Document Type : Original Article
Authors
1
Department of Pharmacy, University of Genoa, Viale Benedetto XV 7, 16132 Genoa, Italy
2
The Technical University of Cluj-Napoca, The Directorate of Research, Development and Innovation Management (DMCDI), Constantin Daicoviciu Street, no. 15, Cluj-Napoca, 400020, Cluj county, Romania.
Abstract
Background: Hepatitis C virus (HCV) infection affects around 170 million people around the world and is a main cause of cirrhosis, liver decompensation and hepatocellular carcinoma (HCC) over time. HIV/HCV coinfection concerns around 2.2 million subjects and represents an unfavourable prognostic factor in the evolution of both infections. The use of direct-acting antivirals (DAAs) has allowed over 90% of patients to be cured and, hopefully, to prevent progression of HCV related disease. The aim of this study is to assess the efficacy and safety of DAAs in clinical practice, comparing results obtained among HCV mono-infected and HIV/HCV-coinfected subjects. Methods: Multicentre prospective observational study. Patients participating in the SCOLTA (Surveillance Cohort Long-Term Toxicity of Antiretrovirals/Antivirals) Project were included. Sustained virological response (SVR) and grade 4 adverse events were evaluated (i.e., pneumonia, hepato-renal syndrome, acute appendicitis, lymphoma, prolymphocytic leukaemia, liver decompensation with oesophageal bleeding, HCC, lung cancer and suicide). Results: Overall, 1152 patients receiving DAAs were included. Of them, 370 (32.1%) were HIV/HCV-coinfected, while 723 (63.8%) individuals had liver cirrhosis. Overall, 93% of subjects reached SVR12, we observed virologic nonresponse (defined as lack of HCV-RNA suppression) in 13 patients (1.1%); additionally, 47 patients (4.1%) relapsed and 11 subjects (1%) discontinued treatment for side effects. There was no significant difference in SVR rates with respect to fibrosis degree, treatment duration or HCV genotype. HIV/HCV coinfection was not associated with a worse virologic outcome. Conclusions: We found SVR rates higher than 95% in a cohort of patients with a high proportion of difficult to treat features. Only the 1% stopped treatment for side effects. HIV infection did not negatively impact on safety and efficacy.
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