Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: a randomized trial in three African countries

BMC Infectious Diseases

Stanley Luchters¹  Timothy MM Farley³  Marie Louise Newell⁶  Marleen Temmerman⁴  Nicolas Meda⁷  Mary Mwaura⁵  Matthew F Chersich⁴  Benn KD Sartorius² 

[1]Centre for International Health, Burnet Institute, 85 Commercial Road, Melbourne, Victoria 3004, Australia

[2]Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Mtubatuba, South Africa

[3]Sigma3 Services SARL, Nyon, Switzerland

[4]International Centre for Reproductive Health, Department of Obstetrics and Gynaecology, Ghent University, Ghent, Belgium

[5]International Centre for Reproductive Health, Mombasa, Kenya

[6]Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, KwaZulu-Natal, South Africa

[7]Centre Muraz, Bobo Dioulasso, Burkina Faso

关键词: Drug toxicity;    Anaemia;    Sub-Saharan Africa;    HIV;    Pregnancy;    Zidovudine;   

Others  :  1145547
DOI  :  10.1186/1471-2334-13-522

 received in 2013-05-27, accepted in 2013-10-22,  发布年份 2013

【 摘 要 】

Background

Although substantiated by little evidence, concerns about zidovudine-related anaemia in pregnancy have influenced antiretroviral (ARV) regimen choice for preventing mother-to-child transmission of HIV-1, especially in settings where anaemia is common.

Methods

Eligible HIV-infected pregnant women in Burkina Faso, Kenya and South Africa were followed from 28 weeks of pregnancy until 12–24 months after delivery (n = 1070). Women with a CD4 count of 200-500cells/mm³ and gestational age 28–36 weeks were randomly assigned to zidovudine-containing triple-ARV prophylaxis continued during breastfeeding up to 6-months, or to zidovudine during pregnancy plus single-dose nevirapine (sd-NVP) at labour. Additionally, two cohorts were established, women with CD4 counts: <200 cells/mm³ initiated antiretroviral therapy, and >500 cells/mm³ received zidovudine during pregnancy plus sd-NVP at labour. Mild (haemoglobin 8.0-10.9 g/dl) and severe anaemia (haemoglobin < 8.0 g/dl) occurrence were assessed across study arms, using Kaplan-Meier and multivariable Cox proportional hazards models.

Results

At enrolment (corresponded to a median 32 weeks gestation), median haemoglobin was 10.3 g/dl (IQR = 9.2-11.1). Severe anaemia occurred subsequently in 194 (18.1%) women, mostly in those with low baseline haemoglobin, lowest socio-economic category, advanced HIV disease, prolonged breastfeeding (≥6 months) and shorter ARV exposure. Severe anaemia incidence was similar in the randomized arms (equivalence P-value = 0.32). After 1–2 months of ARV’s, severe anaemia was significantly reduced in all groups, though remained highest in the low CD4 cohort.

Conclusions

Severe anaemia occurs at a similar rate in women receiving longer triple zidovudine-containing regimens or shorter prophylaxis. Pregnant women with pre-existing anaemia and advanced HIV disease require close monitoring.

Trial registration number

ISRCTN71468401

【 授权许可】

   
2013 Sartorius et al.; licensee BioMed Central Ltd.

【 图 表 】

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