WEUSKOP7136: A global, prospective cohort study to evaluate the real-world use of eltrombopag in adult patients with chronic Hepatitis C Virus infection who are unable to initiate or maintain optimal interferonbased 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 ofbleeding 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 andother 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 assess the safety and effectiveness of eltrombopag in routine clinical practice in patients with HCV who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia.The specific objectives of the study are to:-Assess and compare the incidence of hepatic decompensation and mortality at 3 years among eltrombopag patients who achieve SVR compared to users who do not achieve SVR-Assess the incidence of thromboembolic events among new users of eltrombopag-Assess treatment effectiveness among eltrombopag users with respect to initiating, maintaining and completing antiviral therapy and achievingsustained viral response (SVR)-Evaluate all-cause and cause-specific mortality risk and survival rates among eltrombopag users at 6 months, 12 months, 18 months, 24 months and 36 months after starting eltrombopag-Explore the factors independently related to the risk of hepatic decompensation and the risk of thromboembolic eventsThis study is a global, multi-center, prospective, observational studyconducted to evaluate clinical outcomes and treatment patterns in HCV patients treated with eltrombopag. Country selection will depend on the regulatory approval and reimbursement status of eltrombopag for the HCV associated thrombocytopenia indication, but is expected to include several countries in the US and around the world. The study is designed to enroll approximately 200 patients, with a minimum of 100 patients who are treated with boceprevir, telaprevir or newer direct acting agents (DAAs) that consist of a backbone of interferon-based therapy in at least 40 sites over the course of an enrolment period of at least18 months.Patients will be followed for a period of 3 years after initiating eltrombopag; based on physician visits received in normal routine care, patients will be assessed according to their routine clinical visits during interferon-based therapy and then approximately every 6 months thereafter according to local standard practice. Patients who permanently discontinue eltrombopag will be followed for clinical outcomes and survival, for up to 36 months post-enrollment.The targeted sample size for this study is 200 patients to account for potential variance in the percentage of patients achieving SVR or experiencing hepatic decompensation and the potential for patients lost to follow-up.