• OLYSIO® is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C virus genotype 1 infection. OLYSIO® should not be taken alone. OLYSIO® is not for people with certain types of liver problems. It is not known if OLYSIO® is safe and effective in children under 18 years of age.

OLYSIO works by blocking the viral protease enzyme that enables the hepatitis C virus (HCV) to replicate in host cells. The goal of treatment for chronic hepatitis C is cure, also known as sustained virologic response (SVR), which is defined as undetectable levels of HCV in the patients’ blood 12 to 24 weeks after the end of treatment. For treatment-naïve and prior-relapser patients, a fixed treatment regimen of 12 weeks of OLYSIO™ combined with 24 weeks of pegylated interferon and ribavirin is recommended. For prior partial- and null-responder patients, a treatment regimen of 12 weeks of OLYSIO™ combined with 48 weeks of pegylated interferon and ribavirin is recommended.

Olysio side effects

Get emergency medical help if you have signs of an allergic reaction to Olysio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Read all of your medication guides to learn about possible side effects of other medications you use in combination with Olysio. Ask your doctor or pharmacist if you have any questions.

Call your doctor at once if you have:

• new or worsening liver symptoms, such as nausea, tiredness, loss of appetite, clay-colored stools, or yellowing of your skin or eyes;

• severe skin rash (redness, swelling, burning, blistering);

• eye redness or puffiness;

• mouth sores;

• shortness of breath; or

• (if you also take amiodarone) - confusion, chest pain, extreme weakness or drowsiness, feeling like you might pass out.

Your treatment with Olysio may be permanently discontinued if you have certain side effects.

Common Olysio side effects may include:

• mild itching or rash;

• nausea; or

• headach

• If any of the following side effects occur while taking sofosbuvir, check with your doctor immediately:

  More common:
• chills
• fever
• lower back or side pain
• pale skin
• ulcers, sores, or white spots in the mouth
• unusual tiredness or weakness

• Before using sofosbuvir:

  Some medical conditions may interact with sofosbuvir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are able to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems other than HCV (eg, cirrhosis), HIV infection, or anemia
• if you have kidney problems or you are on dialysis
• if you have had a liver transplant
• if you are taking amiodarone. The risk of slow heartbeat may be increased, especially if you are taking a beta blocker (eg, metoprolol), have heart problems, or have severe liver disease

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