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  • 1. Aims and Scope

    Gut and Liver is an international journal of gastroenterology, focusing on the gastrointestinal tract, liver, biliary tree, pancreas, motility, and neurogastroenterology. Gut atnd Liver delivers up-to-date, authoritative papers on both clinical and research-based topics in gastroenterology. The Journal publishes original articles, case reports, brief communications, letters to the editor and invited review articles in the field of gastroenterology. The Journal is operated by internationally renowned editorial boards and designed to provide a global opportunity to promote academic developments in the field of gastroenterology and hepatology. +MORE

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    Yong Chan Lee Professor of Medicine
    Director, Gastrointestinal Research Laboratory
    Veterans Affairs Medical Center, Univ. California San Francisco
    San Francisco, USA

    Deputy Editor

    Deputy Editor
    Jong Pil Im Seoul National University College of Medicine, Seoul, Korea
    Robert S. Bresalier University of Texas M. D. Anderson Cancer Center, Houston, USA
    Steven H. Itzkowitz Mount Sinai Medical Center, NY, USA
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    All papers submitted to Gut and Liver are reviewed by the editorial team before being sent out for an external peer review to rule out papers that have low priority, insufficient originality, scientific flaws, or the absence of a message of importance to the readers of the Journal. A decision about these papers will usually be made within two or three weeks.
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Special Report

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A Program to Treat Hepatitis B in North Korea: A Model of Antiviral Therapy in a Resource-Poor Setting

Alice Unah Lee1,2, Heidi Linton3, Marcia Kilsby4, David C. Hilmers2,5

1Department of Gastroenterology and Liver Services, Concord Repatriation General Hospital, University of Sydney, Sydney, Australia, 2Hepatitis B Free, Sydney, Australia, 3Christian Friends of Korea, Black Mountain, NC, USA, 4Global Care Partners, Berrien Springs, MI, USA, 5Department of Internal Medicine and Pediatrics, Center for Space Medicine, Baylor College of Medicine, Houston, TX, USA

Correspondence to: Correspondence to: Alice Unah Lee
Department of Gastroenterology and Liver Services, Concord Repatriation General Hospital, University of Sydney, Hospital Road, Concord NSW 2139, Australia
Tel: +61-412133131, Fax: +61-297676767, E-mail: aliceulee@gmail.com

Received: March 9, 2018; Revised: May 29, 2018; Accepted: June 7, 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Gut Liver 2018;12(6):615-622. https://doi.org/10.5009/gnl18115

Published online August 30, 2018, Published date November 15, 2018

Copyright © Gut and Liver.

Abstract

Despite the well-proven, safe and effective therapies for hepatitis B infection, delivery of treatment remains a significant challenge in resource-poor settings. Geopolitical and economic restrictions present additional difficulties in providing care in North Korea. However, treatment of patients with chronic hepatitis B remains a top priority for both the North Korean Ministry of Public Health and international agencies working in North Korean hepatitis healthcare facilities. Working in partnership, a path was created to institute this much-needed program. A consortium of United States and Australian humanitarian non-governmental organizations along with generous individual and corporate donors working in concert with local and national health authorities have succeeded in establishing the first hepatitis B treatment program in North Korea. The essential elements of this program include renovation of existing hepatitis hospitals, access to antiviral medications, establishment of laboratory facilities, creation of medical documentation and record-keeping, training of local health care professionals, and quarterly visits by international volunteer physicians and laboratory experts. Management and treatment decisions are made bilaterally. To date, nearly 1,500 patients have been evaluated, and over 800 have been started on long-term antiviral therapy. It is envisioned that this program will eventually be managed and funded by the Democratic People’s Republic of Korea Ministry of Public Health. This program’s success demonstrates a potential model for delivery of antiviral therapy for patients suffering from hepatitis B in other developing countries.

Keywords: Hepatitis B, Antiviral therapy, Democratic People’s Republic of Korea, HOPE Program, Cirrhosis


Article

Special Report

Gut and Liver 2018; 12(6): 615-622

Published online November 15, 2018 https://doi.org/10.5009/gnl18115

Copyright © Gut and Liver.

A Program to Treat Hepatitis B in North Korea: A Model of Antiviral Therapy in a Resource-Poor Setting

Alice Unah Lee1,2, Heidi Linton3, Marcia Kilsby4, David C. Hilmers2,5

1Department of Gastroenterology and Liver Services, Concord Repatriation General Hospital, University of Sydney, Sydney, Australia, 2Hepatitis B Free, Sydney, Australia, 3Christian Friends of Korea, Black Mountain, NC, USA, 4Global Care Partners, Berrien Springs, MI, USA, 5Department of Internal Medicine and Pediatrics, Center for Space Medicine, Baylor College of Medicine, Houston, TX, USA

Correspondence to:Correspondence to: Alice Unah Lee
Department of Gastroenterology and Liver Services, Concord Repatriation General Hospital, University of Sydney, Hospital Road, Concord NSW 2139, Australia
Tel: +61-412133131, Fax: +61-297676767, E-mail: aliceulee@gmail.com

Received: March 9, 2018; Revised: May 29, 2018; Accepted: June 7, 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Despite the well-proven, safe and effective therapies for hepatitis B infection, delivery of treatment remains a significant challenge in resource-poor settings. Geopolitical and economic restrictions present additional difficulties in providing care in North Korea. However, treatment of patients with chronic hepatitis B remains a top priority for both the North Korean Ministry of Public Health and international agencies working in North Korean hepatitis healthcare facilities. Working in partnership, a path was created to institute this much-needed program. A consortium of United States and Australian humanitarian non-governmental organizations along with generous individual and corporate donors working in concert with local and national health authorities have succeeded in establishing the first hepatitis B treatment program in North Korea. The essential elements of this program include renovation of existing hepatitis hospitals, access to antiviral medications, establishment of laboratory facilities, creation of medical documentation and record-keeping, training of local health care professionals, and quarterly visits by international volunteer physicians and laboratory experts. Management and treatment decisions are made bilaterally. To date, nearly 1,500 patients have been evaluated, and over 800 have been started on long-term antiviral therapy. It is envisioned that this program will eventually be managed and funded by the Democratic People’s Republic of Korea Ministry of Public Health. This program’s success demonstrates a potential model for delivery of antiviral therapy for patients suffering from hepatitis B in other developing countries.

Keywords: Hepatitis B, Antiviral therapy, Democratic People&rsquo,s Republic of Korea, HOPE Program, Cirrhosis

Fig 1.

Figure 1.Simplified guidelines for selection of patients to undergo treatment.
HBsAg, hepatitis B surface antigen; APRI, aspartate aminotransferase to platelet ratio index; GRF, glomerular filtration rate; ALT, alanine aminotransferase; CHB, chronic hepatitis B. *Clinical signs and symptoms of decompensated cirrhosis include ascites, variceal bleeding, hepatic encephalopathy, jaundice, extrahepatic symptoms. Adapted from World Health Organization (WHO) treatment guidelines, 2015.3
Gut and Liver 2018; 12: 615-622https://doi.org/10.5009/gnl18115

Table 1 Summary of WHO Recommendations for Persons with CHB When Viral Load Testing Is Not Available3

Evaluation for cirrhosis
 APRI >2 or Fibroscan score consistent with cirrhosis, decompensated liver disease
Who to treat
 All patients with cirrhosis
 Patients over 30 years with persistently abnormal ALT
Choice of treatment
 First line treatment with entecavir or tenofovir
 Entecavir for children 2–11 years
 In patients with suspected antiviral resistance to other drugs, switch to tenofovir
When to stop treatment
 Lifelong treatment in patients with cirrhosis
 Without cirrhosis, after at least 1 year of treatment with loss of HBsAg positivity and persistently normal ALT
 Restart treatment if signs of reactivation (HBsAg becomes positive, ALT levels increase)
Monitoring
 At least annually: ALT, AST, creatinine, HBsAg, HBeAg, platelets, APRI, Fibroscan, adherence
 More frequently: during first year of treatment, advanced disease, fluctuating ALT if not on treatment, after discontinuation of therapy
 Abdominal ultrasound and alpha-fetoprotein (if available) every 6 months if cirrhotic or family history of hepatocellular carcinoma

WHO, World Health Organization; CHB, chronic hepatitis B; APRI, aspartate aminotransferase (AST) to platelet ratio index; ALT, alanine aminotransferase; HBsAg, hepatitis B surface antigen; HBeAg, hepatitis B e antigen.


Table 2 Contributions of NGO in HOPE

Christian Friends of Korea (CFK), Black Mountain, NC, USA
 Overall coordination of program with MoPH and US authorities
 Infrastructure development (water, electricity, building construction)
 Import licenses, transport and storage of supplies and medications
 Maintenance of patient database and medical records
Hepatitis B Free (HBF), Sydney, Australia
 Overall responsibility for treatment of hepatitis patients
 Acquisition of antivirals
 Patient medical records
 Recruitment of volunteer physicians
 Training of local physicians
Global Care Partners (GCP), Berrien Springs, MI, USA
 Overall responsibility for clinical diagnostic testing of patients’ specimens
 Design of laboratory facilities
 Acquisition of laboratory supplies and analyzers
 Training of local laboratory personnel

NGO, non-governmental organization; HOPE, Hepatitis B Overview and Program to Treat; MoPH, Hepatitis B Overview and Program to Treat.


Table 3 Inclusion and Exclusion Criteria

Inclusion criteria
 Hepatitis B surface antigen positive
 Age 18 or above (ages 3–17 if approved by pediatrician and guardian)
Exclusion criteria
 Inability to comply with program requirements (non-compliance with medications and clinic visits, continued alcohol abuse, refusal of lab testing)
 Life expectancy <6 months
 Known allergy to or intolerance of drugs

Table 4 Point of Care Hepatitis Test Characteristics

SD Bioline HBsAg Rapid Test
 SD Bioline Seoul, South Korea/Alere Diagnostics, Waltham, MA USA
 Advertised sensitivity/specificity: 100%/100%
https://www.alere.com/en/home/product-details/sd-bioline-hbsag.html
ABON Hepatitis B Combo Test (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb)
 ABON Biopharm, Hangzhou, China
 Advertised sensitivity/specificity: 99.0%/96.8%
http://perufreelo.com/deuce/wp-content/uploads/2016/02/ab2.pdf
SD Bioline HCV IgG Rapid Test
 SD Bioline Seoul, South Korea/Alere Diagnostics, Waltham, MA USA
 Advertised sensitivity/specificity: 100%/99.4%
http://gms-world.com/sc001/MISdata/MIS/SD%20MIS/HCV/HCV.pdf

HBsAg, hepatitis B surface antigen; HBsAb, hepatitis B surface anti-body; HBeAg, hepatitis B e antigen; HBeAb, hepatitis B e antibody; HBcAb, hepatitis B core antibody.


Table 5 Characteristics at Baseline of Patients on Treatment

ClinicPyongyangKaesong
Total patients on treatment604249
Age, yr*43.82 (13–71)44.81 (19–65)
Sex, male/female426/178170/79
Fibroscan score, kPa16.1 (3.5–75)17.8 (3.5–75)
APRI2.32 (0.10–56.0)2.01 (0.27–28.88)
Platelets, ×109/L118 (12–358)124 (19–648)
Cirrhotics, % of total by Fibroscan63.469.2
Cirrhotics, % of total by APRI57.050.2
ALT, IU/L59.8 (5.0–955.0)53.9 (12.0–988.4)
AST, IU/L64.0 (5.0–1,373.0)60.6 (18.0–493.5)
Patients on antivirals, tenofovir/entecavir470/134197/52

Data are presented as number or median (range).

APRI, aspartate aminotransferase (AST) to platelet ratio index; ALT, alanine aminotransferase.

*Mean (range);

Fibroscan score ≥12.0 kPa;

APRI ≥2.0.


Gut and Liver

Vol.17 No.1
January, 2023

pISSN 1976-2283
eISSN 2005-1212

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