J Virus Erad. 2017 Jan 1;3(1):1-6.
Advancing the regulatory path on hepatitis B virus treatment and curative research: a stakeholders consultation.Liu J1, Goicochea P2, Block T3, Brosgart CL4, Donaldson EF5, Lenz O6, Gee Lim S7, Marins EG8, Mishra P5, Peters MG9, Miller V2. Author information 1Forum for Collaborative Research, Washington DC, USA; University of California, Berkeley School of Public Health, Division of Infectious Diseases and Vaccinology, California, USA.2Forum for Collaborative Research , Washington DC , USA.3Hepatitis B Foundation , Philadelphia , USA.4University of California , San Francisco , California , USA.5US Food and Drug Administration , Silver Spring , Maryland USA.6Janssen Research and Development , Beerse , Belgium.7National University of Singapore , Singapore.8Roche Molecular Systems , California , USA.9University of California San Francisco , California , USA.
AbstractHepatitis 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.
PMID:28275452
作者: StephenW 时间: 2017-3-10 16:54
J病毒Erad。 2017 Jan 1; 3（1）：1-6。
推进乙型肝炎病毒治疗和治疗研究的监管路径：利益相关者协商。
Liu J1，Goocochea P2，Block T3，Brosgart CL4，Donaldson EF5，Lenz O6，Gee Lim S7，Marins EG8，Mishra P5，Peters MG9，Miller V2。
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