To evaluate the safety and efficacy of transplanting the kidneys from HCV-positive donors to HCV-negative recipients and receiving the antiviral therapy of sofosbuvir (SOF)/velpatasvir (VEL), and to observe the function of transplanted kidneys and prognosis of recipients.

The clinical data of recipients who underwent kidney transplantation in Shulan (Hangzhou) Hospital from October 2019 to October 2021 were retrospectively analyzed. Patients were divided into HCV-positive group (n=30) and control group (n=330) according to whether donors were HCV-positive or not. Patients in the HCV-positive group received the antiviral therapy of SOF/VEL (400/100 mg, once daily) for 12 weeks after surgery. The proportion of HCV RNA-negative recipients in the HCV-positive group 12 weeks after completion of antiviral therapy was observed, and adverse events related to HCV infection or antiviral therapy were analyzed. The serum creatinine, ALT and AST at different time points of the two groups were compared. The recovery of transplanted kidney function and the survival situation of the recipients in the two groups were observed. The measurement data conforming to normal distribution were compared by group t test. Non-normal distribution measurement data were compared by Mann-Whitney U test. The counting data were compared with Chi-square test or Fisher exact test. Kaplan-Meier method was used to draw the survival curve of the two groups, and log-rank test was used to compare the survival rate. A P<0.05 was considered statistically significant.

In the HCV-positive group, six recipients (20.0%) were HCV RNA-positive after surgery and all turned negative after 4 weeks of treatment. At 12 weeks after completing antiviral therapy, thirty recipients (100%) in the HCV-positive group achieved SVR and a total of eight recipients (26.7%) were anti-HCV-positive. None of the recipients in the HCV-positive group experienced acute rejection. One patient was allograft renal dysfunction. One patient had transient elevation of aminotransferases at 3 months after surgery. Six patients had leukopenia. Three patients had bleeding. Thirteen cases were positive for uropolyomavirus, seven cases were positive for CMV-IgM, and one case was considered for Pneumocystis jirovecii pneumonia. None of these adverse events had clear evidence of association with HCV infection or antiviral therapy. The ALT level of recipients in the HCV-positive group was lower than that in the control group at one month after surgery [12.0(10.0, 18.3) and 16.0(11.0, 25.0) U/L], and the difference was statistically significant (Z=-2.096, P<0.05). The AST level of recipients in the HCV-positive group at 1 and 3 months after surgery was lower than that in the control group, and the differences were statistically significant (Z=-3.833 and -2.758, all P<0.05). There were no significant differences in serum creatinine, ALT and AST between the two groups at the remaining time points (all P>0.05). Until October 2022, all recipients in the HCV-positive group survived, while four cases (1.2%) died in the control group. There was no significant difference in mortality between the two groups (P>0.05). The incidence rates of delayed graft function in the HCV-positive group and the control group were 43.3% (13/30) and 36.4% (120/330), and the incidence rates of transplanted kidney failure were 3.3% (1/30) and 5.8% (19/330), respectively. The differences were not statistically significant (χ²=0.573 and 0.019, all P>0.05). In the HCV-positive group, the 1- and 2-year cumulative survival rates of recipients were 100% and 100%, respectively, and the transplanted kidneys survival rates were 96.7% and 96.7%, respectively. The 1- and 2-year cumulative survival rates of recipients in the control group were 98.8% and 98.8%, respectively, and the transplanted kidneys survival rates were 94.2% and 94.2%, respectively. There was no significant difference in the 2-year cumulative survival rates of recipients and transplanted kidneys between the two groups (χ²=0.371 and 0.333, all P>0.05).

The kidney transplantation from HCV-positive donors to HCV-negative recipients, receiving the antiviral therapy of SOF/VEL, is safe and effective. Moreover, the function of transplanted kidneys and prognosis of recipients are all good.