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Efficacy of Sofosbuvir and Daclatasvir in Patients with Fibrosing Cholestatic Hepatitis C After Liver Transplantation

Abstract : BACKGROUND & AIMS: Fibrosing cholestatic hepatitis (FCH) is a life-threating disorder that develops in patients with recurrent hepatitis C virus (HCV) infection after liver transplantation. Until recently, therapeutic options have been limited. We evaluated the efficacy and safety of sofosbuvir- and daclatasvir-based regimens. METHODS: We analyzed data from 23 patients with FCH who participated in a prospective cohort study in France and Belgium of the effects of anti-viral agents in patients with recurrence of HCV infection after liver transplantation, from October 2013 through April 2014. Most of the patients had genotype 1 infections that had not responded to previous treatment; 4 were also infected with HIV. Eight patients (37%) had ascites and 15 (65%) had bilirubin levels \textgreater100 mmol/L; their median serum level of HCV-RNA was 7 log IU/mL. The median time between transplantation and treatment initiation was 5 months. Subjects were given either sofosbuvir and daclatasvir (n=15) or sofosbuvir and ribavirin (n=8), for 24 weeks. The primary outcome was complete clinical response (survival without re-transplantation, bilirubin \textless 34 μmol/L, and no ascites or hepatic encephalopathy 36 weeks after treatment began). RESULTS: All patients survived, without re-transplantation, until week 36. Rapid and dramatic improvements in clinical status were observed. The patients' median bilirubin concentration decreased from 122 μmol/L at baseline to a normal value at week 12 of treatment. Twenty-two patients (96%) had a complete clinical response at week 36. Despite the low rate of rapid virologic response, 22 patients (96%) achieved a sustained virologic response at week 12 (SVR12). The only relapse of HCV infection occurred in a patient with HIV infection who received sofosbuvir and ribavirin. Tolerance was satisfactory, with no grade 3 or 4 adverse events related to sofosbuvir or daclatasvir and no significant interactions among drugs. CONCLUSION: Sofosbuvir therapy with daclatasvir or ribavirin leads complete clinical responses and high rates of SVR12 in most patients with recurrence of HCV infection and FCH following liver transplantation. ClinicalTrial.gov no: NCT01944527
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01162384
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Submitted on : Wednesday, June 10, 2015 - 1:09:19 PM
Last modification on : Sunday, October 25, 2020 - 7:05:49 AM

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Vincent Leroy, Jérôme Dumortier, Audrey Coilly, Mylène Sebagh, Claire Fougerou-Leurent, et al.. Efficacy of Sofosbuvir and Daclatasvir in Patients with Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association, 2015, 13 (11), pp.1993-2001.e2. ⟨10.1016/j.cgh.2015.05.030⟩. ⟨hal-01162384⟩

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