Implications of new hepatitis C treatments for WHO activities

related to people who inject drugs

Implications of new hepatitis C treatments for WHO activities

related to people who inject drugsNicolas Clark, Medical Officer

Management of Substance Use

WHO, Geneva

CREIDU Colloquium

Melbourne 2014

2

Number of deaths/year from selected conditions, 2010

Number of deaths/year from selected conditions, 2010

HIV/AIDS Viral hepatitis Tuberculosis Malaria0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

No

. o

f d

eath

s (m

illi

on

s)

Source: Global Burden of Disease Study 2010 Lozano et al, Lancet 2012

1.4 million people died in 2010 of viral hepatitis

3

Estimated annual deaths from selected causes by region, 2010Estimated annual deaths from

selected causes by region, 2010

Asia Pacific Americas Europe Africa & ME0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

Viral hepatitis HIV TB Malaria

Nu

mb

er

of d

ea

ths/

yea

r

Source: Courtesy of IHME – Global Burden of Disease Study

4

Number of hepatitis deaths by virus type and disease outcome, 2010

Number of hepatitis deaths by virus type and disease outcome, 2010

Acute Hepatitis

HBV - HCC

HBV - cirrhosis

HCV - HCC

HCV - cirrhosis

0.0

50.0

100.0

150.0

200.0

250.0

300.0

350.0

400.0

All

-ag

e d

eath

s (x

1,00

0)

A

B

C

E

Source: Global Burden of Disease Study 2010 Lozano et al, Lancet 2012

Most deaths are due to chronic hepatitis B and C

5

Global prevalence of hepatitis C infection, 2005 adults (19-49 years), by GBD region

Global prevalence of hepatitis C infection, 2005 adults (19-49 years), by GBD region

Source: Hannafiah et al. Hepatology 2013

6

Prevalence of HCV among persons who inject drugs

Prevalence of HCV among persons who inject drugs

HCV prevalence in PWID >50% in most countries; between 60-80% in 25 countriesand >80% in 12 countries

Nelson et al. Global epidemiology of hepatitis B and hepatitis C in people who inject drugs: results of systematic reviews. Lancet, 378 (9791), 2011.

7

Drug use GBD 2010 estimatesDrug use GBD 2010 estimates

8

Disease burden attributable to drug dependence by age in 2010 (Degenhardt et al, Lancet, 2013)

Disease burden attributable to drug dependence by age in 2010 (Degenhardt et al, Lancet, 2013)

9

Hep B immunizationBlood/injection safetyOutbreak controlWater and sanitation

WHO's Hepatitis area of work: evolution…

WHO's Hepatitis area of work: evolution…

2010 2011 2012 2013 2014

World Health Assembly

Resolution onViral Hepatitis

WHAresolution

STAC-Hep

Establishment of Global Hepatitis

Programme (GHP)

Reorganization of Global Hepatitis

Programme

2015(and beyond)

Implementation of Resolution

And Global Action

Plan

Global Framework

10

HIV/AIDS(HIV)

Pandemic and Epidemic Diseases

(PED)

Food Safety, Zoonoses and

Foodborne Diseases

(FOS)

Service Delivery and Safety (SDS)

Essential Medicines and

Health Products

(EMP)

Health Statistics and Information

Systems (HSI)

Management of Noncommunicable Diseases (MND)

Immunization, Vaccines and Biologicals

(IVB)

Mental Health and

Substance Abuse (MSD)

Country Offices

WHO's internal organization of the Global Hepatitis ProgrammeWHO's internal organization of the Global Hepatitis Programme

Country Offices

AFRO EURO SEARO

AMRO EMRO WPRO

RegionalOffices

GHP Secretariat

HQ

11

Global Hepatitis Framework: GoalsGlobal Hepatitis Framework: Goals

Within a health systems framework: Reduce transmission Reduce morbidity and mortality and improve treatment and

care of patients Reduce the socio-economic impact at individual, community

and population levels

Entry-point to link with and support other critical organizational priorities, including universal health coverage affordable access to commodities health inequities

12

Global Hepatitis Framework: Four AxesGlobal Hepatitis Framework: Four Axes

Axis 1: Partnerships, resource mobilization and communication

Axis 2: Data for policy and action

Axis 3: Prevention of virus transmission

Axis 4: Screening, care and treatment

13

Axis 1: Increasing engagement through awareness, partnerships and mobilizing resources

Axis 1: Increasing engagement through awareness, partnerships and mobilizing resources

• Status:– Low levels of awareness, engagement, political action, financial

commitment

• Actions and plans:– Promotion of World Hepatitis Day commemoration– Establish Global Hepatitis Network– Global Hepatitis Policy Report– Global Partners’ meeting on hepatitis– Formation of civil-society reference group

14

World Hepatitis Day 2013 sample postersWorld Hepatitis Day 2013 sample posters

15

WHO Global Policy Report 2013WHO Global Policy Report 2013

Aim: To assess WHO Member States' response to hepatitis – in the context of the WHO Resolution 63.18

Conducted in collaboration with World Hepatitis Alliance

Response rate: 125 of 194 (64%)Member States

16

Status: – Weak surveillance systems leading to poor quality of country-

level data on burden of infection and disease outcomes– Lack of reporting system to monitor implementation of

treatment scale-up

Actions:– Publish global prevalence and burden estimates for viral

hepatitis – Develop guidelines for hepatitis surveillance in low- and

middle-income countries

Axis 2: Evidence-based policy and data for action

Axis 2: Evidence-based policy and data for action

17

WHO sponsored systematic reviews of hepatitis prevalence data

18

Plans:– Establish modelling reference group– Conduct regional adaptation workshops of surveillance

guidance– Conduct country hepatitis burden-of-disease and national

planning workshops– Develop a monitoring and reporting framework for assessing

country and global hepatitis response

Axis 2: Evidence-based policy and data for action

Axis 2: Evidence-based policy and data for action

19

Axis 3: Prevention of virus transmission

Axis 3: Prevention of virus transmission

Status: Effective prevention measures exist but level of implementation is variable

Actions:– Blood safety:

• policy guidance and technical assistance to countries for– universal access to safe blood and blood products – self-sufficiency in safe blood and blood products based on

voluntary unpaid blood donation– Injection safety:

• SIGN Network• WHO-UNICEF-UNFPA for exclusive use of auto-disable syringes in

immunization services• Promotion of harm-reduction guidance and services

20

Axis 3: Prevention of virus transmission

Axis 3: Prevention of virus transmission

Plans:– Immunization:

• Promotion of birth dose administration• Hepatitis E vaccine SAGE working group

– Blood safety:• Continued emphasis on implementation of policies

– Injection Safety:• Launch of Global Injection Safety Campaign

21

Axis 4: TreatmentAxis 4: Treatment

Status:– Dramatic advances in treatment options– Very low levels of:

• Awareness among general public and health-care workers• Access to screening• High-quality, low-cost diagnostics• Laboratory infrastructure• Treatment uptake

– New WHO hepatitis treatment guidelines

22

23

WHO’s role in improving access to hepatitis therapy

WHO’s role in improving access to hepatitis therapy

Awareness Testing ReferralDisease-

stage assessment

Treatment Monitoring

World Hepatitis Day observanceImproved prevalence estimates

Prequalification of diagnosticsScreening/ testing guidelines

Treatment GuidelinesPrequalification of generic medicinesEssential Medicines ListAdvocacy, guidance and technical assistance for improved treatment accessMulti-stakeholder engagement

Screening Care Treatment

24

Topics for WHO hepatitis C screening, care and treatment guidelines

Topics for WHO hepatitis C screening, care and treatment guidelines

Awareness Testing ReferralDisease-

stage assessment

Treatment Monitoring

Who should be tested for hepatitis C (antibodies)?

When to confirm HCV infection (PCR)?

What interventions to slow progression of liver

disease?

How to assess degree of liver fibrosis/cirrhosis?

When to start treatment?

What medicines to use?

How to monitor for response to treatment and drug adverse

reactions?

Screening Care Treatment

25

New Opportunities for treatment scale-upNew Opportunities for treatment scale-up

Current treatment regimens are complex, costly (drugs and monitoring) and have significant toxicities

Dramatic new treatment results, high SVR rates, oral regimens, pan-genotype and high safety profile

WHO published it’s first ever hepatitis C treatment guidelines in April 2014

Successful price reductions, – Egypt $900 for a 12 week course of

sofosbuvir – USA $84,000 in comparison

26

WHO recommendations on diagnosis and treatment of hepatitis C in PWID

WHO recommendations on diagnosis and treatment of hepatitis C in PWID

Screen PWID– anti-HCV antibodies

• rapid testing vs serology

Diagnosis– HCV RNA

Reduce alcohol intake

Staging– liver biopsy– non – invasive test

Treatment – genotype 1,2,3,4

• sofosbuvir• pegylated interferon and

ribavirin

– genotype 1• telaprovrevir or bocepravir

– genotype 1b & 1a (without Q80K polymorphism)• simepravir

27

SVR in PWUDSVR in PWUD

Aspinall et al. (2013)

28

Re-infection rates in PWUDRe-infection rates in PWUD

Aspinall et al. (2013)

29

What can we learn from HIV about increasing services for PWID?

What can we learn from HIV about increasing services for PWID?

30

31

Inequitable access to ART

Wolfe et al, The Lancet 2010; 376:355-66 .

32

Integration and colocation of services

33

Policy guidelines for TB and HIV services for drug users

Policy guidelines for TB and HIV services for drug users

Joint Planning Service providers

National & local coordination body Plans with roles, responsibilities & M&E Human resources and training available Support to operational research

Package of Care

TB infection control plans in care settings

Case finding protocols at services drug users present

Treatment services for TB and HIV available

Isoniazid prevention available

HIV prevention (Harm Reduction Package)

Overcoming Barriers

Integrated services (Link TB/HIV treatment and harm reduction

Equivalence of care in prisons

Adherence support measures

Comorbidity not to be used to withhold treatment

34

Overlapping EpidemicsOverlapping Epidemics

Hepatitis

HIV

IDU

35

HIV ProgramAntiretroviral TreatmentDrug InteractionsVCTToxicity MonitoringProphylaxis of OIsAdherence SupportSecondary PreventionSyringe Exchange

Hepatitis ProgrammeDOTDiagnosisStagingAlcohol counsellingTreatment monitoringAdherence SupportDrug Interactions

Drug TreatmentOpioid Substitution TherapyEffective CounselingDOTUrine MonitoringDrug InteractionsSyringe Exchange

CommunicationCollaboration

Communication

Collabora

tion

Comm

unication

Collaboration

36

models of caremodels of care

• non-integrated– referral– linkage

• integrated care– integrated in general health care

• primary care– multi-skilled team– specialist outreach

• integrated in district hospital– integrated specialist services

• hepatitis treatment provided in drug treatment– multiskilling or specialist outreach

• drug treatment provided in hepatitis clinic• combined addiction and hepatitis specializations

37

Can any part of the health system treat hepatitis?

Can any part of the health system treat hepatitis?

38

requirements for hepatitis treatmentrequirements for hepatitis treatment

• laboratory capacity– serology– NAT/genotype/viral load– testing throughout treatment

• reliable supply of medication

• dispensing capacity

• clinical skills– somewhat complicated treatment algorithms– potentially life threatening adverse events common

39

models of caremodels of care

• non-integrated– referral– linkage

• integrated care– integrated in general health care

• primary care– multi-skilled team– specialist outreach

• integrated in district hospital– integrated specialist services

• hepatitis treatment provided in drug treatment– multiskilling or specialist outreach

• drug treatment provided in hepatitis clinic• combined addiction and hepatitis specializations

40

HIV ProgramAntiretroviral TreatmentDrug InteractionsVCTToxicity MonitoringProphylaxis of OIsAdherence SupportSecondary PreventionSyringe Exchange

Hepatitis ProgrammeDOTDiagnosisStagingAlcohol counsellingTreatment monitoringAdherence SupportDrug Interactions

Drug TreatmentOpioid Substitution TherapyEffective CounselingDOTUrine MonitoringDrug InteractionsSyringe Exchange

CommunicationCollaboration

Communication

Collabora

tion

Comm

unication

Collaboration

41

Case example - UkraineCase example - Ukraine

• Before– example of OST / HIV / TB in Ukraine many years ago

• OST on one side of town, HIV medication on another• no OST in TB hospital…

• Now– multiple models of care

• ARVs in narcology dispensaries• OST in HIV services• both ARV and OST in primary care and public hospitals

42

• Collaboration of 150 NGOs, organised HCV treatment for co-infected individuals

• Negotiated price reduction of interferon and ribavirin from $20,000 to $5,000 dollars per course

• Decentralised approach– “Aids Clinic”– OST clinics– Community Clinics

• Integrated into harm reduction/ART delivery.

• Doctors providing the majority of care

• Estimated to have treated 100 people,

• Issues now with the political instability and clinics in Crimea and Eastern Ukraine have closed

43

Case example - TanzaniaCase example - Tanzania

• Muhimbili medical centre• integrated treatment in an outbuilding of a district hospital• developed by infectious disease unit • integrated treatment:

– drug dependence– HIV– TB– other conditions

• daily dispensing:– methadone– ARV– TB treatment

44

‘One-stop-shop’‘One-stop-shop’

Family support

Overdose, HIV, Hepatitis

prevention

Antiretroviral therapy

General health care

Social assistance &

protection

Mental health care

Drug dependence

treatment

Drug user

45

Current data on treating hepatitis in PWUDCurrent data on treating hepatitis in PWUD

46

47

USA14

CANADA4

AUS8

N.Z.1

SUISSE1

SCOTLAND 2

ENGLAND3

UKRAINE1

ITALY3

NETHERLANDS1

Geographic distribution of models of care

48

Addiction Centres

GP Practices Prison Patient's home

"Public Health Cetres"

Sexual Health Clinic

Specialist HCV clinic

0

2

4

6

8

10

12

14

16

18

2018

13

6

1 1 1 1

Characteristics of Health Care Setting providing HCV care in 38 models of care

Location of HCV treatment

Number of models

49

How to increase rates of adherence in treating PWUD

How to increase rates of adherence in treating PWUD

• accessible

• affordable

• non judgemental

• train staff in how to manage other issues faced by PWUD– psychosocial skills– encourage and provide OST for people who are opioid dependent

• employ people with a history of drug use

• work with the local drug using community

• offer case management and outreach services

50

Other drug and alcohol activities at WHOOther drug and alcohol activities at WHO

• UNODC/WHO programme on drug dependence treatment and care

• mhGAP programme on management of mental health, substance use and neurological conditions in non specialist settings

51

52

53

mhGAP-IG standard course - pilot test version – Oct 2012

53

54

55

56

SummarySummary

• Safe and effective treatment is now available and will be affordable in many low income settings

• PWID have excellent rates of SVR in published trials

• Need to avoid PWID being left behind in the hepatitis treatment scale up

• Need to support the development of the right treatment models

57

SummarySummary

• Support country level hepatitis epidemiology that includes drug use as a risk factor and comorbidity

• Support the development of hepatitis national plans that include appropriate level of concern to PWID

– Support screening in IDU• drug treatment and outreach

– rapid testing and prequalification of diagnostics– reliable supply of medication– alcohol reduction advice– effective models of care for PWID

• OST

• Support the implementation of national plans

• Monitor progress

58

HIV/AIDS(HIV)

Pandemic and Epidemic Diseases

(PED)

Food Safety, Zoonoses and

Foodborne Diseases

(FOS)

Service Delivery and Safety (SDS)

Essential Medicines and

Health Products

(EMP)

Health Statistics and Information

Systems (HSI)

Management of Noncommunicable Diseases (MND)

Immunization, Vaccines and Biologicals

(IVB)

Mental Health and

Substance Abuse (MSD)

Country Offices

WHO's internal organization of the Global Hepatitis ProgrammeWHO's internal organization of the Global Hepatitis Programme

Country Offices

AFRO EURO SEARO

AMRO EMRO WPRO

RegionalOffices

GHP Secretariat

HQ

59

Thank youThank you