Use of Ledipasvir/Sofosbuvir with or without Ribavirin in Patients Post-Liver Transplant: Evaluation of Real-World Datasets.

S. Flamm,¹ M. Charlton,² M. Manns,³ M. Prieto,⁴ I. Fernandez,⁵ M. Londono,⁶ R. Kwok,⁷ C. Smith,⁸ S. Lee,⁹ H. Ngo,⁹ A. Osinusi,⁹ A. Copans,⁹ L. Rossaro,⁹ M. Shoreibah,¹⁰ O. Massoud,¹⁰ M. Curry,¹¹ M. Bourliere.¹²

¹Northwestern University, Chicago
²Intermountain Medical Center, Murray
³Hannover Medical School, Hannover, Germany
⁴Hospital Universitari I Politecnic La Fe, Valencia, Spain
⁵Hospital Universitario 12 de Octubre, Madrid, Spain
⁶Servicio de Hepatología. Hospital Clinic, Barcelona, Spain
⁷Walter Reed National Military Medical Center, DC
⁸Medstar Georgetown University Hospital, Georgetown
⁹Gilead Sciences, Inc., Foster City
¹⁰University of Alabama Birmingham, Birmingham
¹¹Beth Israel Deaconess Medical Center, Boston
¹²Hospital Saint Joseph, Marsielle, France

Meeting: 2017 American Transplant Congress

Abstract number: 145

Keywords: Hepatitis C, Liver, Liver transplantation

Session Information

Session Name: Concurrent Session: Liver: Viral Hepatitis

Session Type: Concurrent Session

Date: Sunday, April 30, 2017

Session Time: 4:30pm-6:00pm

Presentation Time: 4:30pm-4:42pm

Location: E271a

PURPOSE: Post-liver transplant(LT) patients with HCV are considered a difficult-to-treat population. Ledipasvir/sofosbuvir(LDV/SOF) +ribavirin(RBV) for 12 weeks is approved in GT1 LT recipients based on the SOLAR-1 & -2 data. However, patients are often treated with 8, 12 or 24 week regimens ± ribavirin. Recent reports have shown SVR rates achieved in clinical trials are similar to that observed in real-world datasets(RWD). The goal of this analysis is to compare efficacy rates in RWD to clinical trial data in this population.

METHODS: Integrated data on patients without cirrhosis or compensated cirrhosis post LT from 2 open-label phase-2 trials (SOLAR-1 and -2) were compared to 5 RWD. RWD were from academic institutions, community medical centers and specialty pharmacies. Cohorts with less than 50 patients treated with LDV/SOF+RBV were excluded. Demographics, safety data and SVR rates will be presented across cohorts.

RESULTS: In SOLAR-1 & -2, patients were assigned to receive LDV/SOF+RBV for 12 or 24 weeks, with SVR 12 rates 96%-98%. Patients from 5 RWD received LDV/SOF+RBV for 8, 12 or 24 weeks. SVR 12 in the 5 RWD ranged from 94-100%. RWD showed patients who received LDV/SOF without RBV had SVR rates of 94%-100% and those who received LDV/SOF with RBV had SVR12 rates of 96%-100%. Viral relapse rates were low, ranging from 1-2% across all RWD.

CONCLUSIONS: Evaluation of several RWD shows comparable SVR12 rates to clinical trials. Patients post-LT experience high cure rates of HCV with LDV/SOF+RBV. In addition, RWD showed RBV may not be needed in this population.

CITATION INFORMATION: Flamm S, Charlton M, Manns M, Prieto M, Fernandez I, Londono M, Kwok R, Smith C, Lee S, Ngo H, Osinusi A, Copans A, Rossaro L, Shoreibah M, Massoud O, Curry M, Bourliere M. Use of Ledipasvir/Sofosbuvir with or without Ribavirin in Patients Post-Liver Transplant: Evaluation of Real-World Datasets. Am J Transplant. 2017;17 (suppl 3).

To cite this abstract in AMA style:

Flamm S, Charlton M, Manns M, Prieto M, Fernandez I, Londono M, Kwok R, Smith C, Lee S, Ngo H, Osinusi A, Copans A, Rossaro L, Shoreibah M, Massoud O, Curry M, Bourliere M. Use of Ledipasvir/Sofosbuvir with or without Ribavirin in Patients Post-Liver Transplant: Evaluation of Real-World Datasets. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/use-of-ledipasvirsofosbuvir-with-or-without-ribavirin-in-patients-post-liver-transplant-evaluation-of-real-world-datasets/. Accessed May 16, 2025.

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