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Proposal 1134

Title of the Proposed Research

Incidence rate and risk factors associated with Hepatocellular carcinoma development in patients with Chronic Hepatitis C and severe thrombocytopenia: the lesson from Enable studies

Lead Researcher

Prof. Savino Bruno, MD

Affiliation

A.O. Fatebenefratelli e Oftalmico
Milan, Italy

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

20 Feb 2015

Lay Summary

Cirrhotic patients chronically infected with hepatitis C virus (HCV) still represent the leading indication for liver transplant, despite successful antiviral therapy and achievement of sustained virological response (SVR) being associated with a reduction of liver-related events and hepatocellular carcinoma (HCC). However, very few data are available on the incidence and risk factors associated with higher risk of HCC development in patients with chronic hepatitis C and thrombocytopenia which represents a surrogate marker of portal hypertension severity.

ENABLE 1 and 2 are the largest (to date) global phase 3 randomised placebo controlled multicentre studies of chronic Hepatitis C patients with compensated cirrhosis, thrombocytopenia (platelet count <75x109/L) and presumed portal hypertension. Both studies evaluated the ability of eltrombopag, as a supportive treatment, to increase platelets to a level sufficient to initiate and maintain PEG/ribavirin anti-viral therapy. Therefore, data from these studies would permit to achieve a comprehensive and reliable assessment concerning the incidence of HCC during the treatment period in this subset of patients. The availability of this result will permit enhancing the quality of management of patients with such characteristics in daily practice. In detail they will enable to establish a more careful surveillance strategy and to allocate for treatment with potent and efficacious all-oral direct antiviral agents the subset of patients at more urgent risk of poor outcome.

Study Data Provided

Study TPL103922: Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a plus ribavirin)
Study TPL108390: Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2b plus ribavirin)

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation