Safety, efficacy, and predictor factors of sustained-virological-response after 24 weeks of new direct-acting antivirals were evaluated in hepatitis C virus patients with different stages of hepatic disease.260 patients, median age 60 years, of whom 48.1% cirrhotics, 17.7% liver transplant recipients, and 45.7% naive were treated with Sofosbuvir +/- Ribavirine, Sofosbuvir+Simeprevir +/- Ribavirine, Sofosbuvir+Daclatasvir +/- Ribavirine, Sofosbuvir+Ledispavir +/- Ribavirine, Ombitasvir/Paritaprevir/Ritonavir+Ribavirine and Ombitanir/Paritaprevir/Ritonavir+Dasabuvir +/- Ribavirine. Therapy outcomes, hematochemical parameters, viral replication, genotype, and resistance-associated-mutations were analyzed retrospectively. Sustained virological response was 90.4% in the whole population, 83.2% in cirrhotics, 85% in patients with previous virological failure, 93.6 degrees k in patients >60 years, and 95.6% in liver transplant recipients. SVR24 for each drug regimen was 75% Sofosbuvir+Ribavirine, 80.4% Sofosbuvir+Simeprevir +/- Ribavirine, 94.3% Sofosbuvir+Daclatasvir +/- Ribavirine, 98.7% Sofosbuvir+Ledispavir +/- Ribavirine, 100% Ombitasvir/ Paritaprevir/Ritonavir+Ribavirine and Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir +/- Ribavirine. The highest sustained virological response rates were obtained with genotype-1b (95.9%). Twenty-five patients, mostly cirrhotics or suffering from severe liver complications, manifested relapse (84%), breakthrough (12%), or non-response (4%). Mild side effects were observed in 41.1% of patients. Model-for-End-Liver-Disease score <10 and alanine aminotransferase <= 20 U/L at week 8 of therapy proved positive predictors of sustained virological response.Direct-acting antiviral therapy is efficacious and safe even in patients with advanced liver disease and/or previous virological failure; Model-for-End-Liver-Disease <10 and alanine aminotransferase reduction during therapy were found to be reliable predicting markers of sustained-virological-response.

Efficacy, Safety, and Predictors of Direct-acting antivirals in Hepatitis C Virus Patients with Heterogeneous Liver Diseases

De Pace, V
Conceptualization
;
Ravaioli, M;Vero, V
Methodology
;
Re, MC
Methodology
;
Cescon, M
Supervision
;
2019

Abstract

Safety, efficacy, and predictor factors of sustained-virological-response after 24 weeks of new direct-acting antivirals were evaluated in hepatitis C virus patients with different stages of hepatic disease.260 patients, median age 60 years, of whom 48.1% cirrhotics, 17.7% liver transplant recipients, and 45.7% naive were treated with Sofosbuvir +/- Ribavirine, Sofosbuvir+Simeprevir +/- Ribavirine, Sofosbuvir+Daclatasvir +/- Ribavirine, Sofosbuvir+Ledispavir +/- Ribavirine, Ombitasvir/Paritaprevir/Ritonavir+Ribavirine and Ombitanir/Paritaprevir/Ritonavir+Dasabuvir +/- Ribavirine. Therapy outcomes, hematochemical parameters, viral replication, genotype, and resistance-associated-mutations were analyzed retrospectively. Sustained virological response was 90.4% in the whole population, 83.2% in cirrhotics, 85% in patients with previous virological failure, 93.6 degrees k in patients >60 years, and 95.6% in liver transplant recipients. SVR24 for each drug regimen was 75% Sofosbuvir+Ribavirine, 80.4% Sofosbuvir+Simeprevir +/- Ribavirine, 94.3% Sofosbuvir+Daclatasvir +/- Ribavirine, 98.7% Sofosbuvir+Ledispavir +/- Ribavirine, 100% Ombitasvir/ Paritaprevir/Ritonavir+Ribavirine and Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir +/- Ribavirine. The highest sustained virological response rates were obtained with genotype-1b (95.9%). Twenty-five patients, mostly cirrhotics or suffering from severe liver complications, manifested relapse (84%), breakthrough (12%), or non-response (4%). Mild side effects were observed in 41.1% of patients. Model-for-End-Liver-Disease score <10 and alanine aminotransferase <= 20 U/L at week 8 of therapy proved positive predictors of sustained virological response.Direct-acting antiviral therapy is efficacious and safe even in patients with advanced liver disease and/or previous virological failure; Model-for-End-Liver-Disease <10 and alanine aminotransferase reduction during therapy were found to be reliable predicting markers of sustained-virological-response.
De Pace, V; Morelli, MC; Ravaioli, M; Maggi, F; Galli, S; Vero, V; Re, MC; Cescon, M; Pistello, M
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/733403
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