The Hepatitis C Transplant Collaborative

Hepatitis C Clinical Trial

Official title: Nationwide Hepatitis C NAT+ Cardiac Transplant Experience

Status Recruiting

Clinical Trial Summary

In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.

Clinical Trial Description

Organ offers from donors with prior or chronic hepatitis C virus (HCV) exposure have been historically underutilized for orthotopic heart transplantation because of the post-transplantation risks [1, 2]. The use of HCV antibody-positive (Ab+) donors was associated with attenuated survival benefit after heart transplant and increased coronary allograft vasculopathy in the era before new highly effective direct-acting antiviral agents (DAAs) were developed [3-5]. These DAAs target multiple steps in the HCV replication life cycle [6]. Newer, well-tolerated, oral direct-acting antivirals (DAAs) have recently been transforming thoracic transplant outcomes after donor-derived HCV transmission. Moreover, now that HCV nucleic-acid testing (NAT), a polymerase chain reaction (PCR)-based approach to detecting viral activity, is widely available and used on all US donor organs, transplant centers have more relevant information about the donor, allowing better risk assessments.

As a result, the utilization of HCV NAT+ donor hearts for transplantation is rapidly gaining momentum, with the obvious benefits of an enlarged donor pool [7]. Appropriately, clinical safety trials are currently underway, including a multicenter effort led by the PI of this proposal. Moreover, since the last ~2 years many transplant centers across the nation have started transplanting HCV NAT+ donor organs as standard of care. We estimate that the number of HCV+ cardiac transplants is quickly outpacing the number of trial participants. Hence, it is imperative that safety assessments and risk analyses 'catch up with the real world'. ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Transplant; Failure, Heart

• NCT number: NCT04493385
• Study type: Observational
• Source: Baylor Research Institute
• Contact: Joost Felius, PhD
• Phone: 214-818-8943
• Email: Joost.Felius@BSWHEALTH.ORG
• Status: Recruiting
• Start date: September 16, 2019
• Completion date: December 2023