Comparative Pharmacology
Head-to-head clinical analysis: FAVLYXA versus HARVONI.
Peer-Reviewed Evidence
Head-to-head clinical analysis: FAVLYXA versus HARVONI.
FAVLYXA vs HARVONI
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.
Fixed-dose combination of ledipasvir, an HCV NS5A inhibitor, and sofosbuvir, an HCV NS5B nucleotide polymerase inhibitor. Ledipasvir inhibits HCV NS5A protein essential for viral replication and assembly; sofosbuvir is a prodrug that after intracellular metabolism acts as a chain terminator by inhibiting NS5B RNA-dependent RNA polymerase.
200 mg orally twice daily for 10 days.
One tablet (90 mg ledipasvir/400 mg sofosbuvir) orally once daily with or without food for 12 weeks. For treatment-naïve patients with genotype 1 and cirrhosis, 24 weeks may be considered. For genotype 4, 12 weeks recommended.
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).
Ledipasvir: 47 hours; Sofosbuvir: 0.5 hours; GS-331007 (predominant circulating metabolite): 27 hours; clinical context: supports once-daily dosing with no accumulation beyond steady state by day 7
Primarily renal excretion of unchanged drug (approx. 85%) with biliary/fecal elimination accounting for the remainder (approx. 15%).
Ledipasvir: 86% fecal, 1% renal; Sofosbuvir: 80% renal (as inactive metabolite GS-331007), 14% fecal; GS-331007: 78% renal
Category C
Category C
Antiviral
Antiviral