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