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
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.
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.
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.
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.
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.
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.
Long-term follow-up studies of patients after successful HCV eradication are important.