Retrospective Cohort Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Jan 27, 2022; 14(1): 195-208
Published online Jan 27, 2022. doi: 10.4254/wjh.v14.i1.195
Direct-acting antivirals for chronic hepatitis C treatment: The experience of two tertiary university centers in Brazil
Mariana Sandoval Lourenço, Patricia Momoyo Y Zitelli, Marlone Cunha-Silva, Arthur Ivan N Oliveira, Cláudia P Oliveira, Tiago Sevá-Pereira, Flair José Carrilho, Mario G Pessoa, Daniel F Mazo
Mariana Sandoval Lourenço, Marlone Cunha-Silva, Tiago Sevá-Pereira, Daniel F Mazo, Division of Gastroenterology, Department of Internal Medicine, School of Medical Sciences, University of Campinas, Sao Paulo 13083-878, Brazil
Patricia Momoyo Y Zitelli, Arthur Ivan N Oliveira, Cláudia P Oliveira, Flair José Carrilho, Mario G Pessoa, Daniel F Mazo, Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of São Paulo School of Medicine, Sao Paulo 05403-900, Brazil
Author contributions: Lourenço MS and Mazo DF conceived the idea, designed the study, took care of patients, collected and assembled the data, contributed to the data analysis and interpretation and wrote the manuscript; Zitelli PMY, Cunha-Silva M and Oliveira AIN took care of patients, collected and assembled the data; Oliveira CP, Sevá-Pereira T, Carrilho FJ and Pessoa MG critically reviewed the manuscript; all authors approved the final version of the manuscript for publication.
Institutional review board statement: This study was approved by the Ethics Committee of UNICAMP and Clinics Hospital of FMUSP (Approval No. 2042967 and 2670862, respectively).
Informed consent statement: Informed consent was waived for participants.
Conflict-of-interest statement: Mazo DF, Oliveira CP, and Sevá-Pereira T have received lecture fees from Gilead. Pessoa MG has received lecture and advisory board fees from Gilead. The other authors declare no conflict of interest regarding this work.
Data sharing statement: No additional data are available.
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: Daniel F Mazo, MD, PhD, Medical Assistant, Professor, Division of Gastroenterology, Department of Internal Medicine, School of Medical Sciences, University of Campinas, Rua Carlos Chagas 420, São Paulo 13083-878, Brazil. dmazo@unicamp.br
Received: March 24, 2021
Peer-review started: March 24, 2021
First decision: June 15, 2021
Revised: June 22, 2021
Accepted: December 10, 2021
Article in press: December 10, 2021
Published online: January 27, 2022
Abstract
BACKGROUND

Hepatitis C virus (HCV) treatment has undergone major changes in recent years. Previous interferon-based therapies have been replaced by oral direct-acting antivirals (DAA) regimens, with high sustained virologic response (SVR) rates, and a lower incidence of adverse events (AEs).

AIM

To evaluate the efficacy and safety of DAAs for HCV treatment in subjects from two tertiary university centers in Brazil.

METHODS

This is a multicenter retrospective cohort study of 532 patients with chronic hepatitis C (CHC), undergoing treatment with interferon-free regimens from November 2015 to November 2019. The therapeutic regimen was defined by the current Brazilian guidelines for HCV management at the time of treatment. Demographic, anthropometric, clinical, and laboratory variables were evaluated. SVRs were assessed at 12 to 24 wk after therapy by intention-to-treat (ITT), and modified ITT (m-ITT) analysis. AEs and serious adverse events (SAEs) were registered. In the statistical analysis, a P value of < 0.05 was considered significant.

RESULTS

The mean age was 56.88 years, with 415 (78.5%) being HCV genotype 1, followed by genotype 3 (20.1%). Moreover, 306 (57.5%) subjects had cirrhosis, and a third of them had decompensated cirrhosis. Sofosbuvir (SOF) plus daclatasvir ± ribavirin was the most frequently used treatment (66.9%), followed by SOF plus simeprevir (21.2%). The overall ITT SVR was 92.6% (493/532), while the m-ITT SVR was 96.8% (493/509). Variables associated with treatment failure via ITT evaluation were hepatic encephalopathy (OR: 4.320; 95%CI: 1.920-9.721, P = 0.0004), presence of esophageal varices (OR: 2.381; 95%CI: 1.137-4.988, P = 0.0215), previous portal hypertensive bleeding (OR: 2.756; 95%CI: 1.173-6.471, P = 0.02), higher model for end-stage liver disease scores (OR: 1.143, 95%CI: 1.060–1.233, P = 0.0005), lower serum albumin levels (OR: 0.528, 95%CI: 0.322-0.867, P = 0.0115), higher serum creatinine (OR: 1.117, 95%CI: 1.056-1.312, P = 0.0033), and international normalized ratio (INR) levels (OR: 5.542, 95%CI: 2.023-15.182, P = 0.0009). AEs were reported in 41.1% (211/514) of patients, and SAEs in 3.7%. The female gender, higher body mass index, esophageal varices, higher INR values, and longer treatment duration were independently associated with AE occurrence.

CONCLUSION

Treatment with oral DAAs attains a high SVR rate, with fewer SAEs in a real-life cohort of subjects with CHC, from two tertiary university centers in Brazil.

Keywords: Chronic hepatitis C, Antiviral agents, Hepatitis C virus, Sustained virologic response, Liver cirrhosis, Safety

Core Tip: Hepatitis C virus treatment has recently undergone major changes. In this multicenter retrospective cohort study of 532 patients with chronic hepatitis C treated with oral direct-acting antiviral regimens, the overall intention-to-treat (ITT) sustained virologic response (SVR) was 92.6% (493/532), and the modified-ITT SVR was 96.8% (493/509). Advanced liver disease was related to treatment failure. Adverse events (AEs) were reported in 41.1% (211/514) of patients, and serious AEs in 3.7%. The female gender, higher body mass index, presence of esophageal varices, higher international normalized ratio values, and longer treatment were independently linked to AE occurrence.