Treating chronic hepatitis delta: The need for surrogate markers of treatment efficacy

Cihan Yurdaydin; Zaigham Abbas; Maria Buti; Markus Cornberg; Rafael Esteban; Ohad Etzion; Edward J Gane; Robert G Gish; Jeffrey S Glenn; Saeed Hamid; Theo Heller; Christopher Koh; Pietro Lampertico; Yoav Lurie; Michael Manns; Raymundo Parana; Mario Rizzetto; Stephan Urban; Heiner Wedemeyer; Hepatitis Delta International Network (HDIN)

doi:10.1016/j.jhep.2018.12.022

Treating chronic hepatitis delta: The need for surrogate markers of treatment efficacy

J Hepatol. 2019 May;70(5):1008-1015. doi: 10.1016/j.jhep.2018.12.022. Epub 2018 Dec 27.

Authors

Cihan Yurdaydin¹, Zaigham Abbas², Maria Buti³, Markus Cornberg⁴, Rafael Esteban³, Ohad Etzion⁵, Edward J Gane⁶, Robert G Gish⁷, Jeffrey S Glenn⁷, Saeed Hamid⁸, Theo Heller⁹, Christopher Koh⁹, Pietro Lampertico¹⁰, Yoav Lurie¹¹, Michael Manns⁴, Raymundo Parana¹², Mario Rizzetto¹³, Stephan Urban¹⁴, Heiner Wedemeyer¹⁵; Hepatitis Delta International Network (HDIN)

Collaborators

Hepatitis Delta International Network (HDIN):
A Wranke, L M Pinheiro Borzacov, C Lobato, S Hamid, E Ceausu, G N Dalekos, A Turcanu, G A Niro, F Lubna, M Abbas, P Ingiliz, P Ferenci, T Vanwolleghem, T Hayden, N Dashdorj, A Motoc, S Hardtke

Affiliations

¹ Department of Gastroenterology, Ankara University, Ankara, and Department of Internal Medicine, Koc University, Istanbul, Turkey. Electronic address: cihan.yurdaydin@medicine.ankara.edu.tr.
² Department of Hepatogastroenterology, Sindh Institute of Urology and Transplantation, Karachi, Pakistan.
³ Liver Unit, Hospital Universitario Vall d'Hebron and Ciber-ehd, Instituto Carlos III, Barcelona, Spain.
⁴ Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
⁵ Institute of Gastroenterology and Liver Diseases Soroka University Medical Center Faculty of Health Sciences, Ben-Gurion University of the Negev, Beersheba, Israel.
⁶ Auckland Clinical Studies, Auckland, New Zealand.
⁷ Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, Stanford, CA, USA.
⁸ Aga Khan University Hospital, Department of Medicine, Karachi, Pakistan.
⁹ Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.
¹⁰ CRC "A. M. e A. Migliavacca", Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
¹¹ Central Virology Laboratory, Ministry of Health, Chaim Sheba Medical Center, Tel - Hashomer, 52621 Ramat Gan, Israel.
¹² Hepatology Centre of the University Hospital Professor Edgar Santos, Federal University of Bahia, Salvador, Brazil.
¹³ Department of Gastroenterology, University of Turin, Turin, Italy.
¹⁴ Department of Infectious Diseases, Molecular Virology, University Hospital Heidelberg, Heidelberg, Germany.
¹⁵ Department of Gastroenterology and Hepatology, Essen University Hospital, University of Duisburg-Essen, Essen, Germany.

PMID: 30982526
DOI: 10.1016/j.jhep.2018.12.022

Abstract

Chronic hepatitis delta represents the most severe form of chronic viral hepatitis. The current treatment of hepatitis delta virus (HDV) infection consists of the use of interferons and is largely unsatisfactory. Several new compounds are currently in development for the treatment of HDV infection. However, surrogate markers that can be used to develop clinical endpoints in HDV infection are not well defined. In the current manuscript, we aimed to evaluate the existing data on treatment of HDV infection and to suggest treatment goals (possible "trial endpoints") that could be used across different clinical trials.

Keywords: Hepatitis D; New treatment approaches; Surrogate marker; Treatment endpoints.

Publication types

Review

MeSH terms

Biomarkers
Clinical Trials as Topic
Hepatitis B Surface Antigens / analysis
Hepatitis D, Chronic / drug therapy*
Hepatitis D, Chronic / pathology
Humans
Lipopeptides / therapeutic use
Liver / pathology
Nucleic Acids / therapeutic use
Piperidines / therapeutic use
Polymers / therapeutic use
Pyridines / therapeutic use
RNA, Viral / analysis
Treatment Outcome

Substances

Biomarkers
Hepatitis B Surface Antigens
Lipopeptides
Nucleic Acids
Piperidines
Polymers
Pyridines
REP 2139
RNA, Viral
myrcludex-B
lonafarnib