Olysio | simeprevir

Drug Class: Direct Acting Antiviral Agent; Protease inhibitor
Similar Drugs: Incivek, Sovaldi, Victrelis
Manufacturer: Janssen
Approval Date: November 2013

What is Olysio

Olysio is a protease inhibitor used for treating chronic hepatitis C virus (HCV) infections. It is a direct acting antiviral agent. Olysio reduces the activity of hepatitis C virus protease enzymes which leads to the formation of defective viruses that are unable to multiply in the liver. As a result the hepatitis C viral load decreases.

What is Olysio used for

Olysio is used for treatment of chronic hepatitis C infection in adults. It must be used in combination with peginterferon alfa and ribavirin therapy. It is effective for HCV genotype 1 infection with compensated liver disease, including cirrhosis. An alternative therapy should be considered in patients with HCV genotype 1a containing the Q80K polymorphism. HCV has more than six different genotypes. Genotype means the genetic makeup of living things. Genotyping is used to identify the different types of HCV.   

How well does Olysio work

The efficacy of Olysio was evaluated in 4 clinical studies. All subjects received 12 weeks of once daily treatment with 150 mg Olysio or placebo plus pegylated interferon alpha and ribavirin, followed by 12 or 36 weeks of therapy with peginterferon alpha and ribavirin.

• In previously untreated subjects, hepatitis C virus levels were undetectable in 80% of Olysio treated subjects versus 50% of subjects that only received peginterferon alfa and ribavirin.

• In previously untreated subjects with the Q80K polymorphism, hepatitis C virus levels were undetectable in 58% of Olysio treated subjects versus 52% of subjects that only received peginterferon alfa and ribavirin.

• In subjects who failed previous therapy, virus levels were undetectable in 79% of Olysio treated subjects versus 37% of subjects that only received peginterferon alfa and ribavirin.

How is Olysio different from peginterferon alfa and ribavarin

• Olysio is a direct acting hepatitis C virus protease inhibitor.

• It reduces hepatitis C virus to undetectable levels in more patients.

• It is administered for only 12 weeks.

What is the dosage of Olysio

It is supplied as Olysio 150 mg capsules. Dosing is 150 mg administered orally once daily with a meal or snack for 12 weeks in combination with peginterferon alfa and ribavirin. Peginterferon alfa and ribavirin are continued for an additional 12 or 36 weeks depending on response. It can also be combined with sofosbuvir (Sovaldi) for 12 weeks.

What are the side effects of Olysio

Common: rash, photosensitivity (sun sensitivity), pruritus, muscle pain, shortness of breath (dyspnea), and nausea.

Serious: embryofetal toxicity (due to combination with ribavarin), photosensitivity (sun sensitivity), and rash.

Olysio Drug interactions

Olysio interacts with several drugs. Here are some potentially significant interactions in which co-administration is not recommended.

Drugs that Increase breakdown of Olysio leading to decreased blood levels of Olysio and reduced effect:

Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin

Antibiotics: rifampin, rifabutin, rifapentine

Corticosteroids: dexamethasone

St. John's Wort (Hypericum perforatum)

HIV drugs: evafirenz, etravirine, nevirapine

Drugs that decrease breakdown of Olysio, increasing blood levels of Olysio and possibly side effects. 

Antibiotics: erythromycin, clarithromycin, telithromycin

Antifungals: ketoconazole, itraconazole, posaconazole, voriconazole

Milk thistle (Silybum marianum)

HIV drugs:  elvitegravir/cobicistat/emtricitabine/tenofovir, darunavir/ritonavir, ritonavir. Combining Olysio with any HIV protease inhibitor is not recommended. 

What is the price of Olysio

$948.00 for each capsule, which is the dose for one day. The cost of Olysio for 28 days without insurance is $26,544.

How to obtain prescription assistance for Olysio

Use these resources for assistance with the cost of Olysio:

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

Olysio Savings Program

Patient Access Network Foundation

Patient Advocate Foundation

References

Olysio Prescribing Information (package insert) and Patient Information. Titusville, NJ: Janssen, Inc.; 2013.

RED BOOK Online. Olysio. Truven Health Analytics, Inc.; 2014.

Also Read

Are New Hepatitis C Virus (HCV) Treatments Too Expensive? 

New Drugs for Treatment of Hepatitis C: Victrelis, Incivek, Olysio, Sovaldi

Victrelis (boceprevir) Side Effects, Dosing, Price, Package Insert

The material on this site is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider.