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. 2007 Apr 27;2(4):e11.
doi: 10.1371/journal.pctr.0020011.

Haematological safety of perinatal zidovudine in pregnant HIV-1-infected women in Thailand: secondary analysis of a randomized trial

Nelly Briand  1 , Marc Lallemant, Gonzague Jourdain, Somnuek Techapalokul, Preecha Tunthanathip, Surachet Suphanich, Truengta Chanpoo, Patrinee Traisathit, Kenneth McIntosh, Sophie Le Coeur
Affiliations

Haematological safety of perinatal zidovudine in pregnant HIV-1-infected women in Thailand: secondary analysis of a randomized trial

Nelly Briand et al. PLoS Clin Trials. .

Abstract

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.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Flow of Participants
Figure 2
Figure 2. Haematological Parameters between 26 Weeks' Gestation and Delivery in HIV-Infected Women According to Zidovudine Exposure
Measurements occurred at the same visit in the two groups. All values are expressed as means and 95% CIs. Comparison of long (zidovudine exposure from 28 wk of gestation) versus short (zidovudine exposure from 35 wk of gestation) regimens was done by Student's t-test. Broken line, short arm; solid line, long arm. *p < 0.05, **p < 0.01, ***p < 0.001. (A) Haemoglobin level. (B) Leucocyte counts. (C) Absolute neutrophil counts. (D) Absolute lymphocyte counts.
See this image and copyright information in PMC

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