Effectiveness and Safety of Direct-Acting Antivirals in the Treatment of Chronic Hepatitis C: A Real-life Study in Northeastern Brazil.

Abstract

Background: This study aimed to evaluate the effectiveness and safety of direct-acting antivirals (DAAs) for hepatitis C treatment by measuring sustained virologic response (SVR) and serious adverse events to help design effective interventions for reducing disease prevalence.

Methods: This was a retrospective, observational, real-life study of patients with chronic hepatitis C receiving DAA treatment in the state of Ceará, Brazil. Data were collected in REDCap and analyzed using R® software by the Student's t, chi-square, and Fisher's exact tests, with a significance level of 5%.

Results: In this study, 1075 patients who were diagnosed with hepatitis C infection between October 2015 and October 2023 were included. The mean age of the participants was 56.6 ± 11 years and 60.2% were men. The sample included 51 HIV-infected patients (6.6%), 166 (15,4%) liver transplant recipients, 34 (3,1%) kidney transplant recipients, and 446 patients with cirrhosis (41.4%). The overall SVR rate was 96.4%. The sofosbuvir/daclatasvir/ribavirin regimen used in 354 (32.9%) patients achieved an SVR of 96%. The cure rate was 96.5%, with a lower SVR in patients with cirrhosis (93.4%) than in those with less severe fibrosis (97.9%) (p=0.0015). Serious adverse events associated with ribavirin use occurred in 3.5% of patients.

Conclusions: DAA treatment for hepatitis C achieved SVR in real life in all patient profiles, including transplant recipients, HIV carriers, and patients with cirrhosis. Although these drugs are safe, a few decompensated patients with cirrhosis died during treatment.