Published online Jan 27, 2022. doi: 10.4254/wjh.v14.i1.195
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
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 Previous interferon-based therapies have been replaced by oral direct-acting antivirals (DAA) regimens, with high sustained virologic response (SVR) rates, and a lower incidence of adverse events (AEs).
To evaluate the efficacy and safety of DAAs for HCV treatment in subjects from two tertiary university centers in Brazil.
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.
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.
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.
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.