Ledipasvir / Sofosbuvir

Rosuvastatin

Not recommended association.

Available pharmaceutical opinion

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

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Mechanism

Ledipasvir / Sofosbuvir may inhibit hepatic transports OATP1B1/B3 and BCRP and increase plasma concentration of Rosuvastatin.

Ledipasvir / Sofosbuvir

Pharmacodynamic effects

Recommendations

Alternative solution(s)

Rosuvastatin

Pharmacodynamic effects

Possible increase of adverse effects.

Recommendations

Association not recommended.

Choose an alternative.

If deemed clinically possible, discontinue treatment with statin during the taking of ledipasvir/sofosbuvir.

Alternative solution(s)

Statin without interaction with all of the medication.

Monitor

Symptoms of toxicity associated with hypolipidemic agents : gastrointestinal effects, fatigue and muscular weaknesses, myalgias, muscular cramps, myopathies, rhabdomyolysis and myoglobinuria leading to renal insufficiency.

Tests

CK

Lipidic profile

Pharmacokinetic parameters

Comment

Ref #3129: a pharmacokinetic study showed an increase of rosuvastatin AUC by 8-fold (+699%) and Cmax by 17.7-fold (+1670%) when co-administered with the GS-9451/ledipasvir/tegobuvir.

Reference
  • 3073
    Ledipasvir/Sofosbuvir (Harvoni), Gilead, Ontario, Canada, 16 avril 2018.
  • 3129
    Kirby B. Transporters : Role in Clinical Development of HCV Compounds. 15th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, Washington DC USA, 19-21 may 2014. Session 6.