EXPEDITION-V

EXPEDITION-V Study: GLE/PIB in patients with renal impairment

Persico N. EASL 2018, Abs. THU-363

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
2
3
Treatment history
Naive
IFN-Experienced
SOF-experienced
Cirrhosis
Yes
No
Special population
Chronic Kidney disease

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Design


* stage 3b: eGFR = 30 to < 45 mL/min/1.73m² ; stage 4: eGFR = 15 to < 30 mL ; stage 5: eGFR<15 mL or dialysis-dependent

  • GLE/PIB: 100/40 mg 3 tablets QD, administered regardless of timing of dialysis (hemo- or peritoneal)

Primary endpoint

  • SVR12 (HCV < LLOQ)

Baseline characteristics

Primary Endpoint (SVR12)


* 1 patient had missing data and 2 patients discontinued treatment
** 1 patient with NS5A Y93H RAS achieved SVR12

Adverse events and laboratory abnormalities, %


* No AE related to treatment
No death observed

Renal function

  • Of the 24 patients with CKD stage 3b or 4 and with available results, eGFR remained unchanged from screening to end of treatment and post-treatment week 4: 27.1 ± 9.2 vs 26.4 ± 9.8 vs 27.4 ± 11.6 mL/min/1.73m²
  • CKD stage remained unchanged in 22/24 patients with end of treatment results and declined in 2/24 from screening to end of treatment

Summary

  • GLE/PIB is highly efficacious in patients with chronic kidney disease stage 3b to 5 with the label recommended treatment durations based on genotype, cirrhosis status and prior treatment experience
    Treatment was well-tolerated
  • Overall, renal function remained unchanged after treatment in pre-dialysis patients assessed