A single-center pilot study of the use of hepatitis C positive donors for hepatitis C negative lung transplant recipients with post-transplant treatment with Mavyret

Brief description of study

This study is looking to enroll patients who are on a waiting list for lung transpalnt at NYU Langone Health and have agreed to accept a lung from an HCV positive donor. The purpose of this research study is to test the safety and effectiveness of lung transplantation from donors who test positive for a virus called HCV (Hepatitis C), into transplant recipients who are negative for HCV. All study subjects will be treated with MAVYRET, a medicine used to treat Hepatitis C. The study will test whether MAVYRET can be used to treat the virus in subjects who have received a lungtransplant. MAVYRET is a combination pill with two medicines (glecaprevir/pibrentasvir) to treat HCV infection. MAVYRET has been shown to effectively treat HCV infection in non-transplantation HCV patients with success rates of >98% (more than 98 out of 100 times). This study will determine whether eight weeks of treatment with MAVYRET can effectively treat HCV in transplant patients who receive a lung from a donor with HCV infection. Although MAVYRET is approved by the Food and Drug Administration (FDA) for treatment of HCV infection, its use in transplant patients is not approved, and therefore considered investigational.


Clinical Study Identifier: s18-00091
ClinicalTrials.gov Identifier: NCTs18-00091


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