JGH and Asia–Pacific consensus on prevention and management of gastrointestinal and liver diseases

See report on page 825 Recent editorials have discussed the role of the Journal of Gastroenterology and Hepatology (JGH) as a vehicle for communication and cooperation in the specialties of gastroenterology and hepatology in the Asia–Pacific region. 1 The mission of this Journal is to produce a world-class journal committed to promoting the highest standards of clinical practice, education and research in gastroenterology and hepatology, with a particular commitment to the Asia–Pacific region. In this context, reaching an agreement or ‘Consensus’ on how best to prevent diseases and manage the people affected by them is an outstanding challenge. Broadly stated, the purpose of a consensus is to reach an agreement on matters of mutual interest so that recommendations can be made that are useful for education, public policy, best practice guidelines for clinical decision making, and setting research directions to solve outstanding problems. The need for a consensus in the prevention and management of hepatitis B and C in the Asia–Pacific region was articulated in a recent supplement of JGH. 2 In brief, two-thirds of the 350 million people in the world who are chronically infected with the hepatitis B virus (HBV) live in this region, 3, 4 and one-third will die of liver failure or hepatocellular carcinoma (HCC). 5, 6 The prevalence of chronic hepatitis C virus (HCV) infection is also high in parts of Asia, the Pacific and the Middle East, while HCC, which is usually caused by HBV and/or HCV, ranks in the top four causes of cancer death in most countries in Asia and the western Pacific rim. 6, 7 There are now many opportunities to prevent HBV and HCV infections, 4, 8, 9 as well as to reduce the adverse outcomes of chronic viral hepatitis by using an effective antiviral treatment. The latter can prevent fatal hepatitis flares, 10 progression of fibrosis towards cirrhosis and deterioration of liver function, both in hepatitis B and C. 7, 10-13 Much of the research that has led to these developments has come from the Asia–Pacific region. 2 A proportion of people suffering from chronic hepatitis C can be cured of HCV infection with histological improvement of the liver disease and a major reduction of adverse sequelae. 7, 12, 13 In contrast, the number of available treatments is rapidly increasing and each brings its own challenges, such as adverse effects with interferon and ribavirin, 14 and emergence of antiviral resistance with lamivudine. 10, 11 Among those patients who have reached the advanced stage of hepatic decompensation, liver transplantation is a way of saving life, but there are special challenges with HBV and HCV infections. 15-17 There are also exciting new developments in techniques used to improve the scarce supply of donor livers and to improve the clinical outcomes. 18 There still remains a great need for concerted action on the prevention and treatment of chronic viral hepatitis in the Asia–Pacific region and this requires the formation of cooperative groups to plan and facilitate studies in the region. Cooperative action first requires the outstanding questions to be identified clearly, followed by imaginative, determined and effective ways to answer them. This, then, is another purpose of a consensus—to reach an agreement on what are the important research issues and to promote the goodwill and understanding that neighbours need to conduct collaborative studies that address them. The papers arising from a meeting convened to reach a consensus for the control of hepatitis B and C in the Asia–Pacific region were recently published in a supplement of JGH. 2-12, 14-18 This meeting was convened by the senior Editors of the Journal in partnership with the Asian–Pacific Association for the Study of the Liver (APASL); it was held in Kyoto, in September 1999. The Kyoto meeting was a key part of an overall consensus process involving several meetings that began with the appointment (by JGH and APASL) of a Core Planning Committee, comprised of Y-F Liaw (Taipei; Chairman, Hepatitis B), GC Farrell (Sydney; Chairman, Hepatitis C), D-S Chen (Taipei), GW McCaughan (Sydney), M Omata (Tokyo), SK Sarin (New Delhi) and M Yano (Nagasaki; President, APASL). The Core Working Party considered the processes that would be required to achieve a consensus. It was resolved that they should be based, as far as possible, on firm evidence derived from properly conducted scientific studies of the epidemiology, natural history and clinical trials of therapeutic agents. Where such evidence was deficient or conflicting, the views of experts were taken into account, particularly as they reflected local experience. Newer (unpublished) data were also considered in relation to new antiviral treatments, although these were not used to make recommendations as that would be impractical for drugs under study that are not yet licensed for use. Only those recommendations agreed to by at least two-thirds of participants were accepted as representing a consensus view. The Core Working Party first met in Taipei in March 1999, hosted by Professor Yun-Fan Liaw and the Chang Gung Memorial Hospital. Five working parties were appointed, as detailed in the consensus report published in this issue of the Journal. 19 The 37 members of these five working parties reviewed the literature as well as relevant unpublished data, debated the significance of the reported findings within their individual working parties, then presented the draft recommendations to the plenary sessions of the Kyoto meeting. These draft recommendations were debated and accepted, or rejected or revised according to the views expressed and votes taken when required. Although this was not an independent jury approach to consensus, (as has been previously conducted by others), 20 more than 10 countries were represented and the assembled expertise included those from several backgrounds; hepatology, virology, public health, epidemiology and pharmacology. The debate was spirited but constructive and many differences of views were resolved. The issues that remained contentious and for which recommendations could not be made were listed for further study. There was agreement that terminology in the field of hepatitis virus infections and hepatitis (the liver disease) needed clarifying, and the ambiguity of terms like ‘carrier’ or ‘healthy carrier’ was noted. This consensus meeting agreed to adopt the terminology recently put forward by the Indian Association for Study of the Liver (INASL), using the terms ‘chronic HBV infection’ and ‘chronic HCV infection’ (rather than ‘carrier’) and ‘chronic hepatitis B’ or ‘chronic hepatitis C’ when there was evidence of liver disease for more than 6 months. 21, 22 The format of the draft recommendations on the ‘Prevention and Treatment of Chronic Hepatitis B and Hepatitis C’ formulated at the Kyoto meeting were refined by the fourth meeting of the Core Working Party (with the assistance of P Desmond, (Melbourne) and H Yatsuhashi, (Nagasaki)) in Singapore, in April 2000. They were then presented and discussed at the sixteenth biennial meeting of the APASL, in Fukuoka, Japan, 3–4 June, 2000. The draft Consensus Recommendations have also been circulated for wider comment and input, both within the Asia–Pacific region and to several international experts (see Acknowledgements). The finalised Consensus Recommendations are now published in this issue of the Journal. 19 Viral hepatitis is a rapidly changing field. While newer insights into how to prevent HBV and HCV infection are likely to be incremental, a vast amount needs to be done to implement what is already known into more effective public health policies of countries in the region. It is hoped that these recommendations on prevention will clearly indicate some of the things that should be done and how research targeting the outstanding issues could further improve the prospects for the control of hepatitis B and C. The management guidelines are likely to change more rapidly. Even at the time of the meetings, recent deliberations were taking place, and new information about the treatment of hepatitis C with pegylated interferons with or without ribavirin (some of it from pivotal worldwide phase III studies) has gradually been entering the public domain. Trials with potent HBV antivirals, alone or in combination with lamivudine, are planned or underway. Further experience with existing agents used in a variety of situations, such as in milder disease, those with compensated cirrhosis and hepatitis Be antigen-negative chronic hepatitis B patients, should soon allow clearer recommendations to be made because at present, opinions are divided. It is anticipated that investigators from the Asia–Pacific region, who have already contributed much information, will play an increasingly important role in generating such information from carefully conducted, randomized controlled clinical trials, the systematic analysis of which is the only reliable way of making evidence-based guidelines. Collaborations within the region and between regional partners and the rest of the world, such as through the Cochrane collaboration, will assist this process. In the hepatitis field, a substantial revision of management guidelines is likely to be needed within 2 years, and plans are already being devised to monitor the progress and to institute a ‘Consensus Update’ in 2002. The establishment of the JGH Trust was also announced in the April 2000 issue of the Journal. 1 The trust has already sponsored young investigator awards at the Hong Kong Asia–Pacific Congress of Asian Pacific Association of Gastroenterology (APAGE) and the Fukuoka meeting of APASL, as well as the inaugural JGH lectureship at the Hong Kong meeting. The JGH Trust provided the seeding grant that grew into the recently completed Consensus on Hepatitis B and C. A new project into the causes, pathogenesis and better management of chronic pancreatitis, which appears to be unusually common and of a type peculiar to the region, is already underway under the leadersip of two senior editors, RK Tandon (New Delhi) and N Sato (Tokyo). The purpose of the JGH Trust is the same as that of JGH, to stimulate education, research and standards of clinical practice in gastroenterology and hepatology in the Asia–Pacific region. Consensus processes are one way of doing this. The thousand participants of the Fukuoka meeting who participated in the consensus presentations and discussions, and those who enjoyed the vigorous debate held in a spirit of friendly cooperation of the Kyoto meeting, can now testify to the stimulating effect of this process. It is hoped that those who read and adopt the product, the Consensus Recommendations, will also find them of value. The JGH Trust will continue to provide seeding grants to encourage the development of consensus processes. This should facilitate improved standards of health care and better regional cooperation, through shared ideas, agreement on best practice and identification of outstanding issues to be resolved by cooperative research. In a recent editorial, 1 we also saluted the development of Asian Pacific Digestive Week (APDW) as the region's annual scientific meeting, the first to be convened in Sydney in September 2001. The organization of APDW will showcase the region's own strengths, workshop the region's problems and champion the region's trainees and investigators. A presentation of consensus guidelines and the research that should be one of the most important outcomes will be a highlight of the APDW meetings. It is the editors' resolve that JGH, the regions' major international journal in gastroenterology and hepatology, will continue to publish these guidelines and the education and research articles related to them. The following people have provided valued comments on the Draft Recommendations that helped refine the final consensus guidelines: Howard Thomas (London), Solko Schalm (Rotterdam), Jenny Heathcote (Toronto), Rafael Estaban-Mur (Barcelona), Anna Lok (Ann Arbor), Fabien Zoulim (Lyon) and Mario Rizzetto (Turin) The generous support of the following sponsors is also acknowledged for the Consensus on the Prevention and Management of Hepatitis B and C: GlaxoWellcome, Schering-Plough, Roche Pharmaceuticals, Roche Diagnostics, SciClone, The Chang Gung Memorial Hospital. Mr Chris Hum and the staff of Blackwell Science Asia provided enormous professional support in the organization of the meetings that were convened as part of the consensus process, in the preparation of the papers ‘Asia-Pacific consensus on prevention and management of chronic hepatitis B and C’ and in the compilation of the consensus guidelines published in this issue of the Journal.

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