The Molecular Pathology Laboratory in the Hospital of the University of Pennsylvania is actively participating in a new Penn-led clinical trial for an open-labeled trial of Zepatier for treatment of Hepatitis C-negative patients who receive kidney transplants from Hepatitis C-positive donors.

The transplant study known as THINKER (Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients) will determine the safety and efficacy of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with Zepatier after the single kidney transplantation. In the study, only donated kidneys that are infected with a certain strain of HCV are used. There are six genotypes of HCV that have been identified, but patients will only receive HCV genotype 1-infected kidneys, since the viral treatment used in this study has a 95 percent success rate in eradicating this type of HCV in the general population.

The Molecular Pathology laboratory, directed by Vivianna Van Deerlin, MD, PhD, Professor of Pathology and Laboratory Medicine, performs the genotyping test to determine the eligibility of the donor organ. Midhat Farooqi, MD, PhD, a Molecular Genetic Pathology Fellow at Penn at the time, and Caren Gentile, MS, Lead Development Technologist, were instrumental in developing and validating the HCV genotyping test, as well as helping to coordinate the laboratory aspects of the THINKER clinical trial. It is important that the genotype result be available within several hours which requires molecular pathology technologists to be on-call virtually around the clock. The study is currently recruiting participants. Read the Department of Communications press release.
Watch the Penn Medicine YouTube video "Expanding Access: First Clinical Trial Transplants Hepatitis C-Infected Kidneys at Penn Medicine."