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Maternal HAART Reduces Breast Milk-Related HIV Infection

By Deborah Mitchell

BOSTON (Reuters Health) Feb 05 - HIV transmission is significantly reduced in infants born to HIV-infected mothers who are on highly active antiretroviral therapy (HAART), when the infants are given a standard single-dose of nevirapine at birth, according to a 4-year study conducted in Kenya.

Dr. Timothy Thomas of the Centers for Disease Control and Prevention presented the findings of the Kisumu Breastfeeding Study here at the 15th Conference on Retroviruses and Opportunistic Infections.

For this phase IIb study, the investigators put HIV-infected pregnant women on a HAART regimen consisting of a single tablet containing zidovudine and lamivudine plus nevirapine, starting at 34 weeks gestation and continuing to 6 months postpartum.

The women were asked to exclusively breast-feed for 6 months and then rapidly wean. Women with CD4 counts greater than 250 cells per microliter were switched during the course of the study to nelfinavir.

The infants received a single-dose of nevirapine and were followed for 1 year. HIV infection rates were determined by PCR at delivery, 2, 6 and 14 weeks postpartum and after 6, 9 and 12 months. HIV infection data were available for 497 infants.

At 1 week, 12 infants were HIV-positive, for a cumulative infection rate of 2.4%, Dr. Thomas reported. By 1 year, the number of HIV infections had risen to only 27 cases, for a cumulative infection rate of 5.9%.

By comparison, the CDC estimates that mother-child HIV transmission through breast-feeding in resource-poor settings ranges from 28% to 48%.

No differences in transmission rates were seen based on maternal CD4 counts or HAART regimen (nevirapine or nelfinavir).

These findings suggest that the 12-month HIV infection rate through breast feeding can be substantially reduced by HAART initiated in late pregnancy and continued through 6 months.

Dr. Thomas and his colleagues plan to further evaluate factors such as treatment compliance, maternal and infant drug resistance, and optimal timing of the intervention. Before implementation, it will also be necessary to establish the safety, feasibility and patient acceptance of HAART.

A question was recently posed with regards to the ethics of this study. The report states that
"the women were asked to exclusively breast-feed for 6 months and then rapidly wean". This statement in particular begs the question, how ethical is it for the researchers to require women that they know to be HIV positive, to breast feed their new-born infants, as a part of a scientific quest, when discouraging breastfeeding is known to eliminate the risk of mother-to-child transmission of HIV to the otherwise uninfected infant. A colleague extended the following further questions:

1. Were these people fully informed of the nature of research study they were being subjected to?

2. If not, would they have agreed to take part in a research/study that can possibly subject them or their babies to HIV infection if they had been fully informed?

3. If they did give their 'consent' would they have done the same if they had any other choice?

4. What criteria was used for selection of the research destination/s and research subjects?

We pose these questions here for an in-depth discussion on what seems to be a valid concern on the ethics of HIV/AIDS research conducted on subjects in what are now commonly referred to as "resource-deficient countries".