Ledipasvir / Sofosbuvir

Omeprazole

Administration time adjustment is recommended.

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 ledipasvir .

Ledipasvir / Sofosbuvir

Pharmacodynamic effects

Possible decrease of clinical efficacy.

Recommendations

Monitor for clinical efficacy.

Alternative solution(s)

Omeprazole

Pharmacodynamic effects

Recommendations

Give ledipasvir/sofosbuvir simultaneously with the proton-pump inhibitor. Proton-pump inhibitors should not be taken before taking ledipasvir/sofosbuvir.

Recommended dosage : doses 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
HIV/HCV
Dose
Frequency
Cmax
AUC
Ledipasvir / Sofosbuvir
3073
16
-
90 / 400 mg
QD
- 11% / + 12% †
- 4% / ± 0% †
Omeprazole
3073
16
-
20 mg
x 1 *
 
 
Comment

Ref #3073 :
* Omeprazole and Oméprazole et ledipasvir/sofosbuvir taken at the same time.
† GS-331007, sofosbuvir active metabolite : AUC +3% and Cmax +14%.

In another study with ledipasvir alone, there was a 48% and 42% decrease in Cmax and AUC when ledipasvir was given 2 hours after omeprazole 20 mg.

Equivalent doses to omeprazole 20 mg: dexlansoprazole 30 mg; esomeprazole 20 mg; lansoprazole 30 mg; pantoprazole 40 mg; rabeprazole 20 mg.

Reference
  • 3073
    Ledipasvir/Sofosbuvir (Harvoni), Gilead, Ontario, Canada, 16 avril 2018.