SVR SOF Cirrhosis Registry Study

• Research type

  Research Study

• Full title

  GS-US-337-1431: A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection in Gilead-Sponsored Trials

• IRAS ID

  180581

• Contact name

  Graham Foster

• Contact email

  g.r.foster@qmul.ac.uk

• Sponsor organisation

  Gilead Sciences, Inc

• Eudract number

  2014-001249-26

• Duration of Study in the UK

  7 years, 0 months, 0 days

• Research summary

  Research Summary

  Hepatitis C Virus (HCV) infection is a global health challenge with an estimated 180 million individuals infected worldwide. Up to 85 percent of individuals who are infected with HCV fail to fight off the virus and progress to chronic HCV infection. The long-term consequences of HCV infection include liver damage (fibrosis and cirrhosis), liver cancer (hepatocellular carcinoma, HCC) and liver failure that may require transplant or result in death. The progression of hepatitis C liver disease is often clinically silent; in fact, a proportion of patients are not known to have hepatitis C until they present with complications of end-stage liver disease, such as ascites, gastrointestinal bleeding, hepatorenal syndrome (secondary renal failure) and hepatic encephalopathy (secondary neuropsychological changes) .
  Chronic HCV infection with liver cirrhosis can have many complications, is associated with poor clinical outcomes and an increased risk of death. Recent studies have shown a link between attaining a sustained virologic response (SVR) after HCV treatment and a reduction in the all-cause mortality risk. However, these data are limited to interferon (IFN) based treatment regimens. Data for other, non-IFN treatment regimens are currently lacking. Therefore, the goal of this study is to follow patients with liver cirrhosis, who have attained a sustained virologic response (SVR) after receiving Sofosbuvir (SOF) based treatment without IFN as part of a Gilead-sponsored HCV-study.
  Participants will be followed for up to 5 years to assess the durability of their SVR, the clinical progression or regression of their liver disease and the incidence rates of HCC.
  For patients who relapse, it will be determined by laboratory testing whether this is due to a re-emergence of the initial HCV infection, a virus mutation or a re-infection.
  This research also seeks to assess how liver cirrhosis and its clinical manifestations, affect quality of life.
  Lastly, the optional collection of blood and/or liver tissue samples will provide a resource for future research into the disease biology and the association between certain biomarkers and disease progression and/or treatment responses. This, in turn, may yield valuable information to make improvements in diagnostic methods and treatments for HCV infection in future.

  Summary of Results

  The plain language summary (PLS) of this study is available here:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRF6vhqPih045oeN16jakid2-2BSCA8rc2MkAxTRV28wiMfu5ct-2FapXTQtgSnAsUOY0GKcy7oPRY7kViheDHbAe1mHepUtCv-2Fxma4dk-2BX6lMLcXil3Ls-2B8FczrFFqBjAdpBQ-3D-3DuJqT_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJClqyyEILqUKVjB2na9e4jrS4I-2BYi0HvGWTt50RofFE4QTjqt4jhG-2FZuVj16sQwQb5cWOu6KC1c86-2FJd6o8bQkLJZTSl2jViKByeqJ6cuzg87uC3nM3v4f47RFJdUzA1EH0CkDirGEIyYvLd1Mxi6cWZUqWC6nXTFriprBhalxOw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C83380a7a41df439e7a4108dacc82855f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638047158220540457%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1nAEhjNuI3Kr977jP7RKxqCcUOmcrvzhJeiOj8gmeGE%3D&reserved=0

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  15/LO/1138

• Date of REC Opinion

  6 Aug 2015

• REC opinion

  Further Information Favourable Opinion