Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2014
Patients eligible for treatment with simeprevir in a French center.
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Morel Virginie, Duverlie Gilles, Brochot Etienne
Аннотация
BACKGROUND: Simeprevir (Olysio(®)), a second-wave protease inhibitor recently approved for the treatment of chronic hepatitis C, is not indicated in patients with genotype 1a strain harboring the Q80K protease mutation. Phase 2 and 3 studies on this molecule mainly focused on North American patients and the prevalence of Q80K is particularly high in the USA (around 50%). The prevalence of this mutation in other parts of the world is currently unknown.
OBJECTIVES: The purpose of our study was to perform a detection of this mutation in a single PCR technique and to study the prevalence of this Q80K mutation in a non U.S. population. We can thus estimate the proportion of HCV positive patients who can be treated with simeprevir.
STUDY DESIGN: We conducted a meta-analysis of response rates in the presence or absence of this mutation in randomized trials and then describe a simple and reliable method to detect this mutation. We also examined bilirubin levels in our cohort of 95 HCV genotype 1a patients.
RESULTS: Ten patients (10.5%) had a Q80K mutation and 12 patients exhibited bilirubin levels above the upper limit of normal at baseline. In our cohort, 21 patients (22%) were therefore ineligible for treatment with simeprevir. The prevalence of this mutation seems to be much lower in European patients.
CONCLUSION: In conclusion, before considering treatment with simeprevir, physicians must be able to screen for the Q80K mutation.
OBJECTIVES: The purpose of our study was to perform a detection of this mutation in a single PCR technique and to study the prevalence of this Q80K mutation in a non U.S. population. We can thus estimate the proportion of HCV positive patients who can be treated with simeprevir.
STUDY DESIGN: We conducted a meta-analysis of response rates in the presence or absence of this mutation in randomized trials and then describe a simple and reliable method to detect this mutation. We also examined bilirubin levels in our cohort of 95 HCV genotype 1a patients.
RESULTS: Ten patients (10.5%) had a Q80K mutation and 12 patients exhibited bilirubin levels above the upper limit of normal at baseline. In our cohort, 21 patients (22%) were therefore ineligible for treatment with simeprevir. The prevalence of this mutation seems to be much lower in European patients.
CONCLUSION: In conclusion, before considering treatment with simeprevir, physicians must be able to screen for the Q80K mutation.
Предметные рубрики MeSH
AdultAgedAmino Acid SubstitutionAntiviral AgentsCohort StudiesFemaleFranceGenotypeHepacivirusHepatitis C, ChronicHeterocyclic Compounds, 3-RingHumansMaleMiddle AgedMutant ProteinsSimeprevirSulfonamidesViral Nonstructural ProteinsSerine EndopeptidasesNucleoside-TriphosphataseDEAD-box RNA HelicasesViral Proteases