Olysio

Generic name: simeprevir

Drug class: Protease inhibitors

Dosage form: Capsule

Route of administration: Oral

Dose: 150 mg once daily with food

Mechanism of action: Simeprevir is a direct-acting antiviral agent that inhibits the hepatitis C virus (HCV) NS3/4A protease enzyme, essential for viral replication. By blocking this enzyme, simeprevir prevents the cleavage of the HCV polyprotein, thereby inhibiting the formation of mature, infectious virus particles.

Drug usage cases:

• Chronic hepatitis C infection in adults, specifically HCV genotype 1, in combination with other antiviral agents.

Drug contraindications:

• Hypersensitivity to simeprevir or any component of the formulation.
• Co-infection with hepatitis B virus (HBV) without appropriate HBV treatment.
• Severe hepatic impairment (Child-Pugh C) or decompensated cirrhosis.
• Concurrent use with certain medications that are strong inducers of CYP3A, such as rifampin, carbamazepine, and St. John’s wort.

Side effects:

• Rash
• Itching
• Nausea
• Fatigue
• Headache
• Photosensitivity reactions (increased sensitivity to sunlight)

Warnings:

• Monitor liver function tests before and during treatment.
• Assess for HBV infection prior to initiating therapy; co-infection may require additional antiviral treatment.
• Patients with HCV genotype 1a infection should be tested for the NS3 Q80K polymorphism; efficacy may be reduced in its presence.
• Use caution in patients with a history of sulfonamide allergy due to potential cross-reactivity.
• Discontinue therapy if severe skin reactions or signs of hepatic decompensation occur.

Use during pregnancy or breastfeeding:

There is limited data on the use of simeprevir during pregnancy. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Simeprevir is excreted in human milk; caution should be exercised when administered to a nursing woman. The decision to discontinue nursing or the drug should be made based on the importance of the drug to the mother.