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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®

Anti-infectives

  • Antibiotics (systemic administration)
    • Erythromycin
    • Clarithromycin
    • Telithromycin
  • Antifungals (systemic administration)
    • Itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole
  • Antimycobacterials
    • Rifampin, rifabutin, rifapentine

HCV products

  • Antiviral
    • Ledipasvir§

HIV products

  • Cobicistat-containing products
  • NNRTI
    • Efavirenz
  • Other NNRTIs
    • Delavirdine, etravirine, nevirapine
  • PI
    • Darunavir/ritonavir†‖
    • Ritonavir†¶
  • Other HIV products (boosted or unboosted)
    • Atazanavir, fosamprenavir, lopinavir, indinavir, nelfinavir, saquinavir, tipranavir

Antiarrhythmics

  • Amiodarone (coadministered with sofosbuvir)

Herbal products

  • Milk thistle
  • St. John’s wort

Other drugs

  • Anticonvulsants
    • Carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • Dexamethasone (Corticosteroid)
  • Cisapride (Propulsive)
  • Cyclosporine†#(Immunosuppresant)

The following require caution and/or clinical monitoring when coadministered with OLYSIO®

Cardiovascular agents

  • ↑ 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

Immunosuppressants

  • ↑or↓sirolimus

Other drugs

  • 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.

  • Caffeine
  • Daclatasvir
  • Dextromethorphan
  • Escitalopram
  • Ethinyl estradiol/norethindrone
  • Methadone
  • Midazolam (intravenous administration)
  • Omeprazole
  • Raltegravir
  • Rilpivirine
  • Sofosbuvir
  • Tacrolimus
  • Tenofovir disoproxil fumarate
  • Warfarin

No clinically relevant drug interactions expected when OLYSIO® is coadministered with

  • Antacids
  • Azithromycin
  • Bedaquiline
  • Corticosteroids (budesonide, fluticasone, methylprednisolone, prednisone)
  • Dolutegravir
  • H2-receptor antagonists
  • Narcotic analgesics (buprenorphine, naloxone)
  • NRTIs (eg, abacavir, didanosine, emtricitabine, lamivudine, stavudine, zidovudine)
  • Maraviroc
  • Methylphenidate
  • Proton pump inhibitors 

 

 

NNRTI=non-nucleoside reverse-transcriptase inhibitor; NRTI=nucleoside reverse-transcriptase inhibitor; PI=protease inhibitor; PPI=proton pump inhibitor.