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Drug Interactions between Harvoni and simeprevir

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

simeprevir ledipasvir

Applies to: simeprevir and Harvoni (ledipasvir / sofosbuvir)

GENERALLY AVOID: Coadministration of ledipasvir and simeprevir may significantly increase the plasma concentrations of both drugs. The proposed mechanism is ledipasvir inhibition of the OATP1B1-mediated hepatic uptake of simeprevir and, conversely, simeprevir inhibition of the P-glycoprotein-mediated intestinal efflux of ledipasvir. When ledipasvir 30 mg once daily was administered concomitantly with simeprevir 150 mg once daily to 22 healthy volunteers, mean simeprevir peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 161% and 169%, respectively, while mean ledipasvir Cmax and AUC increased by 81% and 92%, respectively. In clinical trials, higher simeprevir exposures have been associated with increased frequency of adverse reactions including rash and photosensitivity.

MANAGEMENT: Concomitant use of ledipasvir-sofosbuvir with simeprevir is not recommended.

References (1)
  1. (2014) "Product Information. Harvoni (ledipasvir-sofosbuvir)." Gilead Sciences

Drug and food interactions

Moderate

simeprevir food

Applies to: simeprevir

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of simeprevir, although the type of food does not seem to matter. In healthy study subjects, administration of simeprevir after a high-fat, high-caloric (928 kcal) breakfast increased systemic exposure (AUC) by 61% and delayed absorption by 1 hour, while administration after a normal caloric (533 kcal) breakfast increased AUC by 69% and delayed absorption by 1.5 hours.

MANAGEMENT: To ensure maximal oral absorption, simeprevir should be administered with food.

References (1)
  1. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


Report options

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.