title: Absence of effect of menopause status at initiation of first-line antiretroviral therapy on immunologic or virologic responses: a cohort study from Rio de Janeiro, Brazil.
abstract: OBJECTIVE
  To compare the effectiveness of first-line combination antiretroviral therapy (cART) between premenopausal and postmenopausal women.
  
  
  METHODS
  ART-naïve women initiating cART between January 2000/June 2010 at the Instituto de Pesquisa Clínica Evandro Chagas Cohort were studied. Women were defined as postmenopausal after 12 consecutive months of amenorrhea. CD4 cell counts and HIV-1 RNA viral load (VL) measurements were compared between pre- and postmenopausal at 6, 12 and 24 months after cART initiation. Women who modified/discontinued a drug class or died due to an AIDS defining illness were classified as ART-failures. Variables were compared using Wilcoxon test, χ2 or Fisher's exact test. The odds of cART effectiveness (VL<400 copies/mL and/or no need to change cART) were compared using logistic regression. Linear model was used to access relationship between CD4 change and menopause.
  
  
  RESULTS
  Among 383 women, 328 (85%) were premenopausal and 55 (15%) postmenopausal. Median pre cART CD4 counts were 231 and 208 cells/mm(3) (p = 0.14) in pre- and postmenopausal women, respectively. No difference in the median pre cART VL was found (both 4.8 copies/mL). Median CD4 changes were similar at 6 and 12 months. At 24 months after cART initiation, CD4 changes among postmenopausal women were significantly lower among premenopausal women (p = 0.01). When the analysis was restricted to women with VL<400 copies/mL, no statistical difference was observed. Overall, 63.7% achieved cART effectiveness at 24 months without differences between groups at 6, 12 and 24 months.
  
  
  CONCLUSIONS
  Menopause status at the time of first-line cART initiation does not impact CD4 cell changes at 24 months among women with a virologic response. No relationship between menopause status and virologic response was observed.
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Guilherme Amaral
authors.initials: GA
authors.lastname: Calvet
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil ; Departamento de Matemática e Estatística, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
authors.forename: Luciane
authors.initials: L
authors.lastname: Velasque
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Paula Mendes
authors.initials: PM
authors.lastname: Luz
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Sandra Wagner
authors.initials: SW
authors.lastname: Cardoso
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Monica
authors.initials: M
authors.lastname: Derrico
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Ronaldo Ismério
authors.initials: RI
authors.lastname: Moreira
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Angela Cristina Vasconcelos
authors.initials: AC
authors.lastname: de Andrade
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Andrea
authors.initials: A
authors.lastname: Cytryn
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Elaine
authors.initials: E
authors.lastname: Pires
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Valdiléa Gonçalves
authors.initials: VG
authors.lastname: Veloso
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Grinsztejn
authors.affiliation: Instituto de Pesquisa Clínica Evandro Chagas (IPEC), Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
authors.forename: Ruth Khalili
authors.initials: RK
authors.lastname: Friedman
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D001938:Brazil; D018791:CD4 Lymphocyte Count / Q000639:trends*; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects / Q000276:immunology* / Q000821:virology*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology* / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood / Q000235:genetics; D019562:Viral Load
chemical_list: D012367:RNA, Viral