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Clinical evaluation of efficacy, tolerability and pharmacokinetics of yimitasvir phosphate in patients infected with hepatitis C virus.
- Source :
-
Journal of Pharmacy & Pharmacology . Jul2018, Vol. 70 Issue 7, p855-864. 10p. - Publication Year :
- 2018
-
Abstract
- Abstract: Objective: Yimitasvir phosphate, an inhibitor of nonstructural protein 5A (NS5A) replication complex of hepatitis C virus (HCV), was evaluated in a double‐blind, placebo‐controlled, parallel, multiple‐dose study. Methods: Twenty‐four patients with chronic HCV genotype 1 infection were randomized to receive a 7‐day course of yimitasvir phosphate at daily doses of 30, 100 or 200 mg or placebo. Antiviral efficacy, resistance profile, pharmacokinetics (PK), safety and tolerability were assessed. Key findings: The maximal reduction in HCV RNA from baseline was 5.17 log10 IU/ml. However, most patients experienced viral rebound on or before day 3 after yimitasvir treatment was initiated. The PK profile revealed median peak plasma concentrations at 4–12 h postdose and a mean terminal half‐life of 14.47–17.09 h, the basis for daily dosing. Steady drug state was achieved following 5 days of daily dosing. The accumulation rate was low (1.29–1.73). There were no significant alterations in vital signs and laboratory findings among all participants. Conclusions: This study shows that yimitasvir phosphate was well tolerated, and the PK profile supported daily dosing regimens. A 1‐week (7‐day) treatment course led to a quick and significant reduction in HCV RNA level in this cohort with HCV GT‐1 infection. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00223573
- Volume :
- 70
- Issue :
- 7
- Database :
- Academic Search Index
- Journal :
- Journal of Pharmacy & Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 130056645
- Full Text :
- https://doi.org/10.1111/jphp.12916