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Hematological safety of perinatal exposure to zidovudine in uninfected infants born to HIV type 1-infected women in Thailand.

ABSTRACT: The evolution of hematological parameters in HIV-1-exposed uninfected infants according to various durations of perinatal zidovudine exposure was studied. We used data prospectively collected among 1122 HIV-uninfected formula-fed infants born to HIV-infected mothers who participated in a clinical trial to prevent perinatal transmission in Thailand (PHPT-1). Infants were exposed to different durations of zidovudine both in utero and after birth. Hemoglobin level and leukocyte, absolute neutrophil, and lymphocyte counts were measured at birth and at 6 weeks of age. The association between hematological parameters at birth and the duration of zidovudine exposure in utero was studied using a linear regression model, and changes between birth and 6 weeks of age and the duration of postnatal zidovudine exposure using mixed effects models. At birth, the hemoglobin level was lower in newborns exposed to zidovudine for more than 7.5 weeks in utero (adjusted regression coefficient: -0.6?g/dl; 95% confidence interval: -1.1 to -0.1). Six weeks after birth, the hemoglobin level had decreased faster in infants administered zidovudine for more than 4 weeks (adjusted regression coefficient: -0.1?g/dl; 95% confidence interval: -0.2 to -0.1). The duration of perinatal zidovudine exposure was not associated with the evolution of leukocyte, neutrophil, and lymphocyte counts. Despite the differences in hemoglobin levels, grade 3 or 4 anemia did not significantly differ by maternal or infant zidovudine duration. The clinical impact appeared modest, but longer exposure may warrant close monitoring.

SUBMITTER: Briand N

PROVIDER: S-EPMC2982712 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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Hematological safety of perinatal exposure to zidovudine in uninfected infants born to HIV type 1-infected women in Thailand.

Briand Nelly N Le Coeur Sophie S Jourdain Gonzague G Hotrawarikarn Somboon S Sirinontakan Surat S Hinjiranandana Temsiri T Kanjanavanit Suparat S Traisathit Patrinee P McIntosh Kenneth K Lallemant Marc M

AIDS research and human retroviruses 20100921 10

The evolution of hematological parameters in HIV-1-exposed uninfected infants according to various durations of perinatal zidovudine exposure was studied. We used data prospectively collected among 1122 HIV-uninfected formula-fed infants born to HIV-infected mothers who participated in a clinical trial to prevent perinatal transmission in Thailand (PHPT-1). Infants were exposed to different durations of zidovudine both in utero and after birth. Hemoglobin level and leukocyte, absolute neutrophil ...[more]

PMID: 20854205

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Project description:OBJECTIVES:To respond to the primary safety objective of the Perinatal HIV Prevention Trial 1 (PHPT-1) by studying the evolution of haematological parameters according to zidovudine exposure duration in HIV-1-infected pregnant women. DESIGN:Multicenter, randomized, double-blind, controlled trial of different durations of zidovudine prophylaxis. SETTING:27 hospitals in Thailand. PARTICIPANTS:1,436 HIV-infected pregnant women in PHPT-1. INTERVENTION:Zidovudine prophylaxis initiation at 28 or 35 wk gestation. OUTCOME MEASURES:Haemoglobin level, leucocytes, total lymphocyte counts, and absolute neutrophil counts were measured at 26, 32, and 35 wk and at delivery. The evolution of haematological parameters was estimated between 26 and 35 wk (zidovudine/placebo) and between 35 wk and delivery to compare a long versus short zidovudine exposure. For each parameter, linear mixed models were adjusted on baseline sociodemographic variables, HIV clinical stage, CD4 count, and viral load. RESULTS:Between 26 and 35 wk, haemoglobin, leucocytes, and absolute neutrophil counts decreased in zidovudine-exposed compared to unexposed women (mean difference [95% CI] -0.4 [-0.5 to -0.3], -423 [-703 to -142], -485 [-757 to -213], respectively). However, between 35 wk and delivery, the haematological parameters increased faster in women exposed to long rather than short durations of zidovudine (0.1 [0.0 to 0.1]; 105 [18 to 191]; 147 [59 to 234], respectively). At delivery, the differences were not statistically significant, except for mean haemoglobin level, which remained slightly lower in the long zidovudine treatment group (difference: 0.2 g/dl). Zidovudine had no negative impact on the absolute lymphocyte counts. CONCLUSION:Zidovudine initiated at 28 wk gestation rather than 35 wk had a transient negative impact on the evolution of haematological parameters, which was largely reversed by delivery despite continuation of zidovudine. This result provides reassurance about the safety of early initiation of zidovudine prophylaxis during pregnancy to maximize prevention of perinatal HIV.

Dataset Information

Hematological safety of perinatal exposure to zidovudine in uninfected infants born to HIV type 1-infected women in Thailand.

Publications

Hematological safety of perinatal exposure to zidovudine in uninfected infants born to HIV type 1-infected women in Thailand.

Similar Datasets

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