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

Liver International Sep 21, 2017

Martini S, et al. - In this work, researchers reported 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. Findings suggested that in these patients: 1. bridging antiviral therapy could be an option for patients still viremic or negative <4 weeks at LT; and 2. clinical improvement to a condition suitable for delisting could occur even in patients with advanced decompensated cirrhosis.

Methods

  • Researchers obtained clinical and virological data of 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 viremic at transplant: 34 patients continued treatment after LT (bridging therapy) (SVR12: 88%), while 15 stopped treatment (SVR12: 53%).
  • Without LT, 98 patients completed SOF/R (SVR12: 73%).
  • In patients with advanced decompensated cirrhosis (basal MELD ≥15 and/or C-P ≥B8), there appeared a marked improvement of the scores in about 50% of cases and almost 20% of decompensated patients without HCC achieved a condition suitable for inactivation and delisting.

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