{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["9(1)"],"submitter":["Calvaruso V"],"pubmed_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."],"journal":["Scientific reports"],"pagination":["585"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6345835"],"repository":["biostudies-literature"],"pubmed_title":["Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program."],"pmcid":["PMC6345835"],"pubmed_authors":["Montalbano M","Milazzo L","D'Offizi G","Fagiuoli S","Belli L","Piai G","Grieco A","Felder M","Angeli E","Pasulo L","Craxi A","Borghi V","Persico M","Alberti A","Mancusi RL","Verucchi G","Mazzarelli C","Puoti M","Biolato M","Calvaruso V","Santantonio T","Carrai P","Guaraldi G","Lionetti R","Badia L","Villa E","Angelico M"],"additional_accession":[]},"is_claimable":false,"name":"Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program.","description":"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.","dates":{"release":"2019-01-01T00:00:00Z","publication":"2019 Jan","modification":"2025-04-26T08:53:54.759Z","creation":"2019-03-26T22:41:52Z"},"accession":"S-EPMC6345835","cross_references":{"pubmed":["30679515"],"doi":["10.1038/s41598-018-36734-0"]}}