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.

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. L., Grieco, A., Angeli, E., D'offizi, G., Fagiuoli, S., Belli, L., Verucchi, G., Puoti, M., Craxì, A., Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program, <<SCIENTIFIC REPORTS>>, 2019; 9 (1): 585-585. [doi:10.1038/s41598-018-36734-0] [http://hdl.handle.net/10807/133216]

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

Alfredo; Biolato;Rossella Letizia; Grieco;Gianpiero; Fagiuoli;
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.
Inglese
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. L., Grieco, A., Angeli, E., D'offizi, G., Fagiuoli, S., Belli, L., Verucchi, G., Puoti, M., Craxì, A., Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program, <<SCIENTIFIC REPORTS>>, 2019; 9 (1): 585-585. [doi:10.1038/s41598-018-36734-0] [http://hdl.handle.net/10807/133216]
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