Comparative Pharmacology
Head-to-head clinical analysis: FAVLYXA versus INCIVEK.
Head-to-head clinical analysis: FAVLYXA versus INCIVEK.
FAVLYXA vs INCIVEK
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Acyclic nucleoside phosphonate prodrug that inhibits viral RNA-dependent RNA polymerase (RdRP) by competing with adenosine triphosphate (ATP). It incorporates into nascent viral RNA causing chain termination after incorporation of the first 1-2 nucleotides.
Inhibitor of the HCV NS3/4A serine protease, preventing cleavage of the HCV polyprotein, thereby inhibiting viral replication.
200 mg orally twice daily for 10 days.
Incivek (telaprevir) is administered orally at a dose of 750 mg (two 375 mg tablets) three times daily (every 7-9 hours) with food (not low-fat).
None Documented
None Documented
Terminal elimination half-life approximately 5-7 hours in patients with normal renal function; prolonged in renal impairment (up to 24 hours in severe impairment).
Terminal elimination half-life ranges from 4 to 13 hours (mean ~7 hours) in healthy volunteers; prolonged to 10-20 hours in HCV-infected patients.
Primarily renal excretion of unchanged drug (approx. 85%) with biliary/fecal elimination accounting for the remainder (approx. 15%).
Approximately 91% of the radiolabeled dose is recovered in feces (79% as unchanged drug) and 9% in urine (1% as unchanged drug).
Category C
Category C
Antiviral
Antiviral