Sofosbuvir / Velpatasvir

Omeprazole

Modification of dose and/or administration time necessary.

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

Pharmacodynamic effects

Possible decrease of clinical efficacy.

Recommendations

Monitor for clinical efficacy.

Alternative solution(s)

Omeprazole

Pharmacodynamic effects

Recommendations

Proton-pump inhibitor can be administered simultaneously with ledipasvir/sofosbuvir when it is taken with food.

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
3250 3250 3250 3250 3250
60 40 38 40 60
- - - - -
400/100 mg 400/100 mg 400/100 mg 400/100 mg 400/100 mg
x 1 ° x 1 °° x 1 °° x 1 °° x 1 °
- 29%/- 36% † + 8%/- 38% †† + 5%/- 26% ††† - 9%/- 53% †††† - 44%/- 55% †††††
- 34%/- 37% † - 16%/- 48% †† - 21%/- 33% ††† - 30%/- 56% †††† - 45%/- 57% †††††
Omeprazole
3250 3250 3250 3250 3250
60 40 38 40 60
- - - - -
20 mg 20 mg 20 mg 40 mg 20 mg
QD * QD ** QD *** QD *** QD ****
         
         
Comment

Ref #3250 :
° Administred in fasting state;
°° Sofosbuvir/velpatasvir adminsitered with food;
* Omeprazole administered at the same time as sofosbuvir/velpatasvir;
** Omeprazole administered 2 hours before sofosbuvir/velpatasvir;
*** Oméprazole administré 4 hours after sofosbuvir/velpatasvir;
**** Omeprazole administered 12 hours before sofosbuvir/velpatasvir;
† GS-331007 : AUC -1% and Cmax -6%;
†† GS-331007 : AUC -1% and Cmax -9%;
††† GS-331007 : AUC -1% and Cmax -9%;
†††† GS-331007 : AUC -1% and Cmax +1%
††††† GS-331007 : SSC -3% and Cmax +26%.

Reference
  • 3250
    Sofosbuvir/Velpatasvir (Epclusa), Gilead Sciences, Ontario, Canada, 5 novembre 2020.
  • 3270
    Mogalian E et al. Drug-drug interaction profile of sofosbuvir/velpatasvir fixed dose combination. 51st Meeting of the European Association for the Study of the Liver (EASL), Barcelona, Spain, April 13-17, 2016. Abstract FRI-168.