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Immunological biomarker discovery in cure regimens for chronic hepatitis B virus infection.
Gehring, Adam J; Mendez, Patricia; Richter, Kirsten; Ertl, Hildegund; Donaldson, Eric F; Mishra, Poonam; Maini, Mala; Boonstra, Andre; Lauer, Georg; de Creus, An; Whitaker, Kathleen; Martinez, Sara Ferrando; Weber, Jessica; Gainor, Emily; Miller, Veronica.
Afiliação
  • Gehring AJ; Toronto Centre for Liver Disease, Toronto General Hospital Research Institute, University Health Network, Toronto, Ontario, Canada; Department of Immunology, University of Toronto, Toronto, Ontario, Canada. Electronic address: adam.gehring@uhnresearch.ca.
  • Mendez P; Gilead Sciences, 333 Lakeside Drive, Foster City, CA 94404, USA.
  • Richter K; F. Hoffmann-La Roche, Roche Innovation Center Basel, Grenzacher Strasse 124, CH-4070 Basel, Switzerland.
  • Ertl H; The Wistar Institute, Philadelphia, PA 19104, USA.
  • Donaldson EF; Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, USA.
  • Mishra P; Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration, USA.
  • Maini M; Division of Infection and Immunity, University College London, London, UK.
  • Boonstra A; Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, The Netherlands.
  • Lauer G; Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  • de Creus A; Janssen Pharmaceuticals, Beerse, Belgium.
  • Whitaker K; Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health, US Food and Drug Administration, USA.
  • Martinez SF; Microbial Sciences, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, US; NeoImmuneTech, LLC 2400 Research Blvd, Suite 250 Rockville, MD 20850, USA.
  • Weber J; Forum for Collaborative Research, University of California, Berkeley, USA.
  • Gainor E; Forum for Collaborative Research, University of California, Berkeley, USA.
  • Miller V; Forum for Collaborative Research, University of California, Berkeley, USA.
J Hepatol ; 77(2): 525-538, 2022 08.
Article em En | MEDLINE | ID: mdl-35259469
There have been unprecedented advances in the identification of new treatment targets for chronic hepatitis B that are being developed with the goal of achieving functional cure in patients who would otherwise require lifelong nucleoside analogue treatment. Many of the new investigational therapies either directly target the immune system or are anticipated to impact immunity indirectly through modulation of the viral lifecycle and antigen production. While new viral biomarkers (HBV RNA, HBcAg, small, middle, large HBs isoforms) are proceeding through validation steps in clinical studies, immunological biomarkers are non-existent outside of clinical assays for antibodies to HBs, HBc and HBe. To develop clinically applicable immunological biomarkers to measure mechanisms of action, inform logical combination strategies, and guide clinical management for use and discontinuation of immune-targeting drugs, immune assays must be incorporated into phase I/II clinical trials. This paper will discuss the importance of sample collection, the assays available for immunological analyses, their advantages/disadvantages and suggestions for their implementation in clinical trials. Careful consideration must be given to ensure appropriate immunological studies are included as a primary component of the trial with deeper immunological analysis provided by ancillary studies. Standardising immunological assays and data obtained from clinical trials will identify biomarkers that can be deployed in the clinic, independently of specialised immunology laboratories.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Hepatite B Crônica / Hepatite B Limite: Humans Idioma: En Revista: J Hepatol Assunto da revista: GASTROENTEROLOGIA Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Hepatite B Crônica / Hepatite B Limite: Humans Idioma: En Revista: J Hepatol Assunto da revista: GASTROENTEROLOGIA Ano de publicação: 2022 Tipo de documento: Article