We reported the efficacy and safety data for daclatasvir (DCV)-based all-oral antiviral therapy in patients treated in the Italian compassionate-use program. 275 patients were included (202 male-73.5%, mean age: 57.4 years, 62 HIV-coinfected, 94 with recurrence of hepatitis C post-OLT). Forty-nine patients (17.8%) had Child-Pugh B, Genotype(G) distribution was: G1a:72 patients (26.2%), G1b:137 (49.8%); G3:40 (14.5%) and G4:26 (9.5%). Patients received DCV with sofosbuvir(SOF) (n = 221, 129 with ribavirin(RBV) or with simeprevir (SMV) or asunaprevir (ASU) (n = 54, 19 with RBV) for up to 24 weeks. Logistic regression was used to identify baseline characteristics associated with sustained virological response at week 12 post-treatment (SVR12). Liver function changes between baseline and follow up were assessed in 228 patients. 240 patients achieved SVR12 (87.3%), post transplant and HIV co-infected patients were equally distributed among SVR and no SVR (35% vs 34.3%; p = 0.56 and 24.2% vs 11.4%, p = 0.13, respectively). SVR rate was significantly higher with the combination DCV + SOF compared with DCV + SIM or ASU (93.2% vs 63.0%, p < 0.0001). Bilirubin value (OR: 0.69, CI95%: 0.54-0.87, p = 0.002) and regimen containing SOF (OR: 9.99, CI95%: 4.09-24.40; p < 0.001) were independently related with SVR. Mean albumin and bilirubin values significantly improved between baseline and follow-up week 12. DCV-based antiviral therapy was well tolerated and resulted in a high SVR when combined with SOF either in pre-transplant and in OLT patients and in "difficult to treat" HCV genotypes. Regimens containing DCV in combination with NS3 protease inhibitors obtained suboptimal results.

Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program / Calvaruso, Vincenza; Mazzarelli, Chiara; Milazzo, Laura; Badia, Lorenzo; Pasulo, Luisa; Guaraldi, Giovanni; Lionetti, Raffaella; Villa, Erica; Borghi, Vanni; Carrai, Paola; Alberti, Alfredo; Biolato, Marco; Piai, Guido; Persico, Marcello; Santantonio, Teresa; Felder, Martina; Angelico, Mario; Montalbano, Marzia; Mancusi, Rossella Letizia; Grieco, Antonio; Angeli, Elena; D'Offizi, Gianpiero; Fagiuoli, Stefano; Belli, Luca; Verucchi, Gabriella; Puoti, Massimo; Craxì, Antonio. - In: SCIENTIFIC REPORTS. - ISSN 2045-2322. - 9:1(2019), pp. 585-593. [10.1038/s41598-018-36734-0]

Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program

Guaraldi, Giovanni;Villa, Erica;
2019

Abstract

We reported the efficacy and safety data for daclatasvir (DCV)-based all-oral antiviral therapy in patients treated in the Italian compassionate-use program. 275 patients were included (202 male-73.5%, mean age: 57.4 years, 62 HIV-coinfected, 94 with recurrence of hepatitis C post-OLT). Forty-nine patients (17.8%) had Child-Pugh B, Genotype(G) distribution was: G1a:72 patients (26.2%), G1b:137 (49.8%); G3:40 (14.5%) and G4:26 (9.5%). Patients received DCV with sofosbuvir(SOF) (n = 221, 129 with ribavirin(RBV) or with simeprevir (SMV) or asunaprevir (ASU) (n = 54, 19 with RBV) for up to 24 weeks. Logistic regression was used to identify baseline characteristics associated with sustained virological response at week 12 post-treatment (SVR12). Liver function changes between baseline and follow up were assessed in 228 patients. 240 patients achieved SVR12 (87.3%), post transplant and HIV co-infected patients were equally distributed among SVR and no SVR (35% vs 34.3%; p = 0.56 and 24.2% vs 11.4%, p = 0.13, respectively). SVR rate was significantly higher with the combination DCV + SOF compared with DCV + SIM or ASU (93.2% vs 63.0%, p < 0.0001). Bilirubin value (OR: 0.69, CI95%: 0.54-0.87, p = 0.002) and regimen containing SOF (OR: 9.99, CI95%: 4.09-24.40; p < 0.001) were independently related with SVR. Mean albumin and bilirubin values significantly improved between baseline and follow-up week 12. DCV-based antiviral therapy was well tolerated and resulted in a high SVR when combined with SOF either in pre-transplant and in OLT patients and in "difficult to treat" HCV genotypes. Regimens containing DCV in combination with NS3 protease inhibitors obtained suboptimal results.
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Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program / Calvaruso, Vincenza; Mazzarelli, Chiara; Milazzo, Laura; Badia, Lorenzo; Pasulo, Luisa; Guaraldi, Giovanni; Lionetti, Raffaella; Villa, Erica; Borghi, Vanni; Carrai, Paola; Alberti, Alfredo; Biolato, Marco; Piai, Guido; Persico, Marcello; Santantonio, Teresa; Felder, Martina; Angelico, Mario; Montalbano, Marzia; Mancusi, Rossella Letizia; Grieco, Antonio; Angeli, Elena; D'Offizi, Gianpiero; Fagiuoli, Stefano; Belli, Luca; Verucchi, Gabriella; Puoti, Massimo; Craxì, Antonio. - In: SCIENTIFIC REPORTS. - ISSN 2045-2322. - 9:1(2019), pp. 585-593. [10.1038/s41598-018-36734-0]
Calvaruso, Vincenza; Mazzarelli, Chiara; Milazzo, Laura; Badia, Lorenzo; Pasulo, Luisa; Guaraldi, Giovanni; Lionetti, Raffaella; Villa, Erica; Borghi, Vanni; Carrai, Paola; Alberti, Alfredo; Biolato, Marco; Piai, Guido; Persico, Marcello; Santantonio, Teresa; Felder, Martina; Angelico, Mario; Montalbano, Marzia; Mancusi, Rossella Letizia; Grieco, Antonio; Angeli, Elena; D'Offizi, Gianpiero; Fagiuoli, Stefano; Belli, Luca; Verucchi, Gabriella; Puoti, Massimo; Craxì, Antonio
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1171399
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