WEUSKOP7135: A prospective observational cohort study nested within the Hepatitis C Therapeutic Registry and Research Network (HCVTARGET) to evaluate real world use of eltrombopag in adult patients with chronic hepatitis C virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia

Trial description: Thrombocytopenia (TCP) is a common complication of chronic hepatitis C virus (HCV) infection that can be caused by the disease itself and/or treatment. The presence of thrombocytopenia, and the consequent risk of bleeding complications, may render patients ineligible for interferon-based antiviral treatment. Patients who are treated with interferon may receive a reduced dose or need to discontinue treatment if their platelet count drops even further, which decreases their probability of successful HCV treatment. Discontinuation and nonadherence due to treatment-related adverse events associated with antiviral therapy are of concern as patients who discontinue therapy or have less-than-optimal treatment doses experience decreased sustained virologic response (SVR) rates.Eltrombopag is a second generation oral thrombopoeitin receptor agonist developed by GlaxoSmithKline (GSK) and approved for the treatment of chronic immune (idiopathic) thrombocytopenia (ITP) and hepatitis C associated thrombocytopenia. This study represents a proactive pharmacovigilance approach in generating real-world safety data, along with short and long-term effectiveness and other outcomes in the post-approval setting to better inform the use of eltrombopag in HCV patients who are unable to initiate or maintain optimal interferon-based therapy due to TCP.The aim of this study is to report the incidence of hepatic decompensation in a real-world setting among eltrombopag users with chronic hepatitis C virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia.Secondary objectives include reporting incidence of thromboembolic events and mortality and identifying risk factors for hepatic decompensation, thromboembolic events and mortality among eltrombopag users in a real-world setting. The study will also report the 3- year incidence of hepatic decompensation and mortality, comparing patients who achieve sustained virologic response to patients who do not achieve SVR among eltrombopag users, a subset of which will be on interferon-based therapy and direct acting agents. The study will also examine effectiveness of eltrombopag to initiate and maintain HCV therapy and achieve early virologic response (EVR) and SVR among eltrombopag users. This study is a multi-center, prospective, observational study nested within the HCV TARGET study, and conducted to evaluate patients treated with eltrombopag. Patients will be followed for a period of up to 3 years after initiating eltrombopag; based on routine care, patients will be assessed regularly during interferon-based therapy and thereafter according to local standard practice.