DAA Regimen Decreases HCV Risk in Kidney Transplant Recipients

November 18, 2020
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

A week-long treatment program prevented HCV transmission in 88% of cases.

Seven days of direct acting antiviral prophylaxis could be enough to avoid a hepatitis C viral (HCV) infection for a HCV kidney recipient from a HCV positive kidney donor.

A team, Idris Yakubu, Virginia Commonwealth University Health System, reported the results of a trial testing a 2-4 day peri-operative DAA prophylaxis using sofosbuvir/velpatasvir (SOF/VEL) for D+/R- transplants prevented hepatitis C transmissions in 88% of cases.

The researchers reported the entire experience based on an adaptive iterative trial design where prophylaxis with SOF/VEL was initially extended to 7 days and ezetimibe was added for a second cohort.

In the past, studies have described a 12-week course of DAA for HCV transmission from infected donors to negative kidney transplant recipients. However, this strategy is limited by high costs and a lack of access to DAA.

One alternative to the limitations could be a prophylactic strategy that is safer and cost-effective.

In the study, the investigators examined wait listed patients who were absent of a living donor, had panel reactive antibodies of at least 50%, were at least 1 year prior transplant, and were in absence of liver disease.

The investigators sought primary outcomes of HCV transmission, defined as 2 consecutive positive HCV nucleic acid tests tested at day 7 and 14-21 post-transplant. Confirmed HCV viremia triggered a 12-week course of direct-acting anti-viral drugs.

Overall, the study included 100 patients with a mean age of 56 years old. These patients received D+/R- transplants between November 2017 and April 2020. The mean wait time to transplant from enrollment was 34 days and the mean KDPI was 67%.

At a median follow-up of 10 months (IQR: 1-30 months), the researchers found graft survival was 99% and patient survival was 98% with no cases of liver dysfunction.

For the first group, 10 patients received 1 dose of SOF/VEL immediately pre-transplant, with a second dose on post-transplant day 1. The viral transmission was 30% in this group.

For the second group, 42 patients received 2 additional treatment doses on days 2 and 3 post-transplant. For this group, viral transmission rate decreased to 9.5%.

All patients then achieved SVR with full DAA therapy in the first 2 groups.

For the third group, prophylaxis was extended to 7 days for the 28 patients with further reductions found in transmission to 3.5%. For the final group, 19 patients received ezetimibe and SOF/VEL for 7 days and viral transmission was 5%.

“A 7-day DAA prophylaxis is effective in preventing donor-derived HCV transmission, can result in significant cost-savings and increase access to transplants,” the authors wrote. “Adding ezetimibe to SOF/VEL did not provide an additional benefit in preventing viral transmission.”

The study, “Direct Acting Antiviral Prophylaxis to Prevent Virus Transmission from Hepatitis C Viremic Donors to Hepatitis C-Negative Kidney Transplant Recipients,” was published online by ASN 2020.