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

• Transplantation: Approaches to Improve Post-Transplant Outcomes
  November 09, 2019 | Location: 151, Walter E. Washington Convention Center
  Abstract Time: 04:30 PM - 04:42 PM

Category: Transplantation

• 1902 Transplantation: Clinical

Authors

• Gupta, Gaurav, Virginia Commonwealth University Health System, Richmond, Virginia, United States

Gaurav Gupta, MD



After completing medical school at AIIMS in India, I did an internal medicine residency at the University of Pittsburgh followed by nephrology and transplant fellowships at Johns Hopkins University. I currently serve as the medical director of the kidney transplant program at the Virginia Commonwealth University Hume-Lee Transplant Center. In addition to being a full-time clinician, my current research efforts are focused on enhancing access to kidney transplantation by the safe utilization of high-infectious risk donor kidneys (PHS high risk, HIV+ and HCV+ donors), expanding the donor pool and the use of molecular diagnostics in kidney transplantation.

• Yakubu, Idris, Virginia Commonwealth University Health System, Richmond, Virginia, United States

Idris Yakubu,

• Alam, Anam, Virginia Commonwealth University, Midlothian, Virginia, United States

Anam Alam,

• Kumar, Dhiren, Virginia Commonwealth University Health System, Richmond, Virginia, United States

Dhiren Kumar,

• King, Anne L., Virginia Commonwealth University, Midlothian, Virginia, United States

Anne L. King,

• Kamal, Layla, Virginia Commonwealth University, Midlothian, Virginia, United States

Layla Kamal,

• Kang, Le, VCU, Richmond, Virginia, United States

Le Kang,

• Moinuddin, Irfan Ahmed, Virginia Commonwealth University Health System, Richmond, Virginia, United States

Irfan Ahmed Moinuddin,

• Bhati, Chandra S., VCU Health system, Richmond, Virginia, United States

Chandra S. Bhati,

• Sharma, Amit, VCU, Richmond, Virginia, United States

Amit Sharma,

• Cotterell, Adrian, Virginia Commonwealth University, Midlothian, Virginia, United States

Adrian Cotterell,

• Levy, Marlon F., VCU, Richmond, Virginia, United States

Marlon F. Levy,

• Sterling, Richard, Virginia Commonwealth University, Midlothian, Virginia, United States

Richard Sterling,

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