Simeprevir for the treatment of chronic hepatitis C

Expert Opin Pharmacother. 2013 Dec;14(18):2581-9. doi: 10.1517/14656566.2013.850074. Epub 2013 Oct 19.

Abstract

Introduction: The addition of protease inhibitors such as telaprevir and boceprevir with PEGylated interferon and ribavirin has significantly improved cure rates for genotype 1 hepatitis C virus (HCV) infection. Simeprevir (TMC435) is a second-generation protease inhibitor that is in development for the treatment of genotype 1 HCV infection.

Areas covered: The authors present: i) an overview of Phases I - III clinical trials of simeprevir for HCV infection based on peer-reviewed literature and congress presentations and ii) an evaluation of the efficacy and safety of simeprevir in the treatment of HCV infection.

Expert opinion: Simeprevir is a once-daily oral medication that combined with PEGylated interferon and ribavirin appears to be a potent and safe agent to treat genotype 1 HCV infection for patients who are treatment-naïve and prior treatment-failures. Compared to telaprevir and boceprevir, simeprevir will likely be the protease inhibitor of choice for genotype 1 HCV infection based on ease of use, lower rates of adverse events, including rash and anemia, and no significant reported drug-drug interactions. Associated side effects inherent with interferon-based regimens may be problematic for patients. As HCV therapies evolve into interferon-free regimens, simeprevir may potentially be combined with other oral direct-acting agents without interferon to treat HCV infection.

Publication types

  • Review

MeSH terms

  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Clinical Trials, Phase III as Topic
  • Drug Therapy, Combination
  • Genotype
  • Hepacivirus / genetics
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / virology
  • Heterocyclic Compounds, 3-Ring / administration & dosage
  • Heterocyclic Compounds, 3-Ring / adverse effects
  • Heterocyclic Compounds, 3-Ring / therapeutic use*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use
  • Polyethylene Glycols / administration & dosage
  • Polyethylene Glycols / adverse effects
  • Polyethylene Glycols / therapeutic use
  • Protease Inhibitors / administration & dosage
  • Protease Inhibitors / adverse effects
  • Protease Inhibitors / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Ribavirin / administration & dosage
  • Ribavirin / adverse effects
  • Ribavirin / therapeutic use
  • Simeprevir
  • Sulfonamides / administration & dosage
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*

Substances

  • Antiviral Agents
  • Heterocyclic Compounds, 3-Ring
  • Interferon alpha-2
  • Interferon-alpha
  • Protease Inhibitors
  • Recombinant Proteins
  • Sulfonamides
  • Polyethylene Glycols
  • Ribavirin
  • Simeprevir
  • peginterferon alfa-2b
  • peginterferon alfa-2a