Pharmacokinetic drug evaluation of velpatasvir plus sofosbuvir for the treatment of hepatitis C virus infection

ABSTRACT

Introduction: The fixed-dose combination therapy of sofosbuvir (SOF) plus velpatasvir (VEL) is the first pangenotypic, direct-acting antiviral (DAA), single-treatment regimen (STR) for the treatment of hepatitis C virus (HCV) infection to be commercialized. It is approved for the treatment of HCV genotypes 1, 2, 3, 4, 5, and 6. Following approval in 2016, new pharmacokinetic and pharmacodynamic data were reported, which led to important clinical applications.

Areas covered: This review provides a summary of the pharmacokinetics, pharmacodynamics, efficacy and safety of SOF/VEL therapy for treatment of HCV infection. The topics covered include data regarding the drug’s absorption, distribution, metabolism, excretion and antiviral activity strategies, such as clinical dose selection and treatment duration.

Expert opinion: This novel combination therapy containing 400 mg of SOF plus 100 mg of VEL, taken orally, once daily, with or without food, has an excellent pharmacokinetic and pharmacodynamic profile. SOF/VEL achieved very high rates of sustained virological response in treatment-naive and treatment-experienced patients with chronic HCV genotype 1–6 infection, including those with compensated cirrhosis or HIV-1 co-infection.

KEYWORDS:

• Pharmacokinetics
• pharmacodynamics
• sofosbuvir
• velpatasvir
• hepatitis C

Declaration of interest

A Rivero has served on the advisory Board of Merck, Gilead Sciences, Bristol Myers Squibb, and Abbvie and has participated in research for these companies. A Rivero-Juarez and T Brieva are supported by the Instituto Maimonides de Investigación Biomédica de Córdoba (IMIBIC). A Rivero is supported by the Sistema Sanitario Público Andaluz (SAS).

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.