BAN study impacts global policy and saves lives

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A research partnership between investigators at UNC Chapel Hill and in Malawi has led to an effective method to reduce the transmission of HIV through breast milk, a change in global health policy and national recognition for the study team.

The Breastfeeding, Antiretroviral and Nutrition (BAN) study, based in Lilongwe, Malawi, is the only large-scale, randomized trial to date comparing infant prophylaxis or maternal treatment to an enhanced standard-of-care arm in the prevention of HIV transmission through breast milk.

After nine years of work, the research team found that both methods were effective in reducing transmission of HIV through breastfeeding.

“BAN is a very important study – it actually showed that you can reduce transmission of HIV to the child using anti-retroviral prophylaxis while breastfeeding,” said Charles Chasela, PhD,  the BAN study coordinator and first author of the article discussing the study’s findings in the June 2010 issue of the New England Journal of Medicine (NEJM).

The work of the study team was most recently acknowledged by the Centers for Disease Control and Prevention (CDC) through the 2011 Charles C. Shepard Science Award, which recognizes excellence in science.  Awards are presented for scientific publications in the following areas: assessment and epidemiology, prevention and control, and laboratory and methods. Publications are evaluated based on scientific merit (including aspects such as originality, difficulty, efficiency, methods, and clarity) and impact on public health (importance and significance). The BAN study team received the award in the area of prevention and control for the 2010 article. To be eligible for the award, the publication must have at least one CDC author; the paper includes authors from CDC’s Division of Reproductive Health.

BAN was first funded in 2001 as a Special Interest Project (SIP) through the CDC Prevention Research Centers (PRC) Program, which provides core funding to the UNC Center for Health Promotion and Disease Prevention (HPDP).  The study is led by investigators at HPDP, the UNC School of Medicine and the UNC Institute for Global Health and Infectious Disease.

“The research is commendable for its impact on one of the world’s most pernicious diseases, yet one identified by CDC as a winnable battle,” said Eduardo Simoes MD, MPH, the director of the PRC Program, in a note of congratulation to the UNC researchers.

“The PRC at the UNC Chapel Hill has been exemplary in making high-quality researchers within the university aware of CDC interests for which their expertise is particularly valuable,” Simoes added.
BAN was recognized by the World Health Organization (WHO) in 2009 when the WHO changed its recommendations regarding breastfeeding by mothers with HIV. BAN was one of several clinical trials advocating that the WHO recommend  HIV-positive mothers use antiretrovirals from 14 weeks of pregnancy through 12 months of breastfeeding to reduce the risk of transmission of HIV. Before 2009, the WHO recommendation cited insufficient evidence to support using antiretrovirals during breastfeeding, which led to many HIV positive mothers not breastfeeding their infants.

BAN researchers tested more than 40,000 women for HIV and randomized 30 to 50 mother-infant teams every day during their recruitment phase. The total enrollment was 2,369 pairs.
Charles van der Horst, MD, the principal investigator of the BAN study, acknowledged the importance of the PRC Program in supporting the research.

“The SIP mechanism is a fabulous program,” said van der Horst.  “As an awardee and from my perspective, it allowed the CDC to target a specific area for research of national and international importance with detailed requirements for the awardee to meet. We welcomed the challenge and were gratified that we were funded initially and then subsequently.”

The BAN team was also able to use the PRC-funded study to leverage millions of additional dollars for their research from industry, the Gates Foundation and the National Institutes of Health, as well as train post-doctoral and graduate students, van der Horst said.

“The work resulted in the WHO changing their guidelines and will save thousands of mothers’ and babies’ lives around the globe,” van der Horst said.

 

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