Sofosbuvir / Velpatasvir / Voxilaprevir

Omeprazole

Potential interaction.

Available pharmaceutical opinion

Document made available to the pharmacist to communicate a drug interaction to the doctor.

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Mechanism

Omeprazole by increasing gastric pH may decrease the solubility, absorption, and plasma concentration of velpatasvir .

Sofosbuvir / Velpatasvir / Voxilaprevir

Pharmacodynamic effects

Possible decrease of clinical efficacy.

Recommendations

Monitor for clinical efficacy.

Alternative solution(s)

Omeprazole

Pharmacodynamic effects

Recommendations

PPI doses should not exceed comparable to omeprazole 20 mg QD either dexlansoprazole 30 mg; esomeprazole 20 mg; lansoprazole 30 mg; pantoprazole 40 mg; rabeprazole 20 mg.

Alternative solution(s)

Monitor

Tests

Pharmacokinetic parameters
Parameters
Reference number
# patients
HCV
Dose
Frequency
AUC
Cmax
Sofosbuvir / Velpatasvir / Voxilaprevir
3379 3379
34 34
- -
400/100/100 mg 400/100/100 mg
x 1 x 1
- 27%/- 54%/- 20% † - 18%/- 51%/- 5% ††
- 23%/- 57%/- 24% † - 6%/- 51%/+ 8% ††
Omeprazole
3379 3379
34 34
- -
20 mg 20 mg
QD * QD **
   
   
Comment

Ref #3379 : * Omeprazole administred 2 hours before sofosbuvir/velpatasvir/voxilaprevir;
** Omeprazole administred 4 hours after sofosbuvir/velpatasvir/voxilaprevir;
† GS-331007 : AUC -3% and Cmax +27%;
†† GS-331007 : AUC -1% and Cmax +19%.

Reference
  • 3379
    Sofosbuvir/Velpatasvir/Voxilaprevir (VOSEVI), Gilead, Ontario, Canada, 28 janvier 2020.