How is Olysio used to treat HCV?
Olysio (simeprevir) is a direct-acting antiviral medication indicated for adults with HCV genotype 1 in addition to treatment with sofosbuvir, who also present without cirrhosis or with compensated cirrhosis.1 Olysio is also indicated for adults with HCV genotype 1 or 4 with peginterferon alfa and ribavirin, who also present without cirrhosis or with compensated cirrhosis. Olysio should not be taken alone and is a direct-acting antiviral medication that acts as an HCV NS3/4A protease inhibitor. There is a potential for hepatitis B reactivation in individuals taking Olysio who have a history of HBV. Prior to taking Olysio, your provider should test you for HBV and note any history you have with the condition. It is important to also consult the prescribing information for any medications you are also taking in combination with Olysio, including sofosbuvir, ribavirin, and peginterferon alfa.2,3
What are the ingredients in Olysio?
The active ingredient in Olysio is simeprevir.
How does Olysio work?
Olysio’s active ingredient, simeprevir is an HCV NS3/4A protease inhibitor. Protease is an essential enzyme require for viral replication. In theory, by inhibiting this enzyme the virus will be prevented from further growth and reproduction. Many direct-acting antivirals work in this manner, targeting proteins, enzymes, and specific steps in the HCV life cycle.
What are the possible side effects of Olysio?
Multiple clinical trials evaluated the safety and efficacy of Olysio. The most common side effects of Olysio with sofosbuvir are headache, tiredness, and nausea. When taken with peginterferon alfa and ribavirin, the most common side effects are rash and photosensitivity, itchiness, and nausea.
This is not an exhaustive list of all potential side effects of Olysio. Talk to your healthcare provider or pharmacist for further information.
Things to note about Olysio
There is a possibility of HBV reactivation while taking Olysio if you have a history of HBV. Your provider will administer a blood test before starting Olysio to monitor your risk of HBV reactivation. Reactivation of HBV could cause serious liver problems including liver failure or death.
When taking Olysio with sofosbuvir there is a chance of developing bradycardia, or abnormally slow heart rate. This risk is especially prevalent in those taking amiodarone, a medicine used to treat heart conditions. Seek immediate help if you experience any of the following related to bradycardia:
- Near-fainting or fainting
- Chest pain
- Shortness of breath
- Memory problems
When taking Olysio, there is also a chance of developing severe liver problems, leading to liver failure or death. Your provider will monitor your liver function before and during treatment, however, you should contact your provider right away if you notice the following liver-related symptoms:
- Loss of appetite
- Nausea and vomiting
- Yellowing of skin or eyes
- Color changes in stools
Olysio in combination with other direct-acting antivirals may also cause skin reactions to sunlight and skin rashes, especially early on during treatment. It is important to practice proper sun safety while taking Olysio, including limiting sunlight exposure, wearing sunscreen, hats, and sunglasses outside, as well as avoiding tanning beds or other types of light therapy. If you notice blistering, redness, swelling, or burning of your skin, red or inflamed eyes, or mouth sores, contact your provider immediately.
Before staring Olysio talk to your provider if you:
- Have or have had hepatitis B infection
- Have or have had liver problems other than those related to HCV
- Have had a liver transplant
- Have any other medical conditions
- Are taking any other medications, supplements, or vitamins (including those for HCV)
- Are pregnant or are planning to become pregnant. It is not known if Olysio will affect an unborn baby.
- Are breastfeeding or planning to breastfeed. It is not known if Olysio can pass through breast milk.
Do not take Olysio with ribavirin if you are pregnant or if your significant other is pregnant. Consult the full prescribing information or your provider if you are pregnant or planning to become pregnant once stopping Olysio.
Olysio is a once-daily oral medication. A typical dose of Olysio is 150mg and is taken with food. Olysio is to be used in conjunction with sofosbuvir or ribavirin and peginterferon alfa. It is not meant to be taken as a standalone treatment. Do not start taking any medications without alerting your provider while on Olysio. Do not stop taking Olysio or change the dose of Olysio without talking to your provider. If you miss a dose, call your healthcare provider or pharmacist. If you take too much Olysio, seek help at your local emergency room immediately.
Olysio was removed from the US market in 2018.
- Olysio Prescribing Information. Janssen Pharmaceuticals. Feb 2017. Available from: https://www.olysio.com/shared/product/olysio/prescribing-information.pdf
- Sovaldi (sofosbuvir) Prescribing Information. Gilead Sciences. Aug 2015. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf
- Copegus (ribavirin) Prescribing Information. FDA.gov. Aug 2011. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf