title: Outcomes in a cohort of women who discontinued maternal triple-antiretroviral regimens initially used to prevent mother-to-child transmission during pregnancy and breastfeeding--Kenya, 2003-2009.
abstract: BACKGROUND
  In 2012, the World Health Organization (WHO) amended their 2010 guidelines for women receiving limited duration, triple-antiretroviral drug regimens during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV (tARV-PMTCT) (Option B) to include the option to continue lifelong combination antiretroviral therapy (cART) (Option B+). We evaluated clinical and CD4 outcomes in women who had received antiretrovirals for prevention of mother-to-child transmission and then discontinued antiretrovirals 6-months postpartum.
  
  
  RESULTS
  The Kisumu Breastfeeding Study, 2003-2009, was a prospective, non-randomized, open-label clinical trial of tARV-PMTCT in ARV-naïve, Kenyan women. Women received tARV-PMTCT from 34 weeks' gestation until 6-months postpartum when women were instructed to discontinue breastfeeding. Women with CD4 count (CD4) <250cells/mm3 or WHO stage III/IV prior to 6-months postpartum continued cART indefinitely. We estimated the change in CD4 after discontinuing tARV-PMTCT and the adjusted relative risk [aRR] for factors associated with declines in maternal CD4. We compared maternal and infant outcomes following weaning-when tARV-PMTCT discontinued-by maternal ARV status through 24-months postpartum. Compared with women who continued cART, discontinuing antiretrovirals was associated with infant HIV transmission and death (10.1% vs. 2.4%; P = 0.03). Among women who discontinued antiretrovirals, CD4<500 cells/mm3 at either initiation (21.8% vs. 1.5%; P = 0.002; aRR: 9.8; 95%-confidence interval [CI]: 2.4-40.6) or discontinuation (36.9% vs. 8.3%; P<0.0001; aRR: 4.4; 95%-CI: 1.9-5.0) were each associated with increased risk of women requiring cART for their own health within 6 months after discontinuing.
  
  
  CONCLUSIONS
  Considering the serious health risks to the woman's infant and the brief reprieve from cART gained by stopping, every country should evaluate the need for and feasibility to implement WHO Option B+ for PMTCT. Evaluating CD4 at antiretroviral initiation or 6-months postpartum can identify pregnant women who would most benefit from continuing cART in settings unable to implement WHO Option B+.
authors.affiliation: Epidemic Intelligence Service, CDC, Atlanta, Georgia, United States of America; Division of HIV/AIDS Prevention, CDC, Atlanta, Georgia, United States of America; Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, United States of America.
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Minniear
authors.affiliation: CDC Information Management Services, ICF International, Atlanta, Georgia, United States of America.
authors.forename: Sonali
authors.initials: S
authors.lastname: Girde
authors.affiliation: Kenya Medical Research Institute/CDC Research and Public Health Collaboration, Kisumu, Kenya.
authors.forename: Frank
authors.initials: F
authors.lastname: Angira
authors.affiliation: Division of HIV/AIDS Prevention, CDC, Atlanta, Georgia, United States of America; Kenya Medical Research Institute/CDC Research and Public Health Collaboration, Kisumu, Kenya.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Mills
authors.affiliation: Division of HIV/AIDS Prevention, CDC, Atlanta, Georgia, United States of America; Kenya Medical Research Institute/CDC Research and Public Health Collaboration, Kisumu, Kenya.
authors.forename: Clement
authors.initials: C
authors.lastname: Zeh
authors.affiliation: Division of HIV/AIDS Prevention, CDC, Atlanta, Georgia, United States of America.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Peters
authors.affiliation: Kenya Medical Research Institute/CDC Research and Public Health Collaboration, Kisumu, Kenya.
authors.forename: Rose
authors.initials: R
authors.lastname: Masaba
authors.affiliation: Kenya Medical Research Institute/CDC Research and Public Health Collaboration, Kisumu, Kenya.
authors.forename: Richard
authors.initials: R
authors.lastname: Lando
authors.affiliation: Division of HIV/AIDS Prevention, CDC, Atlanta, Georgia, United States of America.
authors.forename: Timothy K
authors.initials: TK
authors.lastname: Thomas
authors.affiliation: Division of HIV/AIDS Prevention, CDC, Atlanta, Georgia, United States of America.
authors.forename: Allan W
authors.initials: AW
authors.lastname: Taylor
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D001942:Breast Feeding; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007630:Kenya; D049590:Postpartum Period; D011247:Pregnancy; D016896:Treatment Outcome; D014886:Weaning; D028761:Withholding Treatment; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents
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