title: Safety of nevirapine-containing antiretroviral triple therapy regimens to prevent vertical transmission in an African cohort of HIV-1-infected pregnant women.
abstract: OBJECTIVE
  To assess the incidence and consequences of adverse reactions among African HIV-positive pregnant women treated with fixed-dose combinations of a nevirapine-containing antiretroviral (ARV) triple therapy.
  
  
  METHODS
  A retrospective analysis of the clinical files of 703 HIV-1-positive pregnant women treated with a nevirapine-containing regimen between May 2002 and July 2004 was conducted. Selection criteria for inclusion in the analysis were: (a) taking ARV for more than 14 days; (b) baseline values of transaminases below the threshold of 2.5 times the upper limit of normal (ULN). The women were on a nevirapine-containing regimen for a median of 127 days [interquartile range (IQR) 86-190 days], starting on average at the 27th week of gestation (standard deviation+/-9.5) and continuing up to a maximum of 6 months after delivery. All women were offered formula milk to feed the babies. Highly active antiretroviral therapy (HAART) was continued beyond 6 months only if the patient qualified on the first visit. The main outcome measures were incidence of hepatotoxicity, skin rashes and Stevens-Johnson syndrome. Multivariate analysis to assess the impact of several factors on the adverse reaction rate was performed.
  
  
  RESULTS
  As of 1 August 2004, 554 pregnancies reached term, 96 women were still pregnant, and 53 women dropped out of the programme before giving birth. After 2 months of therapy the percentage of patients with a viral load less than 1000 HIV-1 RNA copies/mL increased to 78.6%; average CD4 cell counts increased from 490 cells/microL before therapy to 630 after therapy. The incidence of grade 3-4 adverse reactions (hepatotoxicity, skin rashes and Stevens-Johnson syndrome) was 6.5, 2.4 and 1.1%, respectively. Five women died during pregnancy (0.88%). Only one of the deaths could be associated with ARV treatment.
  
  
  CONCLUSIONS
  Nevirapine-containing regimens in pregnant woman, at all CD4 cell count levels, appear to be safe in African settings.
authors.affiliation: LUMSA University, Rome, Italy.
authors.forename: M C
authors.initials: MC
authors.lastname: Marazzi
authors.forename: P
authors.initials: P
authors.lastname: Germano
authors.forename: G
authors.initials: G
authors.lastname: Liotta
authors.forename: G
authors.initials: G
authors.lastname: Guidotti
authors.forename: S
authors.initials: S
authors.lastname: Loureiro
authors.forename: A
authors.initials: A
authors.lastname: da Cruz Gomes
authors.forename: M C
authors.initials: MC
authors.lastname: Valls Blazquez
authors.forename: P
authors.initials: P
authors.lastname: Narciso
authors.forename: C F
authors.initials: CF
authors.lastname: Perno
authors.forename: S
authors.initials: S
authors.lastname: Mancinelli
authors.forename: L
authors.initials: L
authors.lastname: Palombi
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D044383:Black People; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D015994:Incidence; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D009073:Mozambique; D019829:Nevirapine / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000517:prevention & control*; D012189:Retrospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine