Publications and Abstracts Press Releases BHP in the News Color Conferences	Maternal and Infant Response to Nevirapine (NVP)-Based Antiretroviral Treatment (ART) Following Peripartum Single-Dose NVP or Placebo (Plc) Shahin Lockman, MD, MSc1, Laura M. Smeaton, MSc2, Roger L. Shapiro, MD, MPH3, Carolyn Wester, MD4, Ibou Thior, MD, MSc4, Lisa Stevens, MD4, Thumbi Ndung'u, PhD4, Caire Moffat, MD, MPH4, Aida Asmelash, MD, MPH4, Patrick Ndase, MD4, Peter Arimi, MD4, Anchilla Owor, MD4, Erik Van Widenfelt, BSc4, Stephen Lagakos, PhD2, Max Essex, DVM, PhD2; 1Brigham and Women's Hospital, Boston, MA,2Harvard School of Public Health, Boston, MA,3Beth Israel Deaconess Medical Center, Boston, MA,4BHP, Gaborone, Botswana. Background Single-dose (sd) NVP reduces peripartum HIV transmission, but often leads to NVP resistance in mothers and infants, which may compromise their subsequent response to NVP-based ART. Methods 1200 HIV+ pregnant women and 491 infants were randomized to receive peripartum sd NVP or placebo (Plc) (+ short-course ZDV) in Botswana. Women with CD4 < 200 cells/mm3 or AIDS-defining illness and all HIV-infected infants were offered ART (NVP, ZDV+ 3TC). Primary endpoints were cumulative virologic failure (confirmed HIV RNA > 400 cp/mL) rates among women (and first of death or virologic falure in infants) in sd NVP and Plc arms by 6,12, and 24 months (mo) after starting ART (Kaplan-Meier estimates). Results 218 women (106 Plc, 112 sd NVP) started NVP-containing ART following sd NVP exposure; 205, 182 and 96 had HIV RNA results at 6,12, and 24 mo, respectively. Sixty (27.5%) women started ART within 6 mo of sd NVP. Comparisons differed by timing of ART following sd NVP (< 6 mo vs > 6 mo) (p =0.008), so stratified analyses are preferable. Maternal results: Months after ART initiation # (%) failing, Plc arm # (%) failing, NVP arm p-value* All women 6 5 (5%) 20 (18.4%) 0.002 12 9 (9.6%) 21 (19.7%) 0.04 24 10 (11.3%) 25 (27.9%) 0.008 ART started < 6 mo after Plc/sd NVP 6 0 (0%) 10 (41.7%) < 0.0001 12 1 (2.9%) 11 (45.8%) < 0.0001 24 1 (2.9%) 11 (45.8%) < 0.0001 ART started > 6 mo after Plc/sd NVP 6 5 (7.8%) 10 (12.0%) 0.39 12 8 (13.8%) 10 (12.0%) 0.76 24 9 (17.1%) 14 (24.7%) 0.38 * Unstratified p-value Median CD4 rise was 122 (160) cells/mm3 at 6 (12) mo, and did not differ by arm. Thirty babies started ART (15 Plc, 15 sd NVP). The # (%) of babies experiencing death or virologic failure were 4 (27.8%) in Plc and 12 (80%) in NVP arms by both 6 and 12 mo (p=0.0009) (3 deaths Plc, 2 deaths sd NVP arms). By 24 mo there was 1 additional failure in Plc arm (p=0.006, Plc vs NVP). Conclusions Exposure to sd NVP was associated with significantly higher rates of virologic failure among women who started ART within 6 mo of exposure, but not among women starting ART > 6 mo after sd NVP / Plc. Infants exposed to sd NVP experienced a much higher rate of death or virologic failure than non-exposed infants.
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