PMID- 35126848 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220208 IS - 1948-5182 (Print) IS - 1948-5182 (Electronic) VI - 14 IP - 1 DP - 2022 Jan 27 TI - Direct-acting antivirals for chronic hepatitis C treatment: The experience of two tertiary university centers in Brazil. PG - 195-208 LID - 10.4254/wjh.v14.i1.195 [doi] AB - 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 Previous interferon-based therapies have been replaced by oral direct-acting antivirals (DAA) regimens, with high sustained virologic response (SVR) rates, and a lower incidence of adverse events (AEs).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. CI - (c)The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved. FAU - Lourenco, Mariana Sandoval AU - Lourenco MS AD - Division of Gastroenterology, Department of Internal Medicine, School of Medical Sciences, University of Campinas, Sao Paulo 13083-878, Brazil. FAU - Zitelli, Patricia Momoyo Y AU - Zitelli PMY AD - Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo 05403-900, Brazil. FAU - Cunha-Silva, Marlone AU - Cunha-Silva M AD - Division of Gastroenterology, Department of Internal Medicine, School of Medical Sciences, University of Campinas, Sao Paulo 13083-878, Brazil. FAU - Oliveira, Arthur Ivan N AU - Oliveira AIN AD - Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo 05403-900, Brazil. FAU - Oliveira, Claudia P AU - Oliveira CP AD - Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo 05403-900, Brazil. FAU - Seva-Pereira, Tiago AU - Seva-Pereira T AD - Division of Gastroenterology, Department of Internal Medicine, School of Medical Sciences, University of Campinas, Sao Paulo 13083-878, Brazil. FAU - Carrilho, Flair Jose AU - Carrilho FJ AD - Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo 05403-900, Brazil. FAU - Pessoa, Mario G AU - Pessoa MG AD - Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo 05403-900, Brazil. FAU - Mazo, Daniel F AU - Mazo DF AD - Division of Gastroenterology, Department of Internal Medicine, School of Medical Sciences, University of Campinas, Sao Paulo 13083-878, Brazil. LA - eng PT - Journal Article PL - United States TA - World J Hepatol JT - World journal of hepatology JID - 101532469 PMC - PMC8790388 OTO - NOTNLM OT - Antiviral agents OT - Chronic hepatitis C OT - Hepatitis C virus OT - Liver cirrhosis OT - Safety OT - Sustained virologic response COIS- Conflict-of-interest statement: Mazo DF, Oliveira CP, and Seva-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. EDAT- 2022/02/08 06:00 MHDA- 2022/02/08 06:01 PMCR- 2022/01/27 CRDT- 2022/02/07 05:31 PHST- 2021/03/24 00:00 [received] PHST- 2021/06/22 00:00 [revised] PHST- 2021/12/10 00:00 [accepted] PHST- 2022/02/07 05:31 [entrez] PHST- 2022/02/08 06:00 [pubmed] PHST- 2022/02/08 06:01 [medline] PHST- 2022/01/27 00:00 [pmc-release] AID - 10.4254/wjh.v14.i1.195 [doi] PST - ppublish SO - World J Hepatol. 2022 Jan 27;14(1):195-208. doi: 10.4254/wjh.v14.i1.195.