Adult Dosing

Chronic Hepatitis C in combination with peginterferon and ribaviron

• 150 mg PO Daily in combination with peginterferon alfa and ribavirin or 12 weeks
• All treatment-naïve and prior relapser patients, including those with cirrhosis, conider additional 12 weeks of peginterferon alfa and ribavirin with simeprevir
• All prior non-responder patients, including those with cirrhosis, should receive an additional 36 weeks of peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin

Note:

• Discontinue if inadequate virologic response
• Must not be used as monotherapy; if peginterferon alfa or ribavirin is discontinued for any reason, simeprevir must also be discontinued
• Refer package insert for dose modifications

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of chronic hepatitis C (CHC) genotype 1a infection in combination with peginterferon alfa and ribavirin

• Hypersensitivity to any of the ingredients of the product
• Pregnant women and in men whose female partners are pregnant
• Monotherapy

• N/A

Renal Dose Adjustment

• No dose adjustments

Hepatic Dose Adjustment

• No dose recommendation

• Therapy may cause birth defects or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Use contraceptive methods during treatment and for 6 months after completion of treatment , and undergo monthly pregnancy tests
• Serious photosensitivity reactions have been reported during combination therapy with simeprevir, peginterferon alfa and ribavirin. Use sun protection measures and limit sun exposure. Consider discontinuation if a photosensitivity reaction occurs
• Rash has been observed during combination therapy with simeprevir, peginterferon alfa and ribavirin. Discontinue simeprevir if severe rash occurs

Pregnancy Category:X (with ribavirin and peginterferon alfa) and C (Olysio)

Breastfeeding: Manufacturer advises caution

• GI: Nausea
• REPRODUCTIVE: Embryo-fetal toxicity
• DERM: Photosensitivity, rash, pruritus
• MUSC: Myalgia
• RESP: Dyspnea

• Antiviral; inhibits the proteolytic activity of HCV NS3/4A protease which is essential for viral replication
• Metabolized by liver. CYP450: 3A, 2C8, 2C19
• Excreted in feces (91%) and urine (<1%)
• Half-life: 41 hr (HCV-infected); 10-13 hr (HCV-uninfected)

US Trade Name(s)

• Olysio

US Availability

Olysio

• CAPS: 150 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Antimicrobials

Antiviral (HIV) Agents

Protease Inhibitors

Infectious Disease

Antiviral (HIV) Agents

Protease Inhibitors