Prevention of hepatitis C recurrence by bridging sofosbuvir/ribavirin from pre- to post-liver transplant: a real-life strategy.

Abstract

BACKGROUND & AIMS:

Hepatitis C virus (HCV) re-infection following liver transplant (LT) is associated with reduced graft and patient survival. Before transplant, Sofosbuvir/Ribavirin (SOF/R) treatment prevents recurrent HCV in 96% of those patients achieving viral suppression for at least 4 weeks before transplant. We evaluated whether a bridging SOF-regimen from pre- to post-transplant is safe and effective to prevent HCV recurrence in those patients with less than 4 weeks of HCV-RNA undetectability at the time of transplant.

METHODS:

From July 2014 SOF/R was given in 233 waitlisted HCV cirrhotics with/without hepatocellular carcinoma (HCC) within an Italian Compassionate Program. One hundred patients were transplanted and 31 patients (31%) treated with SOF/R bridging therapy were studied.

RESULTS:

Liver transplant indication in bridge subgroup was HCC in 22 and decompensated cirrhosis in 9. HCV-genotype was 1/4 in 18 patients. SOF 400 mg/day and R (median dosage 800 mg/day) were given for a median of 35 days before LT. At transplant time, 19 patients were still HCV-RNA positive (median HCV-RNA 58 IU/mL). One recipient had a virological breakthrough at week 4 post-transplant; one died, on treatment, 1-month post-transplant for sepsis and 29/31 achieved a 12-week sustained virological response (94%). Acute cellular rejection occurred in three recipients. On September 2016, 30 recipients (97%) were alive with a median follow-up of 18 months (range 13-25).

CONCLUSIONS:

In patients with suboptimal virological response at LT, a bridging SOF/R regimen helps avoiding post-transplant graft reinfection.

• Authors: Maria Francesca Donato, Cristina Morelli, Renato Romagnoli, Federica Invernizzi, Chiara Mazzarelli, Rosa Maria Iemmolo, Marzia Montalbano, Ilaria Lenci, Sherrie Bhoori, Giulia Pieri, Sonia Berardi, Paolo Caraceni, Silvia Martini, ITACOPS-SOF Bridging Study Group
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 37 Issue 5 Pg. 678-683 (05 2017) ISSN: 1478-3231 [Electronic] United States
• PMID: 27865034 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Antiviral Agents
• Ribavirin
• Sofosbuvir

Topics

• Adult
• Aged
• Antiviral Agents (adverse effects, therapeutic use)
• Carcinoma, Hepatocellular (therapy)
• Drug Therapy, Combination
• Female
• Hepacivirus (genetics)
• Hepatitis C (drug therapy, prevention & control)
• Humans
• Italy
• Liver Cirrhosis (therapy)
• Liver Neoplasms (therapy)
• Liver Transplantation
• Male
• Middle Aged
• Postoperative Period
• Preoperative Period
• Recurrence
• Retrospective Studies
• Ribavirin (adverse effects, therapeutic use)
• Sofosbuvir (adverse effects, therapeutic use)
• Sustained Virologic Response