We reported the efcacy 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 male73.5%, 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 signifcantly 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 signifcantly 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 “difcult to treat” HCV genotypes. Regimens containing DCV in combination with NS3 protease inhibitors obtained suboptimal results.

Calvaruso V, M.C. (2019). Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program. SCIENTIFIC REPORTS, 9(585), 1-8 [10.1038/s41598-018-36734-0].

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

Calvaruso V
;
Craxì A.
Membro del Collaboration Group
2019

Abstract

We reported the efcacy 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 male73.5%, 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 signifcantly 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 signifcantly 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 “difcult to treat” HCV genotypes. Regimens containing DCV in combination with NS3 protease inhibitors obtained suboptimal results.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6345835/
Calvaruso V, M.C. (2019). Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program. SCIENTIFIC REPORTS, 9(585), 1-8 [10.1038/s41598-018-36734-0].
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10447/345341
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