Observational Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 7, 2020; 26(21): 2864-2876
Published online Jun 7, 2020. doi: 10.3748/wjg.v26.i21.2864
M2BPGi for assessing liver fibrosis in patients with hepatitis C treated with direct-acting antivirals
Shereen A Saleh, Mohamed M Salama, Marwan M Alhusseini, Ghada A Mohamed
Shereen A Saleh, Mohamed M Salama, Marwan M Alhusseini, Ghada A Mohamed, Gastroenterology and Hepatology Unit, Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo 11341, Egypt
Author contributions: Saleh SA designed the research; Alhusseini MM participated in the acquisition of data; Saleh SA, Salama MM, Alhusseini MM, Mohamed GA participated in the analysis and interpretation of the data; Saleh SA, Salama MM, Mohamed GA revised the article critically for important intellectual content; Mohamed GA wrote the paper.
Institutional review board statement: The study was reviewed and approved by the institutional review board of Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Informed consent statement: All study participants provided informed written consent prior to study enrolment.
Conflict-of-interest statement: All authors have nothing to disclose.
Data sharing statement: The statistical code and dataset are available from the corresponding author at ghadaabdelrahman@med.asu.edu.eg. The participants gave informed consent for the data sharing.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
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: Ghada A Mohamed, MD, Lecturer, Gastroenterology and Hepatology Unit, Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Khalifa El-Maamon St., Abbassia, Cairo 11341, Egypt. ghadaabdelrahman@med.asu.edu.eg
Received: January 4, 2020
Peer-review started: January 4, 2020
First decision: February 24, 2020
Revised: March 27, 2020
Accepted: May 28, 2020
Article in press: May 28, 2020
Published online: June 7, 2020
Processing time: 153 Days and 15.2 Hours
ARTICLE HIGHLIGHTS
Research background

Assessing liver fibrosis is important for predicting the efficacy of direct-acting antivirals (DAAs) and patient prognosis. Non-invasive techniques to assess liver fibrosis are becoming important. Recently, serum Mac-2 binding protein glycosylation isomer (M2BPGi) was identified as a non-invasive marker of liver fibrosis.

Research motivation

The approval of DAAs was a revolution in hepatitis C virus eradication, with sustained virologic response (SVR) rates exceeding 90%. However, a few reports have documented the improvement in liver fibrosis in patients treated with DAAs. Although liver biopsy is considered the gold standard for stratifying hepatic fibrosis, its clinical utility is substantially limited because of the invasiveness and the sampling variability. Accordingly, serum M2BPGi was evaluated as a non-invasive marker for assessing the grade of hepatic fibrosis in patients who have achieved SVR after antiviral therapy.

Research objectives

We aimed to investigate the diagnostic accuracy of serum M2BPGi levels in assessing the grade of liver fibrosis in patients with chronic hepatitis C (CHC) before and after DAAs-based treatment, as well as to compare its diagnostic value with the FIB-4 score and PAPAS index.

Research methods

Eighty treatment-naïve adult patients with CHC who were eligible for DAAs therapy were consecutively enrolled in this observational cohort study. For 12 weeks, 65 patients were treated with sofosbuvir/daclatasvir, and 15 patients were treated with sofosbuvir/daclatasvir and a weight-based dose of ribavirin. We measured serum M2BPGi levels, PAPAS index, FIB-4 score and liver stiffness measurements (LSM) at baseline and 12 weeks after the end of treatment. Serum M2BPGi levels were measured using enzyme-linked immunosorbent assay.

Research results

All patients achieved SVR12 (100%). Serum M2BPGi levels, LSM, FIB-4 score and PAPAS index decreased significantly at SVR12 (P < 0.05). Serum M2BPGi levels correlated positively with LSM at baseline and SVR12 (P < 0.001). At baseline, compared with the FIB-4 score and PAPAS index, M2BPGi was the best marker to distinguish patients with grade F4 fibrosis (AUC = 0.801, P < 0.001), patients with grade F2 from grade F0-1 fibrosis (AUC = 0.713, P = 0.012), patients with grade F3-4 from grade F0-2 fibrosis (AUC = 0.730, P < 0.001), and patients with grade F2-4 from grade F0-1 fibrosis (AUC = 0.763, P < 0.001). At SVR12, M2BPGi had the greatest AUCs for differentiating patients with grade F4 fibrosis (AUC = 0.844, P < 0.001), patients with grade F3 from grade F0-2 fibrosis (AUC = 0.893, P = 0.002), patients with grade F3-4 from grade F0-2 fibrosis (AUC = 0.891, P < 0.001), and patients with grade F2-4 from grade F0-1 fibrosis (AUC = 0.750, P < 0.001).

Research conclusions

M2BPGi is a reliable marker for the non-invasive assessment and prediction of liver fibrosis regression in patients with CHC who achieved an SVR with DAAs therapy.

Research perspectives

Non-invasive methods have been previously proposed and validated for the assessment of hepatic fibrosis. In this study, we confirm that serum M2BPGi is a reliable marker for liver fibrosis. Further studies are needed to investigate its therapeutic potential and ultimate clinical utility.