The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes
Autor: | Carrai, P, Morelli, C, Cordone, G, Romano, A, Tamé, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, the ITACOPS study group, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A. L. |
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Přispěvatelé: | Carrai, P, Morelli, C, Cordone, G, Romano, A, Tame, M, Lionetti, R, Pietrosi, G, Lenci, I, Piai, G, Russo, F, Coppola, C, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Martini, S, Toniutto, P, Bandiera, F, Bhoori, S, Brillanti, S, Burra, P, Corsale, S, De Luca, A, Fagiuoli, S, Fattovich, G, Fava, G, Felder, M, Forte, P, Galeota-Lanza, A, Gitto, S, Grieco, A, Grossi, P, Ialungo, A, Iemmolo, R, Loiacono, L, Mangia, A, Merli, M, Piacentini, A, Pellicelli, A, Rigamonti, C, Gabriella, V, Zignego, A, Carrai, Paola, Cristina, Morelli, Cordone, Gabriella, Romano, Antonietta, Tamã©, Mariarosa, Lionetti, Raffaella, Pietrosi, Giada, Lenci, Ilaria, Piai, Guido, Russo, Francesco Paolo, Coppola, Carmine, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, Trotta, Maria Paola, Martini, Silvia, Toniutto, Pierluigi, Bandiera, Francesco, Bhoori, Sherrie, Brillanti, Stefano, Burra, Patrizia, Corsale, Sveva, De Luca, Andrea, Fagiuoli, Stefano, Fattovich, Giovanna, Fava, Gianmarco, Felder, Martina, Forte, Paolo, Galeota-Lanza, Alfonso, Gitto, Stefano, Grieco, Antonio, Grossi, Paolo, Ialungo, A. M., Iemmolo, Rosa Maria, Loiacono, Laura, Mangia, Alessandra, Merli, Manuela, Piacentini, A., Pellicelli, Adriano, Rigamonti, Cristina, Gabriella, Verucchi, Zignego, Anna Linda |
Jazyk: | angličtina |
Rok vydání: | 2017 |
Předmět: |
Compassionate Use Trials
Liver Cirrhosis Male 0301 basic medicine Simeprevir cholestatic hepatiti cholestatic hepatitis hepatitis C liver transplantation sofosbuvir Analysis of Variance Antiviral Agents Cohort Studies Confidence Intervals Disease Progression Dose-Response Relationship Drug Drug Administration Schedule Drug Therapy Combination Female Hepatitis C Chronic Humans Italy Liver Function Tests Logistic Models Multivariate Analysis Prognosis Recurrence Ribavirin Risk Assessment Severity of Illness Index Sofosbuvir Treatment Outcome Gastroenterology chemistry.chemical_compound 0302 clinical medicine Chronic Hepatitis C Combination 030211 gastroenterology & hepatology Drug Viral hepatitis medicine.drug medicine.medical_specialty Daclatasvir Transplantation Dose-Response Relationship 03 medical and health sciences Drug Therapy Internal medicine medicine business.industry medicine.disease digestive system diseases Surgery 030104 developmental biology chemistry Liver function business |
Popis: | Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score |
Databáze: | OpenAIRE |
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