Observational Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 7, 2022; 28(45): 6380-6396
Published online Dec 7, 2022. doi: 10.3748/wjg.v28.i45.6380
Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients
Dorota Zarębska-Michaluk, Michał Brzdęk, Jerzy Jaroszewicz, Magdalena Tudrujek-Zdunek, Beata Lorenc, Jakub Klapaczyński, Włodzimierz Mazur, Adam Kazek, Marek Sitko, Hanna Berak, Justyna Janocha-Litwin, Dorota Dybowska, Łukasz Supronowicz, Rafał Krygier, Jolanta Citko, Anna Piekarska, Robert Flisiak
Dorota Zarębska-Michaluk, Michał Brzdęk, Department of Infectious Diseases, Jan Kochanowski University, Kielce 25-317, Poland
Jerzy Jaroszewicz, Department of Infectious Diseases and Hepatology, Medical University of Silesia, Katowice 40-055, Poland
Magdalena Tudrujek-Zdunek, Department of Infectious Diseases, Medical University of Lublin, Lublin 20-059, Poland
Beata Lorenc, Pomeranian Center of Infectious Diseases, Medical University Gdańsk, Gdańsk 80-214, Poland
Jakub Klapaczyński, Department of Internal Medicine and Hepatology, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warszawa 00-241, Poland
Włodzimierz Mazur, Clinical Department of Infectious Diseases, Medical University of Silesia, Chorzów 41-500, Poland
Adam Kazek, ID Clinic, Mysłowice 41-400, Poland
Marek Sitko, Department of Infectious and Tropical Diseases, Jagiellonian University, Kraków 31-088, Poland
Hanna Berak, Hospital for Infectious Diseases, Hospital for Infectious Diseases, Warszawa 02-091, Poland
Justyna Janocha-Litwin, Department of Infectious Diseases and Hepatology, Medical University Wrocław, Wrocław 50-367, Poland
Dorota Dybowska, Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz 85-030, Poland
Łukasz Supronowicz, Robert Flisiak, Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok 15-089, Poland
Rafał Krygier, Infectious Diseases and Hepatology Outpatient Clinic, Gemini NZOZ, Żychlin 62-571, Poland
Jolanta Citko, Medical Practice of Infections, Regional Hospital, Olsztyn 10-561, Poland
Anna Piekarska, Department of Infectious Diseases and Hepatology, Medical University Łódź, Łódź 90-419, Poland
Author contributions: Zarębska-Michaluk D and Flisiak R conceived the study design, acquired the data; Zarębska-Michaluk D and Brzdęk M analyzed and interpreted the data; Zarębska-Michaluk D drafted the manuscript; Brzdęk M prepared tables and figures; Jaroszewicz J acquired the data, performed statistical analysis; Flisiak R prepared figures; Tudrujek-Zdunek M, Lorenc B, Klapaczyński J, Mazur W, Kazek A, Sitko M, Berak H, Janocha-Litwin J, Dybowska D, Supronowicz Ł, Krygier R, Citko J, Piekarska A acquired the data and approved the final version of the manuscript.
Institutional review board statement: According to local law (Pharmaceutical Law of 6th September 2001, art. 37al), non-interventional studies do not require ethics committee approval.
Informed consent statement: All study participants provided informed consent for treatment and processing of personal data.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Dataset available upon reasonable request to the corresponding author at dorota1010@tlen.pl.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Dorota Zarębska-Michaluk, MD, PhD, Professor, Department of Infectious Diseases, Jan Kochanowski University, Radiowa 7, Kielce 25-317, Poland. dorota1010@tlen.pl
Received: August 26, 2022
Peer-review started: August 26, 2022
First decision: September 25, 2022
Revised: October 1, 2022
Accepted: November 19, 2022
Article in press: November 19, 2022
Published online: December 7, 2022
Processing time: 97 Days and 17.9 Hours
ARTICLE HIGHLIGHTS
Research background

The increase in the efficacy of antiviral therapy following the introduction of direct antiviral drugs [direct-acting antiviral (DAA)] was most pronounced in patients infected with hepatitis C virus genotype (GT) 1b described as difficult to treat in the interferon (IFN) era.

Research motivation

We aimed to identify the most effective IFN-free therapy for GT1b-infected patients and to determine positive and negative predictors of virological response in this patient population.

Research objectives

Data of 11385 GT1b-infected patients treated with DAA regimens derived from the Epiter-2 database were analyzed.

Research methods

The effectiveness of treatment for each regimen was assessed by the percentage of sustained virological response (SVR). The primary independent variables with SVR as the dependent variable for the logistic stepwise regression model were selected based on significance in univariate analysis.

Research results

A total of 10903 patients responded to antiviral treatment resulting in a 98.1% in the per-protocol analysis after excluding 273 patients without SVR data. The effectiveness of all regimens exceeded 90% and the highest SVR of 98.9% was achieved in the group of patients treated with a combination of glecaprevir/pibrentasvir. Logistic regression analyses showed that virologic response in GT1b-infected patients was independently associated with female sex, absence of cirrhosis decompensation at baseline, and higher baseline platelets, while the presence of human immunodeficiency virus (HIV) coinfection significantly decreased the odds of response.

Research conclusions

The very high effectiveness was documented across all DAA regimens. Positive predictors of SVR were female sex, absence of decompensated cirrhosis at baseline and higher platelet count, while HIV coinfection reduced the chance of cure.

Research perspectives

The obtained data constitute the basis for selecting the most effective therapy in the case of GT1b-infected patients with no positive predictors and the presence of negative predictors of DAA therapy effectiveness.