Lourenço MS, Zitelli PMY, Cunha-Silva M, Oliveira AIN, Oliveira CP, Sevá-Pereira T, Carrilho FJ, Pessoa MG, Mazo DF. Direct-acting antivirals for chronic hepatitis C treatment: The experience of two tertiary university centers in Brazil. World J Hepatol 2022; 14(1): 195-208 [PMID: 35126848 DOI: 10.4254/wjh.v14.i1.195]
Corresponding Author of This Article
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
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Cohort Study
Open-Access Policy of This Article
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/
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 Processing time: 302 Days and 8.8 Hours
ARTICLE HIGHLIGHTS
Research background
Hepatitis C represents a global health problem and a major cause of cirrhosis, and hepatocellular carcinoma. Hepatitis C virus (HCV) treatment has undergone major changes in recent years with the advent of direct-acting antivirals (DAA) regimens.
Research motivation
In Brazil, acquiring and dispensing of all oral DAA regimens for patients with chronic hepatitis C (CHC) is provided through the national public healthcare system. However, there are few studies in large centers showing experience with DAAs in patients with chronic HCV infection.
Research objectives
We aimed to evaluate the efficacy and safety of DAAs for HCV treatment in subjects from two tertiary public university centers in the southeastern region of Brazil.
Research methods
We evaluated 532 adult patients with CHC who underwent treatment with interferon-free regimens from November 2015 to November 2019. Demographic, anthropometric, clinical, and laboratory variables were evaluated. Sustained virologic response (SVR) rates were assessed at 12 to 24 wk after therapy by intention-to-treat (ITT), and modified ITT (m-ITT) analysis. Adverse events (AEs) and serious adverse events (SAEs) were registered.
Research results
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, presence of esophageal varices, previous portal hypertensive bleeding, higher model for end-stage liver disease scores, lower serum albumin levels, and higher serum creatinine and international normalized ratio (INR) levels. 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.
Research conclusions
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.
Research perspectives
Long-term follow-up studies of patients after successful HCV eradication are important.
