Prophylaxis, Diagnosis and Therapy of Hepatitis B Virus (HBV) Infection: The German Guidelines for the Management of HBV Infection[1]

Structure of the guideline

Preface

The update of the S 3-guideline on “prophylaxis, diagnosis, and therapy of hepatitis B virus (HBV) infection” published in 2004 was agreed upon in cooperation with the German Society for Digestive and Metabolic Diseases (DGVS), the German Society for Pathology (DGP), the Society for Virology (GfV), the Society for Pediatric Gastroenterology and Nutrition (GPGE), and the Competence Network for Viral Hepatitis (Hep-Net). Seven guideline task forces and an advisory board were established. [Table 1] shows the representatives from the four societies. Members represent the disciplines gastroenterology and hepatology, infectiology, virology, pathology, surgery, and epidemiology. The structure of the German health care system was taken into account by involving doctors who work in hospitals and private practices. The patient organization Deutsche Leberhilfe e. V. represents the patients’ point of view ([Table 2]).

Table 1 Members involved in the guideline preparation TF 1: diagnosis TF 2: indication TF 3: therapy TF 4: transplantation 1. Gerlich, W., Gießen2. Löhr, H., Wiesbaden3. Protzer, U., Munich1 4. Rasenack, J. W. F., Freiburg5. Schaefer, S., Rostock6. Schirmacher, P., Heidelberg7. Treichel, U., Düsseldorf8. Wittekind, C., Leipzig 1. Böcher, W. O., Mainz 2. Cornberg, M., Hannover 3. Dollinger, M., Halle 4. Encke, J., Heidelberg 5. Hüppe, D., Herne 6. Niederau, C., Oberhausen 7. Petersen, J., Hamburg1 8. Tannapfel, A., Bochum 9. van Thiel, I., Cologne10. Wasmuth, H. E., Aachen 1. Böker, K., Hannover 2. Fiedler, M., Essen 3. Göser, T., Cologne 4. Hinrichsen, H., Kiel 5. Kautz, A., Cologne 6. Roeb, E., Gießen 7. Sarrazin, C., Homburg 8. Schlaak, J., Essen 9. Somasundaram, R., Berlin10. von Weizsäcker, F., Berlin11. Wedemeyer, H., Hannover1 12. Zachoval, R., Munich 1. Bahr, M., Hannover 2. Bechstein, W. O., Frankfurt 3. Beckebaum, S., Essen 4. Berg, T., Berlin1 5. Jonas, S., Berlin 6. Kahl, A., Berlin 7. Kasper, H. U., Münster 8. Schlitt, H. J., Regensburg 9. Schmidt, H., Münster10. Sterneck, M., Hamburg11. Tillmann, H. L., Leipzig TF 5: prophylaxis TF 6: co-infections TF 7: children advisory board 1. Burdelski, M., Hamburg2. Heintges, T., Neuss3. Höhler, T., Recklinghausen4. Jilg, W., Regensburg1 5. Kallinowski, B., Schwetzingen6. Radun, D., Berlin7. Spengler, U., Bonn8. Thimme, R., Freiburg 1. Böhm, S., Heidelberg2. Erhardt, A., Düsseldorf1 3. Klinker, H., Würzburg4. Mauss, S., Düsseldorf5. Oette, M., Düsseldorf6. Reiser, M., Bochum/Marl7. Rockstroh, J., Bonn 1. Buderus, S., Bonn 2. Henneke, P., Freiburg 3. Lang, T., Starnberg 4. Melter, M., Regensburg 5. Schmidt-Choudhury, A., Bochum 6. Wirth, S., Wuppertal1 7. Zimmer, K.-P., Gießen 1. Blum, H. E., Freiburg 2. Dienes, H. P., Cologne 3. Fleig, W. E., Leipzig 4. Galle, P., Mainz 5. Gerken, G., Essen 6. Häussinger, D., Düsseldorf 7. Lohse, A., Hamburg 8. Manns, M. P., Hannover 9. Neuhaus, P., Berlin10. Nützenadel, W., Mannheim11. Ramadori, G., Göttingen12. Roggendorf, M., Essen13. Sauerbruch, T., Bonn14. Schmidt, W. E., Bochum15. Schmiegel, W., Bochum16. Stark, K., Berlin17. Trautwein, C., Aaachen18. Zeuzem, S., Frankfurt 1Head of task force. Table 2 Additional concensus conference participants 1. Deterding, K., Hannover2. Dreier, M., Münster (GuV)3. Drebber, U., Cologne4. Kasper, H. U., Münster5. Diepolder, H., Munich6. Csepregi, A., Magdeburg 7. Buggisch, P., Hamburg 8. Hellerbrand, C., Regensburg 9. Herrmann, A., Jena10. Böcker, U., Mannheim11. Hütteroth, T. H., Lübeck12. Kaiser, S., Tübingen 13. Stoehr, A., Hamburg 14. Kronenberger, B., Frankfurt15. Lammert, F., Bonn16. Meyer, S., Hannover17. Müller-Schilling, M., Heidelberg 18. Urban, S., Heidelberg19. van Bömmel F., Berlin

Conflict of interest

While professional expertise is necessary when developing the guideline for health care, a commercial dependency or other conflict of interest which could influence or even systematically distort the guideline contents must be strictly avoided. The statements of the authors and participants of the consensus process are important to evaluate the quality of the guideline. Furthermore, they are important for its overall authorization and credibility as seen by the public and politicians. All persons involved in the guideline preparation have signed a statement on their possible conflict of interest. The signed forms are kept at the office of the Competence Network for Viral Hepatitis ([Table 3]).

Table 3 Financial or other connections or conflict of interest of the authors with third parties who are potentially interested in the guideline contents authors affiliation conflict of interest M. Cornberg consultancy or expertise for (Hope for Hep B) Bristol Myers Squibb; paid lectures for Roche, Novartis, Bristol Myers Squibb, Essex, Falk none U. Protzer none none M. Dollinger paid lectures for Gilead, Roche, Essex, Falk; consultancy for Gambro none J. Petersen consultancy or expertise for Bristol Myers Squibb, Gilead, Idenix, Novartis, Roche, Schering-Plough; paid lectures for Bristol Myers Squibb, Falk, Gilead, Glaxo Smith Kline, Idenix, Novartis, Roche, Schering-Plough. Third party funds from Gilead, GlaxoSmithKline, Schering Plough none H. Wedemeyer consultancy or expertise for Bristol Myers Squibb, Gilead, Novartis, Roche; paid lectures for Bristol Myers Squibb,Gilead, Roche, Novartis, Bristol Myers Squibb, Essex, Falk none T. Berg consultancy or expertise for Bristol Myers Squibb, Roche, Novartis, Idenix, Essex, Gilead, Vertex, Tibotec; lectures for Bristol Myers Squibb, Roche, Novartis, Idenix, Essex, Gilead none W. Jilg paid lecture for GlaxoSmithKline, SanofiPasteur MSD, NovartisBehring none A. Erhardt paid lectures for Roche, Novartis, Bristol Myers Squibb, Essex, Falk, Gilead; third party funds from Roche. none S. Wirth none none P. Schirmacher consultancy for Novartis; paid lectures for Roche, Essex none W. E. Fleig paid lectures for Falk none M. P. Manns consultancy or expertise for Schering Plough, Roche, Bristol Myers Squibb, Gilead, Valeant, Boehringer Ingelheim, Novartis, Idenix; paid lectures for Schering Plough, Roche, Bristol Myers Squibb, Novartis, GlaxoSmithKline, Gilead, Falk; third parts funds from Schering Plough, Roche, Gilead, Novartis, Boehringer Ingelheim none

Aims of the guideline

The aim of this guideline is the establishment of standards for the prophylaxis, diagnosis, and therapy of hepatitis B virus infections to reduce new infections, to use diagnostic testing rationally, to prevent complications of chronic hepatitis, and to use evidence based antiviral therapy. The latter minimizes the development of viral resistance.

This includes a critical appraisal of the clinical and viral diagnostic tests, a transparent stage classification and risk stratification, and the recommendation of a risk adapted antiviral therapy. The aim is to achieve the best possible treatment success in combination with a cost-effective management of the patient.

The S 3-guideline was developed according to the criteria of the workshop of the scientific medical professional societies (AWMF). Its purpose is to achieve “evidence”-based, criteria oriented, high quality medical health care, good handling of hepatitis B virus infection management, as well as rational based medical decisions.

The guideline will give the treating physician rational and “evidence”-based instructions to ensure sufficient, appropriate, and cost-efficient therapy of this disease. It focuses not only on “standard” patients, but also on patients before and after organ transplantation, on patients with co-infections, as well as children and adolescents. Therefore, it offers the basis for solving medical questions and problems pertaining to HBV infections by also using multimodal treatment concepts.

It is intended for all doctors in private practices or hospitals, for nurses, as well as employees of health organizations or persons who are directly and indirectly involved in the treatment and care of patients with hepatitis B virus infections. A guideline for patients will be developed on the basis of this guideline in cooperation with Deutsche Leberhilfe e. V.

We would like to point out that special knowledge is necessary for the management and therapy of chronic HBV infections and should be performed by doctors who are experienced in this area.

Preparation of the guideline

The guideline was developed in several steps. The result of the development process is a three step guideline in the context of a three-step-concept of the task force of scientific medical professional societies ([Table 4]). The main focus is a combined, formal process for finding a consensus consisting of a nominal group and consensus process that was multidisciplinary.

Table 4 Three-step-concept of the guideline preparation of the AWMF 1. Step (S1):expert group A representative expert group of scientific medical professional societies develops in formal consensus a guideline that is passed by the executive board of the professional societies. 2. Step (S2):formal consensus finding Available guidelines from step 1 will be consulted in an established consensus process. It will be passed as a guideline step 2. Formal consensus finding methods are nominal group process, Delphi method, and consensus conference. They include a discussion of the “evidence” for the passed statements. The support of a methodologist is helpful. 3. Step (S3):guideline with all elements of systematic preparation The formal consensus process is extended by the following systematic elements:- logical analysis (clinical algorithm),- “evidence”-based medicine,- decision analysis,- outcome analysis. Literature search After the selection and definition of guideline topics and the outlining of the work program, the authors were delegated a task with a coreviewer. The literature search was done using databases such as Cochrane Library, DIMDI- literature databases-superbases, Medline, NHS-Database PubMed as well as personal reference libraries, internet search engines, and individual searches at the pertinent organizations (university clinics, research institutions, pharmaceutical industry). The pertinent literature was systematically collected, saved, and evaluated according to a standard classification scheme (Table 5). Table 5 The following keywords were used for the literature search3 TF1: diagnosis #1: Hepatitis B or Hepatitis D#2: definition* or (clinical* diagnostic*) or (laboratory* diagnostic*) or imaging* or histopathology* or (therapy monitoring) or (drug resistance)#3 = #1 AND #2 314 abstracts TF2: indication #1: Hepatitis B or Hepatitis D#2: (natural course*) or ((prognosis* or prognostic*) and (factor* or value*) or ((therapeutic* and (aim* or goals*) or (indication*) or (contraindication*)#3 = #1 AND #2 306 abstracts TF3: therapy #1: Hepatitis B or Hepatitis D#2: ((standard therapy) or interferon alpha or lamivudine or adefovir or tenofovir or entecavir or telbivudine or clevudine or emcitricitabine or pegylated or (combination therapy) and (dosis* or dosage* or contraindication or (side effects) or monitoring)#3: #1 AND #2#4: (problem* or HBeAg-negative or alcoholic or (drug* abus*) or (interferon and (non-responder or non-response) or (lamivudine resistan*) or (liver cirrhosis) or (immunosuppression) or h*modialysis or (extrahepatic manifestation*) or (HBV carrier*)#5: #1 AND #4#6: #3 AND #5 153 abstracts TF4: transplantation #1: Hepatitis B or Hepatitis D#2: transplantation or re-infection#3: #1 AND #2 316 abstracts TF5: prophylaxis #1: Hepatitis B or Hepatitis D#2: (immunoprophyla* or vaccin* or (booster and vaccination*)#3: #1 AND #2 790 abstracts TF6: coinfections #1: Hepatitis B or Hepatitis D#2: co-infection and (hcv or hiv or hdv)#3: #1 AND #2 53 abstracts TF7: children and adolescents #1: Hepatitis B or Hepatitis D#2: children* or adolescent*#3: #1 AND #2 470 abstracts 1The respective abstracts were made available to the heads of the TF. Further abstracts some of which were released during the guideline process were chosen in addition by the heads of TF. Altogether 481 publications were evaluated and cited in the text. The classification “evidence” and the level of recommendation were performed according to the Oxford Centre of Evidence Based Medicine (http://www.cebm.net/levels_of_evidence.asp) (Table 6). The literature was evaluated by the head of each task force and synchronized with the coreviewer. In case of discrepancies, a consensus within the task force was achieved, which was authorized in the final consensus conference. Table 6 Classification of the “evidence”: “evidence” level (1 - 5) und recommendation grade (A-D) according to Oxford Centre of Evidence Based Medicine recommendation level “evidence” level description A Ia “evidence” by systematic review of randomized controlled studies (RCT) Ib “evidence” by an appropriately planned RCT Ic all or none principle B IIa “evidence” by systematic review of well planned cohort studies IIb “evidence” by a well planned cohort study/RCT of moderate quality (e. g. < 80 % follow-up) IIc “evidence” by outcome-research-studies IIIa “evidence” by systematic review of well planned case-controlled studies IIIb “evidence” by case-controlled studies C IV “evidence” by case-series/cohort and case-controlled studies of moderate quality D V expert opinion without explicit critical evaluation or based on physiologic models, laboratory research results, or “first principles” Wording of the recommendations After preparation and correction of the manuscripts by the coreviewers, they were revised by the individual guideline task forces and accepted according to majority decision. The proposed recommendations were revised in December 2006 during a Delphi-round which all members of the task force and the advisory board attended. The complete manuscript (preliminary guideline) was made available to all participants (task force members, advisory board, and other participants) before the consensus conference that took place in Göttingen on January 27, 2007. In addition to the persons involved in the guideline process, the ones listed in Table 2 participated. Members of the consensus conference were experts in the disciplines of gastroenterology and hepatology, infectiology, virology, pathology, surgery, and epidemiology. The guideline task force and the consensus conference did not approve an inclusion of the pharmaceutical industry in the guideline development process. Any recommendation of the guideline was authorized via TED-system. Consensus was defined as an approval of 80 %. After review and appraisal of the guideline by leading professional societies, the guideline was authorized as an official announcement by the executive boards of the four professional societies. The preparation of the guideline began on January 27, 2006 and was formally completed on April 21, 2007 (Table 7). Table 7 Development of the guideline “prophylaxis, diagnosis, and therapy of hepatitis B virus (HBV) infection” step I Literature search using keywords in Hep-Net- and DGVS-offices. Viewing of available guidelines (DGVS, DGP, GfV, GPGE, AWMF, AASLD, EASL, ECC, EVHEI, Asian-Pacific consensus statement) step II - preparation of recommendations using an informal consensus within the task forces (Sessions: GASL Conference January 2006, GfV Conference March 2006, Hep-Net Conference June 2006, DGVS Conference September 2006; in addition circulation of the updated electronic version 3times)- phrasing of the guideline by the heads of the task forces (Hannover October 2006, telephone conference November 2006) and Delphi-Conference (task forces, advisory board) December 2006 and January 2007- extended Consensus Conference January 27, 2007 including establishment of the guidelines- authorization of the guideline by professional societies April 2007

Financing

The preparation of the guideline was financed by the professional societies that were involved and the Competence Network for Viral Hepatitis. All members of the task forces volunteered their time and were not paid. They were reimbursed for traveling and other expenses according to the Federal Law on Business Trips or according to the regulations common for Universities. Topics and contents were in no way influenced. Financial support by the pharmaceutical industry was explicitly renounced to achieve best possible independence.

Publication/implementation procedures

The guideline “prophylaxis, diagnosis, and therapy of hepatitis B virus (HBV) infection” will be made known to the professional community in the journal of the professional society DGVS, “Zeitschrift für Gastroenterologie”. In addition, the guideline will be presented on the homepage of the GfV (www.g-f-v.org) and the Competence Network for Viral Hepatitis (www.kompetenznetz-hepatitis.de). It can be downloaded free of charge and will be sent to all associated members (about 1300) of the Competence Network for Viral Hepatitis. Presentations of the guideline at conferences and seminars are planned. The Competence Network for Viral Hepatitis will for example hold CME-certified workshops “Hepatitis B guidelines”. The guideline may also be viewed on the AWMF website (http://leitlinien.net). Short versions will be published in various journals (e. g. Hep-Net News, DMW etc.).

To simplify the practical application using algorithms and cross points, a visualization of the guideline is intended with the help of knowledge Tools®. At each cross point there will be a link to the text of the guideline. In addition, files may be provided with further information (publications, diagrams, product information). Thus, the guideline may also be used for educational purposes. This form of the guideline will be accessible via the internet.

Regular revisions

The guideline is effective until April 30, 2010. It is planned to correct new, relevant, and accepted findings that are in contrast to statements in the guideline immediately in the professional journals. A prompt update of the guideline can also be made using knowledge Tools®.

Guideline evaluation

The implementation of the guidelines is supposed to improve the patients’ prognosis [303]. Since the guideline must formally be viewed as a hypothesis, an evaluation within an appropriate time frame is planned. Suitable from a scientific and organizational stand point are for example the Competence Network for Viral Hepatitis and the German Liver Foundation or the Federal Office for Quality Assurance with external comparative quality assurance according to paragraph 137 SGB V. Possible quality indicators are for example number of identified hepatitis B patients, mortality dependent on severity of disease, or changes in antiviral substance prescription. The patient register of the Competence Network for Viral Hepatitis seems to be suitable for monitoring these factors. A precise evaluation concept will be drawn up by a task force which will be specifically established for this purpose.

1 Original publication: Prophylaxis, Diagnosis and Therapy of Hepatitis-B-Virus-(HBV-) Infection: upgrade of the guideline, AWMF-Register 021/011. Z Gastroenterol 2007; 45 (6): 525 - 574.

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1 Original publication: Prophylaxis, Diagnosis and Therapy of Hepatitis-B-Virus-(HBV-) Infection: upgrade of the guideline, AWMF-Register 021/011. Z Gastroenterol 2007; 45 (6): 525 - 574.