Ledipasvir / Sofosbuvir

Famotidine

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

Famotidine 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)

Famotidine

Pharmacodynamic effects

Recommendations

Administrer at the same time and/or 12 hours after the combined drug.

Recommended dosage : dose not exceeding famotidine 40 mg twice daily or equivalent.

Alternative solution(s)

Monitor

Tests

Pharmacokinetic parameters
Parameters
Reference number
# patients
HIV/HCV
Dose
Frequency
Cmax
AUC
Ledipasvir / Sofosbuvir
3073 3073
12 12
- -
90/400 mg 90/400 mg
QD QD
- 20%/+ 15% † - 17%/± 0% ††
- 11%/+ 11 † - 2%/- 5% ††
Famotidine
3073 3073
12 12
- -
40 mg 40 mg
x 1 * x 1 **
   
   
Comment

Ref #3073 :
* At the same time than ledepasvir/sofosbuvir;
† GS-331007, sofosbuvir active metabolite : AUC +6% and Cmax +6%;
** 12 hours after ledipasvir/sofobuvir;
†† GS-331007, sofosbuvir active metabolite : AUC +6% and Cmax +13%.

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