1. Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program
- Author
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Stefano Fagiuoli, Mario Angelico, Paola Carrai, Marzia Montalbano, Marco Biolato, Teresa Santantonio, Luisa Pasulo, Luca S. Belli, Gabriella Verucchi, Gianpiero D'Offizi, Lorenzo Badia, Elena Angeli, Erica Villa, Marcello Persico, Chiara Mazzarelli, Guido Piai, Raffaella Lionetti, Giovanni Guaraldi, Vanni Borghi, Vincenza Calvaruso, Laura Milazzo, Martina Felder, Antonio Grieco, Massimo Puoti, Antonio Craxì, Alfredo Alberti, Rossella Letizia Mancusi, 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, Calvaruso V, Mazzarelli C, Milazzo L, Badia L, Pasulo L, Guaraldi G, Lionetti R, Villa E, Borghi V, Carrai P, Alberti A, Biolato M, Piai G, Persico M, Santantonio T, Felder M, Angelico M, Montalbano M, Mancusi RL, Grieco A, Angeli E, D'Offizi G, Fagiuoli S, Belli L, Verucchi G, Puoti M, Craxì A., Calvaruso, V, Mazzarelli, C, Milazzo, L, Badia, L, Pasulo, L, Guaraldi, G, Lionetti, R, Villa, E, Borghi, V, Carrai, P, Alberti, A, Biolato, M, Piai, G, Persico, M, Santantonio, T, Felder, M, Angelico, M, Montalbano, M, Mancusi, R, Grieco, A, Angeli, E, D'Offizi, G, Fagiuoli, S, Belli, L, Verucchi, G, Puoti, M, and Craxi, A
- Subjects
0301 basic medicine ,Simeprevir ,Liver Cirrhosis ,Male ,Pyrrolidines ,Sofosbuvir ,Sustained Virologic Response ,lcsh:Medicine ,Settore MED/05 ,Gastroenterology ,chemistry.chemical_compound ,0302 clinical medicine ,Liver Function Tests ,INFECTION ,Medicine ,PLUS SOFOSBUVIR ,lcsh:Science ,Sulfonamides ,Multidisciplinary ,Imidazoles ,Valine ,Hepatitis C ,Middle Aged ,Treatment Outcome ,Italy ,SAFETY ,HCV ,SUSTAINED VIROLOGICAL RESPONSE ,Drug Therapy, Combination ,Female ,RIBAVIRIN ,Settore BIO/19 - MICROBIOLOGIA GENERALE ,CHRONIC HEPATITIS-C ,medicine.drug ,Adult ,medicine.medical_specialty ,Daclatasvir ,Drug-Related Side Effects and Adverse Reactions ,Antiviral Agents ,Article ,03 medical and health sciences ,Internal medicine ,Humans ,Aged ,ADVANCED LIVER-DISEASE ,business.industry ,Ribavirin ,VIRUS GENOTYPE 3 ,lcsh:R ,Hepatitis C, Chronic ,HCV HIV Daclatasvir ,medicine.disease ,Isoquinolines ,EFFICACY ,Regimen ,030104 developmental biology ,chemistry ,Asunaprevir ,lcsh:Q ,Liver function ,Carbamates ,business ,030217 neurology & neurosurgery - 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
- Published
- 2019
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