title: Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: a randomized trial in three African countries.
abstract: 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 200-500 cells/mm(3) 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/mm(3) initiated antiretroviral therapy, and >500 cells/mm(3) 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.
  
  
  BACKGROUND
  ISRCTN71468401.
authors.forename: Benn K D
authors.initials: BK
authors.lastname: Sartorius
authors.forename: Matthew F
authors.initials: MF
authors.lastname: Chersich
authors.forename: Mary
authors.initials: M
authors.lastname: Mwaura
authors.forename: Nicolas
authors.initials: N
authors.lastname: Meda
authors.forename: Marleen
authors.initials: M
authors.lastname: Temmerman
authors.forename: Marie Louise
authors.initials: ML
authors.lastname: Newell
authors.forename: Timothy M M
authors.initials: TM
authors.lastname: Farley
authors.affiliation: School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. sluchters@burnet.edu.au.
authors.forename: Stanley
authors.initials: S
authors.lastname: Luchters
mesh_terms: D000328:Adult; D017954:Africa South of the Sahara / Q000453:epidemiology; D000740:Anemia / Q000453:epidemiology*; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D019829:Nevirapine / Q000627:therapeutic use; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D015215:Zidovudine; D019829:Nevirapine