LDV/SOF renal impairment

LDV/SOF for 12 weeks in patients with genotype 1 and severe renal impairment

Lawitz E. AASLD 2017, Abs. 1587

Anti-HCV
Ledipasvir
Sofosbuvir
Genotype
1
Treatment history
IFN-Experienced

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Design

  • LDV/SOF : 90/400 mg 1 tablet QD

Objective

  • SVR12 (HCV RNA < 15 IU/ml)

Baseline characteristics and SVR12

PK sub-study ( drug exposure compared to patients with normal renal function ) :

  • Mean SOF exposure : 103% higher
  • Mean GS-331007 exposure : 501% higher
  • Mean LDV exposure : 57% higher

Adverse events, %


*Acute kidney injury and noncardiac chest pain (n=1), ; dehydration and hypotension (n=1); acute renal failure (n=1); hypotension and syncope (n=1)
**Elevated creatinine (Grade 3, n=3; Grade 4, n=1); decreased hemoglobin (Grade 3, n=3; Grade 4, n=1); elevated glucose (Grade 3, n=3); decreased bicarbonate (Grade 3, n=1); decreased lymphocytes (Grade 3, n=3)

Summary

  • 12 weeks of LDV/SOF led to a 100% SVR 12 rate in patients with genotype 1 infection and severe renal impairment not undergoing dialysis
  • Treatment was safe and well tolerated
  • Plasma concentrations of the SOF metabolite GS-3310007 were close to 6-fold higher than in the LDV/SOF phase 2-3 trials