Nevirapine, sodium concentration and HIV-1 RNA in breast milk and plasma among HIV-infected women receiving short-course antiretroviral prophylaxis

PLoS One. 2015 Mar 26;10(3):e0121111. doi: 10.1371/journal.pone.0121111. eCollection 2015.

Abstract

Introduction: Risk factors for breast milk transmission of HIV-1 from mother to child include high plasma and breast milk viral load, low maternal CD4 count and breast pathology such as mastitis.

Objective: To determine the impact of nevirapine and subclinical mastitis on HIV-1 RNA in maternal plasma and breast milk after intrapartum single-dose nevirapine combined with either 1-week tail of Combivir (zidovudine/lamivudine) or single-dose Truvada (tenofovir/emtricitabine).

Methods: Maternal plasma and bilateral breast milk samples were collected between April 2008 and April 2011 at 1, 4 and 6 weeks postpartum from HIV-infected Tanzanian women. Moreover, plasma samples were collected at delivery from mother and infant.

Results: HIV-1 RNA was quantified in 1,212 breast milk samples from 273 women. At delivery, 96% of the women and 99% of the infants had detectable nevirapine in plasma with a median (interquartile range, IQR) of 1.5 μg/mL (0.75-2.20 μg/mL) and 1.04 μg/mL (0.39-1.71 μg/mL), respectively (P < 0.001). At 1 week postpartum, 93% and 98% of the women had detectable nevirapine in plasma and breast milk, with a median (IQR) of 0.13 μg/mL (0.13-0.39 μg/mL) and 0.22 μg/mL (0.13-0.34 μg/mL), respectively. Maternal plasma and breast milk HIV-1 RNA correlated at all visits (R = 0.48, R = 0.7, R = 0.59; all P = 0.01). Subclinical mastitis was detected in 67% of the women at some time during 6 weeks, and in 38% of the breast milk samples. Breast milk samples with subclinical mastitis had significantly higher HIV-1 RNA at 1, 4 and 6 weeks (all P < 0.05).

Conclusion: After short-course antiretroviral prophylaxis, nevirapine was detectable in most infant cord blood samples and the concentration in maternal plasma and breast milk was high through week 1 accompanied by suppressed HIV-1 RNA in plasma and breast milk.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / pharmacokinetics*
  • Antiretroviral Therapy, Highly Active*
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / transmission
  • HIV Infections / virology*
  • HIV-1 / genetics*
  • Humans
  • Infectious Disease Transmission, Vertical / prevention & control
  • Mastitis / epidemiology
  • Mastitis / etiology
  • Milk, Human / virology*
  • Nevirapine / administration & dosage
  • Nevirapine / pharmacokinetics*
  • Premedication
  • Prevalence
  • RNA, Viral
  • Sodium*
  • Viral Load
  • Young Adult

Substances

  • Anti-HIV Agents
  • RNA, Viral
  • Nevirapine
  • Sodium

Grants and funding

This research was supported by the European & Developing Countries Clinical Trials Partnership (http://www.edctp.org). KS received research funding for this study from Læge Agnethe Løvgreens Legat and Bjørn Astrups Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.