Sofosbuvir / Velpatasvir

Atorvastatin

Dosage adjustment may be necessary.

Available pharmaceutical opinion

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

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Mechanism

Sofosbuvir / Velpatasvir may inhibit P-gp and OATP1B1/3 and increase plasma concentration of Atorvastatin.

Sofosbuvir / Velpatasvir

Pharmacodynamic effects

Recommendations

Alternative solution(s)

Atorvastatin

Pharmacodynamic effects

Possible increase of adverse effects.

Recommendations

Use this combination with caution.

A reduction in dosage may be necessary.

Monitor closely for adverse effects.

Alternative solution(s)

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

Lipidic profile

CK

Pharmacokinetic parameters
Parameters
Reference number
# patients
HCV
Dose
Frequency
AUC
Cmax
Sofosbuvir / Velpatasvir
3366
26
-
400/100 mg
QD
 
 
Atorvastatin
3366
26
-
40 mg
x 1
+ 59%
+ 68%
Comment

Ref #3366 : Metabolites of atorvastatin also increased: o-hydroxyatorvastatin AUC +37% and Cmax +11%; P-hydroxyatorvastatin AUC +77% and Cmax +41%; Atorvastatin lactone AUC +60% and Cmax +82%.
Exposures of sofosbuvir and its metabolites and velpatasvir were similar to historical data.
All treatments were well tolerated.

Reference
  • 3366
    Begley R, Mogalian E, McNabb B, Shen G, Lee S et al. Evaluation of Drug-Drug Interaction Potential between Sofosbuvir/Velpatasvir and Atorvastatin. 18th International Workshop on Clinical Pharmacology of Antiviral Therapy. June 14-16, 2017, Chicago, USA, Abstract P_49.
  • 3250
    Sofosbuvir/Velpatasvir (Epclusa), Gilead Sciences, Ontario, Canada, 5 novembre 2020.