- HCV-positive hearts can be safely transplanted into HCV-negative recipients with acceptable clinical outcomes and high cure rates following antiviral therapy with elbasvir/grazoprevir (EBR/GZR; Zepatier).
Why this matters
- Prior attempts to use HCV+ donor hearts were limited by interferon-related side effects, drug interactions, and upregulated immune response.
- Single-arm USHER trial of 10 HCV-negative white patients aged 40-65 years (median, 52.5 years; 80% male) receiving HCV-1+ donor hearts, then treated with EBR/GZR.
- Funding: Merck & Co., Inc., Kenilworth, NJ, USA.
- Median times:
- Initial waitlisting to trial consent, 94.5 (interquartile range [IQR], 3-842) days.
- Consent to HCV+ transplant, 39 days (IQR, 17-57) days.
- Median donor age, 34 (IQR, 31-37) years; 5 donors provided kidneys for THINKER.
- All recipients were viremic on day 3 posttransplantation (HCV RNA, 25-40 million IU/mL); 9 had undetectable viral load within 4 weeks of EBR/GZR initiation.
- 9 recipients completed treatment and achieved sustained virologic response at 12 weeks posttherapy.
- 1 recipient with a weakly positive cross-match died at 79 days posttransplant from complications of antibody-mediated rejection.
- No serious adverse events reported in relation to HCV transmission or treatment.
- 2 patients developed acute kidney injury, with 1 requiring months of dialysis.
- Sample size, generalizability.