Protocol based on hepatitis C virus nucleic acid testing to optimize renal transplant from seropositive donors to seronegative recipients. An European experience
Antonio Franco1, Francesc Moreso 2, Asuncion Sancho 3, Nuria Esforzado 4, Javier Paul 5, Santiago Llorente 6, Francisco Roncero 7, Marta Crespo 8, Auxiliadora Mazuecos9, Eduardo Mellini 10, Luis Guirado 11.
1Nephrology, Hospital General Alicante, Alicante, Spain; 2Nephrology, Hospital Vall Hebron , Barcelona, Spain; 3Nephrology, Hospital Universitario Doctor Peset, Valencia, Spain; 4Nephrology, Hospital Clinic , Barcelona, Spain; 5Nephrology, Hospital Miguel Servet, Zaragoza, Spain; 6Nephrology, Hospital Virgen de la Arrixaca , Murcia, Spain; 7Nephrology, Hospital Virgen Rocio , sevilla, Spain; 8Nephrology, Hospital Mar , Barcelona, Spain; 9Nephrology, Hospital Puerta del Mar, Cadiz, Spain; 10Nephrology, Hospital Bellvitge, Barcelona, Spain; 11Nephrology, Clinica Puigvert , Barcelona, Spain
The transmission of hepatitis C virus(HCV) has been widely reported.
Based on two key points:HCV-antibodies (HCV-Ab) positive, HCV nucleic acid testing (HCV-NAT) negative donors do no universally transmit the infection and the availability of a treatment with Direct-Acting Antiviral Agents(DAA) to prevent the transmission,we designed a protocol based on the immediate identification of HCV-Ab-positive donor as viremic (HCV-NAT positive), with a high risk of transmission, or non-viremic (HCV-NAT negative) with a low risk of transmission, to start an early treatment with DAA if needed.
This is a propective, observational, multicenter study.
Donors: HCV-Ab positive donors, aged less than 70 years, except those admitted in the penitentiary system and/or with active addiction to parenteral drugs.
Recipients:HCV-Ab negative recipients with no clinical history of liver disease and a signed informed consent.
Test performed: An immediate HCV-NAT test (Xpert HCV VIral Load assay, Cepheid, CA, USA) to detect HCV-NAT and classify the donor as infective or non-infective.
Action taken:
Action taken 1 (recipent from HCV-NAT-positive donors): treatment with glecaprevir and pibrentasvir from 6 hours before trasplant until 8 weeks later.
Action taken 2 (recipient from HCV-NAT-negative donors): No antiviral treatment. Regular monitoring of HCV-NAT to start DAA was planned.
The median follow-up period was 14 months (p25-75:9-20), minumun 6 months.
We included 53 recipients, 35 males and 18 females, aged 57.3 years (IC 95% 54.2-60.4) from 31 deceased donors,19 males and 12 females, aged 54.1 years (IC 95% 50.6-57.6), 15 were previous drugs users (48,3%). Donor genotypes were: 1a:4,1b:13,3:3,4:1 ND :10. A total of 10 donors were HCV-NAT positive and 21 negative(14 of them, 66,6%, previously treated). Nine grafts were excluded from the protocol, 4 trasplanted to HCV-Ab positive recipients and 5 discarded due to bad perfusion.
Action taken 1 (HCV-NAT-positive donors): 17 recipients
Action taken 2 (HCV-NAT-negative donors): 36 recipients
None of our 36 recipents from HCV-NAT-negative donors showed HCV-NAT during a minimun follow-up of 6 months but 2 of 17 recipents from HCV-NAT-positive donors developed high viremias due to a delayed start of DDA and 4 low (<100), but all were negative at 1 week after transplant.
Eigth of 36 recipents (22.2%) from non-infected donors and 13 of 17 (76.4%) from infected donors showed HCV seroconversion during the follow up period, but modification of liver enzymes was not registered. No adverse event associated with DAA was recorded.
One recipient of an HCV-NAT-negative died due to acute necrotizing pancreatitis after trasplantatiton and other had no primary function. The remaining 51 patients had a stable functioning graft at the end of the follow-up period, CKD-EPI between 35 and 65 ml/min.
Conclusion: This data suggest that our protocol based on HCV-NAT testing to optimize the use of DAA in renal transplant from seropositive donors to seronegative recipients is safe.
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