TY - JOUR
T1 - Sofosbuvir plus daclatasvir for post-transplant recurrent hepatitis C
T2 - Potent antiviral activity but no clinical benefit if treatment is given late
AU - Pellicelli, Adriano M.
AU - Montalbano, Marzia
AU - Lionetti, Raffaella
AU - Durand, Christine
AU - Ferenci, Peter
AU - D'Offizi, Gianpiero
AU - Knop, Viola
AU - Telese, Andrea
AU - Lenci, Ilaria
AU - Andreoli, Arnaldo
AU - Zeuzem, Stefan
AU - Angelico, Mario
N1 - Publisher Copyright:
© 2014 Editrice Gastroenterologica Italiana S.r.l.
PY - 2014
Y1 - 2014
N2 - Background: We evaluated efficacy and safety of sofosbuvir and daclatasvir. ±. ribavirin in liver transplant recipients with severe recurrent hepatitis C. Methods: Patients included in an international compassionate use programme for treatment with sofosbuvir and daclatasvir. ±. ribavirin for 24 weeks were prospectively studied. Serum hepatitis C virus RNA was measured at treatment weeks 4, 12, and 24 and during follow-up at weeks 4, 8, and 12. Results: Twelve patients (3 with fibrosing cholestatic hepatitis and 9 with cirrhosis; median model for end-stage liver disease score 20) received sofosbuvir 400. mg/day. +. daclatasvir 60. mg/day, and 6 patients (50%) also received ribavirin 200-800. mg/day. Nine patients completed 24 weeks of treatment (75%), and all had undetectable hepatitis C virus RNA at week 24; 3 patients died (25%, liver failure, gastrointestinal bleeding and sepsis); 4 patients experienced severe liver disease-related adverse events. Post-treatment hepatitis C virus RNA was available for 5 patients (week 8, n=. 2; week 4, n=. 3) and was undetectable in all cases. Mean Child-Pugh score and albumin level improved significantly at week 24. No changes in immunosuppressant doses were needed. Conclusion: All-oral sofosbuvir plus daclatasvir combination shows high virological efficacy in liver transplant recipients and does not interact with immunosuppressants. All adverse events were unrelated to study drugs. These data strongly suggest that this combination must be initiated before decompensation.
AB - Background: We evaluated efficacy and safety of sofosbuvir and daclatasvir. ±. ribavirin in liver transplant recipients with severe recurrent hepatitis C. Methods: Patients included in an international compassionate use programme for treatment with sofosbuvir and daclatasvir. ±. ribavirin for 24 weeks were prospectively studied. Serum hepatitis C virus RNA was measured at treatment weeks 4, 12, and 24 and during follow-up at weeks 4, 8, and 12. Results: Twelve patients (3 with fibrosing cholestatic hepatitis and 9 with cirrhosis; median model for end-stage liver disease score 20) received sofosbuvir 400. mg/day. +. daclatasvir 60. mg/day, and 6 patients (50%) also received ribavirin 200-800. mg/day. Nine patients completed 24 weeks of treatment (75%), and all had undetectable hepatitis C virus RNA at week 24; 3 patients died (25%, liver failure, gastrointestinal bleeding and sepsis); 4 patients experienced severe liver disease-related adverse events. Post-treatment hepatitis C virus RNA was available for 5 patients (week 8, n=. 2; week 4, n=. 3) and was undetectable in all cases. Mean Child-Pugh score and albumin level improved significantly at week 24. No changes in immunosuppressant doses were needed. Conclusion: All-oral sofosbuvir plus daclatasvir combination shows high virological efficacy in liver transplant recipients and does not interact with immunosuppressants. All adverse events were unrelated to study drugs. These data strongly suggest that this combination must be initiated before decompensation.
KW - Cholestatic hepatitis
KW - Cirrhosis
KW - Daclatasvir
KW - Direct antiviral agents
KW - Disease recurrence
KW - HCV
KW - MELD
KW - Sofosbuvir
UR - http://www.scopus.com/inward/record.url?scp=84920941109&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84920941109&partnerID=8YFLogxK
U2 - 10.1016/j.dld.2014.06.004
DO - 10.1016/j.dld.2014.06.004
M3 - Article
C2 - 24997638
AN - SCOPUS:84920941109
SN - 1590-8658
VL - 46
SP - 923
EP - 927
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
IS - 10
ER -