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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
| Yong Chan Lee |
Professor of Medicine Director, Gastrointestinal Research Laboratory Veterans Affairs Medical Center, Univ. California San Francisco San Francisco, USA |
| 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 |
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.
The remaining articles are usually sent to two reviewers. It would be very helpful if you could suggest a selection of reviewers and include their contact details. We may not always use the reviewers you recommend, but suggesting reviewers will make our reviewer database much richer; in the end, everyone will benefit. We reserve the right to return manuscripts in which no reviewers are suggested.
The final responsibility for the decision to accept or reject lies with the editors. In many cases, papers may be rejected despite favorable reviews because of editorial policy or a lack of space. The editor retains the right to determine publication priorities, the style of the paper, and to request, if necessary, that the material submitted be shortened for publication.
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Alice Unah Lee1,2, Heidi Linton3, Marcia Kilsby4, David C. Hilmers2,5
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
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.
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
Gut and Liver 2018; 12(6): 615-622
Published online November 15, 2018 https://doi.org/10.5009/gnl18115
Copyright © Gut and Liver.
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
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.
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
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% |
| |
| ABON Hepatitis B Combo Test (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) |
| ABON Biopharm, Hangzhou, China |
| Advertised sensitivity/specificity: 99.0%/96.8% |
| |
| SD Bioline HCV IgG Rapid Test |
| SD Bioline Seoul, South Korea/Alere Diagnostics, Waltham, MA USA |
| Advertised sensitivity/specificity: 100%/99.4% |
| |
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
| Clinic | Pyongyang | Kaesong |
|---|---|---|
| Total patients on treatment | 604 | 249 |
| Age, yr* | 43.82 (13–71) | 44.81 (19–65) |
| Sex, male/female | 426/178 | 170/79 |
| Fibroscan score, kPa | 16.1 (3.5–75) | 17.8 (3.5–75) |
| APRI | 2.32 (0.10–56.0) | 2.01 (0.27–28.88) |
| Platelets, ×109/L | 118 (12–358) | 124 (19–648) |
| Cirrhotics, % of total by Fibroscan† | 63.4 | 69.2 |
| Cirrhotics, % of total by APRI‡ | 57.0 | 50.2 |
| ALT, IU/L | 59.8 (5.0–955.0) | 53.9 (12.0–988.4) |
| AST, IU/L | 64.0 (5.0–1,373.0) | 60.6 (18.0–493.5) |
| Patients on antivirals, tenofovir/entecavir | 470/134 | 197/52 |
Data are presented as number or median (range).
APRI, aspartate aminotransferase (AST) to platelet ratio index; ALT, alanine aminotransferase.
†Fibroscan score ≥12.0 kPa;
‡APRI ≥2.0.
pISSN 1976-2283
eISSN 2005-1212
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
| Yong Chan Lee |
Professor of Medicine Director, Gastrointestinal Research Laboratory Veterans Affairs Medical Center, Univ. California San Francisco San Francisco, USA |
| 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 |
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.
The remaining articles are usually sent to two reviewers. It would be very helpful if you could suggest a selection of reviewers and include their contact details. We may not always use the reviewers you recommend, but suggesting reviewers will make our reviewer database much richer; in the end, everyone will benefit. We reserve the right to return manuscripts in which no reviewers are suggested.
The final responsibility for the decision to accept or reject lies with the editors. In many cases, papers may be rejected despite favorable reviews because of editorial policy or a lack of space. The editor retains the right to determine publication priorities, the style of the paper, and to request, if necessary, that the material submitted be shortened for publication.
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