Report of an International Workshop: Roadmap for Management of Patients Receiving Oral Therapy for Chronic Hepatitis B
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.
##INSERM, Université Lyon and Hospices Civils de Lyon, Hôtel Dieu, Liver Department, Lyon, France
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.
Supported by an unrestricted educational grant from Idenix Pharmaceuticals and Novartis to Axiomed, Inc., who coordinated the workshop meeting.
1 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.
2 S.Z. is a consultant, member of the speakers’ bureau, and/or a clinical investigator for Gilead, GlaxoSmithKline, Idenix, Novartis, Roche, and Schering-Plough.
3 R.S.K. is a consultant to Idenix and Roche and a member of the speakers’ bureau for Roche and Bristol-Myers Squibb.
4 D.T.D. is a consultant, member of the speakers’ bureau, and receives grant support from Bristol-Myers Squibb, Idenix, Gilead, and Roche.
5 R.E.-M. is a consultant and member of the speakers’ bureau for Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Idenix, Novartis, Schering-Plough, and Vertex.
6 E.J.G. is a consultant on advisory boards for GlaxoSmithKline, Idenix, and Novartis, and has served as a speaker for GlaxoSmithKline and Novartis.
7 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.
8 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.
9 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.
10 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.
11 T.P. is a consultant to GlaxoSmithKline, Novartis, Roche, and Schering-Plough, and has received grant support from Bristol-Myers Squibb, Novartis, and Roche.
12 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.
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