CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

792 EXTENDED PROPHYLAXIS WITH NEVIRAPINE DOES NOT AFFECT GROWTH IN HIV-EXPOSED INFANTS Carolyne Onyango-Makumbi 1 , Ramadhani Mwiru 2 , Arthur Owora 3 , Anthony Mwatha 4 , Alicia Young 4 , Dhayendre Moodley 5 , Hoosen Coovadia 6 , Lynda Stranix- Chibanda 7 , Karim P. Manji 8 , Yvonne Maldonado 9 , Paul Richardson 10 , Philip Andrew 11 , Kathleen George 11 , Wafaie Fawzi 12 , Mary G. Fowler 10 1 Makerere University–Johns Hopkins University Research Collaboration, Kampala, Uganda, 2 CDC Tanzania, Dar es Salaam, Tanzania, United Republic of, 3 Syracuse University, Syracuse, NY, USA, 4 Fred Hutchinson Cancer Research Center, Seattle, WA, USA, 5 CAPRISA, Durban, South Africa, 6 MatCH, Durban, South Africa, 7 University of Zimbabwe, Harare, Zimbabwe, 8 Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania, United Republic of, 9 Stanford University, Stanford, CA, USA, 10 Johns Hopkins University School of Medicine, Baltimore, MD, USA, 11 FHI 360, Durham, NC, USA, 12 Harvard University, Boston, MA, USA Background: Effects of prolonged nevirapine prophylaxis exposure on growth among high risk HIV exposed-uninfected (HEU) infants are unknown. The objective of this secondary data analysis was to examine the impact of extended nevirapine prophylaxis from six weeks to six months on the growth of HEU infants followed for 18 months in the HPTN 046 trial. Correlates of incident wasting, stunting, underweight, and lower head circumference were also determined. Methods: Intention-to-treat analysis examined the effect of extended nevirapine exposure on growth outcomes: weight-for-age Z-score (WAZ), length-for-age Z-score (LAZ), weight-for-length Z-score (WLZ) and head circumference-for-age (HCZ). Linear mixed effects models were used to compare the rate of change in infant growth outcomes (WAZ, LAZ, WLZ, and HCZ) between the two study arms. Each infant was modeled as a random effect nested within treatment group. Time was modeled as a continuous variable. Multivariable Cox proportional hazard models were used to determine correlates of incident growth faltering outcomes. Results: Extended course of prophylactic nevirapine given daily from six weeks to six months did not adversely affect growth (WAZ, LAZ, WLZ, HCZ) in HEU breastfeeding infants (treatment x time effect: p>0.05) when compared with placebo. However, overall growth declined over time (time effect: p<.01) when compared to WHO general population norms. Overall prevalence and incidence did not differ between study groups but male sex, short duration of breastfeeding, and lack of maternal ART exposure were associated with higher risk of growth faltering outcomes (p<.05). Conclusion: It is re-assuring that prolonged exposure to nevirapine for prevention of maternal to child HIV transmission does not appear to restrict growth. However, targeted interventions that support normal growth among at-risk HIV-exposed uninfected infants are needed to curtail the risk of growth faltering outcomes.

791 IMPACT OF IMPROVED NUTRITION/SANITATION ON STUNTING AND ANEMIA IN HIV-EXPOSED INFANTS Bernard Chasekwa 1 , Andrew Prendergast 2 , Ceri Evans 2 , Kuda Mutasa 1 , Mduduzi Mbuya 1 , Rebecca J. Stoltzfus 3 , Laura Smith 4 , Florence D. Majo 1 , Naume Tavengwa 1 , Batsirai Mutasa 1 , Lawrence Moulton 5 , Robert Ntozini 1 , Jean Humphrey 5 , for the SHINE Trial Team 1 Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe, 2 Queen Mary University of London, London, UK, 3 Cornell University, Ithaca, NY, USA, 4 University at Buffalo, Buffalo, NY, USA, 5 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA Background: Stunting (linear growth failure) is associated with child mortality and neurodevelopmental impairment. Anemia often co-exists with stunting and is a further driver of impaired neurodevelopment. HIV-exposed children have a high prevalence of stunting and anaemia, with few effectiv¬¬¬e preventive interventions. We hypothesized that improved infant and young child feeding (IYCF) and improved water, sanitation and hygiene (WASH) would reduce stunting and anemia in HIV-exposed children. Methods: We conducted a cluster-randomised 2x2 factorial trial in rural Zimbabwe, testing the impact of improved IYCF and improved WASH on child linear growth and hemoglobin (ClinicalTrials.gov NCT01824940). Pregnant women were eligible if they lived in study clusters allocated to standard-of-care (SOC; 52 clusters); IYCF (20g Nutributter/day from 6-18mo, complementary feeding counseling; 53 clusters); WASH (pit latrine, 2 hand-washing stations, liquid soap, chlorine, play space, hygiene counseling; 53 clusters); or IYCF+WASH (53 clusters). Masking of participants and fieldworkers was not possible. Intention-to-treat analyses were stratified by maternal HIV status. Primary outcomes were length-for-age Z-score (LAZ) and hemoglobin among HIV- exposed children at 18 months. Secondary outcomes include stunting, anemia and diarrhea. Results: From 726 HIV-positive pregnant women, 668 children from 181 clusters were evaluated at 18 months (147 from 46 SOC clusters; 147 from 47 IYCF clusters; 184 from 43 WASH clusters; 190 from 45 IYCF+WASH clusters). 22 (3%) were HIV-positive, 594 (89%) HIV-exposed uninfected, and 52 (8%) HIV-unknown at 18 months. 2.8% live-born infants were lost to follow-up. IYCF increased mean LAZ by 0.26 (95%CI 0.09, 0.43) and hemoglobin by 0.29g/ dL (95%CI 0.09, 0.49), reducing stunting prevalence from 50.2% to 40.5% (absolute reduction 9.7%, 95%CI 2.1, 17.2) and anaemia from 14.1% to 24 7.3% (absolute reduction 6.8%, 95%CI 2.1, 11.6). There was no evidence of an impact of WASH on length or hemoglobin. There was no evidence of an effect of either intervention on diarrhea. There were no trial-related adverse/serious adverse events. Conclusion: Among HIV-exposed children, improved complementary feeding reduced stunting and anaemia, while there was no evidence of an impact of improved WASH. Delivered at scale, IYCF interventions would have substantial benefit in areas with high antenatal HIV prevalence.

Poster Abstracts

CROI 2019 307