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
Abstract
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.

AIM

To investigate the diagnostic accuracy of M2BPGi in assessing liver fibrosis in patients with chronic hepatitis C (CHC) treated with DAAs.

METHODS

From December 2017 to August 2018, 80 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 at knowledge and technology association for hepatitis C management clinic, Cairo, Egypt. We measured serum M2BPGi levels, PAPAS index, fibrosis-4 (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.

RESULTS

All patients achieved sustained virologic response (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).

CONCLUSION

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.

Keywords: Hepatitis C virus; Liver fibrosis; Human Mac-2 binding protein; Antiviral agents; Sustained virologic response; Elastography

Core tip: For 12 wk, 80 chronic hepatitis C patients received a sofosbuvir/daclatasvir/± ribavirin treatment. All patients achieved sustained virologic response (SVR12). Serum Mac-2 binding protein glycosylation isomer (M2BPGi) levels, liver stiffness measurements, fibrosis-4 (FIB-4) and PAPAS index decreased significantly at SVR12. At baseline, M2BPGi was the best marker to distinguish patients with grade F4 fibrosis, patients with grade F2 from grade F0-1 fibrosis, patients with grade F3-4 from grade F0-2 fibrosis, and patients with grade F2-4 from grade F0-1 fibrosis. At SVR12, M2BPGi had the greatest AUCs for differentiating patients with grade F4 fibrosis, patients with grade F3 from grade F0-2 fibrosis, patients with grade F3-4 from grade F0-2 fibrosis, and patients with grade F2-4 from grade F0-1 fibrosis.