Efficacy and safety of direct-acting antivirals in patients with hepatitis c infection: nationwide real-life data from türkiye

Abstract

Background/Aims: Chronic hepatitis C virus (HCV) infection constitutes a substantial healthcare concern in Türkiye. The clinical application of direct-acting antiviral medications (DAAs) has transformed its management. The goal is to assess the efficacy and safety of DAAs in the real-world setting in Turkish patients with chronic HCV. Materials and Methods: Thirty-seven centers from Türkiye recorded 1807 patients to the database. Patients aged >18 years were enrolled to the study. Their demographics, clinical information, DAAs used, efficacy, and safety information were evaluated. Efficacy and safety results were reported for patients with 12-week post-treatment (SVR12) data. Results: Among the patients, 919 (50.9%) were female with a mean of age 56 ± 15 years (range: 18-97 years) and 238 (13%) were cirrhotic. Liver biopsy was performed in 296 patients. Mean histologic activity index score was 7.68 and fibrosis score was 2.58. Baseline mean viral load was 4.11 × 10⁶ copies/mL. Patients received the following treatments: Paritaprevir+Ritonavir+Ombitasvir+Dasabuvir (PrOD): 706, Ledipasvir+Sofosbuvir: 490, Sofosbuvir+Ribavirin: 176, PrOD+Ribavirin: 175, Ledipasvir+Sofosbuvir+Ribavirin: 156, PrO+Ribavirin: 32, and PrO: 10. Response at the end of treatment was 99.2% (1454/1465) and SVR12 was 97.8% (1289/1318). The DAAs were generally well tolerated. Ten and 13 patients discontinued therapy because of drug-related and unrelated adverse side effects, respectively. Conclusion: This real-world study demonstrated that DAA treatment for HCV is both safe and highly effective. In two-thirds of the patients, the hepatic inflammation is moderate to severe, and fibrosis is moderate to advanced in half of them. Patients' characteristics suggest that HCV infection is often not diagnosed or treated until patients present with moderate-to-severe stage, indicating that diagnostic and therapeutic approaches should be used more effectively.