2005
HCC to HCC mortality
0.605 (0.545–0.676)
Hutchinson 2005
Modelling the predicted impact of treatment
Sweeting 2006
17
Limitations/assumptions
• Progression probabilities
– Comparable with other studies on average, but different age
patterns could change results
– Age-specific, but no data on progression in those infected longterm (>20 years)
• Treatment scenarios do not account for retreatment if no SVR; or re-infection
• Uncertainty of long-term outcomes in cirrhotics
• Non-HCV mortality in people who inject drugs
• Changes in incidence if prevalence is reduced
– Explicit modelling of transmission process
• Alcohol use, heterogeneity, time-dependence…
Modelling the predicted impact of treatment
18
Treatment of HCV in People Who
Use Drugs
Mark Thursz
Male Mortality 1970 - 2005
Main Causes of Liver Disease
•Alcohol
• Obesity
• HCV
• HBV
•
Other (PBC, PSC, AIH, DILI)
Rates of HCV Infection in different risk
groups
60%
50%
40%
30%
20%
10%
0%
PWID
Prison inmates (Female)
Prison inmates (male)
Immigrants (Asia)
Immigrants ((Africa)
Immigrants (E Europe)
Age-Specific Prevalence of HCV
Bruggman et al JVH 2014
Chronic HCV: mortality from both
hepatic and extrahepatic diseases
All causes
(n=2,394)
35
Cumulative mortality (%)
Liver cancer
30
(n=115)
12
30.1%*
Extrahepatic diseases
10.4%*
10
(n=2,199)
20
18
16
25
14
8
12.2%
11.0%
12
20
6
15
12.8%
12.4%
10
8
4
6
10
5
2
0
0
0
2
4
6
8 10 12 14 16 18 20
Follow-up
(Years)
4
1.6%
0.3%
0
Anti-HCV+, HCV RNA detectable
Lee MH, et al. J Infect Dis 2012;206:469–77.
19.8%†
2
4
6
8 10 12 14 16 18 20
Follow-up
(Years)
2
0
0
2
Anti-HCV+, HCV RNA undetectable
4
6
8 10 12 14 16 18 20
Follow-up
(Years)
Anti-HCV-
*P<0.001 for comparison among all 3 groups and P<0.001 for HCV RNA detectable vs. undetectable.
†P<0.001 for comparison among all 3 groups and P=0.002 for HCV RNA detectable vs. undetectable.
Incidence of HCV vs Future Prevalence
of Cirrhosis
HCV incidence has peaked but long-term consequences continue to
increase, as most people were infected 20–30 years ago
Incidence of HCV, by year
in the USA, 1982–20091
Historical and projected % incidence of
cirrhosis among HCV patients in the USA2
1. CDC. Disease Burden from Viral Hepatitis A, B, and C in the United States.
Available at: http://www.cdc.gov/hepatitis/pdfs/disease_burden.pdf. Accessed August 2013;
2. Davis GL et al. Gastroenterology 2010;138:513–21.
HCV - complications in Europe until 2030
Germany
France
Spain
England
Razavi, Waked, Sarrazin et al., J Viral Hepatitis 2014 in press
Increasing Demand for Liver
Transplants in Europe
Number of liver transplants
HCV-related cirrhosis is the commonest indication for
liver transplantation in Europe

Virus-related disease = single largest indication for liver
transplant in Europe

63% HCV-related
Year
European Association for the Study of the Liver (EASL). The burden of liver disease in Europe.
Available at: http://www.easl.eu/assets/application/files/54ae845caec619f_file.pdf. Accessed August 2013.
Growth
limited by
donor
availability
Evolution of HCV Treatment
100%
80%
IFN Mono
PEG Mono
60%
IFN + RIBA
40%
PEG + RIBA
20%
PI + PEG + RIBA
DAA x 2
0%
Genotype 1
Genotype 2&3
Genotype 4
Side Effects of Peg-IFN Ribavirin
•
•
•
•
•
•
•
•
•
Fatigue/lethargy
Pain
Depression
Suicide
Neutropaenia
Thrombocytopaenia
Diarrhoea
Cough
Thyroid dysfunction
• Anaemia
• Teratogenicity
Telaprevir Safety in Cirrhotics
(CUPIC-Wk 16)
Patients, n (% patients with at least one event)
Telaprevir
n=292
Serious adverse events (SAEs)*
132 (45.2%)
Premature discontinuation
Due to SAEs
66 (22.6%)
43 (14.7%)
Death
Septicemia, Septic shock, Pneumopathy, Endocarditis,
Oesophageal varices Bleeding,
5 (2.6%)
Infection (Grade 3/4)
19 (6.5%)
Hepatic decompensation (Grade 3/4)
6 (2.0%)
Asthenia (Grade 3/4)
16 (5.5%)
Rash (Grade 3/SCAR)
14 (4.8%)
Renal failure
5 (1.7%)
(Hézode et al., AASLD 2012)
Restrictions for use of Peg-IFN/RIBA/PI
• Ineligible
– Cirrhosis (CP-B)
– Depression
– Autoimmune disease
• Intolerant
Side Effects with DAA Regimens
Liver-related mortality or
liver transplantation (%)
SVR is associated with a reduction in
liver-related mortality and HCC
Liver-related mortality or liver transplantation
P<0.001
N=530
Without SVR
With SVR
Hepatocellular carcinoma (%)
Time (y)
Hepatocellular carcinoma
P<0.001
N=530
van der Meer AJ, et al. JAMA 2012;308:2584–93.
Without SVR
With SVR
Time (y)
SVR is associated with a reduction in all-cause mortality
International, multicentre, long-term follow-up between 1990–2003
All-cause mortality (%)
5 tertiary care hospitals in 530 advanced fibrosis/cirrhotic HCV patients
P<0.001
Time (y)
van der Meer AJ, et al. JAMA 2012;308:2584–93.
Non-SVR
SVR
IFN: interferon
Effect of Treatment Rates & Efficacy on
Mortality
Wedemeyer JVH 2014
Diagnosis & Treatment Rates
Dore, Ward & Thursz JVH 2014
Effect of Treatment Rates & Efficacy on
Prevalence
Wedemeyer JVH 2014
Reduction in HCV Prevalence Through
Treatment of IVDU
Martin et al. J.Hep 2011
Patient Cascade
100
Public
awareness
Screening
80
60
Education
in 1o care
Treatment
settings
40
20
Clinical
expertise
IFN-free
Efficacy of
new
antivirals
0
People with
HCV
People
People
People
Patients Cured
Diagnosed with Diagnosed with Diagnosed with
HCV
HCV and
HCV and
Referred for
Treated
Treatment
Where to deliver HCV Treatment
Drug & Alcohol
Clinics
Prisons
Primary Care
Secondary Care
Testing *
Testing †
Testing ‡
Testing **
Counselling *
Counselling †
Counselling ‡
Counselling **
Assessment **
Assessment **
Assessment **
Referral
Treatment **
Treatment **
Treatment **
Lab Services **
Commissioned by NHSE
* Provided by Drug & Alcohol services
Commissioned by CCG
** Provided by Secondary Care
Commissioned by PHE
† Provided by Offender Health services
Commissioned by Offender Health
‡ Provided by Primary Care services
Summary
• The majority of people with HCV in the UK are PWID
• Most people with HCV remain undiagnosed
• PEG/RBV is unpleasant, ineffective and occasionally
dangerous
• PEG/RBV is a barrier to patient being diagnosed and treated
• New drug therapy is effective, safe and side effect free
• HCV epidemic can be controlled if HCV is diagnosed and
treated
• Treatment as prevention is cost-effective
• A high proportion of PWID have spells in prison
• There are barriers to treating patients in prison / D&A centres
• You cannot impose Peg-IFN therapy on patients
Hepatitis C in the Drug
using community
The Hepatitis C Trust and Addaction
2014
• Elimination of hep C - in the drug using community
• Drug service interventions
– Workforce development, P2P education, Buddying
• Bridging the gap between drug services and hospitals
– Treatment in the community
• Testing
• Needle and syringe programmes
What we know
216,000+ living with hepatitis C in the UK
Over 100,000 diagnosed in England & Wales alone
90% of new infections from drug use
Considerable drop out along the care pathway
Large DNA rates after referral to specialist care
Nottingham study (Irving et al., 2006)
HCVAction survey estimates 30% attendance
(Harris et al., 2012)
MODELLING PROJECTIONS: CURRENT TREATMENT
RATES INSUFFICIENT TO ACHIEVE OBSERVABLE
DIFFERENCE IN HCV OVER 10 YEARS
Martin NK, et al.
MODELLING PROJECTIONS: ACHIEVABLE SCALE-UP
WOULD MORE THAN HALVE HCV PREVALENCE WITH
NEW DAAs IN 10 YEARS
Martin NK, et al.
ELIMINATION IN CORNWALL
Currently treating 16 PWID of 2000 PWID
Martin NK, et al.
PWID: not a barrier to SVR in OST therapy
H. Jafferbhoy J Vir Hep 2011
Supporting Interventions
• Workforce development
– Discuss hep C with confidence
– Raise awareness, encourage safer practice
– Increased testing
– Better referral / pathway
– Better support for people for HCV
Workforce development
P2P Education
Raising awareness amongst service users
• Myths or inaccurate information that persist within drug
using communities.
• Ensure PWIDs understand the realities of hepatitis C
prevention, transmission, diagnosis, treatment and care.
Hep C Trust P2P project
• Since August 2010
• Spoken to 4000 peers
• Visited 470 services
• Continuous feedback:
– Gary encouraged me to explore my options, and I have since
– accessed specialist care
Our survey said….
• 20 service evaluations after visit
• 18 services said:
– Between 1 – 5 tests after P2P visit
• 7 services said:
– At least one went onto treatment
Buddying
• Peers trained to offer support
• Appointment companions
• One to one visits (Coffee shop)
• Text Reminder / Check in service
Buddying
Positive support between 2012 and 2013
• 185 hospital appointments for 104 service
users
• 36 of these people have been treated
• Majority of the remainder are in the care
pathway
Up scaling the interventions
• Drug and Alcohol services:
– Staff training
– Use existing network of volunteers
– Use existing volunteer management
procedures
Mobilise P2P educators and Buddies
Closing the Gap
Closing the gap between drug services and hospital referral
systems to ensure that patients make it from diagnosis
through to treatment/monitoring if that is their wish.
Fear of hospital visits – Unknown territory / Unknown staff
Stigma – Rumours of not treating PWID
Difficulty in navigating hospital admin systems
Closing the Gap
• DNA rates at hospitals post referral of PWID
– 5 hospitals contacted, ALL experienced high
DNA’s, some as high as 90%
• Solution
– Buddying
– Treatment at the drug service
The evidence is compelling
• WSM Treating in the community!
• Identified huge DNA with CCG
• Part time Nurse comes to drug service
runs clinic
• Currently approx. 20 on treatment
CURRENT HCV TREATMENT RATES AMONG PWID:
4-FOLD DIFFERENCE IN UK SITES
PWID
Population
SITE
Estimate
(min, max)
Bristol
3200 4400
East London 2400 6000
Manchester 2300 4000
Nottingham 1300 2500
Plymouth
110 2000
Tayside/Dundee 2000 3000
North Wales 1700 3400
HCV chronic
prevalence
(min, max)
37%
37%
48%
37%
30%
20%
27%
48%
48%
56%
44%
37%
27%
33%
PWID HCV Rate per 1000
Treatments
PWID
per year
(min, max)
18
25
63
32
17
34
18
4.1
4.2
15.8
12.8
8.5
11.3
5.3
5.6
10.4
27.4
24.6
15.5
17.0
10.6
Defined PWID as on OST or injected <3 years
Martin NK, et al.
Moving into DAA
Treatment
• Community
• Offered alongside
treatment
methadone
prescribing
• Small upscale in
treatment – big
• Possibility of
impact
Directly Observed
Therapy (DOT)
• Treatment of PWID
as prevention
Testing
• What is an offer?
– SU often unable to attend testing next door
– Testing at single point of contact (DBST)
• What is a referral?
– Why do drug services test only to send SU to GP for
further referral and test?
Testing
• Scotland says:
“If you can test or read a test result you can
refer”
• 81% of tests are carried out by support workers, without clinical
qualifications
• Less burden at GP surgeries
NSP Aims
Ensure adequate coverage of needles,
syringes and paraphernalia:
100% coverage of Needle provision:
• through pharmacies
• at one stop drug services
NSP Reality
• Service users are encouraged to stick to
prescribed OST and not use street drugs
• Service user has to collect Needles from the
same building as prescribing
• Service user goes to pharmacy for Needles
where no intervention is encouraged
NSP
• European NSP Guidance:
“Obtaining the trust of the clients ... is essential for the
prevention of infectious diseases”
Many NSP’s are run by service users in Europe
One day
• DAA’s, The Cure will be available to all
• Largely administered within Drug services
– Possibly alongside OST (DOT)
• Hep C will be eliminated
• We need to lay the groundwork
– Changing the peer message in the community
– Better communication between services
Call to Action
• Educating Consultants on PWID
– If not treating, why not?
• Push for treating in the community
– Encourage NHS Staff to leave the hospital
• Treatment Benchmarks to meet our aims
– How many do you need to treat to have
impact
Call to Action
• Direct referrals should be encouraged
• Peer networks utilised
• Independent NSP
“ANYONE SHOULD BE ABLE TO ACCESS
TREATMENT IF THEY WISH – EVEN THOSE
STILL INJECTING DRUGS OR ON OPIOID
SUBSTITUTES”
The Hepatitis C Trust
[email protected].
uk
27 Crosby Row
London, SE1 3YD
www.hepctrust.org.uk