New data reveals positive outcomes for hepatitis C transplant patients

April 11, 2014

New research announced at the International Liver Congress 2014 today provides new hope for the notoriously difficult-to-treat population of liver transplant patients with recurring hepatitis C (HCV).

As part of a compassionate use program, 104 post- with recurring HCV who had exhausted all and had poor clinical prognoses, received sofosbuvir (SOF) and (RBV) with pegylated (PEG) included at the physicians' discretion for up to 48 weeks. Among patients whose have been reported, 62% achieved SVR12. Additionally, 62% of patients had improvements in clinical conditions associated with hepatic decompensation (e.g., ascites and encephalopathy) and/or improvement in liver function tests. SOF+RBV±PEG was well-tolerated and led to high rates of virologic suppression.

EASL's European Policy Councillor Professor Patrizia Burra of the Multivisceral Transplant Unit, Padova University Hospital, Padua, Italy said: "There are currently no effective treatment options for this patient group. However, this new trial involving the nucleotide polymerase inhibitor sofosbuvir (SOF) has demonstrated promising results, providing further evidence of its clinical potential."

"For patients with advanced hepatitis C liver disease, liver transplants offer a second chance," continued Professor Burra, "and for those who continue to suffer post-surgery, it's important for us to keep following up all avenues possible to improve their quality of life."

Other research revealed at the International Liver CongressTM 2014 showed that most patients with mild hepatitis C recurrence diagnosed one year after have excellent long-term outcomes.

In the second study, 172 patients who were diagnosed with mild hepatitis C recurrence one year after undergoing liver transplant surgery between 1999 and 2012 were followed for six and a half years with all relevant transplant-related, donor and recipient variables recorded. The cumulative probability of HCV-related graft loss five and 10 years after liver transplant were 3% and 10%, respectively.

However one third of these patients are still at risk of going on to develop cirrhosis, further demonstrating the need for antiviral therapy pre or post-transplant.

Hepatitis C infection is a common cause of liver transplantation, with virus-related diseases comprising 40% of primary indications for liver transplantation in Europe among patients with cirrhosis.

More than 5,500 liver transplantations are currently performed in Europe per year.3

Disclaimer: the data referenced in this release is based on the submitted abstract. More recent data may be presented at the International Liver Congress 2014.

More information: References

1. X.FORNS ET AL. SOFOSBUVIR COMPASSIONATE USE PROGRAM FOR PATIENTS WITH SEVERE RECURRENT HEPATITIS C INCLUDING FIBROSING CHOLESTATIC HEPATITIS FOLLOWING LIVER TRANSPLANTATION. ABSTRACT PRESENTED AT THE INTERNATIONAL LIVER CONGRESS 2014

2. M.GAMBATO ET AL. LONG TERM OUTCOME OF MILD HEPATITIS C RECURRENCE AFTER LIVER TRANSPLANTATION: A LARGE PROSPECTIVE STUDY. ABSTRACT PRESENTED AT THE INTERNATIONAL LIVER CONGRESS 2014

3. EU BURDEN OF LIVER DISEASE: A REVIEW OF AVAILABLE EPIDEMIOLOGICAL DATA. EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER. 2013. WWW.EASL.EU/ASSETS/APPLICATION/FILES/54AE845CAEC619F_FILE.PDF ACCESSED 16.02.14.

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