Safety of Receipt of Antiretroviral Drugs during Pregnancy among HIV-1-Infected Women in Latin America and the Caribbean: The NICHD International Site Development Initiative (NISDI) Perinatal Study

Introduction: Our objectives were to assess the association between ARVs during pregnancy and adverse events through 6-12 weeks postpartum among HIV-1-infected women in Latin America and the Caribbean.
Methods: We analyzed data from a prospective cohort study of HIV-1-infected women and their infants in Argentina, the Bahamas, Brazil and Mexico (NISDI Perinatal Study). This analysis included ARV-naïve women with HIV-1 infection diagnosed during the index pregnancy followed for at least 6-12 weeks after delivery. Maternal clinical (rash, nausea and/or vomiting, headache) and laboratory (elevated SGPT and SGOT, anemia, leucopenia, thrombocytopenia) adverse events at hospital discharge and at 6-12 weeks postpartum were analyzed.
Results: Of 743 women enrolled as of October 2004, 289 met the inclusion criteria. Most (91%) had mild clinical disease (CDC Category A) at enrollment. Receipt of ARVs during pregnancy was categorized according to the most complex regimen received: Group1: ZDV alone or 2 NRTIs [43 (15%)]; Group2: 2 NRTIs + 1 NNRTI [132 (46%)]; Group3: 2 NRTIs + 1 PI [105 (36%)]; or none/other [9 (3%)]. Significant findings at hospital discharge and at 6-12 weeks postpartum included the following. At hospital discharge, anemia was most common in Group1 (57%) vs. Group2 or Group3 (p = 0.002), while leucopenia was least common in Group3 (5.0%) vs. Group1 or Group2 (p = 0.013). At 6-12 weeks postpartum, rash was most common in Group2 (4.8%) vs. Group1 or Group3 (p = 0.034), while headache was least common in Group1 (4.7%) vs. Group2 or Group3 (p = 0.028); elevated SGPT (18.6%) (p = 0.015) and SGOT (16.3%) (p = 0.014) values were most common in Group1 vs. Group2 and Group3.
Conclusions: Significant associations between maternal ARV regimens during pregnancy and clinical/laboratory abnormalities were observed. Further analyses are underway to more completely characterize toxicities according to ARV regimen.

Ceriotto M.1, Gonin R.2, Duarte G.3, Harris R.2, Aguiar R.4, Warley E.5, Madi J.6, Zala C.7, Read J.8
1Hospital de Agudos Dra. Cecilia Grierson, Buenos Aires, Argentina, 2Westat, Rockville, United States of America, 3University of São Paulo, Ribeirão Preto, Brazil, 4School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil, 5Hospital Diego Paroissien, Buenos Aires, Argentina, 6Universidade de Caxias do Sul, Caxias do Sul, Brazil, 7Hospital Juan Fernández, Buenos Aires, Argentina, 8PAMA Branch, NICHD, NIH, DHHS, Bethesda, United States of America