Infant outcomes after maternal antiretroviral exposure in resource-limited settings
Karin Nielsen-Saines, Lauren Komarow, Susan Cu-Uvin, Gonzague Jourdain, Karin L Klingman, David E Shapiro, Lynne Mofenson, Laura Moran, Thomas B Campbell, Jane Hitti, Susan Fiscus, Judith Currier, ACTG 5190/PACTG 1054 Study Team, Kimberly Hudgens, Edward Acosta, Susan Eshleman, Susan Fiscus, Ana Martinez, Lynne Kidd-Freeman, Apsara Nair, Laura M Stevens, Ann Walawander, Joan Gormley, Carol A Vincent, David L Shugarts, Marlene Cooper, Suzanne Siminski, Barbara Brizz, Kulkanya Chokephaibulkit, Nirun Vanprapar, Nagalingeshwaran Kumarasamy, S Poongulali, Prapaisri Layangool, Jutarat Mekmullica, Virat Sirisanthana, Thanyawee Puthanakit, Chaiwat Ngampiyasakul, Wanna Chamjamrat, Suchat Hongsiriwon, Donyapattra Ekkomonrat, Newton Kumwenda, Pornchai Techakunakorn, Chutima Ruklao Phayao, Portia Kamthunzi, Tionge Kamvaunamwali, Wadzanai Samaneka, Nehemiah Nhando Parirenyatwa, Chulapong Chanta, Kanchana Preedisripipat, Esau C Joao, Maria Letícia S Cruz, Karin Nielsen-Saines, Lauren Komarow, Susan Cu-Uvin, Gonzague Jourdain, Karin L Klingman, David E Shapiro, Lynne Mofenson, Laura Moran, Thomas B Campbell, Jane Hitti, Susan Fiscus, Judith Currier, ACTG 5190/PACTG 1054 Study Team, Kimberly Hudgens, Edward Acosta, Susan Eshleman, Susan Fiscus, Ana Martinez, Lynne Kidd-Freeman, Apsara Nair, Laura M Stevens, Ann Walawander, Joan Gormley, Carol A Vincent, David L Shugarts, Marlene Cooper, Suzanne Siminski, Barbara Brizz, Kulkanya Chokephaibulkit, Nirun Vanprapar, Nagalingeshwaran Kumarasamy, S Poongulali, Prapaisri Layangool, Jutarat Mekmullica, Virat Sirisanthana, Thanyawee Puthanakit, Chaiwat Ngampiyasakul, Wanna Chamjamrat, Suchat Hongsiriwon, Donyapattra Ekkomonrat, Newton Kumwenda, Pornchai Techakunakorn, Chutima Ruklao Phayao, Portia Kamthunzi, Tionge Kamvaunamwali, Wadzanai Samaneka, Nehemiah Nhando Parirenyatwa, Chulapong Chanta, Kanchana Preedisripipat, Esau C Joao, Maria Letícia S Cruz
Abstract
Background and objective: The impact of maternal antiretrovirals (ARVs) during pregnancy, labor, and postpartum on infant outcomes is unclear.
Methods: Infants born to HIV-infected mothers in ARV studies were followed for 18 months.
Results: Between June 2006 and December 2008, 236 infants enrolled from Africa (n = 36), India (n = 47), Thailand (n = 152), and Brazil (n = 1). Exposure to ARVs in pregnancy included ≥ 3 ARVs (10%), zidovudine/intrapartum ARV (81%), and intrapartum ARV (9%). There were 4 infant infections (1 in utero, 3 late postpartum) and 4 deaths with 1.8% mortality (95% confidence interval [CI], 0.1%-3.5%) and 96.4% HIV-1-free survival (95% CI, 94.0%-98.9%). Birth weight was ≥ 2.5 kg in 86%. In the first 6 months, Indian infants (nonbreastfed) had lowest median weights and lengths and smallest increases in growth. After 6 months, African infants had the lowest median weight and weight-for-age z scores. Infants exposed to highest maternal viral load had the lowest height and height-for-age z scores. Serious adverse events occurred in 38% of infants, did not differ by country, and correlated with less maternal ARV exposure. Clinical diagnoses were seen in 84% of Thai, 31% of African, and 9% of Indian infants. Congenital defects/inborn errors of metabolism were seen in 18 (7.6%) infants, of which 17 were Thai (11%: 95% CI, 6.7%-17.0%); none had first trimester ARV exposure.
Conclusions: Infant follow-up in large international cohorts is feasible and provides important safety and HIV transmission data following maternal ARV exposure. Increased surveillance increases identification of congenital/inborn errors.
Trial registration: ClinicalTrials.gov NCT00084136.
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Source: PubMed