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This was a phase 1, open-label, single-center, non-randomized study of telaprevir in combination with Caduet (amlodipine/atorvastatin) 5mg/20mg in 19 healthy subjects. A single dose of Caduet was given on day 1, with a washout of 10 days, followed by administration of telparevir 750mg q8h on days 11 through 26, with a single dose of Caduet given on day 17.
The mean Cmax and AUC0-8 was increased 10.6-fold, and 7.88-fold, respectively for atorvastatin when given as a single dose after seven days of telaprevir 750mg q8h. The manufacturer states that it is contraindicated to administer atorvastatin, lovastatin, or simvastatin with telaprevir because of potential for myopathy, including rhabdomyolysis.
An alternative HMG-CoA reductase inhibitor could be considered if combined use with a protease inhibitor is necessary. For fluvastatin, pitavastatin, pravastatin, and low-dose rosuvastatin, caution is warranted and clinical monitoring is recommended. Always use the lowest possible dose of the HMG-CoA reductase inhibitor and monitor patients closely for any signs or symptoms of toxicity.
Lee EJ, Van Heeswijk RV, Alves K. Effect of the hepatitis c virus protease inhibitor telaprevir on the pharmacokinetics of amlodipine and atorvastatin. Antimicrobial Agents And Chemotherapy . 2011; : 4569-4574.