Efficacy of Short-Course AZT Plus 3TC to Reduce Nevirapine Resistance in the Prevention of Mother-to-Child HIV Transmission A Randomized Clinical Trial 英文参考文献.docVIP

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Efficacy of Short-Course AZT Plus 3TC to Reduce Nevirapine Resistance in the Prevention of Mother-to-Child HIV Transmission A Randomized Clinical Trial 英文参考文献.doc

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Efficacy of Short-Course AZT Plus 3TC to Reduce Nevirapine Resistance in the Prevention of Mother-to-Child HIV Transmission A Randomized Clinical Trial 英文参考文献

EfficacyofShort-CourseAZTPlus3TCtoReduce NevirapineResistanceinthePreventionofMother-to- ChildHIVTransmission:ARandomizedClinicalTrial JamesA.McIntyre1,MarkHopley2,DayaMoodley3,MarieEklund2,GlendaE.Gray1,DavidB.Hall4, PatrickRobinson4,DouglasMayers4¤,NeilA.Martinson1,5* 1Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa, 2Boehringer Ingelheim, Johannesburg, South Africa, 3Department of ObstetricsandGynaecology,NelsonMandelaSchoolofMedicine,UniversityofKwaZuluNatal,Durban,SouthAfrica,4BoehringerIngelheimPharmaceuticals,Ridgefield, Connecticut,UnitedStatesofAmerica,5JohnsHopkinsUniversitySchoolofMedicine,Baltimore,Maryland,UnitedStatesofAmerica Abstract Background:Single-dosenevirapine(sdNVP)—whichpreventsmother-to-childtransmissionofHIV—selectsnon-nucleoside reverse-transcriptaseinhibitor(NNRTI)resistancemutationsinthemajorityofwomenandHIV-infectedinfantsreceivingit. Thisopen-label,randomisedtrialexaminedtheefficacyofshort-coursezidovudine(AZT)andlamivudine(3TC)withsdNVP inreducingNNRTIresistanceinmothers,andasasecondaryobjective,ininfants,inasettingwheresdNVPwasstandard-of- care. MethodsandFindings:sdNVPalone,administeredattheonsetoflabourandtotheinfant,wascomparedtosdNVPwith AZTplus3TC,givenascombivir(CBV)for4(NVP/CBV4)or7(NVP/CBV7)days,initiatedsimultaneouslywithsdNVPinlabour; theirnewbornsreceivedthesameregimens.Womenwererandomised1:1:1.HIV-1resistancewasassessedbypopulation sequencingat:baseline,2,and6wkafterbirth.AnunplannedinterimanalysisresultedinearlystoppingofthesdNVParm. 406pregnantwomenwererandomisedandtookstudymedication(sdNVP74,NVP/CBV4164,andNVP/CBV7168).HIV-1 resistancemutationsemergedin59.2%,11.7%,and7.3%ofwomeninthesdNVP,NVP/CBV4,andNVP/CBV7armsby6wk postpartum; differences between NVP-only and both NVP/CBV arms were significant (p,0.0001), but the difference betweenNVP/CBV4andNVP/CBV7wasnot(p=0.27).EstimatedefficacycomparingcombinedCBVarmswithsdNVPwas 85.6%.SimilarresistancereductionswereseenininfantswhowereHI