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Kidney Week

Abstract: TH-PO1130

Effect of Treatment of Chronic Hepatitis C Virus (HCV) Infection with Glecaprevir/Pibrentasvir (G/P) on Renal Biomarkers in Patients with CKD Stage 3b, 4, or 5

Session Information

Category: CKD (Non-Dialysis)

  • 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Sise, Meghan E., Massachusetts General Hospital, Boston, Massachusetts, United States
  • Chung, Raymond T., Massachusetts General Hospital, Boston, Massachusetts, United States
  • Kaskas, Marwan O., Northwest Louisiana Nephrology, Shreveport, Louisiana, United States
  • Zadeikis, Neddie, AbbVie Inc., North Chicago, Illinois, United States
  • Abunimeh, Manal, AbbVie Inc., North Chicago, Illinois, United States
  • Xue, Zhenyi, AbbVie Inc., North Chicago, Illinois, United States
  • Mensa, Federico, AbbVie Inc., North Chicago, Illinois, United States
  • Persico, Marcello, University of Salerno, Fisciano, Italy
Background

Chronic HCV infection is associated with CKD development and progression to end-stage renal disease (ESRD). HCV elimination may reduce risk of CKD progression. G/P, an all-oral pangenotypic HCV direct-acting antiviral (DAA) regimen, has minimal renal excretion. G/P is approved for patients (pts) with compensated liver disease and any degree of renal impairment, including ESRD, with high cure rates. Here we explore the impact of G/P on renal biomarkers in pts with CKD stage 3b, 4, or 5.

Methods

EXPEDITION-5 was a Phase 3b trial evaluating efficacy and safety of G/P for 8, 12, or 16 weeks (wks) in pts with CKD stage 3b, 4, or 5. Pre- and posttreatment C-reactive protein, tumor necrosis factor-α, urine protein/creatinine ratio (PCR), urine albumin/creatinine ratio, and urine neutrophil gelatinase-associated lipocalin concentrations will be evaluated.

Results

101 pts enrolled. Baseline characteristics are shown (table). 83% of pts received 8 wks of G/P. Sustained virologic response at posttreatment wk 12 (SVR12) was 97% with no virologic failures. There were no DAA-related serious adverse events (AEs) or clinically relevant lab abnormalities. 2 predialysis pts discontinued due to AEs. In predialysis pts (N=24), eGFR (mean±SD, mL/min/1.73 m2) did not change from screening (27.1±9.2) to posttreatment wk (PTW) 4 (27.4±11.6); mean PCR was 2.7 g/g at baseline and 2.6 g/g at PTW4/12; 41% of pts had ≥30% improvement in PCR after G/P.

Conclusion

G/P for 8–16 wks was not associated with eGFR deterioration in predialysis pts. Preliminary data suggest G/P may improve PCR in a substantial number of pts. Other renal biomarker analyses will be presented.

Baseline Characteristics in EXPEDITION-5
Characteristic Predialysis
N=24
Dialysis*
N=77
Overall
N=101
Age, years, mean±SD 64.6±10.757.3±10.659.0±11.0
Compensated cirrhosis, n (%) 5 (21)8 (10)13 (13)
CKD stage, n (%)Stage 3b7 (29)07 (7)
 Stage 417 (71)017 (17)
 Stage 5077 (100)77 (76)
Medical history, n (%)Diabetes15 (63)27 (35)42 (42)
 Hypertension23 (96)65 (84)88 (87)
 Cardiovascular disease23 (96)67 (87)90 (89)

*4 pts were receiving peritoneal dialysis; all other pts were receiving hemodialysis.

Funding

  • Commercial Support