Prophylactic 2-week glecaprevir/pibrentasvir in hepatitis C positive-to-negative kidney transplantation.

BACKGROUND AND HYPOTHESIS

Hepatitis C virus (HCV) positive-to-negative kidney transplants require direct-acting antiviral therapy, but the optimal timing and duration remain unclear. We hypothesized that a 14-day prophylactic course of glecaprevir/pibrentasvir 300/120 mg (GLE/PIB) would be safe and effective at treating donor-derived HCV viremia.

METHODS

This was a prospective, single-center, single-arm, open-label pilot study. Twenty adult HCV-negative recipients of HCV nucleic acid amplification test positive deceased-donor kidneys (HCV positive-to-negative) received a 14-day course of GLE/PIB, with the first dose pretransplant. HCV RNA viral load (VL) was monitored on postoperative days (POD) 1, 3, 7, and 13. If VL was undetectable on POD 13, GLE/PIB was stopped, and if detectable, GLE/PIB was continued to complete an 8-week course. Surveillance monitoring continued after treatment to ensure sustained viral response (SVR). The primary outcome was efficacy of 14-day prophylactic GLE/PIB. Secondary outcomes included patient and allograft survival, the incidence, timing, and clearance of HCV viremia, and safety events.

RESULTS

Seven out of 20 subjects (35%) never developed detectable HCV viremia. Only one subject had a detectable, but nonquantifiable, VL on POD 13 and completed an 8-week course. All subjects achieved SVR 12 weeks post-treatment with no relapses through 1-year follow-up. Mean time to undetectable HCV RNA VL was 10.5 (±4.7) days and mean peak VL was 371 (±715) copies/mL. Six-month and 1-year patient and allograft survival were 100% and 95%.

CONCLUSION

A 14-day course of prophylactic GLE/PIB is safe and effective for HCV positive-to-negative kidney transplants and may prevent HCV transmission or significantly reduce the VL for those with detectable transmission, allowing rapid clearance within 2 weeks.