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
- CKD: Clinical, Outcomes, Trials - I
October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
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±10.7 | 57.3±10.6 | 59.0±11.0 | |
| Compensated cirrhosis, n (%) | 5 (21) | 8 (10) | 13 (13) | |
| CKD stage, n (%) | Stage 3b | 7 (29) | 0 | 7 (7) |
| Stage 4 | 17 (71) | 0 | 17 (17) | |
| Stage 5 | 0 | 77 (100) | 77 (76) | |
| Medical history, n (%) | Diabetes | 15 (63) | 27 (35) | 42 (42) |
| Hypertension | 23 (96) | 65 (84) | 88 (87) | |
| Cardiovascular disease | 23 (96) | 67 (87) | 90 (89) |
*4 pts were receiving peritoneal dialysis; all other pts were receiving hemodialysis.
Funding
- Commercial Support – AbbVie