Prevalence and Clinical Significance of HIV Drug Resistance Mutations by Ultra-Deep Sequencing in Antiretroviral-Na？ve Subjects in the CASTLE Study 英文参考文献.docVIP

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Prevalence and Clinical Significance of HIV Drug Resistance Mutations by Ultra-Deep Sequencing in Antiretroviral-Na？ve Subjects in the CASTLE Study 英文参考文献.doc

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Prevalence and Clinical Significance of HIV Drug Resistance Mutations by Ultra-Deep Sequencing in Antiretroviral-Na？ve Subjects in the CASTLE Study 英文参考文献

PrevalenceandClinicalSignificanceofHIVDrug ResistanceMutationsbyUltra-DeepSequencingin Antiretroviral-Na?¨veSubjectsintheCASTLEStudy MaxLataillade1,2,JenniferChiarella2,RongYang1,StevenSchnittman1,VictoriaWirtz1,JonathanUy1, DanielSeekins1,MarkKrystal1,MarcoMancini1,DonnieMcGrath1,BirgitteSimen3,MichaelEgholm3, MichaelKozal2* 1GlobalDevelopmentandMedicalAffairs,Bristol-MyersSquibb,Wallingford,Connecticut,UnitedStatesofAmerica,2YaleUniversitySchoolofMedicineandVeterans AffairsConnecticutHealthcareSystem,NewHaven,Connecticut,UnitedStatesofAmerica,3454LifeSciences,aRochecompany,Branford,Connecticut,UnitedStatesof America Abstract Background: CASTLE compared the efficacy of atazanavir/ritonavir with lopinavir/ritonavir, each in combination with tenofovir-emtricitabineinARV-na?¨vesubjectsfrom5continents. Objectives:DeterminethebaselinerateandclinicalsignificanceofTDRmutationsusingultra-deepsequencing(UDS)in ARV-na?¨vesubjectsinCASTLE. Methods:Acasecontrolstudywasperformedonbaselinesamplesforall53subjectswithvirologicfailures(VF)atWeek48 and 95 subjects with virologic successes (VS) randomly selected and matched by CD4 count and viral load. UDS was performedusing454LifeSciences/Rochetechnology. Results:Of148samples,141hadsuccessfulUDS(86subtypeB,55non-Bsubtypes).Overall,30.5%ofsubjectshadaTDR mutationatbaseline;15.6%onlyhadTDR(s)at,20%oftheviralpopulation.TherewasnodifferenceintherateofTDRsby B(30.2%)ornon-Bsubtypes(30.9%).VF(51)andVS(90)hadsimilarratesofanyTDRs(25.5%vs.33.3%),NNRTITDRs(11.1% vs.11.8%) and NRTI TDRs (24.4% vs. 25.5%). Of 9 (6.4%) subjects with M184V/I (7 at ,20% levels), 6 experienced VF. 16 (11.3%) subjects had multiple TAMs, and 7 experienced VF. 3 (2.1%) subjects had both multiple TAMs+M184V, and all experiencedVF.Of14(9.9%)subjectswithPITDRs(11at,20%levels):only1experiencedvirologicfailure.Themajorityof PITDRswerefoundinisolation(e.g.46I)at,20%levels,andhadlowresistancealgorithmscores. Conclusion:AmongarepresentativesampleofARV-na?¨vesubjectsinCASTL