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OLYSIO
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Pharmacodynamic properties:
Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
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Mechanism of action:
Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication. In a biochemical assay, simeprevir inhibited the proteolytic activity of recombinant genotype 1a and 1b HCV NS3/4A proteases, with median Ki values of 0.5 nM and 1.4 nM, respectively.
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Indications:
OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.
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Dosage:
The recommended dosage of OLYSIO is one capsule of 150 mg once daily for 12 weeks, taken with food.
OLYSIO must not be administered as monotherapy. OLYSIO must be used in combination with other medicinal products for the treatment of CHC.
Combination treatment with peginterferon alfa and ribavirin.
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AUGISPOV
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– Indications:
Sofosbuvir is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
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– Pharmacotherapeutic group:
Direct-acting antiviral.
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– Mechanism of action:
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7 to 2.6 ?M. GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
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– Dose:
. The recommended dose is one 400 mg tablet, taken orally, once daily with food.
. Sofosbuvir should be used in combination with other medicinal products. Monotherapy of Sofosbuvir is not recommended.
. Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy:
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Patient population : Treatment # Duration
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Patients with genotype 1, 4, 5 or 6 CHC:
Sofosbuvir + ribavirin + peginterferon alfa # 12 weeks
Sofosbuvir + ribavirin (Only for use in patients ineligible or intolerant to peginterferon alfa) # 24 weeks
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Patients with genotype 2 CHC:
Sofosbuvir + ribavirin # 12 weeks
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Patients with genotype 3 CHC:
Sofosbuvir + ribavirin + peginterferon alfa # 12 weeks
Sofosbuvir + ribavirin # 24 weeks
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Patients with CHC awaiting liver transplantation:
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