*Purpose: Given the need for thoracic organs and the high mortality of patients awaiting heart or lung transplantation, it is imperative to find ways to increase the donor pool. We designed and implemented a trial to assess the safety and efficacy of transplanting thoracic organs from HCV positive donors into HCV uninfected recipients.

*Methods: We conducted an open-label, safety and efficacy trial for HCV uninfected adults who were active on the heart or lung transplantation waiting list at our transplant center to receive thoracic organs from donors who were HCV viremic, irrespective of HCV genotype. Participants were pre-emptively treated with sofosbuvir/velpatasvir, a pan-genotypic direct acting antiviral regimen, for 4 weeks, beginning within hours of transplantation. The primary endpoint was a composite of graft survival and HCV clearance at 6 months post-transplantation. This protocol is IRB approved and all participants provided written informed consent. (NCT03086044).

*Results: Between March 1, 2017 and January 15, 2019, 54 participants were enrolled: 44 received lung and 10 received heart transplants. The median donor HCV viral load (VL) was 711,741 IU/mL (IQR 126,751 – 4,692,029). 50 of 54 (93%) recipients had detectable HCV VL within hours of transplantation, with median VL of 1,706 IU/mL (IQR 572 – 7,568). HCV genotypes were 1 (62%), 2 (16%), 3 (16%), and indeterminate (6%). HCV VL became negative by about 2 weeks and subsequently remained undetectable in all participants. 47 of 47 (100%) and 32 of 33 (97%) participants were alive with excellent graft function and an undetectable HCV VL at 6 months and 1-year post-transplantation, respectively. There was 100% treatment adherence and there were no treatment-related serious adverse events identified.

*Conclusions: In HCV uninfected patients receiving thoracic organs from HCV viremic donors, a 4-week antiviral treatment course initiated within hours of transplant prevented establishment of HCV infection. These data demonstrate that thoracic organs from HCV viremic donors can be transplanted safely with excellent graft and recipient survival at 6 and 12 months despite evidence of HCV transmission in nearly all recipients. This finding has the potential to substantially increase the number of thoracic organ transplantations. However, longer-term data are needed to fully define the risk-benefit profile.

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