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Moving towards hepatitis B elimination in Gulf Health Council states: From commitment to action
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Moving towards hepatitis B elimination in Gulf Health Council states: From commitment to action Salah T. Al Awaidy a,∗ , Sayeh Ezzikouri b a b
Office of Health Affairs, Ministry of Health, P.O. Box 393, PC 100, Muscat, Oman Virology Unit, Viral Hepatitis Laboratory, Institut Pasteur du Maroc, Casablanca, Morocco
a r t i c l e
i n f o
Article history: Received 31 May 2019 Received in revised form 30 July 2019 Accepted 3 August 2019 Keywords: Hepatitis B virus Viral hepatitis Hepatitis B elimination Global health sector strategy Gulf Health Council states
a b s t r a c t Introduction: In 2016, the World Health Assembly adopted the hepatitis B (HB) elimination strategy that aims at ending HB by 2030. In this descriptive review we provide the progress made and challenges to achieving hepatitis B elimination by 2030 in Gulf Health Cooperated (GHC) states. Methods: Data record from relevant online databases and reliable resources were reviewed until the end of 2017. The analysis was based on the core indicators of the WHO monitoring and evaluation framework for viral hepatitis B and the targets of the global health sector strategy by 2016–2021. Results: The states introduced HB vaccination, including birth-dose for those under 5 years old, with global coverage of more than 95%, in order to prevent mother-to-child transmission of HBV. The prevalence of HB antigens declined in children under age 5 to less than 1%. However, the rate of vaccination among the most-at-risk populations remains suboptimal. All states have implemented safe blood transfusions and injection safety policies as well as universal laboratory-based surveillance for acute HB. However, surveillance for chronic HB and sequelae as well as estimation methods of morbidity and mortality to evaluate impact are not established. Similarly, harm reduction for people who inject drugs and testing and treatment policies and protocols for people with chronic HB are suboptimal. Conclusions: Additional steps are required to strengthen immunisation among the most-at-risk populations, maintain high quality surveillance, use antiviral therapy to treat chronic HBV and stop unsafe injection practices for drug users. Establishing country-specific national hepatitis responses based on country priorities as well as the capacity of the home health sectors to address these needs are paramount. Achieving elimination targets will require a radical alteration in the current hepatitis response and this goal should be elevated to a higher priority in the public health arena. © 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction Hepatitis B (HB) is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV) and remains a major worldwide health problem. Chronic hepatitis B infection (CHB) is a major cause of severe liver disease, including cirrhosis and hepatocellular carcinoma [1–3]. In 2015, the estimated global prevalence of HBV infection (HBsAg) in the general population was 3.5%, 257 million people are living with CHB, while there were 887,000 reported deaths [4]. The World Health Organization (WHO) established a target for introducing HB vaccination into national immunisation pro-
∗ Corresponding author. E-mail address: [email protected] (S.T. Al Awaidy).
grammes by 1997 [5], and for the administration of a birth dose to all new-born within 24 h of birth by 2009 [4]. In May 2016, the World Health Assembly endorsed the global health sector strategy on viral hepatitis 2016–2021 [4]. The strategy calls for elimination of viral hepatitis as a public health threat by 2030 through implementation at sufficient service coverage of five core interventions [6]. Currently, few countries have analysed and documented the progress towards elimination of hepatitis B by 2030. China [7], UK [8], European Union [9], South-East Asia Region [10] and US [11] showed an impressive progress and identified some gaps in meeting the elimination targets of reducing incidence, vaccination, blood safety, safe injections and harm reduction and the secure resources and political commitment [12]. To lead implementation of the global initiative in the Eastern Mediterranean Region, an Action Plan (2017–2021) for the hepatitis
https://doi.org/10.1016/j.jiph.2019.08.004 1876-0341/© 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article in press as: Al Awaidy ST, Ezzikouri S. Moving towards hepatitis B elimination in Gulf Health Council states: From commitment to action. J Infect Public Health (2019), https://doi.org/10.1016/j.jiph.2019.08.004
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Table 1 The prevalence of HBsAg before and after roll-out of the vaccination programme, Gulf Health Cooperates states. Country
Bahrain Kuwait Oman Qatar Saudi Arabia UAE
Hepatitis B surface Ag prevalence rate (%) before introduction of hepatitis B vaccine
Hepatitis B surface Ag prevalence rate (%) after roll-out of hepatitis B vaccine
0.58 [24] Not available 2.3 [17] Not available 7 [17] Not available
Not available Not available 0.7 [17] 0.0 [18] 0.05–0.22 [33] Not available
response was adopted [13] which urges the member countries to prepare internal plans of action in line with the regional action plan [13,14]. The WHO Eastern Mediterranean Region has among the highest reported prevalence of HBV: an approximated 3.3% of the general population are infected and 21 million people are living with HBV, amounting to 8.1% of the cases globally [15]. The Gulf Health Council (GHC) states are a regional alliance of 6 Middle Eastern countries on the Arabian Peninsula that was founded in 1981 and includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. Despite a number of publications on the epidemiology of HBV, there is a paucity of published works describing the HBV elimination initiative in GHC states [16–18]. This article review the progress made towards HBV elimination in the GHC states, identifies the challenges to be confronted by the National HBV control programme, highlights the lessons learnt and proposes steps towards elimination. Methodology We performed an online search for articles published on hepatitis B and elimination from Medical Journal, Pubmed® , Elsevier, EMBASE® , and Scopus by 2017. We also searched and reviewed reports on hepatitis B data from the Global Hepatitis Report 2017 [4] the GHC states Hepatitis B dashboard and Hepatitis B country profile 2017 [19,20].We reviewed the progress towards hepatitis B elimination during 2015–2017. Our analysis was based on the core indicators of the WHO monitoring and evaluation framework for viral hepatitis B and the targets of the global health sector strategy on viral hepatitis 2016–2021 [15]. Progress towards HB elimination Epidemiology of hepatitis B The epidemiology of HBV infection in the GHC states is varied. Prior to the introduction of the HB vaccine into national immunisation programmes, the prevalence of hepatitis B surface antigen (HBsAg) (a marker of chronic infection) was estimated from high to intermediate [21]. Significant progress has been made since the HB vaccine was introduced three decades ago (1990–1991). The prevalence of HBV in the general population dropped to intermediate to low from 1990 to 2015 and the prevalence of HBsAg declined after roll-out of the vaccination programme in children under age 5 to less than 1% by 2015 as well as the estimated population prevalence [Fig. 1] [19,20]. The prevalence of HBsAg before after roll-out of the vaccination programme is summarized in Table 1. Bahrain From 2000 to 2010, the prevalence of HBV infection in Bahrain was 0.58%. However, infection prevalence was significantly higher
Fig. 1. WHO estimated prevalence of HBs Ag in the Gulf Health Council states, 2015.
in patients having undergone dental procedures and surgical operations and among foreign-born residents [22]. Kuwait Studies estimate the prevalence of HBV carriers is 1% among the general population [23]. However, this prevalence was higher (3.5%) among blood donors of foreign-born residents [24]. Oman In Oman, prior to the introduction of vaccination, a moderate prevalence of chronic HBV infection was estimated at 2–7% [25]. In a national sero-survey conducted in 2005, the HBsAg seroprevalence was 2.3% among students born prior to the national hepatitis B vaccination policy, but was 0.7% among students born after institution of the national policy [17]. The prevalence rates of anti-HBs in the population post vaccination was 1.3% [25]. The impact of vaccination efficacy and coverage was also evaluated in an Omani nationwide survey, which showed that 15 years after the introduction of HBV vaccination of new-born, the prevalence of CHB in children dropped from 2.3% in 1990 to 0.5% in 2005 [17]. Qatar A retrospective cohort study conducted from 2002 to 2006 showed that the HB incidence in Qatar was 4.7% [26]. A cross-sectional study reported that the HB prevalence among professional male athletes in Qatar was 2.2% and a lack of HBV immunity of 53.3% [27]. However, the estimated prevalence based on sero-epidemiology conducted among pregnant women showed HBsAg prevalence was 1% [25]. In 2016, a sero-survey of patients over age 5 using point-of-care test/rapid test yielded zero prevalence HBsAg [18]. Saudi Arabia The first pre-vaccination era large-scale community-based epidemiological study conducted on Saudi children yielded HBsAg sero-prevalence of approximately 7% [28]. Other estimated to be 8.3% with higher prevalence in the Southwestern and Eastern regions (10%) [28]. The exposure rate of HBV infection (anti-HBc marker) ranges from 30% to 80% in different regions of Saudi Arabia, with a median of 50% [28]. The prevalence of HBsAg dropped to 0.5-2% post HB vaccine introduction [29,30]. A recent study in the Aseer Region, in the Southwest of Saudi Arabia, documented an overall prevalence of HBsAg of 5.9%. Here, the authors found a low
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Fig. 2. Gulf Health Cooperated states’ towards implementing HBV elimination.
rate of HBsAg (0.8%) among those under the age of 15, 1.3% among those aged 15–24 and 6.3% among those over the age of 25 who were not vaccinated as children [31]. In 2007, a cross-community study among HBV immunized childhood showed the prevalence rates of 0.05% and 0.22% among children and adults, respectively, ranged from 0.03% to 0.72% among regions [31–33].
United Arab Emirates To date, no prevalence estimations have been done on the general population of the United Arab Emirates. A previous report indicated the prevalence of HBsAg among young adults applying to the police college in Abu Dhabi was 0.3% [34]. Also, a study in 2000 of pregnant women aged 15–45 years, found the HBV prevalence to be 1.5% [25]. A recent retrospective study of patients attend-
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Fig. 3. Status of implementation of priority action areas, GHC states, 2017.
ing a teaching dental hospital found that 2.15% of students tested positive for HBsAg [35].
Governance A single administrative structure has been established to lead the HB elimination strategy in most GHC states (except the UAE) with a national HB central unit and district units to oversee the national hepatitis response. A hepatitis B programme national focal point has also been assigned by all states. Country-specific national hepatitis strategic plans and responses, based on individual needs and priorities as well as findings from a technical advisory group (STAG) on viral hepatitis, have been enabled by most of the states (except Oman) and integrated into the broader national health programmes. Furthermore, access to high-quality HB services has been maintained and is free of charge in all states [Fig. 2C] [19]. However, dialogue between stakeholders at the national and regional levels, including government institutions, clinical experts, professional associations, academia, the private sector and civil society is not well established [19].
Hepatitis B surveillance and monitoring In all states, acute HB reporting is mandatory and was integrated into the National Communicable Disease Surveillance System (NCDSS). In addition, a national network of laboratory services has also been made available and laboratory-based surveillance for acute hepatitis B notification has been integrated into the national communicable diseases surveillance system [19]. The monitoring system of acute HB incidence and other notifiable vaccine preventable diseases requires that all health facilities, including non-public (private) institutions, notify NCDSS of suspected acute HB cases and report their vaccination status. An acute HB case is classified using WHO case definitions and regular reporting from all institutions is to be executed within 7 days of diagnosis. A confirmed case is a suspect case with positive HBsAg [36]. Surveillance for chronic HB, carriers and sequelae as well as estimation methods of morbidity and mortality to evaluate impact are not well established. Monitoring of the prevalence of viral hepatitis infections in blood donors is well established [19], but no system of monitoring post-transfusion hepatitis risk is currently in place. The HB cancer registry is well established. HBV screening has been implemented among the most-at-risk populations, including health care workers (HCWs), people who inject drugs (PWIDs), HIV patients, haemodialysis candidates, prisoners and contacts exposed to HBV index cases. However, the screening does not yet cover sex workers (SW) and men having sex with men (MSM) [19].
Fig. 4. Hepatitis B vaccination coverage (%) for the three-dose among children aged less than one year, GHC states, 2000–2017.
Testing policies and guidelines All states have implemented official guidelines which describe the procedures for diagnosing HB. Primary, secondary and tertiary level facilities offer serological testing for both HBV (i.e., HBsAg) as well as nucleic acid testing for HBV [Figs. 2A and 3 ] [19]. Routine HBV vaccination The GHC states introduced HB vaccination into their national expanded programmes on immunisation around the same time (1990–1991) [12]. The HB vaccine is administered to all newborns at birth, 2, 4, and 6 months. There has been a progressive increase in the vaccine coverage since then. In 2017, it was reported that more than 95% of HBV3 [Fig. 5] [37] and newborns received the birth dose and the three consecutive HB vaccinations [37] [Figs. 2A and 3]. Furthermore, the HB vaccine has been integrated into the primary, secondary and tertiary health care services provided by the MOH and in the private sector free of charge. No financial burden is imposed on foreign-born residents, regardless of GHC immigration or visa status. All GHC states have identified the most-at-risk populations and adopted HBV vaccination policy that includes HCWs, PWIDs, HIV patients, haemodialysis candidates and prisoners [19]. Vaccination coverage for the most-at-risk populations is variable throughout the GHC states and inadequate in most states, while many are not systematically assessed. Furthermore, national policies and guidelines still do not address SW and MSM [19].
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Fig. 5. Status of implementation of other priority action areas, GHC states, 2017.
Fig. 6. Status of implementation of treatment of hepatitis B, GHC states, 2017.
Prevention of mother-to-child transmission (PMTCT) of HBV PMTCT has been achieved through high birth dose coverage among newborns >95% [Fig. 3] [37]. Blood and injection safety All GHC states have implemented safe blood transfusions and now screen almost a hundred percent of blood components and blood products for HBV using standardised procedures. All states also currently participate in a WHO external quality assurance scheme and can ensure safe blood and blood products from regular, voluntary, and non-remunerated blood donors. Injection safety policies have also been widely implemented in health care settings [Figs. 2A and 3] [38].
developing treatment policies and guidelines also provide core services (e.g., treatment) free of charge for resident nationals [Fig. 2B and C] [19]. However, the status of implementation of treatment of hepatitis B is in adequate [Fig. 6]. Further, surveillance activities to monitor and assess treatment outcomes have not yet been implemented. To date, no information on the number of people receiving treatment nor HBV-related mortality. Harm reduction All GHC states claim to have satisfactory treatment of drugdependent HBV patients (including opioid substitution therapy), though implementation of needle and syringe exchange interventions and services has not been incorporated as part of a comprehensive package of harm reduction services [Fig. 2A and B] [19].
Treatment policies, guidelines and HBV-related mortality Community awareness Few GHC states have developed official and comprehensive treatment policies, protocols and other support services for patients diagnosed with CHB. The states that have made progress in
Community-driven HB awareness campaigns took place across the GHC countries on an HB day organised solely by the MOH.
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The approach was culturally relevant. Combined awareness and advocacy campaigns were implemented by other institutions, but campaign impact was never measured. Monitoring and evaluation framework for HBV Indicators for monitoring programme progress towards the achievement of milestones and targets are neither well determined nor embraced [19]. Some prevention indicators are systematically monitored, including hepatitis B vaccine coverage and birth-dose [Fig. 4], as well as health-care injection safety [Fig. 3]. Other core indicators reflecting the cascade of care are not collected [Fig. 5]. Importantly, impact measurement is based on incidence and mortality, though the only relevant data collected is the prevalence of HBV infection among children under 5 years old. Discussion The prevalence of hepatitis B among GHC states ranges between low and intermediate [23]. This is mostly attributed to routine childhood HB vaccination, a well-established and well-financed HB programme with adequate and well-trained staff, and programme activities that have been integrated into primary, secondary and tertiary health care services. The World Health Assembly endorsed the WHO viral hepatitis elimination goals, with the targets of a 65% reduction in mortality and a 90% reduction in incidence by 2030 [4]. Accordingly, elimination can be achieved through sufficient service coverage of five synergistic prevention and treatment interventions. These are (i) immunisation against hepatitis B [Fig. 3], (ii) prevention of motherto-child transmission of HBV [Fig. 3], (iii) blood and injection safety [Fig. 3], (iv) prevention of transmission of HBV among persons who inject drugs through comprehensive harm reduction services, and (v) testing and treatment [39]. The GHC states have implemented most of the substantive components of these five priority actions of the WHO’s framework for HB elimination [40] and Fig. 3 summarises the GHC states progress through the end of 2017. The national GHC states have committed to strong governance and stewardship of the HB programme within the MOH. Nonetheless, some countries are lacking strategic information on local disease burden of viral hepatitis and on the expected impact and cost-effectiveness of various prevention and care interventions. Some country-specific national hepatitis strategic plans do not have strong monitoring guidelines and do not pay much heed to recommendations from STAG [Fig. 5]. The coordination of actors within the health sectors and beyond is crucial in meeting national targets, yet implementing funded national action plans has not been well addressed. Many hepatitis B policies have been integrated into relevant existing policies, such as blood safety, infection control, antenatal care, and inclusion of the most-at-risk populations. However, inclusion of SW and MSM have still not been addressed. Firstly, as of 2017, the third dose of HB vaccine coverage was above 95% across all states (2030 target: 90%) [Fig. 3]. The widespread use of the hepatitis B vaccine in infants has considerably reduced the incidence of new chronic HBV infections and resulted in the prevention of mother-to-child transmission, as the prevalence of chronic HBV infection in children below the age of 5 declined to less than 1% [20]. Secondly, timely birth-dose vaccination (given within 24 h of birth) was greater than 95% across all states, surpassing the WHO 2030 target of 90%. As of 2017, the third dose of HB vaccine coverage was also above 95% across all states, and surpassing the WHO 2030 target. However, further investigations on the prevalence rates of anti-HBs in the GHC populations after vaccination are warranted.
Vaccination effects have been enhanced through systematic antenatal testing and the use of antiviral drugs in all GHC countries except Oman. Although vaccination programmes have been well implemented, policy and coverage are inadequate with regards to the most-at-risk populations, such as sex workers and MSM. Health-care providers have also been identified as at-risk, and here coverage is variable and unequal in most states. Thirdly, universal precautions have been adopted for all invasive medical interventions, injection safety measures promoted and safe supply of blood products at all facilities has been secured, meeting the WHO 2030 target [40]. Fourth, few states have implemented recommendations on the prevention of transmission of HBV among persons who inject drugs through comprehensive harm reduction services, access to sterile injection equipment and effective drug-dependency treatment. The 2030 target is 300 syringes and needles per person who injects drugs per year, but no data are currently being collected on the status of progress in this direction within the GHC states [39]. Fifth, systematic HB testing is done as part of the overall universal health coverage for the most-at-risk populations, however some are not covered, namely SW and MSM. While the treatment was partly available in some countries, no information regarding patients diagnosed or treatment coverage is currently collected (2030 target: 90% of patients diagnosed and 80% of eligible patients treated) [15]. Challenges and the way forward The key challenges to the elimination of HBV in GHC states include (i) scaling up key interventions, (ii) increasing coverage of routine HBsAg screening and HBV vaccination of the most-at-risk populations to include other high risk groups, (iii) linking those diagnosed with HBV to care and treatment facilities to confirm the ultimate suppression of the hepatitis B virus and (iv) intensification of hepatitis surveillance programmes to better gauge the prevalence of chronic HBV infections. This will require stronger national commitment to HBV elimination and monitoring and evaluation, involving both the public and private sectors. These challenges can certainly be managed, and the authors suggest starting with a regular critical review process, focusing on key issues that could prevent reaching the WHO’s 2030 elimination targets. Important steps to take are: (i) declare a national plan, describing each state’s priorities based on in-depth data analysis generated by the existing HB information system; (ii) obtain a national HBV elimination follow-up STAG; (iii) design and implement an efficient and functional monitoring scheme, with special attention paid to individual institutions, and specific 5year national and district operational plans and milestones tracked, making special note and disseminating lessons learned to policy makers, health care workers and other stakeholders; (v) scale-up HB surveillance to enable reliable estimations of national disease burdens and better inform treatment and prevention guidelines; (vi) introduce and maintain HB vaccination coverage among the most at-risk populations; (vii) establish hepatitis treatment and care guidelines and linkages between testing and other related services; (viii) establish harm reduction interventions for people who inject drugs, taking into account domestic contexts. Conclusion The GHC states have made major progress towards the elimination of hepatitis B infection through strong governance, high routine immunisation coverage’s among infant and timely birthdose vaccine for prevention of mother-to-child transmission of HBV as well as some of the most-at-risk groups and by conducting
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high-quality case-based acute HBV surveillance. To achieve further reduction in HBV morbidity and mortality, critical interventions must be urgently adopted. Furthermore, adoption and adherence of all WHO 2030 HBV elimination guidelines are paramount, as is the development of suitable national HB elimination STAGs. States must address the needs of their most-at-risk populations, including harm reduction for people who inject drugs. Additionally, improvements could be made in the surveillance, monitoring, diagnosis and antiviral treatment of chronic HBV. Much has thus far been achieved in the GHC countries, but the authors urge states to act promptly and cooperatively in order to eliminate the HB threat. Funding No funding sources. Competing interests None declared. Ethical approval Not required. Acknowledgements Publication of this manuscript would not have been possible without the contributions, guidance and support of Allison Seeger, Robert Allison and Magda Salim Al Wahebi. References [1] Chaturvedi VK, Singh A, Dubey SK, Hetta HF, John J, Singh MP. Molecular mechanistic insight of hepatitis B virus mediated hepatocellular carcinoma. Microb Pathog 2019;128:184–94, http://dx.doi.org/10.1016/j.micpath.2019.01.004. [2] World Health Organization. Hepatitis B vaccines: WHO position paper—recommendations. Vaccine 2010;28(3):589–90, http://dx.doi.org/ 10.1016/j.vaccine.2009.10.110. [3] Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol 2006;45(4):529–38, http://dx.doi.org/10.1016/j. jhep.2006.05.013. [4] World Health Organization. Global hepatitis report 2017. Geneva: World Health Organization; 2017. Available at: http://apps.who.int/iris/bitstream/10665/ 255016/1/9789241565455-eng.pdf?ua=1. [Accessed 13 July 2017]. 2017. [5] World Health Organization, Available from: http://www.who.int/csr/disease/ hepatitis/whocdscsrlyo20022/en/index5.html. [Accessed 24 July 2013] Global alert and response. Hepatitis B. Prevention and treatment; 2002. [6] Organization WH. Consolidated strategic information guidelines for viral hepatitis planning and tracking progress towards elimination; 2019. [7] Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ 2019;97(3):230–8, http://dx.doi.org/10. 2471/BLT.18.219469. [8] Mandal S. Introduction of universal infant hepatitis B immunisation in the UK—paving the way to elimination. Hum Vaccin Immunother 2019;15(2):440–3, http://dx.doi.org/10.1080/21645515.2018.1528837. [9] Duffell EF, Hedrich D, Mardh O, Mozalevskis A. Towards elimination of hepatitis B and C in European Union and European Economic Area countries: monitoring the World Health Organization’s global health sector strategy core indicators and scaling up key interventions. Euro Surveill 2017;22(9), http://dx.doi.org/ 10.2807/1560-7917.ES.2017.22.9.30476. [10] Childs L, Roesel S, Tohme RA. Status and progress of hepatitis B control through vaccination in the South-East Asia Region, 1992-2015. Vaccine 2018;36(1):6–14, http://dx.doi.org/10.1016/j.vaccine.2017.11.027. [11] Woodring J, Pastore R, Brink A, Ishikawa N, Takashima Y, Tohme RA. Progress toward hepatitis B control and elimination of mother-to-child transmission of hepatitis B virus—Western Pacific Region, 2005-2017. MMWR Morb Mortal Wkly Rep 2019;68(8):195–200, http://dx.doi.org/10.15585/mmwr. mm6808a2. [12] Popping S, Bade D, Boucher C, van der Valk M, El-Sayed M, Sigurour O, et al. The global campaign to eliminate HBV and HCV infection: International Viral Hepatitis Elimination Meeting and core indicators for development towards the 2030 elimination goals. J Virus Erad 2019;5(1):60–6.
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Moving towards hepatitis B elimination in Gulf Health Council states: From commitment to action Salah T. Al Awaidy a,∗ , Sayeh Ezzikouri b a b
Office of Health Affairs, Ministry of Health, P.O. Box 393, PC 100, Muscat, Oman Virology Unit, Viral Hepatitis Laboratory, Institut Pasteur du Maroc, Casablanca, Morocco
a r t i c l e
i n f o
Article history: Received 31 May 2019 Received in revised form 30 July 2019 Accepted 3 August 2019 Keywords: Hepatitis B virus Viral hepatitis Hepatitis B elimination Global health sector strategy Gulf Health Council states
a b s t r a c t Introduction: In 2016, the World Health Assembly adopted the hepatitis B (HB) elimination strategy that aims at ending HB by 2030. In this descriptive review we provide the progress made and challenges to achieving hepatitis B elimination by 2030 in Gulf Health Cooperated (GHC) states. Methods: Data record from relevant online databases and reliable resources were reviewed until the end of 2017. The analysis was based on the core indicators of the WHO monitoring and evaluation framework for viral hepatitis B and the targets of the global health sector strategy by 2016–2021. Results: The states introduced HB vaccination, including birth-dose for those under 5 years old, with global coverage of more than 95%, in order to prevent mother-to-child transmission of HBV. The prevalence of HB antigens declined in children under age 5 to less than 1%. However, the rate of vaccination among the most-at-risk populations remains suboptimal. All states have implemented safe blood transfusions and injection safety policies as well as universal laboratory-based surveillance for acute HB. However, surveillance for chronic HB and sequelae as well as estimation methods of morbidity and mortality to evaluate impact are not established. Similarly, harm reduction for people who inject drugs and testing and treatment policies and protocols for people with chronic HB are suboptimal. Conclusions: Additional steps are required to strengthen immunisation among the most-at-risk populations, maintain high quality surveillance, use antiviral therapy to treat chronic HBV and stop unsafe injection practices for drug users. Establishing country-specific national hepatitis responses based on country priorities as well as the capacity of the home health sectors to address these needs are paramount. Achieving elimination targets will require a radical alteration in the current hepatitis response and this goal should be elevated to a higher priority in the public health arena. © 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction Hepatitis B (HB) is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV) and remains a major worldwide health problem. Chronic hepatitis B infection (CHB) is a major cause of severe liver disease, including cirrhosis and hepatocellular carcinoma [1–3]. In 2015, the estimated global prevalence of HBV infection (HBsAg) in the general population was 3.5%, 257 million people are living with CHB, while there were 887,000 reported deaths [4]. The World Health Organization (WHO) established a target for introducing HB vaccination into national immunisation pro-
∗ Corresponding author. E-mail address: [email protected] (S.T. Al Awaidy).
grammes by 1997 [5], and for the administration of a birth dose to all new-born within 24 h of birth by 2009 [4]. In May 2016, the World Health Assembly endorsed the global health sector strategy on viral hepatitis 2016–2021 [4]. The strategy calls for elimination of viral hepatitis as a public health threat by 2030 through implementation at sufficient service coverage of five core interventions [6]. Currently, few countries have analysed and documented the progress towards elimination of hepatitis B by 2030. China [7], UK [8], European Union [9], South-East Asia Region [10] and US [11] showed an impressive progress and identified some gaps in meeting the elimination targets of reducing incidence, vaccination, blood safety, safe injections and harm reduction and the secure resources and political commitment [12]. To lead implementation of the global initiative in the Eastern Mediterranean Region, an Action Plan (2017–2021) for the hepatitis
https://doi.org/10.1016/j.jiph.2019.08.004 1876-0341/© 2019 The Authors. Published by Elsevier Limited on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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Table 1 The prevalence of HBsAg before and after roll-out of the vaccination programme, Gulf Health Cooperates states. Country
Bahrain Kuwait Oman Qatar Saudi Arabia UAE
Hepatitis B surface Ag prevalence rate (%) before introduction of hepatitis B vaccine
Hepatitis B surface Ag prevalence rate (%) after roll-out of hepatitis B vaccine
0.58 [24] Not available 2.3 [17] Not available 7 [17] Not available
Not available Not available 0.7 [17] 0.0 [18] 0.05–0.22 [33] Not available
response was adopted [13] which urges the member countries to prepare internal plans of action in line with the regional action plan [13,14]. The WHO Eastern Mediterranean Region has among the highest reported prevalence of HBV: an approximated 3.3% of the general population are infected and 21 million people are living with HBV, amounting to 8.1% of the cases globally [15]. The Gulf Health Council (GHC) states are a regional alliance of 6 Middle Eastern countries on the Arabian Peninsula that was founded in 1981 and includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. Despite a number of publications on the epidemiology of HBV, there is a paucity of published works describing the HBV elimination initiative in GHC states [16–18]. This article review the progress made towards HBV elimination in the GHC states, identifies the challenges to be confronted by the National HBV control programme, highlights the lessons learnt and proposes steps towards elimination. Methodology We performed an online search for articles published on hepatitis B and elimination from Medical Journal, Pubmed® , Elsevier, EMBASE® , and Scopus by 2017. We also searched and reviewed reports on hepatitis B data from the Global Hepatitis Report 2017 [4] the GHC states Hepatitis B dashboard and Hepatitis B country profile 2017 [19,20].We reviewed the progress towards hepatitis B elimination during 2015–2017. Our analysis was based on the core indicators of the WHO monitoring and evaluation framework for viral hepatitis B and the targets of the global health sector strategy on viral hepatitis 2016–2021 [15]. Progress towards HB elimination Epidemiology of hepatitis B The epidemiology of HBV infection in the GHC states is varied. Prior to the introduction of the HB vaccine into national immunisation programmes, the prevalence of hepatitis B surface antigen (HBsAg) (a marker of chronic infection) was estimated from high to intermediate [21]. Significant progress has been made since the HB vaccine was introduced three decades ago (1990–1991). The prevalence of HBV in the general population dropped to intermediate to low from 1990 to 2015 and the prevalence of HBsAg declined after roll-out of the vaccination programme in children under age 5 to less than 1% by 2015 as well as the estimated population prevalence [Fig. 1] [19,20]. The prevalence of HBsAg before after roll-out of the vaccination programme is summarized in Table 1. Bahrain From 2000 to 2010, the prevalence of HBV infection in Bahrain was 0.58%. However, infection prevalence was significantly higher
Fig. 1. WHO estimated prevalence of HBs Ag in the Gulf Health Council states, 2015.
in patients having undergone dental procedures and surgical operations and among foreign-born residents [22]. Kuwait Studies estimate the prevalence of HBV carriers is 1% among the general population [23]. However, this prevalence was higher (3.5%) among blood donors of foreign-born residents [24]. Oman In Oman, prior to the introduction of vaccination, a moderate prevalence of chronic HBV infection was estimated at 2–7% [25]. In a national sero-survey conducted in 2005, the HBsAg seroprevalence was 2.3% among students born prior to the national hepatitis B vaccination policy, but was 0.7% among students born after institution of the national policy [17]. The prevalence rates of anti-HBs in the population post vaccination was 1.3% [25]. The impact of vaccination efficacy and coverage was also evaluated in an Omani nationwide survey, which showed that 15 years after the introduction of HBV vaccination of new-born, the prevalence of CHB in children dropped from 2.3% in 1990 to 0.5% in 2005 [17]. Qatar A retrospective cohort study conducted from 2002 to 2006 showed that the HB incidence in Qatar was 4.7% [26]. A cross-sectional study reported that the HB prevalence among professional male athletes in Qatar was 2.2% and a lack of HBV immunity of 53.3% [27]. However, the estimated prevalence based on sero-epidemiology conducted among pregnant women showed HBsAg prevalence was 1% [25]. In 2016, a sero-survey of patients over age 5 using point-of-care test/rapid test yielded zero prevalence HBsAg [18]. Saudi Arabia The first pre-vaccination era large-scale community-based epidemiological study conducted on Saudi children yielded HBsAg sero-prevalence of approximately 7% [28]. Other estimated to be 8.3% with higher prevalence in the Southwestern and Eastern regions (10%) [28]. The exposure rate of HBV infection (anti-HBc marker) ranges from 30% to 80% in different regions of Saudi Arabia, with a median of 50% [28]. The prevalence of HBsAg dropped to 0.5-2% post HB vaccine introduction [29,30]. A recent study in the Aseer Region, in the Southwest of Saudi Arabia, documented an overall prevalence of HBsAg of 5.9%. Here, the authors found a low
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Fig. 2. Gulf Health Cooperated states’ towards implementing HBV elimination.
rate of HBsAg (0.8%) among those under the age of 15, 1.3% among those aged 15–24 and 6.3% among those over the age of 25 who were not vaccinated as children [31]. In 2007, a cross-community study among HBV immunized childhood showed the prevalence rates of 0.05% and 0.22% among children and adults, respectively, ranged from 0.03% to 0.72% among regions [31–33].
United Arab Emirates To date, no prevalence estimations have been done on the general population of the United Arab Emirates. A previous report indicated the prevalence of HBsAg among young adults applying to the police college in Abu Dhabi was 0.3% [34]. Also, a study in 2000 of pregnant women aged 15–45 years, found the HBV prevalence to be 1.5% [25]. A recent retrospective study of patients attend-
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Fig. 3. Status of implementation of priority action areas, GHC states, 2017.
ing a teaching dental hospital found that 2.15% of students tested positive for HBsAg [35].
Governance A single administrative structure has been established to lead the HB elimination strategy in most GHC states (except the UAE) with a national HB central unit and district units to oversee the national hepatitis response. A hepatitis B programme national focal point has also been assigned by all states. Country-specific national hepatitis strategic plans and responses, based on individual needs and priorities as well as findings from a technical advisory group (STAG) on viral hepatitis, have been enabled by most of the states (except Oman) and integrated into the broader national health programmes. Furthermore, access to high-quality HB services has been maintained and is free of charge in all states [Fig. 2C] [19]. However, dialogue between stakeholders at the national and regional levels, including government institutions, clinical experts, professional associations, academia, the private sector and civil society is not well established [19].
Hepatitis B surveillance and monitoring In all states, acute HB reporting is mandatory and was integrated into the National Communicable Disease Surveillance System (NCDSS). In addition, a national network of laboratory services has also been made available and laboratory-based surveillance for acute hepatitis B notification has been integrated into the national communicable diseases surveillance system [19]. The monitoring system of acute HB incidence and other notifiable vaccine preventable diseases requires that all health facilities, including non-public (private) institutions, notify NCDSS of suspected acute HB cases and report their vaccination status. An acute HB case is classified using WHO case definitions and regular reporting from all institutions is to be executed within 7 days of diagnosis. A confirmed case is a suspect case with positive HBsAg [36]. Surveillance for chronic HB, carriers and sequelae as well as estimation methods of morbidity and mortality to evaluate impact are not well established. Monitoring of the prevalence of viral hepatitis infections in blood donors is well established [19], but no system of monitoring post-transfusion hepatitis risk is currently in place. The HB cancer registry is well established. HBV screening has been implemented among the most-at-risk populations, including health care workers (HCWs), people who inject drugs (PWIDs), HIV patients, haemodialysis candidates, prisoners and contacts exposed to HBV index cases. However, the screening does not yet cover sex workers (SW) and men having sex with men (MSM) [19].
Fig. 4. Hepatitis B vaccination coverage (%) for the three-dose among children aged less than one year, GHC states, 2000–2017.
Testing policies and guidelines All states have implemented official guidelines which describe the procedures for diagnosing HB. Primary, secondary and tertiary level facilities offer serological testing for both HBV (i.e., HBsAg) as well as nucleic acid testing for HBV [Figs. 2A and 3 ] [19]. Routine HBV vaccination The GHC states introduced HB vaccination into their national expanded programmes on immunisation around the same time (1990–1991) [12]. The HB vaccine is administered to all newborns at birth, 2, 4, and 6 months. There has been a progressive increase in the vaccine coverage since then. In 2017, it was reported that more than 95% of HBV3 [Fig. 5] [37] and newborns received the birth dose and the three consecutive HB vaccinations [37] [Figs. 2A and 3]. Furthermore, the HB vaccine has been integrated into the primary, secondary and tertiary health care services provided by the MOH and in the private sector free of charge. No financial burden is imposed on foreign-born residents, regardless of GHC immigration or visa status. All GHC states have identified the most-at-risk populations and adopted HBV vaccination policy that includes HCWs, PWIDs, HIV patients, haemodialysis candidates and prisoners [19]. Vaccination coverage for the most-at-risk populations is variable throughout the GHC states and inadequate in most states, while many are not systematically assessed. Furthermore, national policies and guidelines still do not address SW and MSM [19].
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Fig. 5. Status of implementation of other priority action areas, GHC states, 2017.
Fig. 6. Status of implementation of treatment of hepatitis B, GHC states, 2017.
Prevention of mother-to-child transmission (PMTCT) of HBV PMTCT has been achieved through high birth dose coverage among newborns >95% [Fig. 3] [37]. Blood and injection safety All GHC states have implemented safe blood transfusions and now screen almost a hundred percent of blood components and blood products for HBV using standardised procedures. All states also currently participate in a WHO external quality assurance scheme and can ensure safe blood and blood products from regular, voluntary, and non-remunerated blood donors. Injection safety policies have also been widely implemented in health care settings [Figs. 2A and 3] [38].
developing treatment policies and guidelines also provide core services (e.g., treatment) free of charge for resident nationals [Fig. 2B and C] [19]. However, the status of implementation of treatment of hepatitis B is in adequate [Fig. 6]. Further, surveillance activities to monitor and assess treatment outcomes have not yet been implemented. To date, no information on the number of people receiving treatment nor HBV-related mortality. Harm reduction All GHC states claim to have satisfactory treatment of drugdependent HBV patients (including opioid substitution therapy), though implementation of needle and syringe exchange interventions and services has not been incorporated as part of a comprehensive package of harm reduction services [Fig. 2A and B] [19].
Treatment policies, guidelines and HBV-related mortality Community awareness Few GHC states have developed official and comprehensive treatment policies, protocols and other support services for patients diagnosed with CHB. The states that have made progress in
Community-driven HB awareness campaigns took place across the GHC countries on an HB day organised solely by the MOH.
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The approach was culturally relevant. Combined awareness and advocacy campaigns were implemented by other institutions, but campaign impact was never measured. Monitoring and evaluation framework for HBV Indicators for monitoring programme progress towards the achievement of milestones and targets are neither well determined nor embraced [19]. Some prevention indicators are systematically monitored, including hepatitis B vaccine coverage and birth-dose [Fig. 4], as well as health-care injection safety [Fig. 3]. Other core indicators reflecting the cascade of care are not collected [Fig. 5]. Importantly, impact measurement is based on incidence and mortality, though the only relevant data collected is the prevalence of HBV infection among children under 5 years old. Discussion The prevalence of hepatitis B among GHC states ranges between low and intermediate [23]. This is mostly attributed to routine childhood HB vaccination, a well-established and well-financed HB programme with adequate and well-trained staff, and programme activities that have been integrated into primary, secondary and tertiary health care services. The World Health Assembly endorsed the WHO viral hepatitis elimination goals, with the targets of a 65% reduction in mortality and a 90% reduction in incidence by 2030 [4]. Accordingly, elimination can be achieved through sufficient service coverage of five synergistic prevention and treatment interventions. These are (i) immunisation against hepatitis B [Fig. 3], (ii) prevention of motherto-child transmission of HBV [Fig. 3], (iii) blood and injection safety [Fig. 3], (iv) prevention of transmission of HBV among persons who inject drugs through comprehensive harm reduction services, and (v) testing and treatment [39]. The GHC states have implemented most of the substantive components of these five priority actions of the WHO’s framework for HB elimination [40] and Fig. 3 summarises the GHC states progress through the end of 2017. The national GHC states have committed to strong governance and stewardship of the HB programme within the MOH. Nonetheless, some countries are lacking strategic information on local disease burden of viral hepatitis and on the expected impact and cost-effectiveness of various prevention and care interventions. Some country-specific national hepatitis strategic plans do not have strong monitoring guidelines and do not pay much heed to recommendations from STAG [Fig. 5]. The coordination of actors within the health sectors and beyond is crucial in meeting national targets, yet implementing funded national action plans has not been well addressed. Many hepatitis B policies have been integrated into relevant existing policies, such as blood safety, infection control, antenatal care, and inclusion of the most-at-risk populations. However, inclusion of SW and MSM have still not been addressed. Firstly, as of 2017, the third dose of HB vaccine coverage was above 95% across all states (2030 target: 90%) [Fig. 3]. The widespread use of the hepatitis B vaccine in infants has considerably reduced the incidence of new chronic HBV infections and resulted in the prevention of mother-to-child transmission, as the prevalence of chronic HBV infection in children below the age of 5 declined to less than 1% [20]. Secondly, timely birth-dose vaccination (given within 24 h of birth) was greater than 95% across all states, surpassing the WHO 2030 target of 90%. As of 2017, the third dose of HB vaccine coverage was also above 95% across all states, and surpassing the WHO 2030 target. However, further investigations on the prevalence rates of anti-HBs in the GHC populations after vaccination are warranted.
Vaccination effects have been enhanced through systematic antenatal testing and the use of antiviral drugs in all GHC countries except Oman. Although vaccination programmes have been well implemented, policy and coverage are inadequate with regards to the most-at-risk populations, such as sex workers and MSM. Health-care providers have also been identified as at-risk, and here coverage is variable and unequal in most states. Thirdly, universal precautions have been adopted for all invasive medical interventions, injection safety measures promoted and safe supply of blood products at all facilities has been secured, meeting the WHO 2030 target [40]. Fourth, few states have implemented recommendations on the prevention of transmission of HBV among persons who inject drugs through comprehensive harm reduction services, access to sterile injection equipment and effective drug-dependency treatment. The 2030 target is 300 syringes and needles per person who injects drugs per year, but no data are currently being collected on the status of progress in this direction within the GHC states [39]. Fifth, systematic HB testing is done as part of the overall universal health coverage for the most-at-risk populations, however some are not covered, namely SW and MSM. While the treatment was partly available in some countries, no information regarding patients diagnosed or treatment coverage is currently collected (2030 target: 90% of patients diagnosed and 80% of eligible patients treated) [15]. Challenges and the way forward The key challenges to the elimination of HBV in GHC states include (i) scaling up key interventions, (ii) increasing coverage of routine HBsAg screening and HBV vaccination of the most-at-risk populations to include other high risk groups, (iii) linking those diagnosed with HBV to care and treatment facilities to confirm the ultimate suppression of the hepatitis B virus and (iv) intensification of hepatitis surveillance programmes to better gauge the prevalence of chronic HBV infections. This will require stronger national commitment to HBV elimination and monitoring and evaluation, involving both the public and private sectors. These challenges can certainly be managed, and the authors suggest starting with a regular critical review process, focusing on key issues that could prevent reaching the WHO’s 2030 elimination targets. Important steps to take are: (i) declare a national plan, describing each state’s priorities based on in-depth data analysis generated by the existing HB information system; (ii) obtain a national HBV elimination follow-up STAG; (iii) design and implement an efficient and functional monitoring scheme, with special attention paid to individual institutions, and specific 5year national and district operational plans and milestones tracked, making special note and disseminating lessons learned to policy makers, health care workers and other stakeholders; (v) scale-up HB surveillance to enable reliable estimations of national disease burdens and better inform treatment and prevention guidelines; (vi) introduce and maintain HB vaccination coverage among the most at-risk populations; (vii) establish hepatitis treatment and care guidelines and linkages between testing and other related services; (viii) establish harm reduction interventions for people who inject drugs, taking into account domestic contexts. Conclusion The GHC states have made major progress towards the elimination of hepatitis B infection through strong governance, high routine immunisation coverage’s among infant and timely birthdose vaccine for prevention of mother-to-child transmission of HBV as well as some of the most-at-risk groups and by conducting
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high-quality case-based acute HBV surveillance. To achieve further reduction in HBV morbidity and mortality, critical interventions must be urgently adopted. Furthermore, adoption and adherence of all WHO 2030 HBV elimination guidelines are paramount, as is the development of suitable national HB elimination STAGs. States must address the needs of their most-at-risk populations, including harm reduction for people who inject drugs. Additionally, improvements could be made in the surveillance, monitoring, diagnosis and antiviral treatment of chronic HBV. Much has thus far been achieved in the GHC countries, but the authors urge states to act promptly and cooperatively in order to eliminate the HB threat. Funding No funding sources. Competing interests None declared. Ethical approval Not required. Acknowledgements Publication of this manuscript would not have been possible without the contributions, guidance and support of Allison Seeger, Robert Allison and Magda Salim Al Wahebi. References [1] Chaturvedi VK, Singh A, Dubey SK, Hetta HF, John J, Singh MP. Molecular mechanistic insight of hepatitis B virus mediated hepatocellular carcinoma. Microb Pathog 2019;128:184–94, http://dx.doi.org/10.1016/j.micpath.2019.01.004. [2] World Health Organization. Hepatitis B vaccines: WHO position paper—recommendations. Vaccine 2010;28(3):589–90, http://dx.doi.org/ 10.1016/j.vaccine.2009.10.110. [3] Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol 2006;45(4):529–38, http://dx.doi.org/10.1016/j. jhep.2006.05.013. [4] World Health Organization. Global hepatitis report 2017. Geneva: World Health Organization; 2017. Available at: http://apps.who.int/iris/bitstream/10665/ 255016/1/9789241565455-eng.pdf?ua=1. [Accessed 13 July 2017]. 2017. [5] World Health Organization, Available from: http://www.who.int/csr/disease/ hepatitis/whocdscsrlyo20022/en/index5.html. [Accessed 24 July 2013] Global alert and response. Hepatitis B. Prevention and treatment; 2002. [6] Organization WH. Consolidated strategic information guidelines for viral hepatitis planning and tracking progress towards elimination; 2019. [7] Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ 2019;97(3):230–8, http://dx.doi.org/10. 2471/BLT.18.219469. [8] Mandal S. Introduction of universal infant hepatitis B immunisation in the UK—paving the way to elimination. Hum Vaccin Immunother 2019;15(2):440–3, http://dx.doi.org/10.1080/21645515.2018.1528837. [9] Duffell EF, Hedrich D, Mardh O, Mozalevskis A. Towards elimination of hepatitis B and C in European Union and European Economic Area countries: monitoring the World Health Organization’s global health sector strategy core indicators and scaling up key interventions. Euro Surveill 2017;22(9), http://dx.doi.org/ 10.2807/1560-7917.ES.2017.22.9.30476. [10] Childs L, Roesel S, Tohme RA. Status and progress of hepatitis B control through vaccination in the South-East Asia Region, 1992-2015. Vaccine 2018;36(1):6–14, http://dx.doi.org/10.1016/j.vaccine.2017.11.027. [11] Woodring J, Pastore R, Brink A, Ishikawa N, Takashima Y, Tohme RA. Progress toward hepatitis B control and elimination of mother-to-child transmission of hepatitis B virus—Western Pacific Region, 2005-2017. MMWR Morb Mortal Wkly Rep 2019;68(8):195–200, http://dx.doi.org/10.15585/mmwr. mm6808a2. [12] Popping S, Bade D, Boucher C, van der Valk M, El-Sayed M, Sigurour O, et al. The global campaign to eliminate HBV and HCV infection: International Viral Hepatitis Elimination Meeting and core indicators for development towards the 2030 elimination goals. J Virus Erad 2019;5(1):60–6.
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Please cite this article in press as: Al Awaidy ST, Ezzikouri S. Moving towards hepatitis B elimination in Gulf Health Council states: From commitment to action. J Infect Public Health (2019), https://doi.org/10.1016/j.jiph.2019.08.004