title: Sofosbuvir: A Nucleotide NS5B Inhibitor for the Treatment of Chronic Hepatitis C Infection.
abstract: OBJECTIVE
  To review the use of sofosbuvir for the treatment of chronic hepatitis C virus (HCV).
  
  
  METHODS
  Review and nonreview articles were identified through MEDLINE (1996-April 2014), citations of articles, and meeting abstracts using keywords, including NS5B polymerase inhibitor, GS-7977, sofosbuvir, direct-acting antiviral (DAA), and others.
  
  
  METHODS
  Phase 1, 2, and 3 studies describing dose-ranging potential, pharmacokinetics, efficacy, safety, and tolerability of sofosbuvir were identified.
  
  
  RESULTS
  Sofosbuvir is an NS5B polymerase inhibitor that was approved for use by the Food and Drug Administration in December 2013 for the treatment of chronic HCV in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) for genotype 1. Additionally, it has been evaluated with other oral DAAs, such as simeprevir and others in the pipeline. It is not recommended as monotherapy because of lower sustained virological response (SVR) rates in clinical studies. Most of the treatment regimens are 12 weeks in duration; however, certain populations require a longer duration. Sofosbuvir has activity against all 6 genotypes, although most clinical trials evaluated genotypes 1 to 3. Sofosbuvir has a favorable safety and tolerability profile, making it a recommended first-line agent for chronic HCV infection.
  
  
  CONCLUSIONS
  In clinical trials, 12 weeks of sofosbuvir with concomitant peg-IFN and RBV therapy in treatment-naïve and experienced HCV genotype 1 patients resulted in SVR rates of >90%. An all-oral regimen of sofosbuvir and RBV is highly effective for genotype 2 and 3 patients. Sofosbuvir was found to be tolerable with minimal adverse effects (AEs), and no treatment discontinuations occurred secondary to drug related AEs..
authors.affiliation: Western New England University, Springfield, MA, USA lrose@wne.edu.
authors.forename: Lucia
authors.initials: L
authors.lastname: Rose
authors.affiliation: Hahnemann University Hospital, Philadelphia, PA, USA.
authors.forename: Tiffany E
authors.initials: TE
authors.lastname: Bias
authors.affiliation: Western New England University, Springfield, MA, USA.
authors.forename: Clinton B
authors.initials: CB
authors.lastname: Mathias
authors.affiliation: Drexel University College of Medicine, Philadelphia, PA, USA.
authors.forename: Stacey B
authors.initials: SB
authors.lastname: Trooskin
authors.affiliation: MCPHS University-Worcester/Manchester, Worcester, MA, USA.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Fong
keywords: GS-7977; NS5B polymerase inhibitor; chronic hepatitis C infection; sofosbuvir