Evaluation of Persistence of Resistant Variants with Ultra-Deep Pyrosequencing in Chronic Hepatitis C Patients Treated with Telaprevir 英文参考文献.docVIP

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Evaluation of Persistence of Resistant Variants with Ultra-Deep Pyrosequencing in Chronic Hepatitis C Patients Treated with Telaprevir 英文参考文献.doc

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Evaluation of Persistence of Resistant Variants with Ultra-Deep Pyrosequencing in Chronic Hepatitis C Patients Treated with Telaprevir 英文参考文献

EvaluationofPersistenceofResistantVariantswith Ultra-DeepPyrosequencinginChronicHepatitisC PatientsTreatedwithTelaprevir XiomaraV.Thomas1*.,JoepdeBruijne2.,JamesC.Sullivan3,TaraL.Kieffer3,CynthiaK.Y.Ho1, SjoerdP.Rebers1,MicheldeVries4,HendrikW.Reesink2,ChristineJ.Weegink2,RichardMolenkamp1, JankeSchinkel1 1AcademicMedicalCenter,DepartmentofMedicalMicrobiology,SectionofClinicalVirology,Amsterdam,TheNetherlands,2AcademicMedicalCenter,Departmentof Gastroenterology and Hepatology, Amsterdam, The Netherlands, 3Vertex Pharmaceuticals Incorporated, Cambridge, Massachusetts, United States of America, 4AcademicMedicalCenter,DepartmentofMedicalMicrobiology,SectionofHumanRetroVirology,Amsterdam,TheNetherlands Abstract Background Aims: Telaprevir, a hepatitis C virus NS3/4A protease inhibitor has significantly improved sustained viral responserateswhengivenincombinationwithpegylatedinterferonalfa-2aandribavirin,comparedwithcurrentstandard of care in hepatitis C virus genotype 1 infected patients. In patients with afailed sustained response, the emergence of drug-resistantvariantsduringtreatmenthasbeenreported.Itisuncleartowhatextentthesevariantspersistinuntreated patients. The aim of this study was to assess using ultra-deep pyrosequencing, whether after 4 years follow-up, the frequency of resistant variants is increased compared to pre-treatment frequencies following 14 days of telaprevir treatment. Methods: Fifteen patients from 2 previous telaprevir phase 1 clinical studies (VX04-950-101 and VX05-950-103) were included.Thesepatientsallreceivedtelaprevirmonotherapyfor14days,and2patientssubsequentlyreceivedstandardof care.Variantsatpreviouslywell-characterizedNS3proteasepositionsV36,T54,R155andA156wereassessedatbaseline andafterafollow-upof461.2yearsbyultra-deeppyrosequencing.Theprevalenceofresistantvariantsatfollow-upwas comparedtobaseline. Results:Resistanceassociatedmutationsweredetectableatlowfrequencyatbaseline.Ingeneral,prevalenceofresistance mutationsatfollow-upwasno