A Real-Life Study of New Antiviral Therapies in a High Prevalence Geographical Area for Hepatitis C Virus Infection

Abstract

Background: Hepatitis C virus (HCV) infection represents one of the most important causes of chronic liver damage. The development of new therapeutic approaches based on the use of direct-acting antivirals allowed reaching the high rates of sustained virological response and on the other hand, the low rates of drug side effects. Objectives: The study aimed to evaluate the efficacy and safety of multiple direct-acting antiviral (DAA) therapies against the major HCV genotypes in Campania. Methods: We enrolled, in this monocentric observational study, 518 adult patients (> 18-years-old) affected by HCV who received a DAA anti-HCV-based therapy in the routine clinical practice. We collected direct data registered by the Hepatogastroenterology Division of the University of Campania “L. Vanvitelli”, which covers a catchment area from the entire Campania region. Results: A great number (98.2 %) of the 518 enrolled patients was naive to the antiviral treatment and genotype distribution was 1a = 32 (6.2%), 1b = 252 (48.7%), 2 = 146 (28.2%), 3 = 52 (10.1%), and 4 = 36 (6.9%). 300 patients were cirrhotic (57.9%) and most of them had a Child-Pugh A5 score. 79.56 % of the patients belonging to the population of our study were classified as fibrosis Metavir F3 or F4 by Fibroscan. All the enrolled patients completed the treatment with the exception of five (n = 5; 0.96%) who interrupted it due to adverse events. We observed a relapse of infection in three patients treated with Sofosbuvir and Simeprevir for 12 weeks (0.57%). Intention to treat analysis showed an overall rate of 98.46% (n = 510/518) sustained virological response. Six of the eight failure patients had a second line anti-HCV treatment and four of them obtained SVR (two patients are waiting for resistance test results). Conclusions: New antiviral regimens of DAA-based for HCV represent one of the greatest innovations in the scientific context in the last few years. Our prospective observational study confirms the elevated efficacy in terms of SVR12, independently from HCV genotype and disease stage, when these treatments are used as the methods of a good clinical practice.