The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience

Liver Int. 2018 Apr;38(4):733-741. doi: 10.1111/liv.13588. Epub 2017 Oct 6.

Abstract

Background & aims: This study aimed to assess the real-life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within the Italian compassionate use program.

Methods: Clinical and virological data were collected in 224 patients with decompensated cirrhosis and/or hepatocellular carcinoma (HCC) receiving daily SOF/R until LT or up a maximum of 48 weeks.

Results: Of 100 transplanted patients, 51 were HCV-RNA negative for >4 weeks before LT (SVR12: 88%) and 49 negative for <4 weeks or still viraemic at transplant: 34 patients continued treatment after LT (bridging therapy) (SVR12: 88%), while 15 stopped treatment (SVR12: 53%). 98 patients completed SOF/R without LT (SVR12: 73%). In patients with advanced decompensated cirrhosis (basal MELD ≥15 and/or C-P ≥B8), a marked improvement of the scores occurred in about 50% of cases and almost 20% of decompensated patients without HCC reached a condition suitable for inactivation and delisting.

Conclusions: These real-life data indicate that in waitlisted patients: (i) bridging antiviral therapy can be an option for patients still viraemic or negative <4 weeks at LT; and (ii) clinical improvement to a condition suitable for delisting can occur even in patients with advanced decompensated cirrhosis.

Keywords: bridging therapy; decompensated cirrhosis; delisting; direct-acting antivirals; hepatitis C; liver transplantation.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Aged
  • Antiviral Agents / therapeutic use*
  • Carcinoma, Hepatocellular / drug therapy
  • Compassionate Use Trials
  • Drug Therapy, Combination
  • Female
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Italy
  • Kaplan-Meier Estimate
  • Liver Cirrhosis / surgery
  • Liver Cirrhosis / virology
  • Liver Neoplasms / surgery
  • Liver Neoplasms / virology
  • Liver Transplantation*
  • Male
  • Middle Aged
  • Prospective Studies
  • Ribavirin / therapeutic use
  • Sofosbuvir / therapeutic use*
  • Waiting Lists*

Substances

  • Antiviral Agents
  • Ribavirin
  • Sofosbuvir