Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Nov 27, 2020; 12(11): 1076-1088
Published online Nov 27, 2020. doi: 10.4254/wjh.v12.i11.1076
Hepatitis B surface antigen and hepatitis B core-related antigen kinetics after adding pegylated-interferon to nucleos(t)ids analogues in hepatitis B e antigen-negative patients
Teresa Broquetas, Montserrat Garcia-Retortillo, Miquel Micó, Lidia Canillas, Marc Puigvehí, Nuria Cañete, Susana Coll, Ana Viu, Juan Jose Hernandez, Xavier Bessa, José A Carrión
Teresa Broquetas, Montserrat Garcia-Retortillo, Lidia Canillas, Marc Puigvehí, Nuria Cañete, Susana Coll, Ana Viu, Xavier Bessa, José A Carrión, Department of Gastroenterology, Liver Section, Hospital del Mar Medical Research Institute, Barcelona 08003, Spain
Teresa Broquetas, Montserrat Garcia-Retortillo, Marc Puigvehí, Nuria Cañete, Susana Coll, Xavier Bessa, José A Carrión, Departament of de Medicina, Universitat Autònoma de Barcelona, Barcelona 08003, Spain
Miquel Micó, Juan Jose Hernandez, Laboratori de Referencia de Catalunya, El Prat de Llobregat, Barcelona 08820, Spain
Author contributions: Broquetas T completed statistical analysis and drafting of the manuscript; Broquetas T and Carrión JA analyzed and interpreted the data; Micó M and Hernandez JJ analyzed samples; Carrión JA completed concept, design and supervision of the study; all authors performed the acquisition of data, critical revision of the manuscript.
Supported by Instituto de Salud Carlos III, Ministerio de Economía y Competitividad No. PI14/00540; Fondo Europeo de Desarrollo Regional; Unión Europea; Una manera de hacer Europa.
Institutional review board statement: The study protocol was reviewed and approved by the Ethical Committee of our Institution “Comitè Ètic d’Investigació Clínica - Parc de Salut Mar”, study reference 2014/5787/I, in accordance with the ethical guidelines of the 1975 Declaration of Helsinki.
Clinical trial registration statement: The study was registered at http://clinicaltrials.gov with the number NCT02743182.
Informed consent statement: Study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Authors declare no conflict-of-interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: José A Carrión, MD, PhD, Doctor, Department of Gastroenterology, Liver Section, Hospital del Mar Medical Research Institute, Parc de Salut Mar, Passeig Marítim 25-29, Barcelona 08003, Spain. 95565@parcdesalutmar.cat
Received: June 2, 2020
Peer-review started: June 2, 2020
First decision: June 15, 2020
Revised: June 23, 2020
Accepted: September 4, 2020
Article in press: September 4, 2020
Published online: November 27, 2020
Processing time: 174 Days and 20.9 Hours
Core Tip

Core Tip: The functional cure of chronic hepatitis B defined as the loss of the hepatitis B surface antigen is the optimal end-point with the currently available therapies. However, it is rarely achieved in hepatitis B e antigen-negative chronic hepatitis B patients under nucleos(t)ids analogues (NAs). In the present study, we report that the addition of pegylated interferon (Peg-IFN) to NAs during forty-eight weeks caused a greater and faster decrease of hepatitis B surface antigen levels compared to NA monotherapy. No changes in hepatitis B core-related antigen were observed. However, the low applicability and poor tolerance of Peg-IFN make difficult its use in clinical practice.