• July 2019

    Baylor Scott & White Health transplant teams successfully utilize organs from hepatitis C-positive donors

The opioid epidemic has caused the incidence of acute hepatitis C (HCV) in the United States to triple over the last several years. More than 5 million people in the nation carry the virus. Because many of these people are undiagnosed, especially in high-risk populations, many organs from HCV-positive donors are still being procured.

Where once organs from deceased donors infected with HCV were discarded, the development of direct-acting antiviral (DAA) therapy has made it possible to successfully transplant HCV-positive organs into HCV-negative recipients and treat the hepatitis C post-transplant. Baylor University Medical Center, part of Baylor Scott & White Health, and Baylor Scott & White All Saints Medical Center – Fort Worth are among U.S. transplant centers that are offering to use donor livers that are infected with HCV.

In addition, Baylor University Medical Center in Dallas is serving as the lead site for a phase II, multi-center, open-label study being conducted through Baylor Scott & White Research Institute. The investigator-initiated study seeks to evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients. If or when qualified study recipients are confirmed to be HCV positive through HCV polymerase chain reaction (PCR), they are treated with a 12-week course of DAA therapy.

“With the rapid uptake of direct-acting antiviral therapy, the eradication rate for HCV is virtually 100 percent,” says Stevan A. Gonzalez, MD, MS, a hepatologist on the medical staff of Baylor Scott & White – Fort Worth. “The combination regimens most commonly used are pangenotypic, so the therapy works across all genotypes. The therapy is so effective because the agents within these regimens keep the virus from replicating at different times of the HCV life cycle simultaneously.”

Beginning in 2014, the use of livers from HCV-positive donors gradually began to rise, with significant increases each subsequent year. Today, 10% of the livers transplanted are HCV-positive. From June 2018 to March 2019, transplant surgeons on the medical staff at Baylor University Medical Center in Dallas and Baylor Scott & White – Fort Worth have transplanted HCV-positive livers into 13 HCV-negative recipients, seven in Dallas and six in Fort Worth. Three of the 13 patients were antibody-positive but nucleic acid test (NAT)-negative, so no therapy was necessary. The first patient who completed treatment achieved a sustained virologic response (SVR), indicating long-term eradication of the virus. Patients who have finished treatment are HCV-negative, pending confirmation. The remaining patients are currently on treatment.

“We consented the patients and discussed the risks and benefits with the understanding we will treat the hepatitis C as soon as possible post-transplant,” Dr. Gonzalez says. “We’ve improved our therapeutic start times from two to three months down to one month or three weeks in some cases.”

Another striking development in the field of transplantation is a rapid increase in the utilization of kidneys from HCV-positive donors. In 2018, 6.2% of kidneys transplanted in the United States were from HCV-positive donors. Partial data from 2019 show that number has jumped to 9.4%.

The results of two clinical trials support the use of these kidneys. In Goldberg et al. 2017, 20 patients were given preemptive DAA therapy at day 3; all 20 patients achieved SVR. In Durand et al. 2018, 10 patients who were given prophylactic DAA therapy (with the first dose in the OR); all 10 achieved SVR.

“Programs around the country are starting to develop protocols to use HCV-positive kidneys in negative recipients because it makes sense,” Dr. Gonzalez says. “We can use these organs safely and eradicate the virus after transplant. Patients do not have to worry about HCV for the lifetime of the graft.”

The Baylor Scott & White Health transplant programs are currently evaluating the use of HCV-positive kidneys in addition to livers.

To learn more or enroll a patient, search our online clinical trials database.