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Kidney Week

Abstract: SA-OR098

Ultra-Short-Duration Direct-Acting Antiviral Prophylaxis to Prevent Hepatitis C from Viremic Donors to Hepatitis C-Negative Kidney Transplant Patients

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Gupta, Gaurav, Virginia Commonwealth University Health System, Richmond, Virginia, United States
  • Yakubu, Idris, Virginia Commonwealth University Health System, Richmond, Virginia, United States
  • Alam, Anam, Virginia Commonwealth University, Midlothian, Virginia, United States
  • Kumar, Dhiren, Virginia Commonwealth University Health System, Richmond, Virginia, United States
  • King, Anne L., Virginia Commonwealth University, Midlothian, Virginia, United States
  • Kamal, Layla, Virginia Commonwealth University, Midlothian, Virginia, United States
  • Kang, Le, VCU, Richmond, Virginia, United States
  • Moinuddin, Irfan Ahmed, Virginia Commonwealth University Health System, Richmond, Virginia, United States
  • Bhati, Chandra S., VCU Health system, Richmond, Virginia, United States
  • Sharma, Amit, VCU, Richmond, Virginia, United States
  • Cotterell, Adrian, Virginia Commonwealth University, Midlothian, Virginia, United States
  • Levy, Marlon F., VCU, Richmond, Virginia, United States
  • Sterling, Richard, Virginia Commonwealth University, Midlothian, Virginia, United States
Background

Direct-acting anti-viral drug (DAA) prophylaxis of of less than twelve weeks initiated at the time of transplant could have the potential to reduce the cost of deceased HCV-infected viremic donor to non-HCV-infected transplants (D+/R-). In our recently concluded single-center trial (ClinicalTrials.gov: NCT03249194; to be presented at ATC 2019; manuscript under peer review) we reported a HCV transmission rate of 13% with an ultra-short course of DAA prophylaxis given over the first 4 days of transplant. Here we present initial data on our extension open-label clinical protocol [REFORM HEPC (REgistry For the study of ORgan transplants froM HEPatitis C infected donors].

Methods

Waitlisted HCV negative adult kidney transplant candidates without significant liver fibrosis, as assessed by transient elastography, were enrolled. After administration of ultra-short course (4 days) prophylactic Sofusbuvir/Velpatasvir (SOF/VEL), patients were screened for HCV RNA at Days 7, 14, 21 and Month 3. Development of viremia (defined as two consecutive positive RNAs) triggered a full 12 week course of DAA therapy.

Results

Over a period of 4 months (Jan-April 2019), 88 patients were enrolled. Of these, 22 (25%) received D+/R- transplants. The mean wait time to transplant from enrollment was 19 days and the mean donor KDPI was 64%. Of the data available on 11 donors (50%), the median donor viral load was 2.6E+06 IU/mL (IQR:2.5E+02-7.3E+06). A majority were genotype (GT) 1a donors (88%). At a median follow-up of 97 days (IQR: 30-150 days) post-transplant, both patient and graft survivals were 100%. There were no cases of liver dysfunction. Average kidney function as measured by eGFR was 52±25mL/min/1.73m2. There were no episodes of acute rejection or de-novo donor specific antibody formation. Viral transmission rate was 4.5% (1/22; GT1a). The only patient with viremia has a declining viral load on glecapravir/pibrentasvir after 4 weeks of initiating therapy.

Conclusion

Our data suggests that ultra-short duration DAA prophylaxis is highly effective in preventing donor-derived HCV transmission and has the potential of resulting in significant cost-savings by avoiding DAA therapy in a majority of D+/R- transplants.

Funding

  • Clinical Revenue Support