Management of Human Immunodeficiency Virus–Infected Pregnant Women at Latin American and Caribbean Sites

Read, Jennifer S.; Cahn, Pedro; Losso, Marcelo; Pinto, Jorge; João, Esaú; Duarte, Geraldo; Cardoso, Edmundo; Freimanis-Hance, Laura; Stoszek, Sonia K.

doi:10.1097/01.aog.0000265211.76196.ac

Cited by 36 publications

(32 citation statements)

References 9 publications

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“…Details of this cohort have been previously described. 16, 17 The Institutional Review Board approval was obtained from the NICHD, the data management and statistical center (Westat), clinical sites, and in-country ethics boards (Brazil), as required. Signed informed consent was obtained from participating pregnant women.…”

Section: Study Populationmentioning

confidence: 99%

Neurologic Outcomes in HIV-Exposed/Uninfected Infants Exposed to Antiretroviral Drugs During Pregnancy in Latin America and the Caribbean

Spaulding

Civitello

et al. 2016

AIDS Research and Human Retroviruses

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To evaluate antiretroviral (ARV) drug exposure and other factors during pregnancy that may increase the risk of neurologic conditions (NCs) in HIV-exposed/uninfected (HEU) infants. A prospective cohort study was conducted at 24 clinical sites in Latin America and the Caribbean. Data on maternal demographics, health, HIV disease status, and ARV use during pregnancy were collected. Infant data included measurement of head circumference after birth and reported medical diagnoses at birth, 6-12 weeks, and 6 months. Only infants with maternal exposure to combination ARV therapy (cART) ( ‡3 drugs from ‡2 drug classes) during pregnancy were included. Microcephaly, defined as head circumference for age z-score less than -2, and NC were evaluated for their association with covariates, including individual ARVs, using bivariable and logistic regression analyses. From 2002 to 2009, 1,400 HEU infants met study inclusion criteria. At least one NC was reported in 134 (9.6%; 95% confidence interval [CI]: 8.1-11.2), microcephaly in 105 (7.5%; 95% CI: 6.2-9.0), and specific neurologic diagnoses in 33 (2.4%; 95% CI: 1.6-3.3) HEU infants. Microcephaly and NC were not significantly associated with any specific ARV analyzed ( p > 0.05). Covariates associated with increased odds of NC included male sex (odds ratio [OR] = 1.9; 95% CI: 1.3-2.8), birth weight <2.5 kg (OR = 3.1; 95% CI: 2.1-4.8), 1-min Apgar score <7 (OR = 2.5; 95% CI: 1.4-4.4), and infant infections (OR = 2.5; 95% CI: 1.5-4.1). No ARV investigated was associated with adverse neurologic outcomes. Continued investigation of such associations may be warranted as new ARVs are used during pregnancy and cART exposure during the first trimester becomes increasingly common. IntroductionT he long-term safety of in utero and neonatal exposure to antiretroviral (ARV) drugs in HIV-exposed/ uninfected (HEU) infants, children, and youths is still not fully determined. Of particular interest is the impact of ARV exposure on neurologic outcomes in HEU infants. Concerns about toxicity related to zidovudine (ZDV) from in vitro animal 1,2 and adult human studies predated the landmark Pediatric AIDS Clinical Trials Group (PACTG) 076 trial. These concerns became more prominent with the results from the French Perinatal Cohort Study (FPCS) that reported eight (0.3%) cases of established or possible mitochondrial dysfunction (MD) among nearly 1,800 ARV-exposed HEU infants in contrast to zero cases among an approximately equal number of ARV-unexposed HEU infants. 4 Of note, five of the eight cases had neurologic symptoms, and three of these five also had persistent hyperlactatemia.Further epidemiologic surveillance and evaluation by the FPCS identified 18 more children with established or possible MD, with most again having neurologic symptoms. 5Seizures were also prominent in the cohort, seen in 81 (1.8%)

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Section: Study Populationmentioning

confidence: 99%

Neurologic Outcomes in HIV-Exposed/Uninfected Infants Exposed to Antiretroviral Drugs During Pregnancy in Latin America and the Caribbean

Spaulding

Civitello

et al. 2016

AIDS Research and Human Retroviruses

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“…The NISDI Perinatal and NISDI LILAC protocols are prospective cohort studies that enrolled HIV-infected pregnant women and their infants at multiple sites in Argentina, the Bahamas, Brazil, Jamaica, Mexico, and Peru beginning in 2002 (NISDI Perinatal) and in 2008 (NISDI LILAC). 17 Participant follow-up continued for at least six months after delivery/birth (last maternal laboratory assays obtained at 6-12 weeks postpartum in the NISDI Perinatal Protocol). Choice and dosing of ARVs was at the discretion of each subject's physician.…”

Section: Methodsmentioning

confidence: 99%

Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities

Peixoto¹,

Pilotto²,

Stoszek³

et al. 2011

Braz J Infect Dis

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We declare no conflict of interest. ABSTRACT Objectives:To describe laboratory abnormalities among HIV-infected women and their infants with standard and increased lopinavir/ritonavir (LPV/r) dosing during the third trimester of pregnancy. Methods: We evaluated data on pregnant women from NISDI cohorts (2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)) enrolled in Brazil, who received at least 28 days of LPV/r during the third pregnancy trimester and gave birth to singleton infants. Results: 164 women received LPV/r standard dosing [(798/198 . Mean plasma viral load was higher in Group 2. There were statistically significant, but not clinically meaningful, differences between groups in mean AST, ALT, cholesterol, and triglycerides. The proportion of women with Grade 3 or 4 adverse events was very low, with no statistically significant differences between groups in severe adverse events related to ALT, AST, total bilirubin, cholesterol, or triglycerides. There were statistically significant, but not clinically meaningful, differences between infant groups in ALT and creatinine. The proportion of infants with Grade 3 or 4 adverse events was very low, and there were no statistically significant differences in severe adverse events related to ALT, AST, BUN, or creatinine. Conclusion: The proportions of women and infants with severe laboratory adverse events were very low. Increased LPV/r dosing during the third trimester of pregnancy appears to be safe for HIV-infected women and their infants.

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“…6 We assessed the relationship between ARV regimens received during pregnancy and laboratory abnormalities among HIV-1-infected women enrolled in the NICHD International Site Development Initiative (NISDI) Perinatal Study, a prospective cohort study conducted at clinical sites in Latin American and Caribbean countries. 7 All subjects provided signed informed consent prior to study enrollment.…”

Section: Dear Editormentioning

confidence: 99%

Letter to the Editor: Laboratory Abnormalities among HIV-1–Infected Pregnant Women Receiving Antiretrovirals in Latin America and the Caribbean

Ceriotto¹,

Harris

Duarte

et al. 2008

AIDS Patient Care and STDs

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Management of Human Immunodeficiency Virus–Infected Pregnant Women at Latin American and Caribbean Sites

Abstract: Only a minority of women had a viral load of 1,000 copies/mL or more around delivery, and mother-to-child transmission of HIV occurred rarely (1%).

Cited by 36 publications

References 9 publications

Neurologic Outcomes in HIV-Exposed/Uninfected Infants Exposed to Antiretroviral Drugs During Pregnancy in Latin America and the Caribbean

Neurologic Outcomes in HIV-Exposed/Uninfected Infants Exposed to Antiretroviral Drugs During Pregnancy in Latin America and the Caribbean

Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities

Letter to the Editor: Laboratory Abnormalities among HIV-1–Infected Pregnant Women Receiving Antiretrovirals in Latin America and the Caribbean

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