November 22, 2013

Simeprevir for the treatment of chronic hepatitis C

Drug Evaluations

Expert Opin Pharmacother. December 2013, Vol. 14, No. 18 , Pages 2581-2589 (doi:10.1517/14656566.2013.850074)

David M You 1 & Paul J Pockros 2,3

1 Naval Medical Center San Diego, Division of Gastroenterology, Department of the Navy, CA, USA

2 Scripps Clinic, Division of Gastroenterology/Hepatology, 10666 N. Torrey Pines Road, La Jolla, CA 92037,

3 Scripps Translational Science Institute, La Jolla, CA, USA

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-na├»ve 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.

Keywords chronic hepatitis C, genotype 1, protease inhibitor, simeprevir, TMC435


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