HCV+ heart, lungs safe for HCV-negative recipients

  • N Engl J Med
  • 3 Apr 2019

  • International Clinical Digest
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Takeaway

  • HCV-positive hearts and lungs can be safely transplanted into HCV-negative recipients with excellent cure rates and graft outcomes after 4 weeks of sofosbuvir/velpatasvir (Epclusa).

Why this matters

  • Use of HCV-infected organs can expand the donor pool, reduce time to transplantation.
  • Accompanying editorial calls early results encouraging but says "there is still a lot to learn,” noting limited long-term data, particularly for cardiovascular safety.

Study design

  • DONATE HCV trial of 44 HCV-mismatched heart (n=8) and lung (n=36) transplants from 41 donors, Brigham and Women’s Hospital.
  • 4-week course of sofosbuvir/velpatasvir started a few hours posttransplant.
  • Primary outcome: composite, sustained virologic response at 12 weeks posttherapy (SVR12) and 6-month graft survival.
  • Funding: Mendez National Institute of Transplantation Foundation; others.

Key results

  • Median donor viral load, 890,000 (interquartile range [IQR], 276,000-4.63 million) IU/mL.
  • Genotypes included HCV-1 (61%), HCV-2 (17%), HCV-3 (17%), indeterminate (5%).
  • Immediately posttransplant, 42 patients (95%) had detectable viral load (median, 1800 [IQR, 800-6180] IU/mL).
  • All 35 patients with 6-month data achieved composite endpoint with excellent graft function.
    • Viral load became and stayed undetectable after 2 weeks.
  • At 1 year: graft survival in 15/16 patients; 1 heart transplant recipient died at 8 months from unrelated disseminated infection.

Limitations

  • Monocentric design.
  • Small sample.

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