What it is
A three-drug antiretroviral regimen given to HIV-positive women in late pregnancy and through breastfeeding cuts HIV transmission to babies safely, without requiring mothers to stop breastfeeding.
Why it matters
Breastfeeding was long seen as a major HIV transmission risk, yet avoiding it raised the risk of malnutrition, illness and unsafe feeding, especially where resources were limited. This trial showed the two risks didn't have to be traded off against each other.
The story
The Kesho Bora trial enrolled 824 pregnant women living with HIV at five clinics in Burkina Faso, Kenya and South Africa between 2005 and 2008. Women were randomly assigned to receive either a combination of three antiretroviral medicines (AZT + 3TC + LPV/r), started during late pregnancy and continued for six months of breastfeeding, or the treatment approach commonly used at the time: a shorter course of zidovudine during pregnancy and a single dose of nevirapine during delivery. The study aimed to determine which approach was more effective at reducing HIV transmission to babies. [1]
By 12 months, only 5.4% of babies in the triple-drug group had been infected with HIV, compared with 9.5% in the group on the older short-course treatment, a 43% reduction in transmission risk. Among mothers who intended to breastfeed, the reduction was even larger, at 48%. The triple-drug regimen was not linked to any increase in serious side effects for mothers or babies, and infant mortality by 12 months was lower in the triple-drug group, at 6.2% compared with 9.8% in the control group. [1][2]
These results helped shape global HIV treatment guidance. In 2010, the World Health Organization (WHO) recommended that women living with HIV who did not yet need HIV treatment for their own health should receive antiretroviral medicines during breastfeeding to reduce the risk of passing HIV to their babies. Building directly on the Kesho Bora trial findings, the medicines are recommended to be given either to the mother or to the baby, an approach known as Option B. [3] In 2013, WHO updated its guidelines to recommend lifelong antiretroviral therapy for all pregnant and breastfeeding women living with HIV. This approach became known as Option B+. [4]
Countries gradually adopted Option B+. Malawi was the first country to introduce the approach in 2011, and by 2015, 21 of the 22 priority countries tracked by UNAIDS had adopted it.[5] Between 2005 and 2012, more than 850,000 child HIV infections were averted across the priority countries, with sharp declines in new infections among children in Ghana, Namibia, Zimbabwe, Malawi, Botswana, Zambia and Ethiopia. By 2014, new child HIV infections across the 21 African priority countries had fallen below 200,000 for the first time since the 1990s, a 43% decline since 2009.[5]
The impact has reached far beyond the trial itself. Kesho Bora's early results shaped Option B and Option B+, both of which are now improving outcomes on the ground. In Malawi, antiretroviral therapy (ART) initiation among pregnant and breastfeeding women rose by 748% in the first year after Option B+ launched [6], while Option B+ implementations in Zimbabwe [7], Uganda [8] and South Africa [9] found broad acceptance of the new regimen.
Sources:
[2] Mother-to-Child Transmission of HIV. | EDCTP
[8] An early assessment of Uganda's roll-out of Option B+: Service capacity and infant outcomes. | PMC
The Kesho Bora trial was supported by a consortium of international partners, including EDCTP, which provided additional funding for the study. Other contributors included
- French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
- UK Department for International Development
- Thrasher Research Fund
- Belgian development cooperation
- US Centers for Disease Control and Prevention
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction
- Africa Centre for Health and Population Studies at the University of KwaZulu-Natal
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A three-drug antiretroviral regimen given to HIV-positive women in late pregnancy and through breastfeeding cuts HIV transmission to babies safely, without requiring mothers to stop breastfeeding.
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