WHO Study Offers Hope on HIV Positive Breastfeeding. 22/1/11
Rrisk of HIV transmission during breastfeeding could be safely reduced by providing a combination of three antiretrovirals
By Yinka Shokunbi
22 January 2011
It is no news that many HIV positive women in Nigeria and other developing countries, are still at loss over what to make of breast feeding their babies even in their status. The World Health Organisation (WHO) certainly understands this predicament and has not stopped researching into how best to assist such women undergo the natural task of breastfeeding without jeopardising the lives of the newborn with HIV infection.
It is to this end that a study led by the WHO's Department of Reproductive Health and Research in partnership with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS), U.S. Centres 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, offers new insights and new hope for preventing HIV infection and death among infants in settings where many mothers with HIV infection breastfeed.
Referred to as the Kesho Bora study, a community study done in South Africa, was to assess whether the risk of HIV transmission during breastfeeding could be safely reduced by providing a combination of three antiretrovirals (ARVs).
The findings of the Kesho Bora study show that the risk of HIV infection in breastfed infants is greatly reduced when mothers with a CD4 count between 200 and 500 cells/mm3 are given an extended triple-ARV regimen. The study treatment consisted of the anti-HIV drugs zidovudine, lamivudine and lopinavir/ritonavir, from the last trimester of pregnancy and continued during breastfeeding up to the age of six months.
The evidence for providing ARVs to pregnant women with HIV during late pregnancy and delivery to reduce transmission to their infants is well established. But this was the first randomised trial to directly compare the safety and efficacy of a combination of three ARVs given during pregnancy and continued during breastfeeding against the standard regimen recommended by WHO since 2004 of zidovudine started in late pregnancy and stopped after delivery, combined with single-dose nevirapine during labour. The balance of risks and benefits of continuing ARVs during breastfeeding for mothers with an intermediate stage of HIV disease (CD4 count between 200 and 500 cells/mm3) was not known prior to this study.
Between June 2005 and August 2008, at five sites across Africa, researchers enrolled pregnant women with HIV infection and women with a CD4 count below 200 cells/mm3 were given antiretroviral treatment; those with a CD4 count above 500 cells/mm3 (who have a low risk of transmission) were given the control prophylaxis stopping at delivery. A total of 824 women with a CD4 count between 200 and 500 cells/mm3 were randomly assigned to one of two groups. In the intervention group, 412 women were provided with a combination of three ARVs for the last two months of pregnancy, through delivery and during breastfeeding (for a maximum of six months after delivery).
The women were advised to stop all breastfeeding before they stopped taking ARVs. In the control group, the women were given a regimen of zidovudine and single-dose nevirapine, which stops one week after delivery and does not include further administration of ARVs to mother or infant during breastfeeding.
Blood samples were subsequently taken from all infants for HIV testing at birth, and then periodically throughout the study, until they were 12 months old.
At 12 months of age, 9.5 per cent of infants in the control group had acquired HIV, and a further 6.5 per cent had died. By comparison, 5.4 per cent in the triple-ARV group had acquired HIV and a further 4.8 per cent had died.
This corresponds to a 43 per cent decrease in overall HIV infections, 54 per cent reduction in transmissions during breastfeeding and a 36 per cent decrease in HIV infections or deaths. The best results, with the largest number of infections averted, were in the group of women enrolled with a CD4 count between 200 and 350 cells/mm3. The number of adverse events was rare, with similar frequency in the two groups.
The new results published in Lancet Infectious Diseases on January 14, 2011 show that infants of mothers whose virus was fully suppressed (undetectable) by the ARVs at the time of delivery had a very low risk of transmission (only 2.7 per cent infected by the age of one year).
It is therefore important to start combination ARVs early in pregnancy, or even before pregnancy.
Giving HIV-positive pregnant women and those planning pregnancy priority accesses to ARVs will help to eliminate mother-to-child transmission of HIV. About 80 per cent of transmissions occur in women with CD4 counts below 350 cells/mm3.
Therefore, universal coverage of antiretroviral treatment for all women with a CD4 count at or below 350 cells/mm3 has the potential to prevent over three-quarters of HIV infections in infants.
For maximum efficacy, ART should ideally be initiated before pregnancy and therefore women planning to become pregnant should be strongly encouraged to have an HIV test and CD4 count.
In the developed world, mothers with HIV avoid breastfeeding altogether and can instead feed their infants with formula. But in many low- and middle-income countries, formula feeding of infants is neither feasible nor safe. Sanitation is lacking, and clean water to mix formula is often not available. Many families cannot afford infant formula.
It may be difficult to obtain enough fuel to boil the water to prepare formula safely. Formula-fed infants miss out on protective antibodies - passed on through breast milk - that ward off other deadly diseases. Formula feeding may also carry a social stigma in certain settings - the practice may be seen as a sign that a woman has HIV infection