Ledipasvir / Sofosbuvir

Rifampin

Contraindicated.

Available pharmaceutical opinion

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

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Mechanism

Rifampin may induce P-gp and decrease the plasma concentration of Ledipasvir / Sofosbuvir.

Ledipasvir / Sofosbuvir

Pharmacodynamic effects

Possible decrease of clinical efficacy.

Recommendations

Alternative solution(s)

Rifampin

Pharmacodynamic effects

Recommendations

Contraindicated. Use alternative.

Alternative solution(s)

Monitor

Tests

Pharmacokinetic parameters
Parameters
Reference number
# patients
HIV/HCV
Dose
Frequency
Cmax
AUC
Duration (days)
Ledipasvir / Sofosbuvir
3073 3082
31 17
- -
90 mg * 400 mg **
x 1 * x 1 **
- 35% * - 77% ** †
- 59% * - 72% ** †
   
Rifampin
3073 3082
31 17
- -
600 mg 600 mg
QD QD
   
   
  7
Comment

Ref #3073 : * Study conducted with ledipasvir administered as single agent and in the presence of two other investigational HCV direct-acting agents.

Ref #3082 : ** Study conducted with sofosbuvir administered as single agent.
† GS-331007, sofosbuvir active metabolite : AUC ±0% and Cmax +24%.

Reference
  • 3073
    Ledipasvir/Sofosbuvir (Harvoni), Gilead, Ontario, Canada, 16 avril 2018.
  • 3082
    Garrison KL, Wang Y, Brainard DM, Sajwani K, Mathias A et al. The Effect of Rifampin on the Pharmacokinetics of Sofosbuvir in Healthy Volunteers. 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2014). Boston USA, November 7-11, 2014. Abstract 992.