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Sofosbuvir/Ledipasvir without Ribavirin Achieved High Sustained Virologic Response for Hepatitis C Recurrence after Liver Transplantation: Two-Center Experience.

Sofosbuvir/Ledipasvir without Ribavirin Achieved High Sustained Virologic Response for Hepatitis C Recurrence after Liver Transplantation: Two-Center Experience.
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Elfeki M, Abou Mrad R, Modaresi Esfeh J, Zein N, Eghtesad B, Zervos X, Hanouneh I, O'Shea R, Carey W, Alkhouri N,


Elfeki M, Abou Mrad R, Modaresi Esfeh J, Zein N, Eghtesad B, Zervos X, Hanouneh I, O'Shea R, Carey W, Alkhouri N, (click to view)

Elfeki M, Abou Mrad R, Modaresi Esfeh J, Zein N, Eghtesad B, Zervos X, Hanouneh I, O'Shea R, Carey W, Alkhouri N,

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Transplantation 2016 9 14()

Abstract
BACKGROUND AND AIM
Current recommended regimens to treat patients with HCV infection after liver transplantation include the use of ribavirin (RBV). Limited data are available on the efficacy of RBV-free regimens post-transplant, particularly the use of Sofosbuvir/Ledipasvir without RBV in this patient population. We aimed to assess the efficacy and safety of Sofosbuvir/Ledipasvir fixed-dose combination without RBV in patients with HCV recurrence post-transplant.

METHODS
This is a retrospective study of 46 patients with HCV recurrence post-transplant. Sofosbuvir/Ledipasvir without ribavirin was used for 12 weeks in patients with early stage fibrosis (F0-F2) or for 24 weeks in those with advanced fibrosis (F3-F4) and/or cholestatic hepatitis. The primary end point was sustained virologic response at 12 weeks after the end of treatment. Secondary outcomes included relapse after treatment and adverse events.

RESULTS
Forty-six patients, with a mean age of 62 ± 8 years, a median duration since time of transplant of 904 days (range 78-3525 days), an HCV genotype 1, and a mean baseline viral load of 7.79 million IU/ml, were treated. Of these, 32 patients were treated for 12 weeks and 14 patients were treated for 24 weeks. Twenty-five patients (54%) were treatment experienced (21 with Interferon and 4 with Sofosbuvir). All 46 patients(100%) achieved SVR 12. Neither virologic relapses nor serious adverse events were noted.

CONCLUSION
The combination of Sofosbuvir/Ledipasvir without RBV for 12 or 24 weeks produced 100% SVR 12 in patients with HCV recurrence after liver transplantation. The use of RBV may not be necessary to achieve SVR in this patient population.

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