title: Effectiveness and safety of saquinavir/ritonavir in HIV-infected pregnant women: INEMA cohort.
abstract: OBJECTIVE
  The authors had for aim to describe the effectiveness and the safety of a saquinavir/ritonavir (SQV/r) regimen, 1000/100mg twice daily, in HIV-infected pregnant patients.
  
  
  METHODS
  We made a prospective and observational study of HIV positive female patients beginning or going on SQV/r antiretroviral treatment (ART) during pregnancy.
  
  
  RESULTS
  Sixty-two patients were enrolled from July 2007 to June 2009 in 10 infectious diseases units in France. Thirty-six women (group 1) were ART naive on inclusion, 20 (group 2) had been previously treated and then switched to SQV/r, six (group 3) were treated with SQV/r before pregnancy. 58 patients delivered while on SQV/r regimen after a median pregnancy duration of 39 WA. Eighty percent had a viral load below 50 copies/mL and 93% below 400 copies/mL: respectively 77% and 93.5% in group 1, 83% and 89% in group 2, 83% and 100% in group 3. The median SQV minimum concentrations (C(min)) measured at the third trimester and at delivery were adequate, respectively 0.91 mg/L and 0.86 mg/L. Most women (52%) had a vaginal delivery; 12 (21%) had an elective caesarean section, for obstetrics factors in eight cases. None of the newborns were HIV-infected at 6 months of age (n = 59, one death at day 3). Only one severe adverse event occurred due to saquinavir (maternal grade 3 hepatotoxicity).
  
  
  CONCLUSIONS
  SQV/r 1000/100mg twice daily seems to be effective and safe in HIV-infected pregnant women with adequate saquinavir C(min).
authors.affiliation: Service d'Infectiologie, Service de Maladies Infectieuses et Tropicales, Hôtel-Dieu 7(e) Ouest, CHU de Nantes, place Alexis-Ricordeau, 44093 Nantes cedex 01, France. cecile.brunet@chu-nantes.fr
authors.forename: C
authors.initials: C
authors.lastname: Brunet
authors.forename: V
authors.initials: V
authors.lastname: Reliquet
authors.forename: T
authors.initials: T
authors.lastname: Jovelin
authors.forename: N
authors.initials: N
authors.lastname: Venisse
authors.forename: N
authors.initials: N
authors.lastname: Winer
authors.forename: E
authors.initials: E
authors.lastname: Bui
authors.forename: G
authors.initials: G
authors.lastname: Le Moal
authors.forename: P
authors.initials: P
authors.lastname: Perfezou
authors.forename: L
authors.initials: L
authors.lastname: De Saint Martin
authors.forename: F
authors.initials: F
authors.lastname: Raffi
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D015331:Cohort Studies; D036861:Delivery, Obstetric / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000151:congenital / Q000188:drug therapy* / Q000517:prevention & control / Q000635:transmission; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1; D015498:HIV-2; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011446:Prospective Studies; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019258:Saquinavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D014766:Viremia / Q000188:drug therapy; D055815:Young Adult; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D017320:HIV Protease Inhibitors; D015215:Zidovudine; D019258:Saquinavir; D019438:Ritonavir