NATIONAL STRATEGIC PLAN

FOR PREVENTION AND CONTROL

OF VIRAL HEPATITIS IN ETHIOPIA, 2021 – 2025

August 2021

Addis Ababa
I
 NATIONAL STRATEGIC PLAN
FOR PREVENTION AND CONTROL
OF VIRAL HEPATITIS IN ETHIOPIA, 2021 – 2025

II
Table of Contents
FORWARD.................................................................................................................................................. V
ACKNOWLEDEMENT ............................................................................................................................. VI
ACRONYMS ............................................................................................................................................ VII
EXECUTIVE SUMMARY ........................................................................................................................ IX
CHAPTER ONE: BACKGROUND AND EPIDEMIOLOGY OF VIRAL HEPATITIS ............................ 1
INTRODUCTION .................................................................................................................................... 1
EPIDEMIOLOGY OF VIRAL HEPATITIS ............................................................................................ 2
EPIDEMIOLOGY OF VIRAL HEPATITIS IN ETHIOPIA ................................................................... 3
THE CURRENT NATIONAL POLICY AND PROGRAMMATIC RESPONSE .................................. 5
RATIONALE FOR REVISION OF THE 2016 - 2020 VIRAL HEPATITIS NATIONAL STRATEGIC
PLAN ........................................................................................................................................................ 7
CHAPTER TWO: VISION, GOAL, OBJECTIVES AND TARGETS........................................................ 9
STRATEGIC OBJECTIVE 1 ..................................................................................................................... 11
ADVOCACY, COMMUNICATION AND SOCIAL MOBILIZATION .............................................. 11
STRATEGIC OBJECTIVE 2 ..................................................................................................................... 13
VIRAL HEPATITIS PREVENTION PROGRAMS .............................................................................. 13
STRATEGIC OBJECTIVE 3 ..................................................................................................................... 17
ACCESS TO DIAGNOSTIC, TREATMENT AND CARE SERVICES .............................................. 17
STRATEGIC OBJECTIVE 4 ..................................................................................................................... 20
STRENGTHEN GENERATION AND UTILIZATION OF STRATEGIC INFORMATION FOR
EVIDENCE-BASED RESPONSE ......................................................................................................... 20
STRATEGIC OBJECTIVE 5 ..................................................................................................................... 22
HEALTH SYSTEM STRENGTHENING FOR EFFECTIVE AND EFFICIENT VIRAL HEPATITIS
PROGRAM MANAGMENT ................................................................................................................. 22
CHAPTER 3: MONITORING AND EVALUATION ............................................................................... 24
1. DATA REPORTING, DATA FLOW AND QUALITY ASSURANCE ........................................ 25
2. SUPPORTIVE SUPERVISION ..................................................................................................... 25
3. SURVEILLANCES AND SURVEYS ........................................................................................... 26
4. RESEARCH AND DEVELOPMENT............................................................................................ 26
5. MID-TERM AND END-REVIEWS .............................................................................................. 26
CHAPTER 4: COORDINATION MECHANISM AND RESOURCES .................................................... 27
1. COORDINATING THE IMPLEMENTATION............................................................................. 27

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 2. COSTING AND FINANCING ....................................................................................................... 30
ANNEXES .................................................................................................................................................. 32
ANNEX 1. Minimum package for viral hepatitis services at each health facility level ......................... 32
ANNEX 2. Targets for monitoring of HBV and HCV progress – 2021-2025........................................ 33
ANNEX 3. Key inputs and assumptions for the costing of the 2021-2025 viral hepatitis national
strategic plan ........................................................................................................................................... 34
REFERENCE MATERIALS ...................................................................................................................... 38

IV
FORWARD
Acute and chronic viral hepatitis make a substantial contribution to the burden of chronic diseases and
the premature mortality they cause. Infections with hepatitis B and C viruses cause liver cirrhosis and
primary liver cancer. Ethiopia is one of the sub-Saharan African countries where viral hepatitis is
endemic. The availability of a vaccine that offers lifelong protection against infection with the hepatitis
B virus gives public health an opportunity to prevent a leading cause of cancer and chronic liver disease.
The significance of the challenges and opportunities related to viral hepatitis were formally
acknowledged in 2010, when the World Health Assembly adopted its first resolution on a
comprehensive approach to the prevention and control of viral hepatitis. The Ministry of Health
(MOH) considers viral hepatitis prevention and control measures in line with the current drive to
strengthen health systems which includes reaching every child with immunization programs that include
hepatitis B vaccine, protecting against mother-to-child transmission of viruses, ensuring the safety of
blood transfusion services and injection practices.

The MOH recognizes the importance of revising the viral hepatitis national strategic plan as a foundation
for building the prevention and control measures that match the local epidemiological profile and health
system capacities. This strategic plan is developed as part of the national effort in the prevention and
control of viral hepatitis in general and Hepatitis B and Hepatitis C virus infections, in particular.
Hence, this strategic plan are intended to scale-up viral hepatitis preventive measures, and standardize
screening, diagnosis, treatment and care of patients with viral hepatitis to improve outcomes through
reducing morbidity and mortality associated with the disease. The strategic plan will serve as a framework
and a quick reference in line with scaling-up of viral hepatitis prevention, diagnosis, treatment and care
services considering patient factors and local resource settings.

The MOH urges all program managers, care providers and implementing partners to strictly use this
strategic plan as a reference in the program implementation of viral hepatitis prevention and control
programs in the country.

Dereje Duguma, MD, MIH

State Minister of Health,

Federal Democratic Republic of Ethiopia

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ACKNOWLEDEMENT

The ministry of health expresses its appreciation for the institutions participated in the revision of
this national viral hepatitis strategic plan. Special thanks go to CHAI, EGA, and WHO for
supporting the preparation of the 2021-2025 viral hepatitis national strategic plan. The ministry
also recognizes the following experts for their contribution in the preparation of viral hepatitis
national strategic plan:

Name Organization
Mrs. Mirtie Getachew MOH
Mr. Wegene Adugna MOH
Dr. Zerihun Hika MOH
Dr. Petros Mitiku MOH
Mr. Asmamaw Silesh CHAI
Mr. Maru Merigia CHAI
Dr. Mengistu Erkie EGA
Dr. Rezene Berhe EGA
Mrs Eleni Seyoum WHO
Dr Ghion Tirsite WHO
Dr. Seblewongel Abate WHO

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ACRONYMS

anti-HAV Antibody to Hepatitis A virus

anti-HCV Antibody to Hepatitis C virus
CBC Complete Blood Count
CHAI Clinton Health Access Initiative
CI Confidence interval
CLD Chronic Liver Disease
CSO Civil Society Organization
DAA Directly Acting Antiviral
DHIS2 District Health Information System 2
DNA Deoxyribo-Nucleic Acid
DQA Data Quality Assessment
EFDA Ethiopia Food and Drug Administration
EGA Ethiopian Gastroenterology Association
ELISA Enzyme-Linked Immunosorbent Assay
EPHI Ethiopian Public Health Institute
EPI Expanded Program on Immunization
EPSA Ethiopian Pharmaceutical Supply Agency
EQA External Quality Assessment
HAV Hepatitis A Virus
HBsAg Hepatitis B Virus Surface Antigen
HBV Hepatitis B Virus
HCV Hepatitis C Virus
HDSS Health and Demographic Surveillance System
HDV Hepatitis D Virus
HEP Health Extension Program
HEV Hepatitis E Virus
HEW Health Extension Worker
HIV Human Immunodeficiency Virus
HMIS Health Management Information System
HO Health Officer
IPC Infection Prevention & Control
MOH Ministry of Health
M&E Monitoring & Evaluation
NBTS National Blood Transfusion Service
NCD Non-Communicable Disease
NSP National Strategic Plan
PCR Polymerase Chain Reaction
PrEP Pre-Exposure Prophylaxis
PSM Procurement and Supply Management
PWID People with Injecting Drug
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RHB Regional Health Bureau
RNA Ribonucleic acid
SBCC Social Behavioral Change Communication
SDG Sustainable Development Goals
SOP Standard Operating Procedure
STI Sexually Transmitted Infection
SPA+ Service Provision Assessment Plus
SWOT Strength Weakness Opportunity & Threat
TB Tuberculosis
TOT Training of Trainer
TWG Technical Working Group
VCT Voluntary Counseling & Testing
VL Viral Load
WASH Water, Sanitation and Hygiene
WHO World Health Organization

VIII
EXECUTIVE SUMMARY

Hepatitis viruses, such as HAV, HBV, HCV, HDV and HEV cause potentially life-threatening
inflammation of the liver, which is characterized by acute and chronic forms of liver disease.
Despite its high prevalence and highly infectious nature, viral hepatitis infections remain under-
diagnosed and under-reported in Ethiopia. Regarding HAV, it is known that there is high
prevalence rate and nearly all older children and adults acquired anti-HAV antibody immunity.
HEV is also one of the leading causes of major outbreaks of acute viral hepatitis, especially in
developing countries.

It was reported that 12% of the hospital admissions and 31% of the mortality in medical wards in
Ethiopian hospitals were due to all causes of chronic liver disease (CLD) 1. The national sero-
survey conducted by MoH and EPHI in 2017, the prevalence of Hepatitis B surface antigen
(HBsAg) was estimated to be 9.4% among the general population aged 15 years and above.
There were variations in the prevalence of HBsAg across regions, with the highest prevalence
rate being found in the Afar region (28.8%). Overall, there was a minimally higher prevalence in
rural areas (9.7% vs 8.35%). The pooled prevalence of anti-hepatitis C virus antibody (anti-
HCV) was 3.1% (95%CI: 2.2–4.4).

The viral hepatitis-HIV co-infection and subsequent severe forms of clinical complications could
be potentially high. The population based seroprevalence of hepatitis B surface antigen (HBsAg)
among HIV positive adults ages 15-64 years in urban Ethiopia is 4.8% (3.6% in women and
7.4% in men)2. Unlike HBV, the anti-HCV prevalence in HIV infected individuals was higher
(5.5%, 95% CI: 3.8–7.8%, p = 0.01) than the prevalence observed in the other subgroup of study
population3.

1
Tsega E. Current views on liver diseases in Ethiopia. Ethiop Med J. 1977;15(2):75–82.
2
EPHIA 2017-2018. Ethiopia population-based HIV impact assessment
3
Yeshambel Belyhun et al. Hepatitis viruses in Ethiopia: a systematic review and meta-analysis. BMC Infect
Dis. 2016; 16: 761

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Viral hepatitis is generally preventable, treatable and potentially curable. Thus, it is crucial that
appropriate intervention measures are put in place. With the latest advances in technology
relating to screening and diagnosis of the disease, as well as the availability of effective and
relatively affordable treatment, the prevention, treatment and cure of viral hepatitis are now
possible.

Ethiopia has recognized the clinical and public health burdens of viral hepatitis and is committed
towards combating viral hepatitis by 2030. In working towards achieving this commitment, this
national strategic plan has been developed; the second for the country. This national strategic
plan document provides a comprehensive strategy, key interventions, program coordination and
partnership and monitoring and evaluation of viral hepatitis program in the country. The strategic
plan is intended for the use by all stakeholders at various levels, from policy makers to
implementers at the service delivery points. The strategic plan also outlines the proposed budget
requirements for five years from 2021 to 2025.

The strategic plan defines the vision, goal, objectives and targets in alignment with the national
health policy and Health Sector Transformation Plan II that aims achieving the global viral
hepatitis elimination targets by 2030.

VISION

To see Ethiopians free from viral hepatitis by halting transmission while those living with
hepatitis have access to safe, affordable and effective diagnosis, care and treatment.

GOAL

To promote national response to the elimination of viral hepatitis as a public health threat in
Ethiopia through providing access to safe, affordable and effective prevention, diagnosis,
treatment and care of the highest possible quality in an equitable manner.

OBJECTIVES

• To create an enabling environment for viral hepatitis through strengthening advocacy,

policy discussion, coordination, and leadership.
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 • To provide effective and affordable promotive and preventive services for viral hepatitis.
• To reduce the morbidity from viral hepatitis through early detection and case
management.
• To improve the survival and quality of life among individuals with chronic liver disease.
• To generate and timely utilize data and research for evidence-based decision making.
• To promote partnerships with relevant stakeholders for the prevention, control, diagnosis,
treatment and care of viral hepatitis.
• To mobilize resource and maximize efficiencies in allocation and utilization.

STRATEGIC OBECTIVES

There are five main strategies to be undertaken under this plan, namely:
Strategic objective 1: Advocacy, communication and social mobilization
Strategic objective 2: Viral hepatitis prevention programs
Strategic objective 3: Access to diagnostic, treatment and care services
Strategic objective 4: Strengthen generation and utilization of strategic information for
evidence-based response
Strategic objective 5: Health system strengthening for effective and efficient viral
hepatitis program

STRATEGIC TARGETS

Strategic targets are set for 2025 to be in line with the WHO target of combating hepatitis B and
C to reach elimination by 2030.
• To diagnose 90% of the population living with viral hepatitis B & C.
• To reduce the number of new cases of viral hepatitis B & C by 90%.
• To reduce mortality due to viral hepatitis B & C by 65%.
• To treat 80% of the population with viral hepatitis B & C in need of treatment.

XI
CHAPTER ONE: BACKGROUND AND EPIDEMIOLOGY OF VIRAL
HEPATITIS

INTRODUCTION
Viral hepatitis is an inflammation of the liver, caused by five distinct hepatitis viruses (A, B, C,
D, and E). Hepatitis A, C, D and E viruses are RNA viruses while hepatitis B is a DNA virus.
While all of these viruses cause liver disease, they vary significantly in terms of epidemiology,
natural history, prevention, diagnosis, treatment and health outcomes. The natural history of viral
hepatitis is summarized as follow:

1. Hepatitis A virus (HAV) is present in the faeces of infected persons and is most often
transmitted through consumption of contaminated water or food. Infections are in many
cases mild, with most people making a full recovery and remaining immune from further
HAV infections. However, HAV infections can also be severe and life threatening. Most
people in areas of the world with poor sanitation have been infected with this virus. Safe
and effective vaccines are available to prevent HAV.

2. Hepatitis B virus (HBV) is transmitted through exposure to infectious blood, semen, and
other body fluids. HBV can be transmitted from infected mothers to infants at the time of
birth or from family member to infant in early childhood. Transmission may also occur
through transfusions of HBV contaminated blood and blood products, contaminated
injections during medical procedures, and through people with injecting drugs (PWID).
HBV also poses a risk to healthcare workers who sustain accidental needle stick injuries
while caring for HBV infected patients. A safe and effective vaccine is available to
prevent HBV.

3. Hepatitis C virus (HCV) is mostly also transmitted through exposure to infectious blood.
This may happen through transfusions of HCV contaminated blood and blood products,
contaminated injections during medical procedures, and through injection drug use.
Sexual transmission is also possible but is much less common. There is no vaccine for
HCV.

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 4. Hepatitis D virus (HDV) infections occur exclusively in persons who are infected with
HBV. The dual infection of HDV and HBV can result in a more serious disease and
worse outcome. Safe and effective hepatitis B vaccines provide protection from HDV
infection.

5. Hepatitis E virus (HEV), like HAV, is transmitted through consumption of contaminated

water or food. HEV is a common cause of hepatitis outbreaks in developing countries and
is increasingly recognized as an important cause of disease in developed countries. Safe
and effective vaccines to prevent HEV infection have been developed but are not widely
available.

EPIDEMIOLOGY OF VIRAL HEPATITIS

As indicated in the WHO Global Health Sector Strategy on viral hepatitis 2016–2021 published
on June 2016, viral hepatitis is an international public health challenge, comparable to other
major communicable diseases, including HIV, tuberculosis and malaria. Despite the significant
burden it places on communities across all global regions, hepatitis has been largely ignored as a
health and development priority until recently. It will no longer remain hidden, however, with
the adoption of the resolution on the 2030 Agenda for Sustainable Development (SDG)– Target
3.3 calls for specific action to combat viral hepatitis.

The viral hepatitis pandemic takes a heavy toll on lives, communities and health systems.
Worldwide, approximately 240 million people have chronic hepatitis B virus infection and 130–
150 million have chronic hepatitis C virus infection. According to the WHO Global Health
Sector Strategy on viral hepatitis 2016–2021, in 2013, viral hepatitis was the seventh highest
cause of mortality in the world. It was responsible for an estimated 1.4 million deaths per year
globally, mostly from hepatitis-related liver cancer and cirrhosis. Of those deaths, approximately
47% are attributable to hepatitis B virus, 48% to hepatitis C virus and the remainder to hepatitis
A virus and hepatitis E virus. Viral hepatitis is also a growing cause of mortality among people
living with HIV. About 2.9 million people living with HIV are co-infected with hepatitis C virus
and 2.6 million with hepatitis B virus. Unfortunately, most people with chronic viral hepatitis are
not aware of their status and do not receive appropriate treatment.

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Without an expanded and accelerated response, the number of people living with hepatitis B
virus is projected to remain at high level for the next 40–50 years, with a cumulative 20 million
deaths occurring between 2015 and 2030. The number of people living with hepatitis C virus is
also increasing, despite the existence of an effective cure.

Every year more than 200,000 people in Africa are dying from complications of viral hepatitis B
and C-related liver disease, including cirrhosis and liver cancer. Sixty million people in sub-
Saharan Africa were living with chronic hepatitis B infection in 2015. More than 4.8 million of
them are children under five years old. A further 10 million are infected with hepatitis C, most
likely due to unsafe injection practices within health facilities or by communities.

EPIDEMIOLOGY OF VIRAL HEPATITIS IN ETHIOPIA

Since the 1980s, over 30 studies have been conducted in Ethiopia by different groups of
investigators to determine the sero-prevalence of various hepatitis viruses in the country. The
aim here is not to try and present an exhaustive summary of the entire medical literature but
rather to highlight significant trends and observations over time. The studies have focused on
hepatitis B and hepatitis C virus infections, mainly due to the involvement of these 2 viruses in
causing chronic liver disease, which is a significant public health problem nationally. It was
reported that 12% of the hospital admissions and 31% of the mortality in medical wards in
Ethiopian hospitals were due to all causes of chronic liver disease (CLD)4.

From the systematic review and meta-analysis of hepatitis virus in Ethiopia, the first documented
HBsAg prevalence rate was 3.9% in 1968. Then later the magnitude of the peak HBsAg
prevalence (10.8%) was available in 1986 and 1989 and then decreased to 6.2% in 2003 and
5.3% in 2007. However, studies conducted in blood donors reported a slightly higher median
prevalence of 8.7% than the 6.2% median prevalence rate in the community-based studies. The
HBsAg was also reported among various segments of the society such as healthcare
professionals (7.3–9.0%), medical waste handlers (6.0–6.3%), outpatient and inpatient
department attendants (4.7–7.4%), street dwellers (10.9%), pregnant women (3.0–7.3%), diabetic
patients (3.7%), HIV VCT clients (5.7%) and commercial sex workers (6.0%). The HBsAg

4
Tsega E. Current views on liver diseases in Ethiopia. Ethiop Med J. 1977;15(2):75–82.

3
prevalence among Ethiopians Jews who immigrated to Israel in different times also showed 6.2
to 19% prevalence rate. Overall, the median HBsAg prevalence in the general population showed
6.3% over the last five decades5.

The national sero-survey conducted by MoH and EPHI in 2017, the prevalence of Hepatitis B
surface antigen (HBsAg) was estimated to be 9.4% among the general population aged 15 years
and above. There were variations in the prevalence of HBsAg across regions, with the highest
prevalence rate being found in the Afar region (28.8%). Overall, there was a minimally higher
prevalence in rural areas (9.7% vs 8.35%). The pooled prevalence of anti-hepatitis C virus
antibody (anti-HCV) was 3.1% (95%CI: 2.2–4.4). Unlike HBV, the anti-HCV prevalence in HIV
infected individuals was higher (5.5%, 95% CI: 3.8–7.8%, p = 0.01) than the prevalence
observed in the other subgroup of study population6.

More importantly, because of HIV pandemic and possible epidemiological overlap as the result
of shared transmission ways and risk factors, viral hepatitis-HIV co-infection and subsequent
severe forms of clinical complications could be potentially high in the country. The population
based seroprevalence of hepatitis B surface antigen (HBsAg) among HIV positive adults ages
15-64 years in urban Ethiopia is 4.8 (3.6% in women and 7.4% in men ages)7.

In summary, the different studies conducted in Ethiopia, mainly on HBV and HCV have
produced various seroprevalence estimates. However, arriving to a consensus estimate for each
of the hepatitis virus for the country as a whole, remains a significant challenge. This is because
the studies have been conducted in different population groups (having increased or lower risk
probability), utilized different sample sizes, and most of all, used different laboratory screening
methods, some with, and others without, the benefit of confirmatory testing, to arrive at
seroprevalence estimations. In addition, the studies have a wide geographical distribution. In

5
Yeshambel Belyhun et al. Hepatitis viruses in Ethiopia: a systematic review and meta-analysis. BMC Infect
Dis. 2016; 16: 761
6
Yeshambel Belyhun et al. Hepatitis viruses in Ethiopia: a systematic review and meta-analysis. BMC Infect
Dis. 2016; 16: 761
7
EPHIA 2017-2018. Ethiopia population-based HIV impact assessment

4
light of the above limitations, further population based seroprevalence studies are required to
know the real magnitude the problem in the country.

THE CURRENT NATIONAL POLICY AND PROGRAMMATIC RESPONSE

The country follows prevention-first strategy for all health sector and invested a lot on
establishing prevention structure in the community, a model of its nature, the health extension
program that address the community level prevention services. As viral hepatitis has prevention,
treatment and care services, the existing health care facilities are the main service delivery points
for primary prevention, case identification through screening and provision of treatment and care
for those infected with hepatitis B and hepatitis C viruses.

The prevention of viral hepatitis which is key target has usually been embedded in the
context of existing health programs. For example, since 2007, hepatitis B vaccine has been
integrated within the childhood EPI program whereas; universal precaution and infection
prevention has been implemented at all levels of the health system, using the National
Infection Prevention Guideline developed by the MOH. At the same time, the National Blood
Bank Service has implemented robust initiatives in 100% screening of blood for HBV and HCV.
In addition, compelling efforts are ongoing in awareness creation and promotion of safer sex
as part of the overall HIV prevention national effort, that this effort also has relevance for
preventing infections due to HBV and HCV.

In line with the World Health Assembly resolutions on viral hepatitis in 2010 and 2014; and the
WHO Regional Committee resolutions in 2014, Ethiopia has recognized viral hepatitis as a
public health problem. To this effect, the government of Ethiopia has prepared the first five-year
national strategic plan for viral hepatitis (2016–2020). Based on the national strategic plan, the
national viral hepatitis prevention, diagnosis, care and treatment guidelines developed to
standardize and scale-up of the services in public health approach.

To strengthen the leadership and coordination of viral hepatitis program, MoH has moved the
national the program from NCD team to HIV team – this restructuring is helpful for efficient
program management as well as in alignment of the national practice to the global trend. A focal

5
person for viral hepatitis program is assigned in MoH and the national viral hepatitis technical
working group (TWG) is established and meets regularly.

During the previous national strategic plan period, viral hepatitis interventions including
preparation of training materials and M&E tools, capacity building of health workers,
quantification and procurement of medicines, standardization of diagnosis, care and treatment
services in selected teaching hospitals, advocacy and awareness activities - commemoration of
world hepatitis days were implemented. Furthermore, hepatitis B vaccination was provided for
more than 450,000 health care providers and students of health science colleges. Piloting of
hepatitis B birth dose is initiated aiming the national scale -up in 2022.

However, the overall viral hepatitis program management and services were not strong, and
accessibility was limited only to certain tertiary hospitals. The viral hepatitis program SWOT
analysis is summarized as below:

Strengths Weaknesses
• Availability of policy documents (National • Treatment is limited to selected treatment centers
guidelines and strategic plan) (only 13 hospitals); it is not decentralized in public
• Presence of coordination platform/TWG health approach.
that includes partners providing technical • No systematic screening for high risk groups (HIV
support positives, pregnant women and etc.)
• Childhood hepatitis vaccination coverage is • Inadequate of trained health care providers due to
high (>90%) absence of adequate continuous capacity building
• Piloting of birth dose initiated aiming activity
national scale-up • Low public awareness of the burden of the disease
• Presence of IPC program that incorporates and treatment
injection safety and blood safety • Access to diagnostics (rapid tests, PCR) is very
• Availability of blood safety program limited; expensive service in private settings
• Availability of M&E tools with standard • There is no practice of linking those who are
indicators positive to treatment at blood donation centers
• Gap on establishing social insurance system instead
of out of pocket service.
• Key/relevant indicators are not incorporated in the
DHIS2 (no national data)
• Hepatitis surveillance not being done for hepatitis
B&C to monitor the trend

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Opportunity Threat
• Commitment of Gastroenterologists’ • High cost of the drugs and the diagnostics
association to support the national program • Less attention given at global and national levels
• Availability of antiviral that cure/treat • Limited donors to support the program
Hepatitis “C”/”B”
• Possibility of getting drugs through price
negotiation
• Presence of global hepatitis elimination
strategy by 2030 and inclusion of hepatitis
in SDG agenda.

RATIONALE FOR REVISION OF THE 2016 - 2020 VIRAL HEPATITIS NATIONAL

STRATEGIC PLAN
Following the global direction on viral hepatitis elimination by 2030 Ethiopia developed its first
National strategic plan of hepatitis (2016-2020). During the strategic planning period, some
efforts have been initiated and carried out and midterm review conducted in 2018. The feedback
gained from the review process was an important element to the improvement of hepatitis
program. The national technical working group has been discussing on the importance of
revising the national strategic plan considering recent updates and gaps on the current strategic
plan. Some of the rationale behind the consensus of revising the strategic plan are:
• Even though the country has a strategic plan (2016-2020), the implementation was not
properly done as per the strategic directions... Therefore, this updated strategic document
is required for the planning, implementation, monitoring and evaluation of the national
viral hepatitis program.
• The ministry of health is currently working on HIV/viral hepatitis program integration
and the revision of the viral hepatitis strategic plan will be used as an opportunity for
advocacy and resource mobilization. This also helps for meaningful engagement of
relevant national and global stakeholders.
• The international and national data used in the strategic plan are outdated; and recent
information on the status and efforts towards the response need to be reflected in the
revised document.

7
• There is a need for strategic plan focusing on public health approach including simplified
and standardized quality service package, service decentralization through task sharing
and task shifting and optimization of viral hepatitis diagnostics and treatment.

• Global direction on strategies to reach key and priority population and strengthening of
program management, coordination and alignment of targets towards elimination has to
be properly addressed.

• The current NSP lacks M&E framework with precise list of indicator definitions. As the
country progresses towards viral hepatitis elimination, strong guidance for well-designed
M&E framework is very crucial to monitor the prevention, care and treatment services.
Therefore, strategies to guide functional and quality data system should be addressed in
order to generate data needed for efficient program impact.

8
CHAPTER TWO: VISION, GOAL, OBJECTIVES AND TARGETS
This national strategic plan addresses all five hepatitis viruses (hepatitis A, B, C, D and E), with
particular focus on hepatitis B and C, owing to the relative public health burden they represent.
The strategy defines the vision, goal, objectives and targets in alignment with the national health
policy and Health Sector Transformation Plan II that aims achieving the global viral hepatitis
elimination targets by 2030.

VISION

To see Ethiopians free from viral hepatitis by halting transmission while those living with
hepatitis have access to safe, affordable and effective diagnosis, care and treatment.

GOAL

To promote national response to the elimination of viral hepatitis as a public health threat in
Ethiopia through providing access to safe, affordable and effective prevention, diagnosis,
treatment and care of the highest possible quality in an equitable manner.

OBJECTIVES

• To strengthen national policies for the prevention, control, diagnosis, treatment and care
of viral hepatitis.
• To provide effective and affordable promotive and preventive services for viral hepatitis
• To reduce the morbidity and mortality from viral hepatitis through early detection and
case management of hepatitis B and C
• To improve the survival and quality of life among individuals with chronic liver disease.
• To generate and timely utilize national data and research for evidence-based decision
making.
• To promote partnerships with relevant stakeholders for the prevention, control, diagnosis,
treatment and care of viral hepatitis B and C.
• To mobilize resource and maximize efficiencies in allocation and utilization.

9
STRATEGIC OBECTIVES

There are five main strategies to be undertaken under this plan, namely:
Strategic objective 1: Advocacy, communication and social mobilization
Strategic objective 2: Viral hepatitis prevention programs
Strategic objective 3: Access to diagnostic, treatment and care services
Strategic objective 4: Strengthen generation and utilization of strategic information for
evidence-based response
Strategic objective 5: Health system strengthening for effective and efficient viral
hepatitis program

STRATEGIC TARGETS

Strategic targets are set for 2025 to be in line with the WHO target of combating hepatitis B and
C to reach elimination by 2030.
• To diagnose 90% of the population living with viral hepatitis.
• To reduce the number of new cases of viral hepatitis by 90%.
• To reduce mortality due to viral hepatitis by 65%.
• To treat 80% of the population in need of treatment.

GUIDING PRINCIPLES

The following key principles will guide the strategic plan:

a) Leadership for ownership

• There are already preventive and control initiatives that exist at the national and sub-
national levels that are not optimally coordinated and monitored. The plan aims to ensure
coordination on multiple fronts and provide oversight to enhance universal access to
prevention and control efforts. Guidance is important in developing, adopting and
applying new technologies, tools and approaches including research that will lead the
country towards viral hepatitis elimination by 2030.

10
b) Fostering partnership for sustainability
• A strong coalition involving all sectors of society and ensuring that all partners align their
support to the national hepatitis response as set out by the government will eventually
result to achievement of country key targets on viral hepatitis. A desired partnership aims
to further enhance mutual trust and complementarily among stakeholders. The inter-
sectoral cooperation where all key stakeholders work together will create sustainable,
locally appropriate solutions to limit the burden posed by viral hepatitis on health care
systems, society and, most importantly, infected persons and their communities.
c) Access and Equity
• Universal health coverage is the overarching framework to ensure that all people obtain
the viral hepatitis services they need without suffering financial hardship when paying for
them. Emphasis will be on increasing access to prevention, screening, diagnostic testing,
referrals, treatment and support for people infected with viral hepatitis.
d) Integration for efficiency
• This plan aims to integrate hepatitis services into existing health systems and strategies,
avoiding stand-alone viral hepatitis programs and strengthening the interface between the
health sector and other sectors in the country. For example, the existing HIV prevention
interventions has also impact in the prevention of hepatitis transmission.
e) Focused actions for impact
• The viral health national strategic plan has taken into consideration the global guidance,
which advocates for a public health approach based on simplified and standardized
interventions and services that can readily be taken to scale and bringing them nearer to
the population in need. Similarly, the country plan has taken priorities to interventions
that can be undertaken based on local epidemiology, contexts, needs and capacities.

STRATEGIC OBJECTIVE 1

ADVOCACY, COMMUNICATION AND SOCIAL MOBILIZATION

Viral hepatitis is recognized as a major public health problem and countries are required to take a
strong action towards prevention and control interventions. In Ethiopia, the overall national and
sub-national viral hepatitis program is not strong and there is inadequate dedicated funding for

11
the provision of viral hepatitis services, including prevention, diagnosis, care & treatment, and
strategic information system. Because there is no adequate resource, public health institutes are
severely challenged in carrying out their important role in responding the impact of viral
hepatitis infections.
Advocacy is one of many strategies that aimed at drawing attention to and influencing
policy/decision makers on important issues. Advocacy measures and messages will clearly
demonstrate the disease burden, economic impact, pros and cons of action and inaction, and the
overall impact of viral hepatitis on development. Based on relevant evidences, an effective
advocacy can inform the policy/decision makers and program managers including but not limited
to the regulatory bodies, laboratory agencies, procurement agencies and research institutes and
facilitates working towards improving the existing policies, regulations and the budgets to
strengthen the national viral hepatitis program.

Social mobilization through community engagement and participation is crucial for increasing
the public awareness and reducing the stigma and discrimination. Community awareness on viral
hepatitis must be achieved through well designed communication strategy to increase the public
awareness on the magnitude of the problem and benefits of viral hepatitis prevention, diagnosis
and treatment interventions.

To achieve the national viral hepatitis prevention and control objectives and targets, MOH in
collaboration with key partners including the CSOs, development partners, private sector, and
other relevant stakeholders will implement the following key interventions.

KEY INTERVENTIONS:
• Concerted advocacy efforts to decentralize the viral hepatitis SBCC, prevention,
diagnosis, care and treatments services in the principles of public health approach and
universal health coverage;
• Gather relevant evidences and publish periodical country fact sheets, news release, media
spots and informative videos about viral hepatitis to stimulate the strengthening of
preventive and control measures;

12
 • Advocate and incorporate key viral hepatitis SBCC and prevention elements in the health
extension program to promote and strengthen viral hepatitis awareness among the
community and the general public;
• Integrate key viral hepatitis SBCC elements in the existing national programs such as
WASH for hepatitis A & E, immunization for hepatitis Band infection control including
injection and blood safety for hepatitis B & C;
• Promote and strengthen viral hepatitis awareness among targeted populations, including
those at high risk of infection and/or the serious consequences of viral hepatitis infection,
especially hepatitis B and C;
• Promote and strengthen viral hepatitis education and awareness among healthcare
professionals and care providers;
• Recognize association of people affected with viral hepatitis and/or CSOs advocating for
viral hepatitis and actively involve participating in the national viral hepatitis program
planning, implementation and monitoring processes, whenever necessary;
• Support and work together with association of people affected with viral hepatitis and/or
CSOs advocating for viral hepatitis in addressing the stigma and discrimination resulting
in greater willingness of people to be tested and find out if they are infected;
• Commemorate annual World Hepatitis Day at national and sub-national levels and should
be leveraged for nationwide advocacy and awareness raising activities;
• Identify viral hepatitis good-will ambassador (national champion) and conduct periodic
national hepatitis awareness campaigns to raise the public awareness and accelerate
accessing viral hepatitis services.

STRATEGIC OBJECTIVE 2

VIRAL HEPATITIS PREVENTION PROGRAMS

Viral hepatitis (A, B, C, D and E viruses) mode of transmission differ from one to the other, and
the prevention and control strategies need to be tailored accordingly. Viral hepatitis A and E are
food and water-borne infections that can result in acute outbreaks in communities with unsafe
water and poor sanitation. Infections are in many cases mild, with most people making a full
recovery and remaining immune from further infections. However, the infections can also be

13
severe and life threatening. Hepatitis B virus is transmitted through exposure to infectious blood,
semen, and other body fluids. The transmission of hepatitis B virus is significantly higher from
infected mothers to infants at the time of birth or from family member to infant in early
childhood. The hepatitis B virus infection during early childhood contributes for higher
proportion of liver cirrhosis and liver cancer in adults. Hepatitis D virus infections occur
exclusively in persons who are infected with hepatitis B virus. The dual infection of hepatitis B
& D can result in a more serious disease and worse outcome. Hepatitis C virus is mostly also
transmitted through exposure to infectious blood. Sexual transmission is also possible but is
much less common.

Countries need to strengthen effective and efficient prevention efforts to achieve the global
ending viral hepatitis targets by 2030. A comprehensive approach to the prevention of viral
hepatitis includes several strategies. To have greatest impact, effective interventions should be
combined and tailored for the specific population, location and setting. These include:
• Safe and effective vaccines are available for hepatitis A, B and E vaccines but only
vaccine for hepatitis B virus childhood vaccination programs is widely available in
developing countries;
• Prevention of mother-to-child transmission of hepatitis B virus through timely hepatitis
B virus birth-dose vaccination;
• Rigorous application of infection prevention and control interventions;
• Harm reduction for people who inject drugs;
• Promoting safer sex and condom use;
• Accessing sanitation and access to safe food and water.

Opportunities exist for ministry of health to collaborate with the existing programs to effectively
and efficiently implement the prevention interventions. This can be realized through working in
coordination with the national immunization, HIV, WASH and infection prevention and control
(including injection and blood safety) programs. To this line, this national strategic plan will
indicate key effective and efficient viral hepatitis prevention interventions.

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KEY INTERVENTIONS:
1. Infant immunization
• Strengthening of routine immunization services to achieve and sustain at least 90%
childhood hepatitis B vaccine third dose coverage (part of pentavalent vaccination)
among infants;
• Promote hepatitis B vaccination for high-risk and vulnerable adult population including
the health care providers.
2. Prevention of mother-to-child transmission
• Work closely with MOH national immunization program in implementation and
monitoring of hepatitis B birth dose piloting exercise;
• Work closely with immunization program to Scale-up the delivery of timely hepatitis B
birth dose (within 24 hours of birth) based on the findings of the piloting exercise;
• Integrate and work closely with the national elimination of HIV and congenital syphilis
mother-to-child transmission program;
• Pre-Exposure Prophylaxis (PrEP) – Tenofovir (TDF) for eligible pregnant women to
prevent mother-to-child transmission of Hepatitis B.
3. Infection prevention and control (injection and blood safety)
The injection and blood safety need to be implemented based on the MOH infection
prevention & control reference manual and national strategy for national blood transfusion
services. Key interventions include:
• Strengthen and sustain routine infection prevention and control practices in health care
settings (public and private), including in laboratories;
• Implement the injection safety policy with the aim of reducing unnecessary injections;
• Provide hepatitis B virus post-exposure prophylaxis to health care workers who have
accidental occupational exposure;
• Ensure the availability of safe blood and blood products through universal screening for
hepatitis B & C;
• Establish systems of surveillance, hemovigilance and monitoring of the incidence and
prevalence of viral hepatitis infections in blood donors and on post-transfusion hepatitis
risk;

15
 • Establish and strengthen the linkage mechanism for tested hepatitis B & C positive cases
to viral hepatitis care and treatment services.
4. Harm reduction
People with injection drug (PWID) use are those men and women, who, because of using illegal
injectable substances are at high risk of acquiring HIV and viral hepatitis infections. The harm
reduction programs will be implemented to prevent, and control HIV, viral hepatitis and blood
borne diseases among PWID. Harm reduction interventions will be implemented jointly with
national HIV program based on the 2021-2025 HIV national strategic plan. The key
interventions include:
• Work closely with national HIV program in developing a multi-sectoral approach to
address policy issues around establishing a program for people with injecting drug;
• Promote sterile needle and syringe programs through social marketing, non-
governmental, civil society organizations and private sector;
• Integrate opioid substitution therapy for in mental health services of government, non-
governmental and civil society organizations;
• Integrate HIV, viral hepatitis, other blood borne diseases, STIs and condom promotion
services with harm reduction and rehabilitation interventions;
• Design, develop and promote risk reduction communication for PWID;
• Establish and strengthen the linkage mechanism for tested hepatitis B & C positive cases
to viral hepatitis care and treatment services.
5. Promote safer sex and condom use
Although sexual transmission of viral hepatitis B and C plays a minor role in most hepatitis
epidemics, specific attention should be given to certain populations, particularly heterosexual
persons who have with multiple sexual partners. The key interventions include:
• Promote BSCC on safer sex practices, including minimizing the number of sexual
partners;
• Promote consistent and correct use of male and female condoms to protect against viral
hepatitis B and C, HIV infection, and a range of other sexually transmitted infections.
6. Assuring improved access to safe food and water supply
Poor sanitary and hygienic practices, unsafe water supplies, and poor food hygiene are prevalent
in Ethiopia. Assuring access to safe food, drinking water and sanitation systems can dramatically

16
reduce the transmission and occurrence of acute outbreak of viral hepatitis A and E. The key
interventions include:
• Multi-sectoral collaboration of relevant sector offices to work towards improved access
to safe food and water supply;
• Advocacy and communication for improved food safety practices through education of
the public and enforcement of food safety practices for food handlers;
• Improve proper disposal systems to eliminate sanitary waste;
• Promote SBCC for improved hygienic practices.

STRATEGIC OBJECTIVE 3

ACCESS TO DIAGNOSTIC, TREATMENT AND CARE SERVICES

Early diagnosis of hepatitis infection is critical for effective treatment and care. Even though,
there was a global plan to increase the number of people with chronic viral hepatitis who are
aware of their status from less than 5% at 2016 to 30% by 2020, there is no clear evidence as to
how much was achieved mainly because the yet underdeveloped monitoring and evaluation
framework for viral hepatitis programs across countries.

Since the development of the first strategic plan in Ethiopia, efforts have been in place to
improve the coverage of diagnosis and testing services. However, due to the limited resources
and associated global momentum, the public health approach to scale-up diagnostic and
treatment services have been limited for the most part. Efforts to improve public awareness, put
reliable diagnostics in place and strengthening of laboratory capacity didn’t go well either still
because of financial constraints.

During this strategic period, the country intends to seek a major increase in diagnosis of chronic
viral hepatitis B and C infection, with 65% of people infected knowing their status by 2025 and
90% by 2030. The strategy is increasing early diagnosis through targeted testing strategies and
strengthening laboratory services. Discussed below are selected key area interventions in the
diagnosis and treatment of viral hepatitis which would help our 2025 targets.

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KEY INTERVENTIONS:
1. Scale-up diagnosis of viral hepatitis and improve linkage to treatment
Currently screening for viral hepatitis is practiced in most hospitals and private facilities,
however the service is not adequately standardized and monitored. In the coming five years,
MOH will further scale-up diagnostic services in a systematic and coordinated manner across the
country through implementing the following activities. The key interventions include:
• Avail viral hepatitis rapid testing in all hospitals and health centers. Whenever
resources are constrained the testing should be made available to those who are more
likely to get infected or have had chronic infections. The following are lists of
population groups prioritized for testing:
o People who have received medical or dental interventions in settings where
infection control practices are substandard
o Pregnant women
o Children born to HBV or HCV positive mothers
o People with injecting drugs
o People living with HIV
o Health care workers exposed to biological fluids
o People who ever received blood or blood products
o Inmates of correctional facilities
o Household and sexual contacts of HBsAg positive people
o Female Sex workers
o History of multiple sexual partners or STIs
o Patients undergoing renal dialysis
o People needing immunosuppressive therapy
• Ensure EPHI to standardize rapid tests, revise algorithms and build the capacity of
laboratory technologists/ other health workers;
• Integrate viral hepatitis diagnostics with the existing multi-disease plate forms;
• Build the capacity of EPHI and regional laboratories in order to ensure the quality
management system for viral hepatitis;

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 • Prepare SOP which aims to integrate screening/ diagnosis of viral hepatitis, HIV and STI
to take advantage of the fact that these diseases share common social determinants and
consequently having a wide overlap of target population;
• Integrate sample transport services already in place for HIV and Tuberculosis to include
viral hepatitis tests;
• Ensure timely quantification, procurement and distribution of supplies needed for the
diagnosis of viral hepatitis in collaboration with EPSA;
• Establish key linkages between testing and other services to improve referral and access
to quality assured treatment and other support services;
• Actively engage private facilities at service delivery and program management.
2. Treatment of viral hepatitis
Effective antiviral agents against viral hepatitis B and C have the potential to dramatically reduce
morbidity and mortality, including among people co-infected with HIV. Not all people with
chronic hepatitis infection require, or are eligible for, treatment. Individuals need to be assessed
for liver disease to determine whether treatment is indicated, and if not eligible for treatment,
regularly monitored to determine when treatment should be initiated. Direct-acting antivirals
(DAA) for the treatment of chronic hepatitis C virus have cure rates exceeding 95%. Effective
treatment is available for chronic hepatitis B virus infection, although lifelong treatment is
usually required. WHO guidelines for treatment of chronic viral hepatitis B and C infection
promote a public health approach with a move towards simpler and safer oral treatment
regimens.
There is no available treatment capable of altering the course of acute hepatitis. Prevention is the
most effective approach against the disease. Hospitalization is required for people with fulminant
hepatitis and should also be considered for symptomatic pregnant women. Considering these
facts, the treatment options discussed here will mainly focus on HBV and HCV.
During this strategic period, the country will strive to achieve 60% treatment rate for both
hepatitis B & C among the eligible. Supportive chronic care will be the mainstay for those not
eligible. The following activities will be implemented throughout the strategic period with the
aim of achieving the treatment target 60% by 2025 and 80% by 2030. The key interventions
include:

19
 • Scale-up treatment services for viral hepatitis through public health approach. That means
various services of viral hepatitis will be implemented according to the capacity available
at each tier of the health system guided by standardized care and treatment guidelines and
integrating with and further strengthening referral networks for HIV, TB and STI.
Furthermore, capacity of health workforce will be further strengthened through provision
of job aids, regular and continues training, supportive supervision and clinical mentoring;
• Define and re-define minimum package of services to be provide at each level of the
health system starting from health posts;
• Regularly update viral hepatitis treatment guidelines and treatment protocols, following
global updates in the diagnosis and treatment of viral hepatitis B&C;
• Provide quality treatment that ensures standardized care of people with chronic hepatitis
infection, including appropriate disease staging, timely treatment initiation, patient and
drug toxicity monitoring, management of liver cirrhosis, hepatocellular carcinoma and
liver failure;
• Address common comorbidities, including HIV infection and risk factors that may
accelerate progression of liver disease, including alcohol use and provide palliative and
end-of-life care, including access to adequate analgesia;
• Make sure equitable distribution of DAA to eligible patients is made and work closely
with EPSA and regional hubs to perform timely and regular quantification, procurement,
distribution of drugs as well as monitor utilization by facilities.

STRATEGIC OBJECTIVE 4

STRENGTHEN GENERATION AND UTILIZATION OF STRATEGIC

INFORMATION FOR EVIDENCE-BASED RESPONSE
Information interpreted and used for planning and decision-making to improve the direction of a
program. Data are needed to measure the performance, improve program management and
increase accountability. The data that constitute strategic information can come from a wide
variety of sources, for example, monitoring systems, evaluations, program reviews, surveillance,
surveys, researches, vital event registration, human interest story, and computer modeling etc.
Computer modeling like SPECTRUM that is being used for HIV estimation and projection are

20
helpful in the estimation of the country-level disease burden. This tool can be used for viral
hepatitis too; to enable the country produces evidence-based and cost effective polices and plan.

Surveillance, surveys, and research are powerful tools and provide a sound foundation for the
planning and implementation of evidence-based prevention and treatment approaches. Therefore,
availing accurate data enable policy makers and decision makers at all levels to understand the
burden of disease caused by viral hepatitis, to prioritize resources, and to tailor different
interventions. In order to promote evidence-based decision-making viral hepatitis program the
following action needs to be undertaken during the strategic planning period.

KEY INTERVENTIONS
• Increase the understanding of the viral hepatitis epidemic and response in the country
through effective data collection, analysis, reporting and use at all levels;
• Prepare a national viral hepatitis epidemiological synthesis using the existing available
triangulated data and disseminate at national and regional level;
• Ensure for timely submission of global report on viral hepatitis;
• Promote the inclusion of key selected viral hepatitis indicators including biomarkers in
the Ethiopian Demographic Health Survey (EDHS);
• Promote and ensure the integrating of viral hepatitis in the existing HIV– SPECTRUM
computer modeling for a national viral hepatitis estimation and projection;
• Advocate for the instituting continuous quality improvement tool and dashboard in HIV
and hepatitis treatment centers and integrate with HIV data quality activities in the
existing DHIS2 system;
• Advocate the establishment of sentinel surveillance for viral hepatitis;
• Promote the integration of viral hepatitis research track at national level with the other
similar research tracks including TB and HIV;
• Ensure the timely development of global hepatitis report and its submission;
• Promote for producing viral hepatitis and HIV quarterly bulletin.

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STRATEGIC OBJECTIVE 5

HEALTH SYSTEM STRENGTHENING FOR EFFECTIVE AND EFFICIENT VIRAL

HEPATITIS PROGRAM MANAGMENT
A comprehensive public health approach is critical in scaling-up and decentralization of viral
hepatitis prevention and control services. This will be realized through:
• designing people-centered health services;
• well-functioning laboratories and sample transportation mechanism;
• a secure supply of affordable medicines and diagnostics;
• an appropriately trained health workforce;
• adequate resources for essential services; and
• active involvement of affected communities.
KEY INTERVENTIONS
1. Service delivery
• Scale-up decentralized viral hepatitis prevention and control services in the context of
simplified and standardized public health approach;
• Strengthen the integration and linking of viral hepatitis services with other relevant
health services (including immunization, HIV, STIs, broader sexual and reproductive
health, harm reduction and drug use disorders, IPC, blood safety, WASH, and non-
communicable diseases);
• Improve the quality of services by ensuring the implementation of global and national
norms and standards, and continuously monitoring and reviewing;
• Ensure continuum of viral hepatitis services at all levels and actively engage the
community;
• Strengthen the multi-sectoral collaboration of viral hepatitis services with relevant sector
offices (including correctional services, police and justice, social welfare, water and
sanitation);
• Define the roles and responsibilities of different levels of the health system in delivering
viral hepatitis services, from community-based and primary health services through to
tertiary referral centers;

22
 • Actively engage the affected populations in developing policy/strategies, programs and
also in addressing viral hepatitis related stigma and discrimination;
• Promote differentiated viral hepatitis service delivery models (in health facility, drop-in
centers for sex workers and PWID, prisons, refugee camps, CSOs, etc.).
The minimum service packages for viral hepatitis prevention and control program across the
health system is summarized in Annex 1.
2. Human resource capacity building
• Identify opportunities for task-shifting and task-sharing to extend the capacity of the
health workforce and community health workers with adequate support;
• Integrating viral hepatitis contents into the training of health workers and defining core
competencies relevant to delivering hepatitis services at different levels of the health
system;
• Build the capacity of health workers through ongoing TOTs and cascade trainings (both
in pre-service and in-service training), mentoring and supervisions;
• Promote community-based and peer-support workers in demand creation, linking people
with viral hepatitis to care, supporting treatment adherence;
• Implement occupational health measures that address the risk of viral hepatitis
transmission within health care settings and address the needs of health workers living
with viral hepatitis.
3. Access to medicines, diagnostics & other commodities
• Advocate and negotiate for price reduction of viral hepatitis medicines with
manufactures;
• Strengthen the country’s capacity in generating data to forecast the need for viral
hepatitis medicines, diagnostics and commodities;
• Strengthen the integration of viral hepatitis medicines, diagnostics and commodities to
the broader national procurement and supply management system;
• Assess the quality and performance of commercially available hepatitis diagnostics and
issue appropriate recommendations;
• Support regulatory authorities in pre-market assessment and registration of new hepatitis
medicines and diagnostics, with post-market surveillance;
• Promote and strengthen the local manufacturing capacity to benefit from reduced prices
and guarantee supply.

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CHAPTER 3: MONITORING AND EVALUATION

Effective viral hepatitis prevention, care and treatment services require standardized data
recording and reporting system. Data recording and reporting is used to systematically monitor
and evaluate the progress of patient/s and treatment outcome as well as the overall program
performance.

Monitoring and evaluation is done at different levels of the health system where epidemiological
and operational indicators of viral hepatitis program are compiled, analyzed, reported and used.
The viral hepatitis program indicators are integrated into the HMIS/DHIS2 and all forms and
registers are standardized accordingly. Health facilities are the primary sources of data. All
required information concerning people living with viral hepatitis should be recorded correctly
and completely. All health facilities should have an updated registers and reporting forms and
should be used properly.

Monitoring and evaluation is key in helping health facility and program managers in assessing
the effectiveness of the interventions and the linkages between services along the cascade of
testing, diagnosis, treatment and care of viral hepatitis and associated conditions. Such
information is essential for early detection and timely response to the identified bottlenecks
and/or gaps of the program. Patient monitoring system is also important to support the follow-up
of people living with the disease receiving treatment and ensure retention in care.

In order to strengthen the viral hepatitis national monitoring and evaluation (M&E) system, the
following key elements are important:
• Clear goal, objectives and targets of the program: cascading the national viral hepatitis
goal, objectives and targets to regions and sub-regional levels is essential in owning the
program at different levels.
• A core set of indicators and targets: it is important to identify priority/core indicators and
additional indicators that cover program inputs, activities/processes, outputs, outcomes
and impact. Also, selection of indicators needs to be through full participation of
stakeholders and maintaining relevance and comparability.

24
 • Presence of an M&E focal person: assigning M&E focal person with relevant
qualification and experience at national & regional level facilitates the tracking of key
indicators, analyzing and reporting of the program implementation.
• A viral hepatitis M&E framework: an overall national level data collection and analysis
plan is important. The plan has also to address the data collection and analysis system at
different levels.
• A clear plan for data dissemination and use: establishment of an overall national level
data dissemination plan is important.

1. DATA REPORTING, DATA FLOW AND QUALITY ASSURANCE

Until all the required global and national viral hepatitis indicators are incorporated in
HMIS/DHIS2, data collection and reported will be continued through parallel reporting
mechanism. Routine viral hepatitis data are collected and reported on a monthly basis. Facilities
aggregate and review their data monthly and report to the woreda (district) office. Woreda
(district) health office aggregates the data received from facilities and report to zonal health
office; the same true is for zonal health office to regional health bureau and regional health office
to MOH.

Emphasis should be given for an improved data quality particularly at the facility level where the
entry point for HMIS. Periodic DQA activities should be carried out at different levels. Data
analysis and data use at different levels is very important to track the program implementation,
planning exercise and decision making.

2. SUPPORTIVE SUPERVISION
Ongoing supportive supervision is an important component for monitoring and evaluation.
Supportive supervision is a facilitative approach that promotes communication, mentorship, joint
problem-solving practices, and appropriate use of resources. Thus, periodic supportive
supervision should be carried out at each level. Monitoring the implementation of
recommendations/action points of each round of supportive supervision is crucial in improving
the overall quality of the services.

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3. SURVEILLANCES AND SURVEYS
Efforts should be made to establish and/or integrate viral hepatitis surveillance system based on
the availability of resources. Periodical surveys will be conducted both at a facility and
population level in order to understand the epidemiology of viral hepatitis and effectiveness of
interventions.

4. RESEARCH AND DEVELOPMENT

MOH in collaboration with EPHI will encourage efforts to generate further evidences that shape
and contribute to the national prevention and control of viral hepatitis. Ongoing basic, social and
operational researches are important through coordinated manner and aligned with national
research ethics.

5. MID-TERM AND END-REVIEWS

Mid-term review of this national strategic plan will take place in mid-2023 while the end-term
review will be conducted just before the end-date of the strategy. The mid-term review will
assess the results in the achievement of the targets, analyzing the available data to verify the
outcome and impact in comparison with baseline values for core indicators. The review will not
only assess the effectiveness of the overall national response but will also take into consideration
the quality and efficiency of the interventions. If it is necessary, the national strategic plan will
be revised based on the findings and recommendations of the review.

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CHAPTER 4: COORDINATION MECHANISM AND RESOURCES

1. COORDINATING THE IMPLEMENTATION

The viral hepatitis program will be managed and coordinated at different levels of the health
system: The ministry of health, regional health bureaus, zonal health offices and woreda health
offices will have different areas of work and responsibilities in the prevention and control of
viral hepatitis.

To strengthen the leadership and coordination of viral hepatitis program, MOH and RHBs have
moved the viral hepatitis program from NCD team to HIV team – this restructuring is helpful for
efficient program management. A focal person for viral hepatitis program is assigned in MOH
and RHBs. Furthermore, zonal and woreda health offices will assign their respective viral
hepatitis focal person. Ministry of health and regional health bureaus at different levels will be
responsible for the coordination of sectors.

A functional viral hepatitis TWG is in place at the national level and the partners like CHAI,
EGA, and WHO, are actively engaged in the work of this coordinating structure. The TWG is
advising MOH in advocacy, policy development, capacity building and supply chain
management. Though the lists are not exhaustive, the key roles and responsibilities of the
stakeholders are summarized as below:

Ministry of Health
• Leads and coordinates the viral hepatitis program at different levels for effective and
efficient program implementation and for improved quality of services;
• Develop national viral hepatitis strategic plan, guidelines, training materials and tools;
• Capacity building of viral hepatitis program managers and health care workers;
• Facilitate clinical mentorship in improving quality of viral hepatitis services at different
levels;
• Monitor and report the implementation of the strategic plan and guidelines (national &
global);

27
 • Strengthen the partnership with relevant stakeholders through involving in TWG,
operational planning exercises, monitoring and evaluation activities;
• Advocates and negotiate for price reduction of viral hepatitis medicines and diagnostics;
• Mobilize domestic and external resources for viral hepatitis program;
• Strengthen inter-program and multi-sectoral collaboration;
• Ensure data quality and use at different level.

Ethiopian Pharmaceutical and Supply Agency (EPSA)

• Leads and coordinates the viral hepatitis program supply chain management;
• Actively engages in the national viral hepatitis TWG and related national forums;
• Conduct annual viral hepatitis medicines and diagnostics quantification exercises;
• Coordinates the procurement and distribution of the necessary viral hepatitis commodities
by integrating into the existing supply chain management system;
• Update the reporting and requisition formats to incorporate commodities needed for viral
hepatitis;
• Integrate viral hepatitis in supply chain training manual;

Ethiopian Public Health Institute (EPHI)

• Leads and coordinates the national viral hepatitis laboratory services;
• Actively engages in the national viral hepatitis TWG and related national forums;
• Standardizes the national viral hepatitis B & C testing algorithm;
• Setting up functional diagnostic systems/platforms for viral hepatitis at various levels;
• Leads the development and revision of training manual as well as provision of trainings
for laboratory professionals;
• Builds the diagnostic capacities at national, regional and facility levels;
• Promotes integration of viral hepatitis viral load testing into the existing multi-disease
diagnostic platforms (GeneXpert, conventional VL machines);
• Strengthen the EQA of viral hepatitis lab tests through integrating into existing quality
assurance mechanisms;
• Conduct surveys, surveillance and operational research as needed.

28
Ethiopian Food and Drug Administration (EFDA)
• Actively engage in national viral hepatitis TWG and related national forums;
• Enlists and approves viral hepatitis medicines and diagnostics in the national drug list as
per the recommendation of the national guideline;
• Ensures pre-market assessment and registration of new hepatitis medicines and
diagnostics, with post-market surveillance.

Regional Health Bureaus (RHB)

• Lead and coordinate the viral hepatitis program at regional and sub-regional levels for
effective and efficient program implementation and for improved quality of services;
• Prepare annual operational plan aligned with the national viral hepatitis plan;
• Cascade the national viral hepatitis strategic plan, guidelines, training materials and tools;
• Cascade the viral hepatitis trainings to program managers and health care workers;
• Facilitate clinical mentorship to improve quality of viral hepatitis services at different
levels;
• Monitor and report the implementation of the national strategic plan and guidelines;
• Strengthen the partnership with regional stakeholders through establishing TWG and
involve stakeholders in the operational planning exercises, monitoring and evaluation
activities;
• Allocate resources for viral hepatitis program;
• Strengthen inter-program and multi-sectoral collaboration;
• Ensure data recording and reporting, data quality, and use at different level.

Civil Society Organization (CSO)

• Advocates to avail accessible and affordable viral hepatitis services;
• Actively engage of affected communities in the national viral hepatitis response;
• Creates awareness and community mobilization for viral hepatitis prevention, diagnosis,
treatment and care services;
• Address viral hepatitis related stigma and discrimination;
• Mobilize domestic and international resources.

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Development partners
• Engage actively in national viral hepatitis TWG and related national forums;
• Support the country adaptation and revision of national policy documents based on the
global updates;
• Provide technical and financial support to the viral hepatitis national response based on
country need;
• Enhance local and international resource mobilization and build technical and
institutional capacities to sustain effective and efficient national response;
• Ensure the alignment and harmonization of operational plans.

Private health sector

• Engage in national viral hepatitis TWG and related national forums;
• Ensure the provision of viral hepatitis services as per the national guidelines;
• Improve data recording and reporting mechanism as per the national guidance;
• Contribute in the national resource mobilization efforts.

NB: the roles and responsibilities of public health facilities will be reflected in the standard
operating procedures, which will be prepared and disseminated.

2. COSTING AND FINANCING

Over the next five years, it is important to promote for sustained domestic commitment to fund
the national response to viral hepatitis. The costs for each intervention are estimated as the
population in need of the service multiplied by the coverage (the percentage actually using the
service) multiplied by the unit costs. The total funding needs for the NSP is $900,046,797
million for the period of 2021-2025. The annual resources needed for each activity is
summarized in the below table and the key inputs and assumptions for the costing of the viral
hepatitis national strategic plan are described in Annex 3.

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 Financial resource estimates needed for implementation of
2021-2025 viral hepatitis NSP in Ethiopia (in USD)
Cost Item Year 1 Year 2 Year 3 Year 4 Year 5 Cumulative
HCWs Training 32,000 85,600 965,600 965,600 965,600 3,014,400
Guidelines and NSP 10,000 19,280 36,800 36,800 36,800 139,680
printing
Advocacy/ 9,475 29,000 29,000 29,000 29,000 125,475
Communication
Vaccination for HCWs 19,474 21,420 23,563 25,920 28,502 118,879
HBV medicines 477,882 2,477,319 10,262,699 21,234,314 35,658,709 70,110,923
HCV medicines 2,763,845 14,327,664 59,354,683 122,809,402 206,233,396 405,488,989
VL tests for HBV 2,064,808 10,703,883 44,342,582 91,748,211 154,072,448 302,931,933
VL tests for HCV 680,947 3,530,004 14,623,618 30,257,389 50,811,127 99,903,084
Screening test / RDTs 121,136 627,966 260,1450 5,382,600 9,038,981 17,772,133
both for HBV & HCV
M&E 63,328 88,458 100,528 88,458 100,528 441,300
Total Cost 6,242,894 31,910,594 132,340,524 272,577,694 456,975,091 900,046,797

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ANNEXES

ANNEX 1. Minimum package for viral hepatitis services at each health facility level
Minimum package for viral hepatitis services at each health facility level
Level/Provider Prevention Laboratory Treatment

Community - Prevention message - Provide information to the - Program adherence support

- HEWs/HEPs - Provide information to community - Provide information to the community
the community
Health Center - Prevention message - Rapid tests for screening - Assess eligibility criteria for HBV and
- General - Vaccination of newborn - Hematology HCV using available capacities
Practitioner - Adults vaccination - CBC - Counselling (adherence, lifestyle)
- Health - Pre / Post exposure - Initiate HBV treatment for simple
officers prophylaxis cases
- Nurse - Capacity building of - Follow up of patients on HBV and
- Laboratory HEWs/HEPs HCV treatment
Technician - Refer complicated cases to the next
level as appropriate
District Hospital - Prevention message - Rapid tests for screening - Clinical assessment for cirrhosis
- General - Vaccination of newborn - Liver function tests - Counselling (adherence, lifestyle)
Practitioner - Adults vaccination - Renal function tests - Assess eligibility criteria for HBV and
- Health - Pre/Post exposure - Hematology HCV using available capacities
officers prophylaxis - Capacity building of Lab - Initiate HBV treatment for
- Nurse - Supervision and clinical technicians at health intermediary complicated cases
- Laboratory mentorship of Health center level (Training, - Initiate HCV treatment
Technician Centers Mentorship) - Follow up of patients on HBV and
HCV treatment
- Refer complicated cases to the next
level as appropriate
- Capacity building of Nurses/HO at
Health Center Level (Training,
Mentorship)
Referral - Prevention message - Rapid tests for screening - Counselling (adherence, lifestyle)
Hospital/Private - Vaccination of newborn - Liver function tests - Advanced clinical assessment for
hospitals - Adults vaccination - Renal function tests cirrhosis
- Specialist - Pre/Post exposure - Hematology - Assess eligibility criteria for HBV and
- General prophylaxis - ELISA Tests HCV using available capacities
Practitioner - Capacity building of - Viral Load Monitoring - Initiate HBV treatment complicated
- Nurse medical at District - Capacity building of cases
- Laboratory Hospitals & Health medical at District - Initiate HCV treatment
Technician centers (Training, Hospitals & Health - Follow up of patients on HBV and
- Nutritionist Mentorship, Centers (Training, HCV treatment
Supervision) Mentorship, Supervision) - Provide guidance on HCV and HBV
end of treatment
- Capacity building of medical at
District Hospitals (Training,
Mentorship, Supervision)

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ANNEX 2. Targets for monitoring of HBV and HCV progress – 2021-2025

S. Service coverage targets Baseline Data 2021 2022 2023 2024 2025
No. Year Value sources
1 Hepatitis B Virus Vaccination: 2020 67% DHIS2/ 81% 85% 89% 92% 95%
Childhood vaccine coverage (Third EDHS
Dose)
Numerator: Number of children aged one year, receiving three doses of pentavalent vaccine
Denominator: Number of surviving infants in a particular year (Census-CSA)
2 Prevention of Hepatitis B mother- 2020 0 DHIS2/ 80% 83% 86% 89% 92%
to-child transmission: (under EDHS
Hepatitis B virus birth dose piloting)
vaccination coverage
Numerator: Number of infants receiving HBV birth dose vaccine within 24 hrs. after birth
Denominator: Expected live births in a particular year
3 Blood safety: Proportion of donated 2020 100% NBTS 100% 100% 100% 100% 100%
bloods screened for HBV & HCV report
with quality assurance
Numerator: Number of donated bloods screened for HBV & HCV with quality assurance
Denominator: Total number of donated bloods in a particular year
4 Safe injections: Percentage of 2020 100% SPA+/ 100% 100% 100% 100% 100%
injections administered with safety Survey
in the health facilities
Numerator: Number of health facilities providing safe injections
Denominator: Total number of public and private health facilities in a particular year
5 Viral Hepatitis B diagnosis coverage 2020 NA DHIS2 <1% 5% 20% 40% 65%
Numerator: Number of individuals diagnosed positive for HBV
Denominator: Estimated people living with HBV infection
6 Viral Hepatitis C diagnosis 2020 NA DHIS2 <1% 5% 20% 40% 65%
coverage:
Numerator: Number of individuals diagnosed positive for HCV
Denominator: Estimated people living with HCV infection
7 Viral Hepatitis B treatment 2020 NA DHIS2 <1% 5% 15% 35% 60%
coverage
Numerator: Number of people testing positive for HBV who received treatment
Denominator: Number of people with positive HBV test and eligible for treatment
8 Viral Hepatitis C treatment 2020 NA DHIS2 <1% 5% 15% 35% 60%
coverage
Numerator: Number of people testing positive for HCV who received treatment
Denominator: Number of people with positive HCV testing results

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ANNEX 3. Key inputs and assumptions for the costing of the 2021-2025 viral hepatitis
national strategic plan
1. Health care workers training:
• An average of 1,500 ETB would be enough per person per day for per diem,
transportation, refreshment, and meeting hall costs. It was also assumed that the
conversion rate of 1 USD is 45 ETB.
• The number of trainees include three clinical staff (physician, HO or nurse), 1
laboratory staff and 1 pharmacy staff from each of the health facilities that provide viral
hepatitis diagnostic and treatment services. Besides, focal persons from each of the 12
regional health bureaus will be trained every year.
• Training will be provided for staff from 28 hospitals and 95 hospitals (22
referral/specialized hospitals and 73 general hospitals) in Year 1 and Year 2,
respectively. In the remaining three years, training will be provided for staff from 1,195
hospitals (22 referral/specialized hospitals, 73 general hospitals and 1,100 primary
hospitals) every year. Besides, 12 staff from RHBs will be trained every year
considering that there would be attrition or rotation of focal persons.
• The training duration will be three days for clinical and laboratory staff, and two days
for pharmacy staff.
• For each of the training participants, an average of two travel days is also considered.
2. Printing of guideline and national strategic plan:
• Both the national viral hepatitis strategic plan and the national viral hepatitis guideline
will be printed in 500, 964, 1840, 1840, 1840 in year 1, year 2, year 3, year 4 and year
5, respectively.
• The estimated printing costs per copy for both documents will be 10 USD.
3. Advocacy and communication:
• It was assumed that there will be 60 media spots in each of the years to advocate and
promote viral hepatitis services.
• The estimated cost for each of the media spots will be 150 USD. This cost assumption
was taken from the current television and radio spots broadcasted on HIV related
messages.

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 • It is also planned to print 95 copies of SBCC materials in year 1 and 4,000 copies of
SBCC materials in each of the remaining four years. The estimated printing cost for one
copy of SBCC materials is 5 USD.
4. Hepatitis B vaccination of health care workers:
• It was assumed that all health care workers who worked previously or currently in
health facilities are vaccinated for HBV. Here, it is assumed that only those newly
graduated are eligible for HBV vaccination.
• The number of eligible health care workers in the country for year 1, year 2, year 3,
year 4 and year 5 is 3462, 3,808, 4,189, 4,608, and 5,067, respectively.
• Each health care worker will receive three doses of the HBV vaccine.
• The estimated cost of one dose HBV vaccine is 1.50 USD, including 20% margin for
procurement and supply management costs and 5% wastage cost.
5. Monitoring and evaluation costs:
• It was assumed that 56 health facilities will be supervised in year 1, and 241 health
facilities will be supervised in each of the remaining four years. The estimated cost of
supportive supervision per health facility is 138 USD that includes per diem and
transportation.
• It was also assumed that viral hepatitis registers with 40 copies in year 1, and 1,207
copies in each of year 3 and year 5 will be printed.
• It was also planned to conduct two review meetings per year, three assessments
(baseline, midline, and end line) during the five years, and one planning workshop
every year.
6. HBV medicines:
• As per the EPHI survey, the HBV national prevalence was taken to be 9.4%.
• Number of HBV infected people was calculated by multiplying the prevalence and the
adult (>15 years) population size, which was projected by the Central Statistics
Agency, for each year.
• The number of HBV infected people diagnosed in each of the years was determined
based on the targets as indicated in the monitoring and evaluation framework of the
national strategic plan.

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 • Based on the opinions of gastroenterology specialists, 15% of HBV diagnosed people
are eligible for antiviral treatment.
• It was also assumed that 90% of this eligible for treatment will be treated using TDF
while the remaining 10% will be treated using entecavir as these patients could be
either contraindicated to TDF because of renal disease or due to age or failure to TDF
treatment.
• The price of 1 pack (30 tablets) of TDF and 1 pack (30 tablets) of entecavir was taken
to be 3 USD and 16 USD, respectively, including supply chain management costs or
EPSA margins. The reference price was taken from the recent procurement of EPSA.
7. HCV medicines:
• As per systematic review and meta-analysis, the HCV national prevalence was taken to
be 3.1%.
• Number of HCV infected people was calculated by multiplying the prevalence and the
adult (>15 years) population size, which was projected by the Central Statistics
Agency, for each of the ears.
• The number of HCV infected people diagnosed in each of the years was determined
based on the targets as indicated in the monitoring and evaluation framework of the
national strategic plan.
• All of HCV diagnosed people were taken to be eligible for antiviral treatment.
• It was also assumed that 80% of HCV diagnosed people will be treated using
combination of SOF 400mg and DCV 60mg tablet while the remaining 20% will be
treated using combination of SOF 400mg and VEL100mg FDC tablet. It was assumed
that 20% of HCV diagnosed clients have either previous treatment failure with DCV
60mg based regimen or contraindicated to DCV 60mg and hence need SOF
400mg+VEL100mg FDC treatment.
• The price of 1 pack (28 tablets) of SOF 400mg + DCV 60mg tab co-blister tablets and
1 pack (28 tablets) of SOF 400mg+VEL100mg FDC tablet was taken to be 38.75 USD
and 75.00 USD, respectively, including supply chain management costs or EPSA
margins. The reference price was taken from the recent procurement of EPSA.

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8. Viral load tests for both HBV and HCV clients:
• One viral load test will be conducted once in a year for each of the HBV and HCV
diagnosed clients.
• The price for one VL test was taken to be 34 USD including supply chain management
costs or EPSA margins. The reference price was taken from the recent procurement of
EPSA.
9. Screening test / RDTs both for HBV & HCV:
• One RDT test will be conducted once for each of the HBV and HCV diagnosed clients.
• The price for one RDT test was taken to be 1.5 USD including supply chain
management costs or EPSA margins. The reference price was taken from the recent
procurement of EPSA.

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 REFERENCE MATERIALS
1. Global health sector strategy on viral hepatitis 2016–2021: Towards ending viral hepatitis,
WHO 2016
2. Prevention and control of Viral hepatitis infection Framework for Global action, WHO, 2012
3. Guidelines for the screening, care and treatment of persons with hepatitis C infection, WHO,
2014
4. Guidelines for the prevention, care and treatment of person’s with chronic Hepatitis B
infection March 2015
5. Prevention & control of viral hepatitis infection: A strategy for global action, WHO 2011
6. HIV/AIDS national strategic plan for Ethiopia 2021-2025, FHAPCO 2021
7. Five-year strategic plan for the national blood transfusion service 2015/16-2019/20, MoH
8. National expanded program on immunization - comprehensive multi-year plan, 2021-2025,
MoH

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