title: Effect of HIV-1 antiretroviral prophylaxis on hepatic and hematological parameters of African infants.
abstract: OBJECTIVE
  To measure hepatic and hematological parameters among neonates randomized to receive ultra-short antiretroviral regimens.
  
  
  METHODS
  As part of an on-going clinical trial in Malawi, infants born to women who received (early presenters) or did not receive (late presenters) standard intrapartum nevirapine (NVP) dosing were randomized to receive orally either single dose NVP alone or NVP plus zidovudine (twice daily for 1 week). An additional group of untreated infants (born to HIV-uninfected women) was enrolled as a control.
  
  
  METHODS
  Laboratory measurements were performed at birth and repeated at 6 weeks of age. Serum alanine aminotransferase (ALT) was measured on approximately 200 infants consecutively enrolled and randomized at the start of the trial. Complete blood count (CBC) was performed on approximately 800 infants at birth and 600 infants at 6 weeks of age. ALT and CBC were also determined on approximately 200 control infants.
  
  
  RESULTS
  At birth there were no differences in ALT values between the groups of children. At 6 weeks of age, ALT levels were significantly higher among the treated groups compared with control group (geometric mean of 11.5 U/l for controls and 16.2-19.1 U/l for treated groups; P < 0.0001). Hematological parameters did not differ between groups at birth. At 6 weeks of age, levels of hemoglobin, hematocrit, granulocytes, and platelets were significantly (P < 0.0001) lower among antiviral drug-treated groups compared with controls. These changes were consistent with grade 1 (mild) toxicity, and were more noticeable among HIV-infected infants.
  
  
  CONCLUSIONS
  Hepatic and hematologic abnormalities associated with short-term neonatal antiretrovirals among African children are minimal.
authors.affiliation: Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland 21205, USA.
authors.forename: Taha E
authors.initials: TE
authors.lastname: Taha
authors.forename: Newton
authors.initials: N
authors.lastname: Kumwenda
authors.forename: Amanda
authors.initials: A
authors.lastname: Gibbons
authors.forename: Donald
authors.initials: D
authors.lastname: Hoover
authors.forename: Valentino
authors.initials: V
authors.lastname: Lema
authors.forename: Susan
authors.initials: S
authors.lastname: Fiscus
authors.forename: Joshua
authors.initials: J
authors.lastname: Mukiibi
authors.forename: George
authors.initials: G
authors.lastname: Liomba
authors.forename: Robin
authors.initials: R
authors.lastname: Broadhead
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D008111:Liver Function Tests; D008295:Malawi; D019829:Nevirapine / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D015215:Zidovudine / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine; D019829:Nevirapine; D000410:Alanine Transaminase