Simeprevir is a direct-acting antiviral (DAA) agent against the hepatitis C virus.

OLYSIO is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
• OLYSIO efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotype 1 infected subjects with compensated liver disease (including cirrhosis).
• OLYSIO must not be used as monotherapy.
• Screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline is strongly recommended. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism.

• One 150 mg capsule taken once daily with food.
• OLYSIO should be administered with both peginterferon alfa and ribavirin. The recommended treatment duration of OLYSIO with peginterferon alfa and ribavirin is 12 weeks, followed by either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on prior response status.
• For specific dosage instructions for peginterferon alfa and ribavirin, see their respective prescribing information.
• A dose recommendation cannot be made for patients of East Asian ancestry.
• A dose recommendation cannot be made for patients with moderate to severe hepatic impairment.

The most common reported adverse reactions (greater than 20% of subjects) in subjects receiving the combination of OLYSIO with peginterferon and ribavirin and occurring with at least 3% higher frequency compared to subjects receiving placebo in combination with peginterferon alfa and ribavirin during the first 12 weeks of treatment were: rash (including photosensitivity), pruritus and nausea.

• All contraindications to peginterferon alfa and ribavirin also apply to OLYSIO combination treatment with peginterferon alfa and ribavirin.
• Because ribavirin may cause birth defects and fetal death, OLYSIO in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant.

• Embryofetal Toxicity (Use with Ribavirin and Peginterferon Alfa): Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects; avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
•Photosensitivity: Serious photosensitivity reactions have been observed during combination therapy with OLYSIO, peginterferon alfa and ribavirin. Use sun protection measures and limit sun exposure. Consider discontinuation if a photosensitivity reaction occurs.
• Rash: Rash has been observed during combination therapy with OLYSIO, peginterferon alfa and ribavirin. Discontinue OLYSIO if severe rash occurs.