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Short Duration Perioperative Administration of Ledipasvir/Sofosbuvir Is Safe and Effective in Preventing HCV Recurrence After Liver Transplant.

E. Verna,1 J. Levitsky,2 J. O'Leary,3 N. Bzowej,4 D. Moonka,5 R. Hyland,6 D. Brainard,6 J. McHutchison,6 N. Terrault.7

1Columbia Univ., NY
2Northwestern Univ., Chicago
3Baylor Univ., Dallas
4Ochsner Clinical Foundation, New Orleans
5Henry Ford Hospital, Detroit
6Gilead Sciences, Foster City
7UCSF, San Francisco.

Meeting: 2016 American Transplant Congress

Abstract number: 369

Keywords: Hepatitis C

Session Information

Date: Tuesday, June 14, 2016

Session Name: Joint Plenary Session III

Session Time: 8:30am-9:15am

 Presentation Time: 9:00am-9:15am

Location: Veterans Auditorium

Related Abstracts
  • Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients with Chronic Genotype 1 or 4 HCV Infection.
  • Safety and Efficacy of Ledipasvir/Sofosbuvir (LS) with or without Ribavirin (RBV) for Treatment of Recurrent Hepatitis C Infection Post-Liver Transplant.

Background:The optimal timing and duration of DAA therapy in HCV patients undergoing liver transplant(LT) is unknown. CRUSH-C is an open-label, Phase 2 study evaluating the safety and efficacy of short, perioperative ledipasvir(LDV)/sofosbuvir(SOF) for 4 weeks in HCV genotype(GT) 1 or 4 patients to prevent HCV recurrence post-LT.

Methods:25 patients, with chronic HCV GT 1 or 4, listed for LT, not receiving antiviral therapy, were enrolled to receive a single dose of LDV/SOF the day before LT followed by LDV/SOF for an additional 28 days post-LT. Patients were required to have a baseline eGFR ≥40 mL/min at screening and day of LT. Receipt of a liver from an anti-HCV positive donor was an exclusion criterion. Immunosuppression management was at investigator discretion.

Results:Interim data on the first 11 transplanted patients are available. Most patients were female(55%), Caucasian(82%), IL28B non-CC(64%). Four (36%) were treatment-experienced, all were GT 1. Baseline CTP class: A(27%), B(36%), and C(36%). The median MELD score was 13(range 7-16). 4/11 patients received a liver from a living donor. One patient met CrCl stopping rules (eGFR <30 mL/min) at Day 7, and discontinued. All other patients completed the planned therapy, 9/10(90%) have achieved SVR4; the patient with relapse has initiated protocol-defined retreatment with LDV/SOF for 12 weeks.

Treatment was safe and well tolerated. 9/11(82%) patients had an AE, the majority being mild or moderate. One grade 2 AE (dry eyes) was considered related to study drug. Three patients had SAEs: bile duct stenosis; acute kidney injury, elevated creatinine, and post-operative peri-incisional wound cellulitis; and decreased hepatic artery flow. All were assessed by the investigator as unrelated to study medication. No subjects have died or experienced graft loss. Updated results will be presented.

Conclusions:These preliminary data support the safe use of LDV/SOF in the immediate pre- and perioperative transplant period. Preemptive use of LDV/SOF administered as a single dose pre-LT and for 4 weeks following transplant may represent an effective strategy to prevent HCV recurrence.

CITATION INFORMATION: Verna E, Levitsky J, O'Leary J, Bzowej N, Moonka D, Hyland R, Brainard D, McHutchison J, Terrault N. Short Duration Perioperative Administration of Ledipasvir/Sofosbuvir Is Safe and Effective in Preventing HCV Recurrence After Liver Transplant. Am J Transplant. 2016;16 (suppl 3).

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To cite this abstract in AMA style:

Verna E, Levitsky J, O'Leary J, Bzowej N, Moonka D, Hyland R, Brainard D, McHutchison J, Terrault N. Short Duration Perioperative Administration of Ledipasvir/Sofosbuvir Is Safe and Effective in Preventing HCV Recurrence After Liver Transplant. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/short-duration-perioperative-administration-of-ledipasvirsofosbuvir-is-safe-and-effective-in-preventing-hcv-recurrence-after-liver-transplant/. Accessed March 3, 2021.

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