Transplantation of NAT+HCV Donor Lungs into Non-Infected Recipients Followed by Treatment with Sofosbuvir/Velpatasvir (S/V)

Abstract

Purpose One of the most promising strategies to increase organ donation is the use of organs from donors with Hepatitis C (HCV). We evaluated the safety of transplanting NAT+HCV donors into non-infected lung recipients. Methods Between Oct 2017 and Oct 2018, NAT+HCV donors in North America were considered. Recipients consented to receive such organs under study protocol NCT03112044. Exclusion criteria included existence of liver disease or multi-organ transplant. Outcomes of study recipients were compared to patients receiving non-infected donors. Primary endpoints were survival and HCV status at 6 months after transplantation. All patients becoming viremic received S/V starting at least 2 weeks after transplantation. Results During the one-year study period 200 lung transplant procedures were performed at our center. Of these, 20 (10%) were from NAT+ HCV donors. Compared to standard donors, HCV donors were significantly younger (33y vs. 52y, p=0.002), more likely to be located in the United States vs. Canada (75% vs 5%, p=0.001), and more likely to be smokers (95% vs. 47%, p=0.0001). Donor P/F ratio (383 mmHg vs. 424 mmHg) and proportion of DCD (10% vs. 27%) were not statistically different between the 2 groups. Recipient age, lung disease, urgency status and positive donor HLA crossmatch were similar between the 2 groups. There was a significantly higher proportion of single lung transplants in the HCV group (55% vs. 15%, p=0.002). Post-transplant time on ventilation, ICU and hospital length of stay, use of ECMO and survival (100% in HCV group) were similar between the 2 groups. All patients, except 1 became viremic within 1 week after transplantation. 12 weeks treatment with S/V started at a median of 21 days after transplantation (range 14-71). All patients achieved negative HCV PCR from 2 to 6 weeks after treatment initiation. Two patients presented with HCV relapse within 3 months after S/V termination. One of the relapses was associated with alteration in liver enzymes. Conclusion Excellent intermediate-term clinical outcomes were achieved using NAT+HCV donors to non-infected recipients and this practice should continue to be encouraged. However, a higher relapse rate (10% to date) than previously reported in non-lung transplant patients was observed and novel strategies aiming at prevention of transmission should be further studied. One of the most promising strategies to increase organ donation is the use of organs from donors with Hepatitis C (HCV). We evaluated the safety of transplanting NAT+HCV donors into non-infected lung recipients. Between Oct 2017 and Oct 2018, NAT+HCV donors in North America were considered. Recipients consented to receive such organs under study protocol NCT03112044. Exclusion criteria included existence of liver disease or multi-organ transplant. Outcomes of study recipients were compared to patients receiving non-infected donors. Primary endpoints were survival and HCV status at 6 months after transplantation. All patients becoming viremic received S/V starting at least 2 weeks after transplantation. During the one-year study period 200 lung transplant procedures were performed at our center. Of these, 20 (10%) were from NAT+ HCV donors. Compared to standard donors, HCV donors were significantly younger (33y vs. 52y, p=0.002), more likely to be located in the United States vs. Canada (75% vs 5%, p=0.001), and more likely to be smokers (95% vs. 47%, p=0.0001). Donor P/F ratio (383 mmHg vs. 424 mmHg) and proportion of DCD (10% vs. 27%) were not statistically different between the 2 groups. Recipient age, lung disease, urgency status and positive donor HLA crossmatch were similar between the 2 groups. There was a significantly higher proportion of single lung transplants in the HCV group (55% vs. 15%, p=0.002). Post-transplant time on ventilation, ICU and hospital length of stay, use of ECMO and survival (100% in HCV group) were similar between the 2 groups. All patients, except 1 became viremic within 1 week after transplantation. 12 weeks treatment with S/V started at a median of 21 days after transplantation (range 14-71). All patients achieved negative HCV PCR from 2 to 6 weeks after treatment initiation. Two patients presented with HCV relapse within 3 months after S/V termination. One of the relapses was associated with alteration in liver enzymes. Excellent intermediate-term clinical outcomes were achieved using NAT+HCV donors to non-infected recipients and this practice should continue to be encouraged. However, a higher relapse rate (10% to date) than previously reported in non-lung transplant patients was observed and novel strategies aiming at prevention of transmission should be further studied.