title: Maternal and Breastmilk Viral Load: Impacts of Adherence on Peripartum HIV Infections Averted-The Breastfeeding, Antiretrovirals, and Nutrition Study.
abstract: BACKGROUND
  Antiretroviral (ARV) interventions are used to reduce HIV viral replication and prevent mother-to-child transmission. Viral suppression relies on adherence to ARVs.
  
  
  METHODS
  A 2-phase study was conducted using data from the Breastfeeding, Antiretrovirals, and Nutrition study. We included mothers randomized to 28 weeks of postpartum ARVs with ≥1 plasma or breastmilk specimen. All mothers who transmitted HIV to their infants from 2-28 weeks (n = 31) and 15% of mothers who did not (n = 232) were included. Adherence was measured by pill count [categorized as poor (0%-80%), partial (81%-98%), and near perfect (>98%)]. Associations between adherence and breastmilk RNA were assessed using mixed-effects models. Cox models were used to estimate associations between breastmilk RNA and HIV transmission. Using Monte Carlo simulation, we estimated the number of transmissions that would occur had everyone randomized to maternal ARVs been 90% and 100% adherent.
  
  
  RESULTS
  Partial or near perfect ARV adherence significantly reduced the odds of having detectable (≥40 copies/mL) breastmilk RNA, compared with poor adherence (Odds Ratio (OR) 0.23, 95% CI: 0.08 to 0.67; OR 0.36, 95% CI: 0.16 to 0.81, respectively). Detectable breastmilk RNA was associated with increased breastmilk transmission compared with undetectable breastmilk RNA (hazard ratio 3.8, 95% CI: 1.2 to 12.1). All transmitting mothers had ≥1 plasma viral load specimen >100 copies per milliliter. An estimated similar number of transmissions would occur with 90% adherence compared with 100%.
  
  
  CONCLUSIONS
  Helping patients adhere to ARVs throughout breastfeeding is important for realizing the full potential of recommended ARV interventions to prevent mother-to-child HIV transmission. Maintaining plasma viral load <100 copies per milliliter may prevent breastmilk transmission.
authors.affiliation: *Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC; †Division of Infectious Diseases, Department of Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC; ‡Currently, Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA; §Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC; ‖Division of Epidemiology and Biostatistics, School of Public Health, University of Witwatersrand, Parktown, South Africa; ¶UNC Project, University of North Carolina, Lilongwe, Malawi; #Department of Microbiology and Immunology, School of Medicine, Center for AIDS Research, University of North Carolina, Chapel Hill, NC; **Division of Global Women's Health, Department of Obstetrics & Gynecology, Institute for Global Health and Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC; and ††Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Davis
authors.forename: William C
authors.initials: WC
authors.lastname: Miller
authors.forename: Michael G
authors.initials: MG
authors.lastname: Hudgens
authors.forename: Charles S
authors.initials: CS
authors.lastname: Chasela
authors.forename: Dorothy
authors.initials: D
authors.lastname: Sichali
authors.forename: Dumbani
authors.initials: D
authors.lastname: Kayira
authors.forename: Julie A E
authors.initials: JA
authors.lastname: Nelson
authors.forename: Susan A
authors.initials: SA
authors.lastname: Fiscus
authors.forename: Gerald
authors.initials: G
authors.lastname: Tegha
authors.forename: Deborah D
authors.initials: DD
authors.lastname: Kamwendo
authors.forename: Joseph
authors.initials: J
authors.lastname: Rigdon
authors.forename: Jeffrey S A
authors.initials: JS
authors.lastname: Stringer
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Juliano
authors.forename: Sascha R
authors.initials: SR
authors.lastname: Ellington
authors.forename: Athena P
authors.initials: AP
authors.lastname: Kourtis
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Jamieson
authors.forename: Charles
authors.initials: C
authors.lastname: van der Horst
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D001942:Breast Feeding; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission / Q000821:virology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D008895:Milk, Human / Q000821:virology*; D058725:Peripartum Period; D010949:Plasma / Q000821:virology*; D011247:Pregnancy; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents