Sofosbuvir/Velpatasvir/Voxilaprevir Experience in Treatment-Naive Chronic Hepatitis C Patients: Preliminary Findings of Real World Data

Abstract

Objectives: The aim of this study was to present the preliminary findings of real-world data of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in treatment-naive chronic hepatitis C (CHC) patients, which was approved for the first time in treatment-naive patients in Turkey. Materials and Methods: This retrospective, cross-sectional, multicenter and national study comprised treatment-naive CHC patients receiving SOF/VEL/VOX between June-December 2022 in ten centers from Turkey. The sustained virological response (SVR) was defined as undetectable hepatitis C virus (HCV)-RNA after at least 12 weeks or more from the end of antiviral therapy. Results: Forty one patients initiating SOF/VEL/VOX were included in the study; median age 55 [interquartile range (IQR): 34.5-61 years], 63.4% males, and median HCV-RNA 521,644 IU/mL. Genotype distribution ranged from 1 to 4 in 28 patients who underwent genotype analysis, and genotype-1 was detected in 24 (85.7%) patients. The most common risk factor was substance abuse (n=10, 24.4%) and the most common comorbidity was hypertension (n=111, 26.8%). 3 (7.3%) patients had compensated cirrhosis and one (2.4%) had hepatocellular carcinoma. While in the 1st month of treatment, HCV-RNA was negative in all patients except one patient, at the end of treatment all patients' viral load was negative. SVR12 results were available in 23 patients and SVR24 in 10 patients. SVR12 and SVR24 were achieved in all patients who could be evaluated (100%) (SVR12, 23/23; SVR24, 10/10). Adverse events were reported by two patients: Diarrhea (2.4%) and nausea (2.4%), but did not lead to a discontinuation of treatment. Conclusion: The preliminary results of our study corroborated the efficacy and well tolerateability of SOF/VEL/VOX in treatment- naive CHC patients. High SVR rates were also observed across genotypes 1, 2, 3, 4 with the pangenotypic SOF/VEL/VOX.