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Volume 5, Issue 8 , Pages 890-897, August 2007

Report of an International Workshop: Roadmap for Management of Patients Receiving Oral Therapy for Chronic Hepatitis B

Emmet B. Keeffe
- Stanford University School of Medicine, Stanford, California
- E.B.K. is a consultant to and member of the speakers’ bureau for Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Idenix, Novartis, and Roche, and receives grant support from Roche and Romark.
- Address requests for reprints to: Emmet B. Keeffe, MD, Stanford University School of Medicine, 750 Welch Road, Suite 210, Palo Alto, California 94304-1509. fax: (650) 498-5692.
Stefan Zeuzem
- J.W. Goethe University Hospital, Frankfurt, Germany
- S.Z. is a consultant, member of the speakers’ bureau, and/or a clinical investigator for Gilead, GlaxoSmithKline, Idenix, Novartis, Roche, and Schering-Plough.
Raymond S. Koff
- University of Connecticut School of Medicine, Farmington, Connecticut
- R.S.K. is a consultant to Idenix and Roche and a member of the speakers’ bureau for Roche and Bristol-Myers Squibb.
Douglas T. Dieterich
- Mount Sinai School of Medicine, New York, New York
- D.T.D. is a consultant, member of the speakers’ bureau, and receives grant support from Bristol-Myers Squibb, Idenix, Gilead, and Roche.
Rafael Esteban–Mur
- Universitat Autonoma de Barcelona, Barcelona, Spain
- R.E.-M. is a consultant and member of the speakers’ bureau for Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Idenix, Novartis, Schering-Plough, and Vertex.
Edward J. Gane
- Auckland Hospital, Auckland, New Zealand
- E.J.G. is a consultant on advisory boards for GlaxoSmithKline, Idenix, and Novartis, and has served as a speaker for GlaxoSmithKline and Novartis.
Ira M. Jacobson
- Weill Medical College of Cornell University, New York, New York
- I.M.J. is a consultant for Bristol-Myers Squibb, Coley, Gilead, GlaxoSmithKline, GlobImmune, Human Genome Sciences, Idenix, Intermune, Merck, Novartis, Nucleonics, Phizer, Schering, Valeant, and Vertex, and a member of the speakers’ bureau for Bristol-Myers Squibb, Gilead, Schering, and TAP, and receives grant support from Coley, Gilead, GlobImmune, Idenix, Intermune, Schering, Valeant, and Vertex.
Seng G. Lim
- National University Hospital, Singapore
- S.G.L. is a consultant to Bristol-Myers Squibb, GlaxoSmithKline, Idenix, Novartis, and Schering-Plough, a member of the speakers’ bureau for Gilead and GlaxoSmithKline, and receives grant support from Novartis.
Nikolai Naoumov
- University College London Institute of Hepatology, London, United Kingdom
- N.N. is currently an employee of Novartix Pharma, which began in March 2007 after completion of the work on this manuscript; he was formerly a consultant to, member of the speakers’ bureau, and/or a clinical investigator for Gilead GlaxoSmithKline, Idenix, Novartis, Roche, and Schering.
Patrick Marcellin
- Hôpital Beaujon, Clichy, France
- P.M. is a consultant for Bristol-Myers Squibb, Coley, Cytheris, Gilead, GlaxoSmithKline, Human Genome Sciences, Idenix, Intermune, Novartis, Roche, Schering-Plough, Valeant, Vertex, and Wyeth, and receives grant support from Bristol-Myers Squibb, Cytheris, Gilead, GlaxoSmithKline, Human Genome Sciences, Idenix, Intermune, Novartis, Roche, Schering-Plough, Valeant, Vertex, and Wyeth, and is a speaker for Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Idenix, Novartis, Roche, Schering-Plough, and Schering-Plough.
Teerha Piratvisuth
- Songklanagarind Hospital, Hat Yai, Thailand
- T.P. is a consultant to GlaxoSmithKline, Novartis, Roche, and Schering-Plough, and has received grant support from Bristol-Myers Squibb, Novartis, and Roche.
Fabien Zoulim
- INSERM, Université Lyon and Hospices Civils de Lyon, Hôtel Dieu, Liver Department, Lyon, France
- F.Z. is a consultant for Abbott, Gilead, Idenix, and Novartis, a member of the speakers’ bureau for Bristol-Myers Squibb, Gilead, Idenix, and Novartis, and receives research support from Biomerieux, Bioalliance, and Gilead.

published online 16 July 2007.

An international group of experienced hepatologists and virologists conducted a single-day workshop to review the management of patients with chronic hepatitis B receiving treatment with oral nucleosides or nucleotides. Guidelines regarding on-treatment management and available published data on the importance of serum hepatitis B virus (HBV) DNA as a marker of outcomes were reviewed. On-treatment monitoring strategies to define early virologic responses that might be predictive of better outcomes and a reduced risk of viral resistance were proposed for further study. This treatment plan, labeled the roadmap concept, recommends monitoring of serum HBV DNA levels to identify outcomes of therapy. Primary treatment failure was defined as a reduction of serum HBV DNA levels by less than 1 log10 IU/mL from baseline at week 12. Measurement of the HBV DNA level at week 24 was considered essential to characterize virologic responses as complete, partial, or inadequate. Complete virologic response was defined as negative HBV DNA by a sensitive assay (<60 IU/mL or <300 copies/mL); partial virologic response was defined as HBV DNA levels less than 2000 IU/mL (4 log10 copies/mL), and inadequate virologic response was defined as HBV DNA levels of 2000 IU/mL or greater (4 log10 copies/mL). Strategies are proposed for managing patients in each of these categories, depending in part on the rapidity with which HBV DNA suppression is achieved and the emergence of genotypic mutations that reduce the effectiveness of a specific drug. Future studies of the use of the roadmap concept in improving outcomes of chronic hepatitis B are warranted.

Abbreviations used in this paper: ALT, alanine aminotransferase, anti-HBe, antibody to hepatitis B e antigen, HBeAg, hepatitis B e antigen, HBsAg, hepatitis B surface antigen, HBV, hepatitis B virus, HCC, hepatocellular carcinoma