hcv screening in a changing scenario - virology...
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SCREENING POLICIES
ANGELOS HATZAKISProfessor of Epidemiology & Preventive Medicine, Athens University
Medical School/ Co-Chair, Hepatitis B & C Public Policy Association
1st European Roundtable on Hepatitis Cure & Eradication
Frankfurt, 9 September 2015
Disclosures
Research Grants: Gilead
Advisory Boards: BMS, Gilead
Unrestricted Grants: AbbVie, BMS, Gilead, Novartis
Co-Chair, Hepatitis B & C Public Policy Association,
supported by AbbVie, BMS, Gilead
Back to Basics
Challenges for a Screening Programme to Control or
Eliminate HCV/HBV
Is Elimination of HCV/HBV possible?
Recommendations
Conclusions
Back to Basics
Continuum of HCV diagnosis, care and treatment
HCV infected
Unaware of HCV
Screening offered
Screening accepted
Screening diagnosis
Screening results offered
Linked to care
Retained to care
Need treatment
No contraindication
Treatment cost covered
On treatment
Sustained viral response (cure)
Yehia BR et al. PlosOne 2014: 9, 7
Goals of a Hepatitis Screening, Care and Treatment
Programme
To control HCV/HBV: To decrease incidence of cirrhosis
and HCC following reduction of HCV incidence.
To eliminate HCV/HBV: Zero or near zero incidence of
HCV infection with major reduction in the incidence of
cirrhosis and HCC in a specific area.
To eradicate HCV/HBV: Zero or near zero incidence of
HCV infection with major reduction in the incidence of
cirrhosis and HCC at global level.
WHO, 2015
Challenges for a Screening Programme to
Control or Eliminate HCV/ HBV
Challenges for designing an efficient screening
programme to control or eliminate HCV/HBV
1) Knowledge of HCV/HBV epidemiology and burden of disease.
2) Issues related to the screening process (goals, testing
algorithms, testing strategy, operational and ethical problems).
3) Improvements in all steps of treatment cascade.
4) Availability of resources for testing, care and treatment (health
infrastructure, affordable care and treatment).
HCV epidemiology
1) Observational studies (prevalence, incidence, risk factors,
mortality).
2) Modelling studies for prediction of natural history, burden
of disease and economic burden.
HCC, Decompensated Cirrhosis and Transplant, 1950-2030
England, France, Germany and Portugal
Razavi H, et al. J Viral Hepat 2014; 21 Suppl 1: 34-59.
Cirrhosis, 2013-2030
England, France, Germany and Portugal
Wedemeyer H, Duberg AS, Buti M, et al. .J Viral Hepat 2014; 21 Suppl 1: 60-89.
Estimated Viremic Infections, 2013-2030
Czech Republic, Denmark and Egypt
Wedemeyer H, Duberg AS, Buti M, et al. JVH 2014; 21 Suppl 1: 60-89.
Is Elimination of HCV/HBV
possible?
Is elimination of HCV/HBV possible?
Important parametres
1) Viremic prevalence
2) Age and sex distribution of HCV/HBV
3) Diagnostic rate
4) Distribution of CHC/CHB by fibrosis stage
5) Status of primary prevention
6) Treatment rate
7) Increase in the future treatment coverage
8) Efficient testing strategy
9) Availability of resources for testing, care and treatment
infrastructure
10) Ethical issues
Historical Distribution by Age and Gender
Canada, Czech Republic, Denmark and Egypt
Bruggmann P, Berg T, Ovrehus AL, et al. Historical epidemiology of hepatitis C virus (HCV) in select countries. J Viral Hepat 2014; 21 Suppl 1: 5-33.
Historical Distribution by Age and Gender
Argentina, Finland, Greece and India
Saraswat V, Norris S, de Knegt RJ, et al. Historical epidemiology of hepatitis C virus (HCV) in select countries – volume 2. J Viral Hepat 2015; 22 Suppl S1: 6-25.
Wedemeyer et al. JVH, 2014. 21 (Suppl S1), 60-89
Distribution of CHC by fibrosis stage
Status of Primary Prevention
It is reflected in the assumed number of new HCV/HBV
infections per year in the past and up to 2030.
Past infections are estimated by various methods (back-
calculation, population surveys etc).
HBV vaccination initiation and coverage.
Increase in the future treatment coverage
Efficient testing strategy (1)
1) Risk groups
2) Age-based or birth cohort screening
3) Combination of the above
WHO Recommendation on Screening
(risk-based)
It is recommended that HCV serology testing be offered to
individuals who are part of a population with high HCV
seroprevalence, or who have a history of HCV risk
exposure/behaviour.
It is suggested that nucleic acid testing for the detection of HCV
RNA be performed directly, following a positive HCV serological
test to establish the diagnosis of chronic HCV infection, in
addition to nucleic acid testing for HCV RNA as part of the
assessment for starting treatment for HCV infection.
WHO Guidelines , April 2014
AASLD Recommendation for HCV Testing (1)
One-time HCV testing is recommended for persons born between 1945 and 1965*,
without prior ascertainment of risk (birth-cohort screening)
Other persons should be screened for risk factors for HCV infection, and 1-time
testing should be performed for all persons with behaviors, exposures and
conditions associated with an increased risk of HCV infection (risk-based screening)
Risk exposures: • Long-term hemodialysis (ever)
• Getting a tattoo in an unregulated setting
• Healthcare, emergency medical and public safety workers after
needlesticks, sharps or mucosal exposures to HCV-infected blood
• Children born to HCV-infected women
• Prior recipients of transfusions or organ transplants, including persons who
1) were notified that they received blood from a
donor who later tested positive for HCV infection, 2) received a
transfusion of blood or blood components or underwent an organ
transplant before July 1992, 3) Received clotting factor
concentrates produced before 1987
• Persons who were ever incarcerated
*Regardless of country of birth
AASLD Recommendation for HCV Testing (2)
Risk behaviors: • Injection-drug use (current or ever, including those who inject once)
• Intranasal illicit drug use
Other: • HIV infection
• Unexplained chronic liver disease and chronic hepatitis, including
elevated alanine aminotransferase levels
• Solid organ donors (deceased and living)
Risk-based screening
Practitioner-based targeted (risk-group) screening is more
efficient in terms of screening uptake and cases detected.
The less efficient strategy is the media/information based
intervention.
(Aspinall et al. 2015)
Anti-HCV positive patients according to year of birth.
An increase in the anti-HCV prevalence cannot be observed either in
the US American or in the German baby boomer generation
Wolffram I et al. J Hepatol 2015; 62, 6: 1256
Efficient testing strategy (2)
Martin NK et al. Hepatol 2013. 58: 5
Treatment as prevention
Wedemeyer H et al. JVH. 2014, 21
Gane et al. JVH, 2015. 22, (Suppl S1), 46-73
Types of screening programmes
Integrated: Screening programmes that are integrated within
already existing health care facilities (STD clinics, HIV/STD
service providers, sexual and reproductive health clinics,
emergency departments, community centers, prisons, health
clinics, public laboratories, occupational physicians etc).
Non-integrated: Screening programmes that are exclusively
set up for screening (community health clinics, private practice
offices, outreach community screening, city programmes,
schools etc).
Cost and cost-effectiveness studies (1)
1) Increasing number of CE studies of chronic HCV
treatment with interferon free regimens.
2) Few cost-effectiveness (CE) studies with interferon free
regimens to assess HCV screening.
Cost and cost-effectiveness studies (2)
Intervention: PegIFN-Riba-Sofosbuvir or Sofosbuvir-Riba
compared to PegIFN-Riba-PI
Population: US population aged older than 20 (birth cohort
screening)
Result 1: Sofasbuvir regimens reduced deaths by 80682 at an
incremental cost of 26.2billion.
Result 2: The ICER was estimated 47,304 USD/QALY gained.
Result 3: The ICERs were decreasing with decrease cost of
treatment, better post-SVR quality of life, advanced fibrosis
stage.
Rein DB et al. CID 2015
Cost and cost-effectiveness studies (3)
Intervention: Sofosbuvir-Ledipasvir compared with PegIFN-Riba-PI
therapies, in the US population.
Result 1: Sofosbuvir-Ledipasvir therapies have an incremental cost-
effectiveness ratio (ICER) 55400 USD/QALY
Result 2: Sofosbuvir-Ledipasvir compared with interferon based
therapies would cost an additional 65 billion USD with savings of
16 billion USD.
Result 3: ICERs were decreasing with decreasing cost of treatment,
better post-SVR quality of life, advanced fibrosis stage, decreasing
age and in females.
Chhatwal J et al. Ann Intern Med. 2015
Ethical issues
1) Stigma
2) Inequalities
3) HCV/HBV screening should be connected with
affordable care and treatment
4) Screening and treatment in balance with primary
intervention
Recommendations
Considerations for the implementation of successful screening programmes for
HBV and HCV
Develop clear public awareness campaigns targeted at the general public and at risk groups.
Need a clear clinical strategy to deal with HBV- and HCV-infected persons.
Revise clinical guidelines to endorse HBV and HCV screening in specified risk groups and
reinforce dissemination of best practices for case finding.
Integrate screening into existing public health and care practices whenever possible.
Conduct HBV and HCV screening in HIV/AIDS clinics, prisons, drug user services as
well as in primary care clinics.
Simplify screening criteria, e.g. adopt age-based criteria for HCV, birth place for HBV with
the aim of providing clear guidance to GPs and those screening patients.
Educate providers about the needs for screening and about the management pathways for
HBV- and HCV- infected individuals.
Always carry out screening in an evidence-based way that defines when and how often
screening should be offered and respects the human rights of those screened.
Always accompany screening with appropriate counselling of the individual and his or her
family.
In the case of marginalized or stigmatized groups such as migrants or IDUs, one must
ensure that individuals are not stigmatized because of their group membership or their viral
hepatitis status.
Hatzakis A et al. JVH 2011, 18 (supp.1)
Conclusions
Conclusions
A screening/treatment strategy aiming to eliminate HCV/HBV should optimize all steps of treatment cascade.
The epidemiologic profile of HCV/HBV in many developed countries is favourable for elimination of new infections, cirrhosis and HCC, assuming increased screening uptake and treatment coverage of DAAs.
Elimination of new HCV infections by increased coverage of screening/treatment will be facilitated with an HCV vaccine, in groups where HCV is hyperendemic (IDUs).
The main barrier of screening/treatment expansion is cost, although the rapidly fallen treatment prices suggest that large and effective screening programmes are feasible in the near future.
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