Randomized Clinical Trial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. May 18, 2016; 8(14): 625-631
Published online May 18, 2016. doi: 10.4254/wjh.v8.i14.625
Co-treatment with pegylated interferon alfa-2a and entecavir for hepatitis D: A randomized trial
Zaigham Abbas, Mohammad Sadik Memon, Muhammad Amir Umer, Minaam Abbas, Lubna Shazi
Zaigham Abbas, Department of Gastroenterology, Ziauddin University Hospital, Karachi 74400, Pakistan
Zaigham Abbas, Muhammad Amir Umer, Department of Medicine, Orthopedic and Medical Institute, Karachi 74400, Pakistan
Zaigham Abbas, Minaam Abbas, Lubna Shazi, Liver Stomach Clinic Zamzama, Karachi 75500, Pakistan
Mohammad Sadik Memon, Asian Institute of Medical Sciences, Hyderabad 71000, Pakistan
Author contributions: Abbas Z was responsible for the study conception and design, data analysis and interpretation, and manuscript drafting; Abbas Z and Memon MS recruited patients for the study; Umer MA, Abbas M and Shazi L coordinated study related activities and helped in manuscript drafting; all authors reviewed and approved the final version to be submitted for publication.
Institutional review board statement: The study was approved by Independent Ethics Review Board and Institutional Review Board.
Clinical trial registration statement: This investigator initiated trial was registered with the Roche (ML25746).
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Authors do not have any conflict of interest to declare.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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/
Correspondence to: Dr. Zaigham Abbas, FCPS, FRCP, Department of Gastroenterology, Ziauddin University Hospital, Shahrah-e-Ghalib, Karachi 74400, Pakistan. drzabbas@gmail.com
Telephone: +92-21-35862939 Fax: +92-21-35862940
Received: January 25, 2016
Peer-review started: January 27, 2016
First decision: March 9, 2016
Revised: March 30, 2016
Accepted: April 14, 2016
Article in press: April 18, 2016
Published online: May 18, 2016
Processing time: 107 Days and 18.5 Hours
Core Tip

Core tip: Chronic hepatitis D is a difficult to treat infection. Six months post treatment response is seen only in one quarter of the patients treated with pegylated interferon alfa (PEG-IFNα). In an attempt to improve the response of PEG-IFN, we combined entecavir. This is the first study to evaluate the efficacy of PEG-IFN with entecavir compared to PEG-IFN alone for the treatment of hepatitis D infection. Our study showed that the combination treatment did not have any additional benefit in terms of hepatitis D virus RNA suppression and hepatitis B surface antigen reduction as compared to PEG-IFN alone.