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Global reporting system for hepatitis (GRSH) – project description

Contents

1. Background ..................................................................................................................................................................... 2

2. Target audience for this document ............................................................................................................................. 2

3. Data to be reported through the Global Reporting System for Hepatitis ............................................................. 2

3.1 Policy uptake indicators............................................................................................................................................... 2

3.2 Service coverage indicators ........................................................................................................................................ 3

3.3 Impact indicators .......................................................................................................................................................... 4

4. Implementing the Global Reporting System for Hepatitis....................................................................................... 5

5. Strengthening national reporting processes.............................................................................................................. 6

6. Future development of the Global Reporting System for Hepatitis ...................................................................... 6

7. References....................................................................................................................................................................... 7

Annex 1. Policy uptake indicators for viral hepatitis ..................................................................................................... 8

Annex 2. Aggregated reporting form to monitor the cascade (outline for national reporting, to be expanded

with meta-data) using 2017 as a reference year ........................................................................................................... 9

Annex 3. WHO template for a chronic hepatitis B and C patient management card.............................................10

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1. Background In May 2016, the World Health Assembly endorsed the 2016–2021 global health sector strategy on viral hepatitis

that proposes to eliminate viral hepatitis as a public health threat by 2030 (1). Five core interventions

implemented with sufficient service coverage should lead to elimination, defined as a 90% reduction in people

newly infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) and a 65% reduction in mortality

(compared with the 2015 baseline (Table 1)). In addition, the 13th WHO General Programme of Work, endorsed by

the World Health Assembly in 2018, has integrated the global health sector strategy targets within the “three

bil l ions” and universal health coverage agenda (2).

In 2016, WHO published two guidance documents for strategic information on viral hepatitis. Guidance on

surveillance explains how to collect data on incidence, prevalence and mortality (3). A monitoring and evaluation

framework describes indicators covering core interventions, including prevention, care and treatment (4). The

monitoring and evaluation framework describes 10 core indicators, labelled from C1 to C10. Of these, a subset of

these focuses on the service coverage of the core interventions and on the impact indicators that define

elimination (Table 1). The Global hepatitis report, 2017 (5) documented baseline service coverage estimates for

2015 for these interventions, including testing and treatment (the cascade of care and cure).

Since WHO Member States have pledged to eliminate viral hepatitis, they have mandated WHO to monitor

progress towards elimination and to report back. WHO has therefore established the Global Reporting System for

Hepatitis, to be run for the first time in 2018 (Member States will then report on data collected for 2017). The

objectives of this project description document are:

• to outline the reporting required from Member States to WHO; and

• to describe the Global Reporting System for Hepatitis.

2. Target audience for this document • National viral hepatitis programme managers

• WHO staff members and other international stakeholders providing technical assistance to countries

3. Data to be reported through the Global Reporting System for Hepatitis

The Global Reporting System for Hepatitis will include indicators for (a) critical policy uptake, (b) service coverage

and (c) impact. Indicators already collected by other systems will not be reported.

3.1 Policy uptake indicators WHO included a number of policy uptake indicators to monitor the adoption of WHO -recommended policy

options (such as the existence of a national plan, testing and treatment poli cies and licensing of medicines). The

policy uptake indicators selected for inclusion were extracted from the country profile survey conducted in 2017

(Annex 1).*

* The results were presented at the World Hepatitis Summit in São Paulo, Brazil, 1–3 November 2017.

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3.2 Service coverage indicators

Prevention indicators Prevention indicators include (1) immunization, (2) prevention of mother -to-child transmission, (3) infection

control and (4) harm reduction (Table 1). These indicators are reported through other programmes within WHO

and therefore will not be reported in the Global Reporting System for Hepatitis.

Table 1. Monitoring the coverage of the interventions that will lead to impact based on the global health sector strategy for viral hepatitis

Targets Indicators Reporting system Service coverage

1. Hepatitis B vaccination: • Give three doses to infants

C.3.b: Coverage of third dose of hepatitis B vaccine among infants

WHO/UNICEF joint reporting form

2. Prevention of mother-to-child transmission of hepatitis B virus:

• Use birth-dose vaccination or other approach to preventing mother-to-child transmission

C.3.a: Coverage of timely hepatitis B vaccine birth dose (within 24 hours) and other interventions to prevent the mother-to-child transmission of HBV†

WHO/UNICEF joint reporting form

3. Infection control • Administer safe health-care

injections • Reduce the rates of

transmission of transfusion-transmissible infections

C.5: Facility-level injection safety National Demographic Health Surveys

A.17: Facility-level blood safety WHO’s Global Database on Blood Safety

4. Harm reduction: • Provide sterile needles and

syringes for people who inject drugs

C.4: Needle and syringe distribution

WHO/UNAIDS Global AIDS Monitoring

5. Testing and treatment: • Diagnose people with HBV

or HCV infection • Treat people with chronic

HBV or HCV infection

C.6.a/b: People with HCV and/or HBV diagnosed

Global Reporting System for Hepatitis C.7.a/b: Treatment coverage and

initiation for HBV (regardless of eligibility) and HCV infection C.8.a/b: Cure (HCV) or viral suppression (HBV)

Impact Incidence: • Reduce new chronic HBV

and HCV infections

C.9.a: Cumulated incidence of HBV infection among children five years old

Ongoing systematic reviews of biomarker survey data

C.9.b: Incidence of HCV infection Mortality: • Reduce deaths from viral

hepatitis B and C

C.10: Deaths from hepatocellular carcinoma, cirrhosis and chronic l iver diseases attributable to HBV and HCV infections

Global Reporting System for Hepatitis

Indicators of the cascade of care and treatment Indicators that focus on the cascade of care and treatment (Table 1) include the number of people (a) diagnosed,

(b) placed on treatment and (c) cured (for HCV) or having suppressed viral loads (for HBV). These indicators will be

† This is a composite indicator built on data from different systems, according to the strategy chosen to prevent mother-to-child transmission. See the monitoring and evaluation framework (4) document for details.

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reported through the Global Reporting System for Hepatitis. Analysis of this data generates the cascade of care

for HBV and the cascade of cure for HCV (Fig. 1).

Fig. 1. Cascade of care for HBV (left) and cascade of cure for HCV infection (right) by WHO region, 2016

3.3 Impact indicators Impact indicators include incidence and mortality (Table 1). These are the criteria that define elimination.

Incidence The incidence of chronic infection is measured through the following.

• The prevalence of the surface antigen of HBV (HBsAg) among children five years old is measured. The

prevalence of chronic infection at five years of age is a surrogate indicator of the cumulated incidence of

chronic infections in the first five years of l ife: indicator C.9.a, Table 1. The data source is population-based

biomarker surveys.

• The incidence of HCV infection is modelled using seroprevalence data and information from acute hepatitis

surveillance: indicator C.9.b, Table 1 (4).22 The data source is modelled based on (1) a population-based

biomarker survey and (2) trends in new infections reported through enhanced case reporting.

To estimate incidence, WHO will rely on ongoing systematic reviews of biomarker surveys conducted by WHO for

HBV (6) and by partners for HCV (7). The Global Reporting System for Hepatitis will not capture the results of

biomarker surveys. Other mechanisms to search published studies and reports on an ongoing basis are a more

effective mechanism to obtain updated data on biomarker surveys and on prevalence than a ro utine reporting

system.

Mortality Mortality from HBV and HCV infection, indicator C10 (Table 1), is measured using two sources of data.

• One source is data on mortality from cirrhosis and hepatocellular carcinoma. WHO, including th e

International Agency for Research on Cancer, already capture this information from vital registration and

cancer registries.

• The fraction of cirrhosis and hepatocellular carcinoma that is attributable to HBV and HCV is measured (from

sentinel surveillance for late-stage chronic l iver diseases) (4). These indicators will be reported through the

Global Reporting System for Hepatitis.

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4. Implementing the Global Reporting System for Hepatitis Country reporting to WHO or other regional organizations will require political will to share official data and the

technical capacity to collect, transmit, validate and analyse this data.

Tool to be used for reporting To convey the data to the Global Reporting System for Hepatitis, WHO’s Global Hepatitis Programme has

developed a web-based District Health Information System (DHIS2) module located on the WHO integrated data

platform, a collaboration managed by several WHO departments. The Department of Neglected Tropical Diseases

coordinates this collaboration. National focal points who have login credentials can access the platform and enter

data. Thus, even countries that do not use DHIS2 for national reporting can still use the Global Reporting System

for Hepatitis for reporting to WHO.

Annual reporting process The annual reporting process will be implemented as described in Fig. 2).

Fig. 2. Proposed annual process of the Global Reporting System for Hepatitis

• WHO headquarters will send a request to report to Member States , via the WHO regional offices.

• WHO will coordinate brief training to facilitate data entry. Training will include data entry screens annotated

with extracts from the strategic information guidance, a separate training package with short video tutorials

and training webinars.

• WHO will open the online platform for reporting:

- national focal points collating data (Annex 1 Annex 2);

- the focal point receiving a unique login and password to access the online reporting tool;

- the national focal point entering data online; and

- the health ministry approving the data.

• The WHO country office, regional office and headquarters will be able to see the data to engage in a

validation process. Responsibility for validation will l ie with country office first and then the regional office.

• WHO headquarters will freeze the data for analysis when the validation phase is completed.

• WHO will analyse the data. Data from countries will be aggregated, and regional estimates will be pub lished

in a WHO global report planned for publication in December 2018. The regional estimates will be sent for

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WHO data clearance before publication. Certain country case studies may be used in the report following

country validation.

5. Strengthening national reporting processes The data reported at the international level will be only as good as what get collated at the national level. Thus,

WHO will work with partners such as the health data collaborative (www.healthdatacollaborative.org ) in the long

term to build capacity in Member States for routine reporting of the viral hepatitis cascade data from health -care

facil ities to the national level.

Individual or aggregated reporting from health care facilities The standardized viral hepatitis patient card (Annex 3) summarizes the data elements that are necessary to

manage a person with chronic HBV or HCV infection and can be used in paper or electronic form. The patient card

is primarily designed for clinicians to record key pieces of information to ensure appropriate care and was

developed by WHO through consultation with key partners and experts. Data on the cascade can be reported by

health-care facilities, both public and private, as individual records or as aggregated data. Encouraging private

health-care facilities to report may require some innovative strategies such as public -private partnerships in the

context of national viral hepatitis elimination goals.

If the choice is to report individual records, several data elements from the patient card can be entered in a

database (for paper records) or extracted from the database (for electronic medical records). A data cleaning

stage may be needed for countries that would export data from electronic medical records.

If the choice is to report aggregated data, health care facil ities can report numbers that reflect the services

delivered (such as the number of people tested and the number of people starting treatment) and the degree to

which national guidelines are implemented at the facil ity level. This would generate a data flow from the health

care facil ities towards the subnational or national level. DHIS2 is one established tool that could be used to

convey the information to the subnational or national level. DHIS2 is an open-source software platform for

reporting, analysing and disseminating data for all health programmes. Other software may also be used to report

aggregated data.

Transmitting and compiling aggregated data Whether facil ities initially report individual or aggregated data, the reporting requirements of the Global

Reporting System for Hepatitis (Annex 2) can be used to report aggregated data up to the national level.

6. Future development of the Global Reporting System for Hepatitis

Subsequent to the first year of reporting, WHO will review the Global Reporting System for Hepatitis. Subject to

the outcome of this review and feedback received from countries, the Global Reporting System for Hepatitis will

be refined and/or expanded. Possible developments include:

• greater levels of disaggregation;

• including data from national partners and nongovernmental organizations on the cascade of care and cure;

• including indicators that reflect the provisi on of and access to services for priority populations such as people

who inject drugs, prisoners and pregnant women; and

• reporting on the proportion of people with HBV infection who are eligible for treatment.

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7. References 1. Global health sector strategy on viral hepatitis, 2016–2021. Geneva: World Health Organization; 2016

(http://apps.who.int/iris/bitstream/10665/246177/1/WHO-HIV-2016.06-eng.pdf?ua=1, accessed 4 July 2018). 2. Draft thirteenth general programme of work 2019−2023, advance edited version. Geneva: World Health

Organization; 2016 (http://www.who.int/about/what-we-do/gpw-thirteen-consultation/en, accessed 4 July 2018). 3. Technical considerations and case definitions to improve surveillance for viral hepatitis: surveillance document.

Geneva: World Health Organization; 2016 (http://apps.who.int/iris/bitstream/10665/204501/1/9789241549547_eng.pdf?ua=1, accessed 4 July 2018).

4. Monitoring and evaluation for viral hepatitis B and C: recommended indicators and framework. Geneva: World Health Organization; 2016 (http://apps.who.int/iris/bitstream/10665/204790/1/9789241510288_eng.pdf, accessed 4 July 2018).

5. Global hepatitis report, 2017. Geneva: World Health Organization; 2017 (http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en, accessed 4 July 2018).

6. Global and country estimates of immunization coverage and chronic HBV infection. Geneva: World Health Organization; 2018 (http://whohbsagdashboard.com/#global-strategies, accessed 4 July 2018).

7. Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2:161–76.

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Annex 1. Policy uptake indicators for viral hepatitis Country Name of the respondent

Institution reporting Email address of the respondent

Policy framework In your country, is there a civil society representative involved in advising the government on their response to viral hepatitis?

Yes – a member of the strategic technical advisory group or official working group Yes – not a member of the strategic technical advisory group or official working group, but civil society has been consulted No – the plan is to involve civil society in the strategic technical advisory group or official working group

No – no plan to involve civil society in the strategic technical advisory group or official working group

In your country, is there a national plan or strategy that covers the national response to viral hepatitis?

Yes – published Yes – drafted No

In your country, are funds allocated from the national budget to implement the national plan?

Yes – both HBV and HCV Yes – only HBV Yes – only HCV No

In your country, are there policies or laws that address stigma and/or discrimination against people with hepatitis B or C?

Yes – there are policies or laws that specifically address stigma and/or discrimination against people with hepatitis B or C Yes – there are anti -discrimination policies or laws, but they are not specific to hepatitis B or C No

National guidelines

In your country, is there official guidance on which test to use for diagnosing HBV and/or HCV?

Yes – both HBV and HCV Yes – only HBV Yes – only HCV No

In your country, are there official guidelines or protocols recommending that all people diagnosed with HBV and/or HCV be routinely referred for treatment and care?

Yes – both HBV and HCV Yes – only HBV Yes – only HCV No

In your country, is tenofovir or entecavir considered the first line of treatment for people with chronic hepatitis B (not coinfected with hepatitis D virus)?

Yes – all patients Yes- but only for select patients according to the priorities set No

In your country, are interferon-free direct-acting antiviral regimens considered the first line of treatment for people with chronic hepatitis C?

Yes – all patients Yes- except for certain genotypes Yes – but only for select people according to the priorities set No

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Annex 2. Aggregated reporting form to monitor the cascade (outline for national reporting, to be expanded with meta-data) using 2017 as a reference year Data from 1 January 2017 to 31 December 2017

Testing and diagnosis (C6) Treatment initiation and continuation (C7) Monitoring of treatment effectiveness (C8)

Mortality from sequelae* (C10)

Number of infected people already

identified before the

selected year (treated or

not)

Number of people

tested with serology

(HBsAg or anti-HCV) in the selected

year†

Number of infected people newly diagnosed with infection in the selected year (HBsAg positive or HCV RNA or

HCV core antigen positive, treated or not)

Number of people

continuing a treatment

started before the

year of reporting‡

Number of people newly starting treatment in the

selected year§

Number of people

completing treatment**

Number of people

assessed for treatment

effectiveness††

Number of people with

effective treatment‡‡

Proportion (%) of

people dying from

cirrhosis who were

positive for viral

hepatitis infection

Proportion (%) of people dying

from hepatocellular carcinoma who were positive

for viral hepatitis infection

Total Among people who

injected drugs in the

past 12 months

(among the total above)

HBV

Not applicable

HCV

Not applicable

* Estimates from sentinel sites. † Needs to include testing activities conducted with rapid diagnostic tests. ‡ Does not apply to HCV infection. § Regardless of eligibility (HBV infection). ** Does not apply to HBV infection. †† Tested for viral suppression with ALT or HBV DNA (HBV) or tested for sustained viral response using HCV RNA or HCV core antigen (HCV). ‡‡ Normal ALT or viral suppression (HBV) or sustained viral response (HCV).

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Annex 3. WHO template for a chronic hepatitis B and C patient management card Identification Unique identifier |_|_|_|_|_|_|_|_|_|_|

District: ________________ Health unit: _____________________ District clinician or team: _____________

Name: ________________ First name: ______________________ Patient clinic number: ______________

Sex: |_|Female |_| Male|_| Other Date of birth (DD/MM/YYYY): ___ / ___ / ___ Nationality: ______________ Address: ________________ District: ______________________ Telephone: ______________

Infection status on enrolment Enrolment date: ___ / ___ / ___

HBsAg: |_|Positive|_| Negative |_| Not done HBV DNA (IU/mL): |_____|Value|_| Negative |_| Not done HBeAg: |_|Positive|_| Negative |_| Not done

Date of first diagnosis of HBV infection: ___ / ___ / ___ HDV RNA (IU/mL): |_|Positive|_| Negative |_| Not done Anti-HDV: |_|Positive|_| Negative |_| Not done

Anti-HCV: |_|Positive|_| Negative |_| Not done HCV RNA (IU/mlL: |_|Value|_| Negative |_| Not done HCV core antigen: |_|Positive|_| Negative |_| Not done Date of first diagnosis of HCV infection: ___ / ___ / ___ HCV genotype: |_|

Anti-HIV: |_|Positive|_| Negative |_| Not done HIV treatment regimen: ______________ Date HIV treatment started: ______________

Latest HIV viral load (copies/mL): _____________|_| Not done CD4 count (cells/mm3): _____________ |_| Not done

Tuberculosis: |_|Active|_| On treatment|_| No

Injection drug use: |_|Active (last 12 months) |_| Past history |_| No Daily alcohol consumption: __________________________ Metabolic syndrome: ____________________

Staging Staging date: ___ / ___ / ___ ALT: ____ IU/mL AST: ____ IU/mL PLT: ____ /mm3 Clinical diagnosis of cirrhosis: |_|Yes|_| No If yes, child Pugh score: ______

APRI score: ___ |_| Not done FIB4: _____ |_| Not done Transient elastography (kPa): ____________ |_| Not done Liver biopsy stage (F): ____________ |_| Not done

Bilirubin: Total_______μmol/L and direct: _____μmol/L Ultrasound scan: ________________________________ Prothrombin time/INR: ____________

Hepatitis B treatment Past experience with treatment: |_|Yes|_| No Past treatment regimen: ______________________

HBV treatment regimen started (medicine): ______________________ Date stated: ___ / ___ / ___ Date stopped: ___ / ___ / ___

First annual viral response assessment Date tested: ___ / ___ / ___ HBV DNA (IU/mL): |_|Positive|_| Negative |_| Not done ALT: ____ IU/mL

Hepatitis C treatment Past experience with treatment: |_|Yes|_| No Past treatment: ______________________

HCV treatment regimen started: ______________________ Date stated: ___ / ___ / ___ Date completed: ___ / ___ / ___

Sustained viral response assessment after treatment (usually at SVR12: 12 weeks after the treatment ends)

Date tested: ___ / ___ / ___ HCV RNA: |_|Positive|_| Negative |_| Not done

Follow-up visits

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Unique identifier |_|_|_|_|_|_|_|_|_|_| Name: ________________ First name: ______________________ Patient clinic number: ______________

Date

Clinical

assessment

Liver function test and staging HBV tests HCV tests

Renal function

Screening for

hepatocellular carcinoma

Treatment regimen

used

Side-

effects and

toxicity Observations

ALT

(IU/mL)

AST

(IU/mL)

Platelets

(number/mL) APRI

Transient elastography

(kPa)

HBsAg

(±)

HBeAg

(±)

HBV DNA

(IU/mL)

HCV RNA

(±)

Creatinine

(mg/dl) Ultrasound

AFP

(ng/mL)

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