ELIMINATION OF HBV AND HCV - hepbcppa.org€¦ · Epidemiologic Update WHO Strategy for Viral...

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ELIMINATION OF HBV AND HCV -April 2017- ANGELOS HATZAKIS, MD PROFESSOR OF EPIDEMIOLOGY & PREVENTIVE MEDICINE NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS MEDICAL SCHOOL GEORGE PAPATHEODORIDIS, MD PROFESSOR IN MEDICINE AND GASTROENTEROLOGY NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS MEDICAL SCHOOL

Transcript of ELIMINATION OF HBV AND HCV - hepbcppa.org€¦ · Epidemiologic Update WHO Strategy for Viral...

Page 1: ELIMINATION OF HBV AND HCV - hepbcppa.org€¦ · Epidemiologic Update WHO Strategy for Viral Hepatitis Elimination •Overview •Vision and Goal ... Prevalence of HBV infection

ELIMINATION OF HBV AND HCV

-April 2017-

ANGELOS HATZAKIS, MD PROFESSOR OF EPIDEMIOLOGY & PREVENTIVE MEDICINE NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS

MEDICAL SCHOOL

GEORGE PAPATHEODORIDIS, MD PROFESSOR IN MEDICINE AND GASTROENTEROLOGY

NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS MEDICAL SCHOOL

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Definitions

Epidemiologic Update

WHO Strategy for Viral Hepatitis Elimination

• Overview

• Vision and Goal

• Targets

• Framework of Action

• Strategic Directions 1-5

“Diagnostic” Checklist for HCV/HBV Elimination

HCV Elimination in EU-28

HCV Elimination Manifesto “Hepatitis C-Free Europe”

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DEFINITIONS

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Control, Elimination, Eradication of HBV/HCV

To control HCV/HBV: To decrease incidence of new infections, cirrhosis and HCC

To eliminate HCV/HBV: Zero or near zero incidence of new infections with major reduction in the incidence of cirrhosis, HCC and deaths in a specific area

To eradicate HCV/HBV: Zero or near zero incidence of new infections with major reduction in the incidence of cirrhosis, HCC and deaths at global level

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EPIDEMIOLOGICAL UPDATE

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Cumulated incidence of chronic HBV infection, 2015 (prevalence of HBsAg in children under 5 years) after the use of the vaccine by WHO region: about 1.3% of under-5 children have

developed chronic HBV infection

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Prevalence of HBV infection (HBsAg) in the general population by WHO region, 2015: the WHO African and Western Pacific regions have the highest prevalence

and the largest number of persons living with HBV

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Incidence of HCV infection in the general population, by WHO region, 2015: 1.75 million new infections in 2015

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Prevalence of HCV infection (HCV RNA positive) in the general population, by WHO region, with uncertainty intervals, 2015:

71 million living with HCV worldwide

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The results of the global prevalence study were published in Lancet Gastroenterology and Hepatology

- The Polaris Observatory HCV Collaborators, Blach S, Zeuzem S, et al. Global prevalence and genotype distribution of

hepatitis C virus infection in 2015: a modelling study. The Lancet Gastroenterology & Hepatology 2016; Under Review.

The global prevalence of viremic HCV was 1·0% (95% uncertainty interval 0·8–1·1) in 2015, or 71·1 million (62·5–79·4) viremic infections.

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Genotype distribution by GBD region

The Polaris Observatory HCV Collaborators, The Lancet 2017

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Deaths from viral hepatitis, by virus and types of sequelae, 2015: most viral hepatitis deaths are due to the late complications

of HBV and HCV infection

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WHO STRATEGY FOR VIRAL HEPATITIS ELIMINATION

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First Global Health Sector Strategy on Viral Hepatitis Elimination

was approved by WHO General Assembly (May 2016). It is based on

previous WHO General Assembly resolutions in 2010 and 2014.

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Estimated global number of deaths due to viral hepatitis, HIV, malaria and TB, 2000-2015

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Overview

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Vision and Goal

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Targets for reducing new cases of and deaths from chronic viral hepatitis B and V infection

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Service coverage indicators for the core interventions of the Global Health Sector Strategy (GHSS) on viral hepatitis:

2015 baseline and targets

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WHO-EURO Regional Targets up to 2020

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Summary of the 2015 baseline estimates of the indicators of the global health sector strategy on viral hepatitis, be region

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Strategic Directions 1-5

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Strategic Direction 1: “Who and Where”

1.1 Data for Informed Decisions

• Surveillance

• Hepatitis indicators

1.2 Evidence-based National Planning

• National Action Plans

• National Governance Structure

• Monitoring and evaluation mechanisms

• Awareness campaigns and communication strategies

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WHO, MONITORING AND EVALUATION FOR VIRAL HEPATITIS B AND C-RECOMMENDED INDICATORS AND FRAMEWORK- TECHNICAL REPORT

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Strategic Direction 2: Interventions for Impact. The “What”

PREVENTION 2.1 HBV immunization and prevention of mother-to-child

transmission

2.2 Blood and Injection Safety

2.3 Prevention of Transmissions Associated with Injecting Drug Use

2.4 Prevention of Sexual Transmissions (and other sexually transmitted infections)

2.5 Ensuring Food and Water Safety

TREATMENT 2.6 Testing and Treatment: Diagnosing Hepatitis Virus Infections

2.7 Enhancing Chronic hepatitis Care and Treatment

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Three-dose hepatitis B vaccine coverage, by WHO region, 2000-2015: a major increase in coverage at the beginning of the 21st century

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Hepatitis B birth dose coverage, by WHO region, 2000-2015: good progress in the Region of the Americas and

Western Pacific Region

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Proportion of health-care injections given equipment reused without sterilization, by WHO region, 2010: problems persist specifically in the

Eastern Mediterranean and South-East Asia regions

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Role of injection drug use in acquisition of new infections, chronic infections and deaths from HBV and HCV, 2015

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Size of the population injecting drugs and harm reduction indicators, by region: major gaps towards targets of the global strategy

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Strategic Direction 3: Delivering for Equity. The “How”

3.1 Public Health Approach

3.2 Optimization of Services Delivery

3.3 Continuum of Hepatitis Services

3.4 Respect of Principle of Equity and Human Rights

3.5 Sufficient Health Care Workforce

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Treatment Cascade or 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)

Follow up and chronic care

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The continuum of viral hepatitis services and the retention cascade

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Cascade of care for HBV infection, by WHO region, 2015: effective treatment is underused in most regions

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Cascade of care for HCV infection, by WHO region, 2015

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The latest HCV treatment data was released through social media and email

• Reached out to collaborators in >80 countries

• Treatment data for 2016 were available in 65 countries

– The breakdown by DAA/non-DAA regimens was available for 60 countries

– Treatment guidelines by fibrosis stage were available for 56 countries

• For 20 countries, without 2016 treatment estimates, the 2015 estimates were used.

• In 2016,1.6 million patients were treated across 85 countries

– Approximately 80% of patients were treated with DAAs

– Nearly 70% of patients were treated in a country with no fibrosis restrictions

• Adjusting for countries without data, there were an estimated 1.7 million patients treated in 2016

0

400,000

800,000

1,200,000

1,600,000

2,000,000

Global

Reported Scaled

Polaris Observatory Board Meeting 2017

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In 2017, the WHO endorsed CDA/Polaris HCV prevalence and cascade of care estimates -Major gaps in viral hepatitis-

Polaris Observatory Board Meeting 2017

Page 41: ELIMINATION OF HBV AND HCV - hepbcppa.org€¦ · Epidemiologic Update WHO Strategy for Viral Hepatitis Elimination •Overview •Vision and Goal ... Prevalence of HBV infection

In 2017, the WHO endorsed CDA/Polaris HCV prevalence and cascade of care estimates -Major gaps in viral hepatitis-

Polaris Observatory Board Meeting 2017

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Strategic Direction 4: Financing and Sustainability. The “Financing”

4.1 Hepatitis Services without Experiencing Financial Hardship

4.2 Sufficient Allocation of National Resources

3.3 Assessment of Services by Cost-Effectiveness and Budget

Impact

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Availability of Resources: The cost of implementing the global health sector strategy on viral hepatitis,

2016-2030 (US$ million)

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Availability of Resources for Testing- Care and Treatment (1)

Direct-Acting Antiviral Agents for Patients With Hepatitis Virus Genotype 1 Infection Are Cost Saving

Chhatwal J et al, CGH 2016

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Chhatwal J et al, CGH 2016

Availability of Resources for Testing- Care and Treatment (2)

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Reported prices (originators and generics) for a 28-day supply of sofosbuvir in selected countries, per country income group

(price information updates as of November 2016)

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Reported prices (originators and generics) for a 28-day supply of daclatasvir in selected countries, per country income group

(price information updates as of November 2016)

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Strategic Direction 5: Innovation for Acceleration . The “Future”

5.1 Research and Innovation Along the Entire Continuum

of Prevention, Diagnosis, Treatment and Care Services

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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 prevention

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DIAGNOSTIC CHECKLIST OF HBV/HCV ELIMINATION

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“Diagnostic” Checklist for HCV/HBV Elimination

1) Status of primary prevention

2) Viremic prevalence

3) Age and sex distribution of HCV/HBV

4) Diagnostic rate

5) Distribution of CHC/CHB by fibrosis stage

6) Efficient testing strategy

7) Treatment rate

8) Increase in the future treatment coverage

9) Availability of resources for testing, care and treatment

10) Ethical issues

Treatment Cascade

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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.

Assumed number of new infections in the past can be reliably estimated for some groups where yearly seroprevalence data are available (e.g. PWIDs).

Past infections are estimated by various methods (back-calculation, population surveys, modelling etc).

HBV vaccination coverage by time.

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HCV ELIMINATION IN EU-28

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1st EU HCV Policy Summit “Hepatitis C:The Beginning of the End: Key Elements for Successful European and National Strategies

to Eliminate HCV in Europe”.

Brussels, February 17, 2016

The Burden of HCV and Treatment Cascade in the European Union: Is Elimination Possible?

H. Razavi et al, 2016

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Parameters of Treatment Cascade in European Union 2015

3,207,000

1,174,000

162,000 144,000

-

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

3,500,000

Viremic Infections

Diagnosed Newly Treated

Cured

Razavi H et al, 2016

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HCV prevalence and total infected in the European Union

Prevalence(Viremic)

Total Infected

700,000

0.0%-0.56%

0.56%-0.75%

0.75%-1.3%

1.3%-2.95%

10,000

Razavi H et al, 2016

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Sensitivity analyses – Country viremic infection uncertainty (top 10 shown)

1,516,085

536,249

300,349

562,912

218,516

205,641

219,488

164,929

109,059

74,010

484,133

186,993

103,994

416,819

105,728

100,660

141,946

88,225

51,126

28,132

2,500,000 3,000,000 3,500,000 4,000,000 4,500,000

Italy

Spain

Germany

Romania

France

UK

Poland

Greece

Bulgaria

Belgium

2015 European Union Viremic HCV Prevalence

Razavi H et al, 2016

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European Union viremic infections by age cohort, 2015

-

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

450,000

Cases

Total Viremic Infections by Age Cohort (2015)

Razavi H et al, 2016

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Total viremic HCV infections, by country, 2015

0

500,000

1,000,000

1,500,000

2,000,000

Cases

Total Viremic Infections by Country (2015)

80% of all HCV infections

Razavi H et al, 2016

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2015

Razavi H et al, 2016

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2015

Razavi H et al, 2016

Treatment rate = number of treated 2015/ number of viremic infections 2015

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Cured rate = number of cured 2015/ number of viremic infections 2015

2015

Razavi H et al, 2016

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HCV Prevalence, Diagnosis and Treatment Rates, 2015

FRA

LUX

BEL

AUT

BGR

DNK

FIN

DEU

IRL

ITA

POL

SVK

SWE

GBR

HRV

GRC

ESP

CZE

NLD

EST

HUNLVA

LTU

ROU

SVNCYPMLT

PRT

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Tre

atm

ent

Rat

e

Diagnosis Rate

Razavi H et al, 2016

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-

50,000

100,000

150,000

200,000

250,000

Treate

d P

ati

en

tsAnnual Number of Treated HCV Patients in

the EU 2004-2015

Razavi H et al, 2016

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Number of treated patients, by country, 2015

42,600

38,000

23,200

19,400

9,0005,300

4,000

3,400

2,300

2,000

2,000

2,100

1,300

1,200

910

880

940

840

650

630 450 350 300 150 150 150 46 12

0

10,000

20,000

30,000

40,000

Treated

P

atien

ts

Total Number of Treated HCV Patients by Country (2015)

80% of all Treated

Razavi H et al, 2016

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Projection of HCV Morbidity and Mortality, by Diagnosis and

Treatment Strategy, 2014-2030

-

1,000,000

2,000,000

3,000,000

4,000,000

Total Infected Cases (Viremic) - EU

Historical Trend Current SoC WHO Target

-

6,000

12,000

18,000

24,000

30,000

Liver related Deaths - EU

Historical Trend Current SoC WHO Target

-

7,000

14,000

21,000

28,000

HCC - EU

Historical Trend Current SoC WHO Target

-

10,000

20,000

30,000

40,000

50,000

60,000

Decompensated Cirrhosis - EU

Historical Trend Current SoC WHO Target

Razavi H et al, 2016

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Projection of HCV Morbidity and Mortality, by Diagnosis and

Treatment Strategy, 2014-2030

Historical Trend ----

Genotype-Weighted HCV (Fibrosis ≥ F1).Treatment with PEG/RIBA. Annual treatment of 79.000 patients

Current Standard of Care

Use of DAAs (Fibrosis ≥ F2). Annual treatment of 162.000 patients

WHO Target

65% reduction in liver related deaths and 90% reduction on new infections by 2030. Annual treatment of 174.000 patients plus improvements in harm-reduction and screening strategies

Razavi H et al, 2016

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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.

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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.

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HCV ELIMINATION MANIFESTO “HEPATITIS C- FREE EUROPE”

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HCV Elimination Manifesto

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HCV Elimination Manifesto

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HCV Elimination Manifesto

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HCV Elimination Manifesto

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1st EU HCV Policy Summit “Hepatitis C:The Beginning of the End: Key Elements for Successful European and National Strategies to Eliminate HCV in Europe”.

Brussels, February 17, 2016

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1st EU HCV Policy Summit “Hepatitis C:The Beginning of the End: Key Elements for Successful European and National Strategies to Eliminate HCV in Europe”.

Brussels, February 17, 2016

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Acknowledgements

• Homie Razavi, Center for Disease Analysis, USA