A new study published in Lancet Infectious Diseases of 14 January 2011 shows that giving a triple antiretroviral therapy (ART) during pregnancy, delivery and breastfeeding cuts the risk of mother-to-child transmission (MTCT) of HIV by 43% compared with the standard regimen of zudovidine and niverapine recommended by World Health Organization (WHO) from 2004. Funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), this new approach will increase the chances of mothers living with HIV to breastfeed with reduced risk of passing on the virus to their babies.

In developing countries, breastfeeding is crucial for child health. Unfortunately in low-resource countries, formula feeding of infants is neither feasible nor safe. They lack in sanitation and scarcity of clean water to mix the formula. Additionally, many families cannot afford infant formula. Therefore, often mothers with HIV have been advised to breastfeed their babies although they carried the risk of transmitting the virus to a child who escaped infection during childbirth through their breast milk.

The Kesho Bora study - 'A better future' in Swahilli - offers a new hope for preventing HIV infection and death among infants in low-resource settings where many mothers with the virus breastfeed. The study was a randomised controlled trial in antiretroviral-naïve pregnant woman infected with HIV-I conducted in five sites in Africa: the Centre Muraz in Bobo-Dioulasso, Burkina Faso; the International Centre for Reproductive Health in Mombassa, Kenya; Kenyatta National Hospital in Nairobi, Kenya; the University of KwaZulu-Natal in Durban, South Africa; and the Africa Centre, University of KwaZulu-Natal in Somkhele, South Africa. It aimed to assess the efficacy and safety of triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis in pregnant woman, which was the regimen recommended by WHO guidelines.

From June 2005 to August 2008, 882 women were enrolled, 824 of whom were randomised and gave birth to 805 singleton or first, liveborn infants. Inclusion criteria were pregnancy less than 32 weeks' gestation; women with CD4 below 200 cells per μL; and women with CD4 between 200-500 cells per μL. Women were randomly assigned to receive the triple antiretroviral combination or the zidovudine and single-dose nevirapine according to the WHO guidelines. The results published in Lancet Infectious Diseases on 14 January 2011 show that providing a combination of three ARVs to pregnant and breastfeeding mothers is a safe and effective way to reduce HIV transmission to infants.

The findings of the Kesho Bora study have strongly influenced the revised WHO guidelines on prevention of mother-to-child transmission of HIV, and infant feeding. WHO now recommends providing combination ART to all pregnant women with CD4 count at or below 350 cells per μL and to provide ARV prophylaxis (either to the mother or to the child) for the entire duration of breastfeeding if the mother is not already on ART.

Professor Charles Mgone, the Executive Director of EDCTP welcomed these positive findings. In his words he pointed out the importance of fostering collaboration among funders and in strengthening international research networks, as is the case in the Kesho Bora study group, to enhance clinical research efforts and capacity to fight HIV/AIDS in sub-Saharan Africa. Capacity building, networking and conduct of quality clinical trials are at the centre of funding streams that EDCTP provides.

The Kesho Bora study is led by WHO Department of Reproductive Health and Research in partnership with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS), US Centers for Disease Control and Prevention (CDC) and Eunice Kennedy Shriver National, Institute of Child Health and Human Development (NICHD) of the National Institutes of Health, and funded by Agence nationale de recherches sur le sida et les hépatites virales (ANRS), Belgian Directorate General for International Cooperation, Centers for Disease Control and Prevention (CDC), Department for International Development, Development and Research Training in Human Reproduction (WHO/HRP), EDCTP, Eunice Kennedy Shriver National Institute of Child Health and Human Development (National Institutes of Health), Thrasher Research Fund, UNDP/UNFPA/World Bank/WHO Special Programme of Research and UNICEF.

Source:
European and Developing Countries Clinical Trials Partnership (EDCTP)