CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

Methods: We extracted obstetric records from HIV+ women at the 2 largest maternities in Botswana from 2009-11 when Botswana National Guidelines recommended ZDV from 28 weeks gestational age (GA) for CD4 >350 and ART for CD4 <350, and again in 2013-14 after implementation of Atripla for PMTCT regardless of CD4 or GA. Outcomes included small for gestational age (SGA) (<10 th % birthweight for gestational age), preterm delivery (PTD) (<37 weeks GA) and stillbirths (SB). Using logistic regression, we compared women who initiated Atripla vs. other ART (restricting analyses CD4 <350); Atripla vs. ZDV (restricting analyses to CD4 >350); and Atripla vs. any other ARV in pregnancy. Comparisons included only ARV starts before 30 wks GA and outcomes >30 wks GA. Results: Data were collected on 5247 women who initiated ARVs in pregnancy: 1468 (28%) initiated Atripla; 772 (15%) other 3-drug ART combinations; 2929 (56%) zidovudine (ZDV); and 78 (1.5%) unspecified ARVs. Pregnancy CD4 count was available in 59%, and 70% started ARVs by 30 wks GA. Prevalence of adverse birth outcomes was high overall (18% SGA, 21% PTD and 3% SB), and among women initiating Atripla (12% SGA, 22% PTD and 3% SB). Compared with initiating other ART in pregnancy, Atripla had fewer SGA infants (aOR 0.4, 95% CI 0.2,0.7) and no significant differences in PTD (aOR 1.3, 95%CI 0.8,2.4) or SB (aOR 0.5, 95%CI 0.1,1.5). Compared with initiating ZDV, Atripla may have had fewer SGA infants (aOR 0.7, 95%CI 0.5,1.0) and no difference in PTD (aOR 1.0, 95%CI 0.7,1.4) or SB (aOR 1.0, 95% CI 0.4,2.1). Compared with initiating any other ARV (ART or ZDV) without CD4 restriction, Atripla had fewer SGA infants (aOR 0.6, 95% CI 0.4,0.8) and no difference in PTD (aOR 1.0, 95%CI 0.8,1,3) or SB (aOR 0.8, 95% CI 0.4,1.5).

Conclusions: Adverse birth outcomes remain high among HIV+ women in Botswana. Atripla appeared at least as safe as other ARVs started by 30 weeks gestation, and was associated with fewer SGA infants. Larger studies with Atripla exposures from conception are needed to evaluate earlier pregnancy outcomes and neural tube defects. 879 Growth and Bone Markers in Malawian Infants Pre- and Postnatally Exposed to Tenofovir Giuseppe Liotta 2 ; Marco Floridia 1 ; Mauro Andreotti 1 ; Haswell Jere 3 ; Clementina Galluzzo 1 ; Sandro Mancinelli 2 ; Maria Cristina Marazzi 4 ; StefanoVella 1 ; Marina Giuliano 1 ; Leonardo Palombi 2 1 Istituto Superiore di Sanità, Rome, Italy; 2 University of Tor Vergata, Rome, Italy; 3 Community of S.Egidio, Blantyre, Malawi; 4 Lumsa University, Rome, Italy Background: Tenofovir (TDF) is known to affect bone metabolism in HIV-infected patients. Prenatal and postnatal exposure to tenofovir might therefore affect negatively bone metabolism and postnatal growth in infants frommothers who received tenofovir in pregnancy and continue treatment after delivery while breastfeeding. No data are available on bone metabolismmarkers and infant growth status in this population. Methods: We studied 103 mother/child pairs enrolled in Malawi in an Option B-Plus program. All women received tenofovir+lamivudine+efavirenz in pregnancy (started at a median gestational time of 23 weeks) and during a breastfeeding time of up to 2 years. Bone markers and growth status was assessed in infants at 6 and 12 months of age, measuring serum Bone-specific alkaline phosphatase (BAP), as a specific marker of bone formation, and C-terminal telopeptide of type I collagen (CTX), as a bone resorption marker. Gender-adjusted weight-for-age z-scores (WAZ) and height-for-age z-score (HAZ) were calculated using the WHO standards (2006). Results: Median (IQR) BAP levels in infants were 278 (117-371) IU/ml at 6 months and 186 (82-287) IU/ml at 12 months, respectively. Corresponding median CTX levels at the same times were 320 (225-565) ng/L and 590 (260-865) ng/L, respectively. Levels of bone markers showed no differences by gender or by presence of severe weight or height reduction (WAZ or HAZ <10° WHO percentile), both at 6 and 12 months. Mean (SD) WAZ and HAZ were -0.77 (1.33) and -1.19 (1.25) at 6 months and -0.97 (1.22) and -1.40 (1.23) at 12 months, respectively. Conclusions: Based on published data, BAP and CTX levels showed no evidence of a negative impact on bone metabolism, with BAP levels slight higher and CTX levels lower compared to values previously reported in general pediatric populations. Although the infants were clearly below the WHO standards for both weight and for height measures, we found no evidence of a link between growth impairment and bone markers levels. Further studies that also take into account the potential role of inadequate nutritional intake in this setting are needed. 880 Lower Insulin, Acylcarnitines, and Branch-Chain Amino Acids in HIV-Exposed Infants Jennifer Jao 1 ; Brian Kirmse 2 ; ChunliYu 3 ; Fanny Epie 4 ; Emmanuel Nshom 4 ; Rhoda Sperling 5 ; Elaine J. Abrams 6 ; Derek LeRoith 7 ; Mitchell Geffner 8 ; Irwin Kurland 9 1 Icahn School of Medicine at Mount Sinai, New York, NY, US; 2 Children’s National Health System, Washington, DC, US; 3 Icahn School of Medicine at Mount Sinai, New York, NY, US; 4 Cameroon Baptist Convention Health Services, Bamenda, Cameroon; 5 Icahn School of Medicine at Mount Sinai, New York, NY, US; 6 ICAP at Columbia University, New York, NY, US; 7 Icahn School of Medicine at Mount Sinai, New York, NY, US; 8 Keck School of Medicine at University of Southern California, Los Angeles, CA, US; 9 Albert Einstein College of Medicine, New York, NY, US Background: In utero HIV/ARV exposure can cause mitochondrial dysfunction and may affect fetal metabolic programming. No studies have evaluated intermediary energy metabolism and insulin levels in HIV-exposed (HEU) and -unexposed (HUU) uninfected infants in Africa.

Poster Abstracts

530

CROI 2015