In the pursuit to cure* chronic hepatitis C virus (HCV) genotype 1 infection…Consider once-daily OLYSIO® in combination with sofosbuvir (SOF) for your individual patient needs
OLYSIO® has a demonstrated safety profile
Coadministration of OLYSIO® with substances that are moderate or strong inducers or inhibitors of cytochrome P450 3A (CYP3A) is not recommended, as this may lead to significantly lower or higher exposure of OLYSIO®, respectively, which may result in reduced therapeutic effect or adverse reactions.
Potentially significant drug interactions—drug-drug interactions (DDIs)
The following drugs are not recommended to be coadministered with OLYSIO®
Antibiotics (systemic administration)
Antifungals (systemic administration)
- Itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole
- Rifampin,†‡ rifabutin, rifapentine
- Cobicistat-containing products
- Delavirdine, etravirine, nevirapine
Other HIV products (boosted or unboosted)
- Atazanavir, fosamprenavir, lopinavir, indinavir, nelfinavir, saquinavir, tipranavir
- Amiodarone (coadministered with sofosbuvir)
- Milk thistle
- St. John’s wort
- Carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- Dexamethasone (Corticosteroid)
- Cisapride (Propulsive)
The following require caution and/or clinical monitoring when coadministered with OLYSIO®
- ↑ Digoxin†
Antiarrhythmics (oral administration) (↑ drugs)
- Amiodarone (coadministered without sofosbuvir), disopyramide, flecainide, mexiletine, propafenone, quinidine
Calcium channel blockers (oral administration) (↑ drugs)
- Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil
Statins (↑ drugs)
- Pitavastatin, pravastatin, rosuvastatin,† atorvastatin,† simvastatin,† lovastatin, fluvastatin
Phosphodiesterase type 5 inhibitors for pulmonary arterial hypertension (↑ drugs)
- Sildenafil, tadalafil, vardenafil
- Midazolam (Sedatives/Anxiolytics),† triazolam (↑ drugs; oral administration)
*Virologic cure (SVR12) was defined as sustained virologic response 12 weeks after actual (OPTIMIST-1) or planned (COSMOS) end of treatment (EOT).
†These interactions have been studied in healthy adults with the recommended dose of OLYSIO® 150 mg once daily unless otherwise noted.
‡The dose of OLYSIO® in this interaction study was 200 mg once daily, both when given alone and when coadministered with rifampin 600 mg once daily.
§The interaction between simeprevir and ledipasvir was evaluated in a pharmacokinetic study in HCV-infected patients by comparing simeprevir exposure following simeprevir + 90/400 mg ledipasvir/sofosbuvir dosing versus simeprevir + 400 mg sofosbuvir dosing and by comparing ledipasvir exposure following simeprevir + 90/400 mg ledipasvir/sofosbuvir dosing versus 90/400 mg ledipasvir/sofosbuvir dosing.
‖The dose of OLYSIO® in this interaction study was 50 mg once daily when coadministered in combination with darunavir/ritonavir, compared with 150 mg once daily in the OLYSIO®-alone treatment group.
¶The dose of OLYSIO® in this interaction study was 200 mg once daily, both when given alone and when coadministered in combination with ritonavir 100 mg twice daily.
#Studied in combination with daclatasvir and RBV in a Phase 2 trial in HCV-infected post-liver transplant patients.
Additional Drug-Drug information—No expected clinically relevant DDIs
Interactions between OLYSIO® and the following drugs were evaluated in clinical studies. No dose adjustments are needed for either drug.
- Ethinyl estradiol/norethindrone
- Midazolam (intravenous administration)
- Tenofovir disoproxil fumarate
No clinically relevant drug interactions expected when OLYSIO® is coadministered with
- Corticosteroids (budesonide, fluticasone, methylprednisolone, prednisone)
- H2-receptor antagonists
- Narcotic analgesics (buprenorphine, naloxone)
- NRTIs (eg, abacavir, didanosine, emtricitabine, lamivudine, stavudine, zidovudine)
- Proton pump inhibitors
NNRTI=non-nucleoside reverse-transcriptase inhibitor; NRTI=nucleoside reverse-transcriptase inhibitor; PI=protease inhibitor; PPI=proton pump inhibitor.