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

Vincenza Calvaruso, Chiara Mazzarelli, Laura Milazzo, Lorenzo Badia, Luisa Pasulo, Giovanni Guaraldi, Raffaella Lionetti, Erica Villa, Vanni Borghi, Paola Carrai, Alfredo Alberti, Marco Biolato, Guido Piai, Marcello Persico, Teresa Santantonio, Martina Felder, Mario Angelico, Marzia Montalbano, Rossella Letizia Mancusi, Antonio GriecoElena Angeli, Gianpiero D'Offizi, Stefano Fagiuoli, Luca Belli, Gabriella Verucchi, Massimo Puoti, Antonio Craxì

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalScientific Reports
Volume9
Issue number1
DOIs
Publication statusPublished - Jan 24 2019

ASJC Scopus subject areas

  • General

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