Data from a large, real-world study contributed to the growing safety and efficacy evidence of transplanting hepatitis C-infected organs into aviremic patients in the direct-acting antiviral era.
“The introduction of direct-acting antiviral agents (DAAs) has led to a paradigm shift in the way HCV is approached. Several studies have now demonstrated their efficacy and safety in the posttransplant population,” Nikhil Kapila, MD, from the Cleveland Clinic in Florida and colleagues wrote. “More recently, HCV viremic allografts have been utilized successfully in viremic recipients, however their use in aviremic recipients is an area of intense interest.”
Between January 2018 and December 2018, 297 patients without HCV underwent solid organ transplants with viremic organs at the Cleveland Clinic. These included 64 cases of kidney transplantation, seven cases of heart transplantation, four cases of liver transplantation, two patients who underwent combined liver-kidney transplant, and one who underwent combined heart-kidney transplant.
“The optimal timing for initiation of DAA therapy post-transplant remains controversial,” the researchers wrote. “Initially, our center’s approach was to initiate DAA therapy within one month of transplant, however 10 patients were observed to have detectable HCV after 4 weeks of treatment. The persistence of HCV, despite DAA treatment, led to a modification in our protocol whereby we aimed to begin DAA therapy 12 weeks after transplant.”
As of April 20, 2019, 58 patients who received HCV-infected kidneys have either started or completed DAA treatment. Forty-one patients achieved SVR, 10 patients achieved undetectable viral loads posttreatment without clinical SVR, and seven patients remain on treatment. One patient did not respond to DAA therapy due to NS5A resistance and remains on treatment.
All patients who received liver transplants started treatment with Mavyret (glecaprevir/pibrentasvir, AbbVie) without ribavirin posttransplant. Three achieved SVR, one completed therapy and is awaiting SVR readout, and two remain on treatment.
Patients who received heart transplants also started DAA therapy posttransplant, of whom four received glecaprevir/pibrentasvir and the other half received Harvoni (ledipasvir/sofosbuvir, Gilead Sciences). Six achieved SVR and the others remain on treatment.
“Based on our center’s real-world experience, we believe that DAA therapy should be ordered and initiated once a patient is confirmed to be viremic, clinical parameters have stabilized, and insurance approval is obtained,” Kapila and colleagues wrote. “As transplant centers expand their donor pool and increase utilization of HCV viremic organs, the early initiation of anti-viral therapy should become the standard of care.” – by Talitha Bennett
Disclosures: The authors report no relevant financial disclosures.