Effect of Postnatal HIV Treatment on Clinical Mastitis and Breast Inflammation in HIV-Infected Breast-feeding Women

Paediatr Perinat Epidemiol. 2017 Mar;31(2):134-143. doi: 10.1111/ppe.12337. Epub 2017 Feb 16.


Background: The relationship between mastitis and antiretroviral therapy among HIV-positive, breast-feeding women is unclear.

Methods: In the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study, conducted in Lilongwe, Malawi, 2369 mother-infant pairs were randomized to a nutritional supplement group and to one of three treatment groups: maternal antiretroviral therapy (ART), infant nevirapine (NVP) or standard of care for 24 weeks of exclusive breast-feeding and 4 weeks of weaning. Among 1472 HIV-infected women who delivered live infants between 2004 and 2007, we estimated cumulative incidence functions and sub-distribution hazard ratios (HR) of mastitis or breast inflammation comparing women in maternal ART (n = 487) or infant nevirapine (n = 492) groups to the standard of care (n = 493). Nutritional supplement groups (743 took, 729 did not) were also compared.

Results: Through 28-weeks post-partum, 102 of 1472 women experienced at least one occurrence of mastitis or breast inflammation. The 28-week risk was higher for maternal ART (risk difference (RD) 4.5, 95% confidence interval (CI) 0.9, 8.1) and infant NVP (RD 3.6, 95% CI 0.3, 6.9) compared to standard of care. The hazard of late-appearing mastitis or breast inflammation (from week 5-28) was also higher for maternal ART (HR 6.7, 95% CI 2.0, 22.6) and infant NVP (HR 5.1, 95% CI 1.5, 17. 5) compared to the standard of care.

Conclusions: Mastitis or breast inflammation while breast-feeding is a possible side effect for women taking prophylactic ART and women whose infants take NVP, warranting additional research in the context of postnatal HIV transmission.

Keywords: Mastitis; breast-feeding; human immunodeficiency virus; infant nevirapine; prophylactic antiretroviral therapy.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, American Recovery and Reinvestment Act
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Anti-HIV Agents / adverse effects*
  • Breast Feeding*
  • Dietary Supplements
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / epidemiology
  • Humans
  • Malawi / epidemiology
  • Mastitis / chemically induced*
  • Mastitis / epidemiology
  • Postnatal Care
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy*
  • Risk Factors


  • Anti-HIV Agents