efficacy of short-course azt plus 3tc to reduce nevirapine resistance in the prevention of mother-to-child hiv transmission a randomized clinical trial功效的短程azt + 3 tc减少奈韦拉平抵抗预防母婴传播艾滋病毒的随机临床试验.pdfVIP

Efficacy of Short-Course AZT Plus 3TC to Reduce Nevirapine Resistance in the Prevention of Mother-to- Child HIV Transmission: A Randomized Clinical Trial 1 2 3 2 1 4 James A. McIntyre , Mark Hopley , Daya Moodley , Marie Eklund , Glenda E. Gray , David B. Hall , Patrick Robinson4, Douglas Mayers4¤, Neil A. Martinson1,5* 1 Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa, 2 Boehringer Ingelheim, Johannesburg, South Africa, 3 Department of Obstetrics and Gynaecology, Nelson Mandela School of Medicine, University of KwaZulu Natal, Durban, South Africa, 4 Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, United States of America, 5 Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America Abstract Background: Single-dose nevirapine (sdNVP)—which prevents mother-to-child transmission of HIV—selects non-nucleoside reverse-transcriptase inhibitor (NNRTI) resistance mutations in the majority of women and HIV-infected infants receiving it. This open-label, randomised trial examined the efficacy of short-course zidovudine (AZT) and lamivudine (3TC) with sdNVP in reducing NNRTI resistance in mothers, and as a secondary objective, in infants, in a setting where sdNVP was standard-of- care. Methods and Findings: sdNVP alone, administered at the onset of labour and to the infant, was compared to sdNVP with AZT plus 3TC, given as combivir (CBV) for 4 (NVP/CBV4) or 7 (NVP/CBV7) days, initiated simultaneously with sdNVP in labour; their newborns received the same regimens. Women were randomised 1:1:1. HIV-1 resistance was assessed by population sequencing at: baseline, 2, and 6 wk after birth. An unplanned interim analysis resulted in early stopping of the sdNVP ar