A transient early HBV-DNA increase during PEG-IFNα therapy of hepatitis D indicates loss of infected cells and is associated with HDV-RNA and HBsAg reduction.


Journal

Journal of viral hepatitis
ISSN: 1365-2893
Titre abrégé: J Viral Hepat
Pays: England
ID NLM: 9435672

Informations de publication

Date de publication:
02 2021
Historique:
received: 30 04 2020
revised: 02 09 2020
accepted: 19 10 2020
pubmed: 14 11 2020
medline: 1 9 2021
entrez: 13 11 2020
Statut: ppublish

Résumé

HBV-DNA levels are low or even undetectable in the majority HDV-infected patients. The impact of PEG-IFNα on HBV-DNA kinetics in HDV-infected patients has not been studied in detail. We analysed data of a prospective treatment trial where 120 HDV-RNA-positive patients were randomized to receive PEG-IFNα-2a plus tenofovir-disoproxil-fumarate (PEG-IFNα/TDF, n = 59) or placebo (PEG-IFNα/PBO; n = 61) for 96 weeks. At week 96, HBV-DNA was still quantifiable in 71% of PEG-IFNα/PBO-treated patients but also in 76% of PEG-IFNα/TDF-treated patients, despite low HBV-DNA baseline values. Surprisingly, a transient HBV-DNA increase between weeks 12 and 36 was observed in 12 in PEG-IFNα/TDF-treated and 12 PEG-IFNα/PBO-treated patients. This increase was positively associated with HBsAg loss [(P = 0.049, odds ratio (OR) 5.1] and HDV-RNA suppression (P = 0.007, OR 4.1) at week 96. Biochemical markers of cell death (M30 and ALT) were higher during the HBV-DNA peak but no distinct systemic immune pattern could be observed by screening 91 soluble inflammatory markers. In conclusion, an early increase in HBV-DNA during PEG-IFNα-2a therapy occurred in more than 20% of patients, even in TDF-treated patients. This transient HBV-DNA rise may indicate PEG-IFNα-induced cell death and lead to long-term HDV-RNA suppression and HBsAg loss.

Identifiants

pubmed: 33185325
doi: 10.1111/jvh.13439
doi:

Substances chimiques

Antiviral Agents 0
DNA, Viral 0
Hepatitis B Surface Antigens 0
Interferon-alpha 0
Polyethylene Glycols 3WJQ0SDW1A
RNA 63231-63-0

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

410-419

Informations de copyright

© 2020 John Wiley & Sons Ltd.

Références

Chen H-Y, Shen D-T, Ji D-Z, et al. Prevalence and burden of hepatitis D virus infection in the global population: a systematic review and meta-analysis. Gut. 2019;68(3):512-521.
Wedemeyer H, Manns MP. Epidemiology, pathogenesis and management of hepatitis D: update and challenges ahead. Nat Rev Gastroenterol Hepatol. 2010;7(1):31-40.
Wedemeyer H, Yurdaydìn C, Dalekos GN, et al. Peginterferon plus adefovir versus either drug alone for hepatitis delta. N Engl J Med. 2011;364(4):322-331.
Niro GA, Ciancio A, Gaeta GB, et al. Pegylated interferon alpha-2b as monotherapy or in combination with ribavirin in chronic hepatitis delta. Hepatology. 2006;44(3):713-720.
Wranke A, Serrano BC, Heidrich B, et al. Antiviral treatment and liver-related complications in hepatitis delta. Hepatology. 2017;65(2):414-425.
Wedemeyer H, Yurdaydin C, Hardtke S, et al. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019;19(3):275-286.
Heidrich B, Yurdaydin C, Kabacam G, et al. Late HDV RNA relapse after peginterferon alpha-based therapy of chronic hepatitis delta. Hepatology. 2014;60(1):87-97.
Giersch K, Allweiss L, Volz T, et al. Hepatitis Delta co-infection in humanized mice leads to pronounced induction of innate immune responses in comparison to HBV mono-infection. J Hepatol. 2015;63(2):346-353.
Dahari H, Shudo E, Ribeiro RM, Perelson AS. Modeling complex decay profiles of hepatitis B virus during antiviral therapy. Hepatology (Baltimore, MD). 2009;49(1):32-38.
Guedj J, Rotman Y, Cotler SJ, et al. Understanding early serum hepatitis D virus and hepatitis B surface antigen kinetics during pegylated interferon-alpha therapy via mathematical modeling. Hepatology (Baltimore, MD). 2014;60(6):1902-1910.
Mederacke I, Bremer B, Heidrich B, et al. Establishment of a novel quantitative hepatitis D virus (HDV) RNA assay using the Cobas TaqMan platform to study HDV RNA kinetics. J Clin Microbiol. 2010;48(6):2022.
Proteomics O.Data normalization and standardization. https://wwwolinkcom/content/uploads/2018/05/Data-normalization-and-standardization_v10pdf. 2018.
Marcellin P, Heathcote EJ, Buti M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008;359(23):2442-2455.
Marcellin P, Ahn SH, Ma X, et al. Combination of tenofovir disoproxil fumarate and peginterferon α-2a increases loss of hepatitis B surface antigen in patients with chronic hepatitis B. Gastroenterology. 2016;150(1):134-144.e110.
Akarca U, Ersoz G, Gunsar F, et al. Interferon-lamivudine combination is no better than lamivudine alone in anti-HBe-positive chronic hepatitis B. Antivir Ther. 2004;9:325-334.
Lütgehetmann M, Mancke LV, Volz T, et al. Humanized chimeric uPA mouse model for the study of hepatitis B and D virus interactions and preclinical drug evaluation. Hepatology. 2012;55(3):685-694.
Alfaiate D, Lucifora J, Abeywickrama-Samarakoon N, et al. HDV RNA replication is associated with HBV repression and interferon-stimulated genes induction in super-infected hepatocytes. Antivir Res. 2016;136:19-31.
Yurdaydin C, Borochov N, Kalkan C, et al. Hepatitis delta virus kinetics under the prenylation inhibitor lonafarnib suggest HDV-mediated suppression of HBV replication. J Hepatol. 2016;64(2):S587.
Testoni B, Lebossé F, Scholtes C, et al. Serum hepatitis B core-related antigen (HBcrAg) correlates with covalently closed circular DNA transcriptional activity in chronic hepatitis B patients. J Hepatol. 2019;70(4):615-625.
Yurdaydin C, Keskin O, Kalkan Ç, et al. Optimizing lonafarnib treatment for the management of chronic delta hepatitis: The LOWR HDV-1 study. Hepatology. 2018;67(4):1224-1236.
Hengst J, Falk CS, Schlaphoff V, et al. Direct-acting antiviral-induced hepatitis C virus clearance does not completely restore the altered cytokine and chemokine milieu in patients with chronic hepatitis C. J Infect Dis. 2016;214(12):1965-1974.
Sawa Y, Arima Y, Ogura H, et al. Hepatic interleukin-7 expression regulates T cell responses. Immunity. 2009;30(3):447-457.
Oo YH, Shetty S, Adams DH. The role of chemokines in the recruitment of lymphocytes to the liver. Dig Dis. 2010;28(1):31-44.
Tan AT, Hoang LT, Chin D, et al. Reduction of HBV replication prolongs the early immunological response to IFNα therapy. J Hepatol. 2014;60(1):54-61.
Micco L, Peppa D, Loggi E, et al. Differential boosting of innate and adaptive antiviral responses during pegylated-interferon-alpha therapy of chronic hepatitis B. J Hepatol. 2013;58(2):225-233.

Auteurs

Olympia E Anastasiou (OE)

Institute of Virology, Essen University Hospital and Medical Faculty of the University of Duisburg-Essen, Duisburg, Germany.

Cihan Yurdaydin (C)

Department of Gastroenterology and Hepatology, Koç University Medical School, Istanbul, Turkey.

Benjamin Maasoumy (B)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Svenja Hardtke (S)

University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
German Center for Infectious Disease Research (DZIF), HepNet Study-House, Hannover, Germany.

Florin Alexandru Caruntu (FA)

National Institute for Infectious Diseases Prof. Dr. Matei Bals, Bucharest, Romania.

Manuela G Curescu (MG)

Spitalul Clinic de Boli Infectioase, University of Medicine and Pharmacy Timisoara, Timisoara, România, Romania.

Kendal Yalcin (K)

Dicle University Medical Faculty, Diyarbakir, Turkey.

Ulus S Akarca (US)

Ege University Medical Faculty, Izmir, Turkey.

Selim Gürel (S)

Uludağ University Medical Faculty, Bursa, Turkey.

Stefan Zeuzem (S)

Johann Wolfgang Goethe University Medical Center, Frankfurt/Main, Germany.

Andreas Erhardt (A)

Heinrich Heine University, Düsseldorf, Germany.

Stefan Lüth (S)

Center of Internal Medicine II, University Hospital Brandenburg, Brandenburg Medical School, Brandenburg, Germany.

George V Papatheodoridis (GV)

School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.

Monica Radu (M)

National Institute for Infectious Diseases Prof. Dr. Matei Bals, Bucharest, Romania.

Stephanie Liebig (S)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Heike Bantel (H)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Birgit Bremer (B)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Michael P Manns (MP)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
German Center for Infectious Disease Research (DZIF), HepNet Study-House, Hannover, Germany.

Markus Cornberg (M)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
German Center for Infectious Disease Research (DZIF), HepNet Study-House, Hannover, Germany.

Heiner Wedemeyer (H)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
German Center for Infectious Disease Research (DZIF), HepNet Study-House, Hannover, Germany.
Dept. of Gastroenterology and Hepatology, Essen University Hospital and Medical Faculty of the University of Duisburg-Essen, Duisburg, Germany.

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