title: Advancing the regulatory path on hepatitis B virus treatment and curative research: a stakeholders consultation.
abstract: Hepatitis B infection remains a significant disease burden around the world, with an estimated two billion individuals infected and 350 million living with chronic hepatitis B. Current antivirals are efficacious, but require lifelong treatment for the majority of infected individuals. The field is galvanised to improve diagnostics and treatment with the goal to develop shorter, finite treatments leading to viral control after treatment discontinuation. Achievement of complete and functional cure is challenged by the complexity of the virus life cycle, the lack of adequate preclinical models, the cccDNA-mediated persistence of HBV in liver cells, the lack of validated biomarkers to predict viral control and cure, and the probable need for combination treatment involving antiviral- and immune-based strategies. Experts from diverse stakeholder groups participating in the HBV Forum (a project of the Forum for Collaborative Research) contributed their expertise and perspective to resolving issues and overcoming barriers in the regulatory path for novel HBV therapeutic strategies; addressing gaps in preclinical models, diagnostics, clinical trial design, biomarkers and endpoints, and public health efforts. Interviewees highlighted the need for open and collaborative ongoing dialogues among stakeholders in a neutral space as a critical process to move the field forwards. The Forum model facilitates dialogue and deliberation of this nature, with dedicated experts from all stakeholder groups participating. The promise of an HBV cure is exciting. Now is the time to work together toward that goal.
authors.affiliation: Forum for Collaborative Research, Washington DC, USA; University of California, Berkeley School of Public Health, Division of Infectious Diseases and Vaccinology, California, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Liu
authors.affiliation: Forum for Collaborative Research , Washington DC , USA.
authors.forename: Pedro
authors.initials: P
authors.lastname: Goicochea
authors.affiliation: Hepatitis B Foundation , Philadelphia , USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Block
authors.affiliation: University of California , San Francisco , California , USA.
authors.forename: Carol L
authors.initials: CL
authors.lastname: Brosgart
authors.affiliation: US Food and Drug Administration , Silver Spring , Maryland USA.
authors.forename: Eric F
authors.initials: EF
authors.lastname: Donaldson
authors.affiliation: Janssen Research and Development , Beerse , Belgium.
authors.forename: Oliver
authors.initials: O
authors.lastname: Lenz
authors.affiliation: National University of Singapore , Singapore.
authors.forename: Seng
authors.initials: S
authors.lastname: Gee Lim
authors.affiliation: Roche Molecular Systems , California , USA.
authors.forename: Ed G
authors.initials: EG
authors.lastname: Marins
authors.affiliation: US Food and Drug Administration , Silver Spring , Maryland USA.
authors.forename: Poonam
authors.initials: P
authors.lastname: Mishra
authors.affiliation: University of California San Francisco , California , USA.
authors.forename: Marion G
authors.initials: MG
authors.lastname: Peters
authors.affiliation: Forum for Collaborative Research , Washington DC , USA.
authors.forename: Veronica
authors.initials: V
authors.lastname: Miller