Pharmacokinetics and pharmacodynamics of sofosbuvir and ledipasvir for the treatment of hepatitis C

ABSTRACT

Introduction: The sofosbuvir (SOF) plus ledipasvir (LDV) fixed dose combination is the first direct action antiviral (DAA) single-treatment regimen (STR) to be commercialized. It is approved for the treatment of Hepatitis C virus (HCV) genotypes 1,3,4,5 and 6. Following approval in 2014, new pharmacokinetics and pharmacodynamics data were reported, which led to important clinical applications.

Areas covered: This article reviews the pharmacokinetic and pharmacodynamic properties of the SOF/LDV fixed dose combination for the treatment of HCV. The topics covered include data regarding the drug´s absorption, distribution, metabolism and excretion and antiviral activity strategies such as the clinical dose selection and treatment duration.

Expert opinion: The SOF/LDV fixed dose combination has good pharmacological properties that lead to a high sustained virological response after 12 or 24 weeks of treatment; there is minimal interference with other drugs or associated renal or hepatic impairment, such that dose adjustment is not necessary.

KEYWORDS:

• Pharmacokinetics
• pharmacodynamics
• sofosbuvir
• ledipasvir
• hepatitis C

Declaration of interest

A Rivero-Juarez and Francisca Cuenca-Lopez are supported by the Instituto Maimonides de Investigación Biomédica de Córdoba (IMIBIC). A Rivero is supported by the Sistema Sanitario Público Andaluz (SAS). A Rivero has received consulting fees from Bristol-Myers Squibb, Abbott, Gilead, Roche, Boehringer Ingelheim, GlaxoSmithKline, Merck Sharp & Dohme, Janssen-Cilag, and has received lecture fees from GlaxoSmithKline, Roche, Abbott, Bristol-Myers Squibb, Boehringer Ingelheim and Schering-Plough. A Rivero-Juarez has received consultance fees from Bristol-Myers Squibb, Abbott, Gilead, and Janssen-Cilag. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was not funded.