Persistence of virologic response after liver transplant in hepatitis c patients treated with ledipasvir/sofosbuvir plus ribavirin pretransplant

Eric M. Yoshida, Paul Kwo, Kosh Agarwal, Christophe Duvoux, François Durand, Markus Peck-Radosavljevic, Leslie Lilly, Bernard Willems, Hugo E Vargas, Princy Kumar, Robert S. Brown, Yves Horsmans, Shampa De-Oertel, Sarah Arterburn, Hadas Dvory-Sobol, Diana M. Brainard, John G. McHutchison, Norah Terrault, Mario Rizzetto, Beat Müllhaupt

Research output: Contribution to journalArticle

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Abstract

Introduction. Recurrence of HCV infection in patients with chronic hepatitis C virus (HCV) at the time of liver transplantation is nearly universal and reduces the likelihood of graft and patient survival. Materials and methods. We evaluated outcomes of 17 patients (16 with HCV genotype 1 and 1 with genotype 4) who received up to 12 or 24 weeks of ledipasvir/sofosbuvir plus ribavirin prior to or up to the time of liver transplant in the SOLAR-1 and SOLAR-2 trials. In all patients, HCV RNA was < 15 IU/mL prior to transplant. At screening, 6 patients were Child-Pugh-Turcotte (CPT) class B and 11 were CPT class C. Seven patients underwent transplant prior to completing assigned treatment, with 4 treated for < 12 weeks. The primary endpoint was posttransplant virologic response 12 weeks after transplant (pTVR12) in patients with HCV RNA < 15 IU/mL at their last measurement prior to transplant. Results. Overall, 94% (16/17) achieved pTVR12. All who achieved pTVR12 received at least 11 weeks of treatment. The single patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. The patient had HCV RNA < 15 IU/mL at post-transplant week 2 but died 15 days post-transplant because of multi-organ failure and septic shock. Conclusion. Among a small population of HCV patients with decompensated cirrhosis, virologic response to ledipasvir/sofosbuvir plus ribavirin prior to liver transplantation was maintained after transplantation, even if treatment was stopped early. Administration of ledipasvir/sofosbuvir plus ribavirin before liver transplant can prevent post-transplant HCV recurrence.

Original languageEnglish (US)
Pages (from-to)375-381
Number of pages7
JournalAnnals of Hepatology
Volume16
Issue number3
DOIs
StatePublished - 2017

Fingerprint

Ribavirin
Hepatitis
Hepacivirus
Transplants
Liver
RNA
Liver Transplantation
Genotype
sofosbuvir drug combination ledipasvir
Recurrence
Graft Survival
Chronic Hepatitis C
Virus Diseases
Septic Shock
Fibrosis
Therapeutics
Transplantation

Keywords

  • Decompensated cirrhosis
  • Direct-acting antivirals
  • Liver transplant
  • NS5A inhibitor
  • NS5B inhibitor

ASJC Scopus subject areas

  • Hepatology

Cite this

Persistence of virologic response after liver transplant in hepatitis c patients treated with ledipasvir/sofosbuvir plus ribavirin pretransplant. / Yoshida, Eric M.; Kwo, Paul; Agarwal, Kosh; Duvoux, Christophe; Durand, François; Peck-Radosavljevic, Markus; Lilly, Leslie; Willems, Bernard; Vargas, Hugo E; Kumar, Princy; Brown, Robert S.; Horsmans, Yves; De-Oertel, Shampa; Arterburn, Sarah; Dvory-Sobol, Hadas; Brainard, Diana M.; McHutchison, John G.; Terrault, Norah; Rizzetto, Mario; Müllhaupt, Beat.

In: Annals of Hepatology, Vol. 16, No. 3, 2017, p. 375-381.

Research output: Contribution to journalArticle

Yoshida, EM, Kwo, P, Agarwal, K, Duvoux, C, Durand, F, Peck-Radosavljevic, M, Lilly, L, Willems, B, Vargas, HE, Kumar, P, Brown, RS, Horsmans, Y, De-Oertel, S, Arterburn, S, Dvory-Sobol, H, Brainard, DM, McHutchison, JG, Terrault, N, Rizzetto, M & Müllhaupt, B 2017, 'Persistence of virologic response after liver transplant in hepatitis c patients treated with ledipasvir/sofosbuvir plus ribavirin pretransplant', Annals of Hepatology, vol. 16, no. 3, pp. 375-381. https://doi.org/10.5604/16652681.1235480
Yoshida, Eric M. ; Kwo, Paul ; Agarwal, Kosh ; Duvoux, Christophe ; Durand, François ; Peck-Radosavljevic, Markus ; Lilly, Leslie ; Willems, Bernard ; Vargas, Hugo E ; Kumar, Princy ; Brown, Robert S. ; Horsmans, Yves ; De-Oertel, Shampa ; Arterburn, Sarah ; Dvory-Sobol, Hadas ; Brainard, Diana M. ; McHutchison, John G. ; Terrault, Norah ; Rizzetto, Mario ; Müllhaupt, Beat. / Persistence of virologic response after liver transplant in hepatitis c patients treated with ledipasvir/sofosbuvir plus ribavirin pretransplant. In: Annals of Hepatology. 2017 ; Vol. 16, No. 3. pp. 375-381.
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abstract = "Introduction. Recurrence of HCV infection in patients with chronic hepatitis C virus (HCV) at the time of liver transplantation is nearly universal and reduces the likelihood of graft and patient survival. Materials and methods. We evaluated outcomes of 17 patients (16 with HCV genotype 1 and 1 with genotype 4) who received up to 12 or 24 weeks of ledipasvir/sofosbuvir plus ribavirin prior to or up to the time of liver transplant in the SOLAR-1 and SOLAR-2 trials. In all patients, HCV RNA was < 15 IU/mL prior to transplant. At screening, 6 patients were Child-Pugh-Turcotte (CPT) class B and 11 were CPT class C. Seven patients underwent transplant prior to completing assigned treatment, with 4 treated for < 12 weeks. The primary endpoint was posttransplant virologic response 12 weeks after transplant (pTVR12) in patients with HCV RNA < 15 IU/mL at their last measurement prior to transplant. Results. Overall, 94{\%} (16/17) achieved pTVR12. All who achieved pTVR12 received at least 11 weeks of treatment. The single patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. The patient had HCV RNA < 15 IU/mL at post-transplant week 2 but died 15 days post-transplant because of multi-organ failure and septic shock. Conclusion. Among a small population of HCV patients with decompensated cirrhosis, virologic response to ledipasvir/sofosbuvir plus ribavirin prior to liver transplantation was maintained after transplantation, even if treatment was stopped early. Administration of ledipasvir/sofosbuvir plus ribavirin before liver transplant can prevent post-transplant HCV recurrence.",
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AU - Yoshida, Eric M.

AU - Kwo, Paul

AU - Agarwal, Kosh

AU - Duvoux, Christophe

AU - Durand, François

AU - Peck-Radosavljevic, Markus

AU - Lilly, Leslie

AU - Willems, Bernard

AU - Vargas, Hugo E

AU - Kumar, Princy

AU - Brown, Robert S.

AU - Horsmans, Yves

AU - De-Oertel, Shampa

AU - Arterburn, Sarah

AU - Dvory-Sobol, Hadas

AU - Brainard, Diana M.

AU - McHutchison, John G.

AU - Terrault, Norah

AU - Rizzetto, Mario

AU - Müllhaupt, Beat

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N2 - Introduction. Recurrence of HCV infection in patients with chronic hepatitis C virus (HCV) at the time of liver transplantation is nearly universal and reduces the likelihood of graft and patient survival. Materials and methods. We evaluated outcomes of 17 patients (16 with HCV genotype 1 and 1 with genotype 4) who received up to 12 or 24 weeks of ledipasvir/sofosbuvir plus ribavirin prior to or up to the time of liver transplant in the SOLAR-1 and SOLAR-2 trials. In all patients, HCV RNA was < 15 IU/mL prior to transplant. At screening, 6 patients were Child-Pugh-Turcotte (CPT) class B and 11 were CPT class C. Seven patients underwent transplant prior to completing assigned treatment, with 4 treated for < 12 weeks. The primary endpoint was posttransplant virologic response 12 weeks after transplant (pTVR12) in patients with HCV RNA < 15 IU/mL at their last measurement prior to transplant. Results. Overall, 94% (16/17) achieved pTVR12. All who achieved pTVR12 received at least 11 weeks of treatment. The single patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. The patient had HCV RNA < 15 IU/mL at post-transplant week 2 but died 15 days post-transplant because of multi-organ failure and septic shock. Conclusion. Among a small population of HCV patients with decompensated cirrhosis, virologic response to ledipasvir/sofosbuvir plus ribavirin prior to liver transplantation was maintained after transplantation, even if treatment was stopped early. Administration of ledipasvir/sofosbuvir plus ribavirin before liver transplant can prevent post-transplant HCV recurrence.

AB - Introduction. Recurrence of HCV infection in patients with chronic hepatitis C virus (HCV) at the time of liver transplantation is nearly universal and reduces the likelihood of graft and patient survival. Materials and methods. We evaluated outcomes of 17 patients (16 with HCV genotype 1 and 1 with genotype 4) who received up to 12 or 24 weeks of ledipasvir/sofosbuvir plus ribavirin prior to or up to the time of liver transplant in the SOLAR-1 and SOLAR-2 trials. In all patients, HCV RNA was < 15 IU/mL prior to transplant. At screening, 6 patients were Child-Pugh-Turcotte (CPT) class B and 11 were CPT class C. Seven patients underwent transplant prior to completing assigned treatment, with 4 treated for < 12 weeks. The primary endpoint was posttransplant virologic response 12 weeks after transplant (pTVR12) in patients with HCV RNA < 15 IU/mL at their last measurement prior to transplant. Results. Overall, 94% (16/17) achieved pTVR12. All who achieved pTVR12 received at least 11 weeks of treatment. The single patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. The patient had HCV RNA < 15 IU/mL at post-transplant week 2 but died 15 days post-transplant because of multi-organ failure and septic shock. Conclusion. Among a small population of HCV patients with decompensated cirrhosis, virologic response to ledipasvir/sofosbuvir plus ribavirin prior to liver transplantation was maintained after transplantation, even if treatment was stopped early. Administration of ledipasvir/sofosbuvir plus ribavirin before liver transplant can prevent post-transplant HCV recurrence.

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KW - NS5A inhibitor

KW - NS5B inhibitor

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