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Breast-feeding guidelines for HIV-positive mothers evaluated
Experts, data and WHO differ on when to wean for infant survival regardless of serostatus.
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LOS ANGELES — The benefits of extending breast-feeding duration for children born to mothers living with HIV and AIDS in developing countries may outweigh concerns of mother-to-child transmission, according to several studies presented at the 14th Conference on Retroviruses and Opportunistic Infections, held here.
In the world’s poorest regions, mother-to-child transmission (MTCT) risk is often necessary as the water can be unsafe to drink and formula is scarce.
Infants who were weaned abruptly at 6 months to meet WHO guidelines for MTCT prevention were typically malnourished and diagnosed with severe gastroenteritis and pneumonia. Some of the infants died. Researchers further concluded that HIV-exposed and HIV-positive infants might need the protective immunities and nutrition provided by breast milk more than non-exposed infants.
Breast-feeding duration recommendations ranged from 6 months to beyond 24 months based on ongoing studies located in several African nations. Most researchers said breast-feeding should be preserved at all costs despite MTCT risk.
“Breast-feeding is a pillar for all children, including HIV-positive children,” said Hoosen Coovadia, MD, MBBS, a professor at the Doris Duke Medical Research Institute at the University of KwaZulu-Natal, South Africa. Coovadia, an expert on MTCT in breast-feeding, said that antiretrovirals have been successful in the developed world where breast-feeding can be precluded, but in resource-poor countries, mothers have scare alternatives.
Zambia trials
In 2001, WHO and other organizations encouraged women with HIV to stop breast-feeding to prevent MTCT earlier than they would under their cultural norms.
“But these guidelines were made without any experimental data to aid, support or refute the recommendations,” Moses Sinkala, MD, MPH, said. Sinkala is site director of the Lusaka District Health Management Team, which oversees the Zambia Exclusive Breast-feeding Study (ZEBS).
In ZEBS, 958 women living with HIV and their infants were recruited prenatally from two clinics in Lusaka. After the births, mother-daughter pairs were randomly assigned to two groups, either abrupt weaning at 4 months or continued breast-feeding for the duration of the mother’s choice. Pairs were followed for 24 months. HIV infection was diagnosed by polymerase chain reaction.
In this study, abrupt breast-feeding cessation at 4 months was associated with less than anticipated reduction of HIV transmission. In HIV-positive infants, mortality risk was also associated with early breast-feeding cessation.
By 24 months of age, there was no significant difference in HIV-free survival between the two groups. At 4 months, 17% of HIV-negative infants in the abrupt weaning group (n=329), and 19% of the 331 infants in the non-restricted group had HIV or had died (P=.21). Among 153 infants with HIV infection at 4 months, there was a benefit for continued breast-feeding because mortality at 12 months was 57% in the abrupt weaning group vs. 29% in the continued breast-feeding group (P=.01).
“Our results do not support current recommendations that encourage cessation of breast-feeding by HIV-infected mothers,” Sinkala said. “Early cessation of breast-feeding has a price.”
ZEBS researchers concluded infants should be breast-fed until 24 month of age for numerous health benefits and because of lack of alternatives.
Gastroenteritis studied
In Kampala, Uganda, researchers found an association between breast-feeding cessation and serious cases of gastroenteritis among HIV-exposed infants. In the study, rates of serious gastroenteritis doubled from the breast-feeding period until three months post-weaning compared with rates from another trial of breast-feeding infants with no abrupt cessation.
Infant deaths rose significantly within the three months after breast-feeding cessation.
To prevent MTCT, the Uganda Ministry of Health recommends exclusive breast-feeding and abrupt weaning between 3 and 6 months of age. Researchers assessed serious gastroenteritis events in an ongoing antiretroviral trial, hyperimmune globulin in pregnant women (HIVIGLOB), in which mothers were counseled to cease breast-feeding at 6 months.
Data were compared to another trial, HIVNET012, in which mothers could wean at their own discretion. HIVNET 012 was a landmark clinical trial begun in Uganda in 1997 to test the efficacy and safety of nevirapine. Most mothers in the HIVIGLOB study stopped breast-feeding when the infants were 3 months of age.
Sixty-five (11.2%) of the 579 HIV-negative children had serious gastroenteritis events; the median age of these infants was 6 months. Fifteen infant deaths were reported in the study, of which five were attributed to gastroenteritis. All deaths were in the post-weaning period; no deaths were reported while the infants were being breast-fed.
“Our data indicate the need to carefully reassess current WHO and Ministry of Health guidance encouraging early breast-feeding cessation among HIV-infected women,” said Carolyne Onyango, MD, a researcher for the Makerere University/Johns Hopkins University Research Collaborative. “We would recommend that babies are exclusively breast-fed up until 6 months of age.”
An investigation into the high morbidity and mortality rates in the HIVIGLOB trial is ongoing, but researchers think the babies were being weaned off breast milk too early for them to gain immunities.
“The protective factor in the breast milk were being withheld from these babies much earlier than they were supposed to be,” Onyango said.
Factors including inaccessibility of safe food alternatives and clean water likely contributed.
Malawi study
Researchers in Blantyre, Malawi, found a similar elevated risk for severe gastroenteritis in HIV-exposed infants after weaning. Deaths and hospitalizations were likely caused by lack of clean water, utensils and inadequate nutrition.
During an ongoing, phase-3, randomized control trial of three antiretroviral regimens to prevent MTCT among HIV-infected breast-feeding infants, researchers found an increase in severe gastroenteritis. Researchers analyzed the adverse event aspect of the Post-Exposure Prophylaxis in Infants (PEPI) study, in which mothers weaned abruptly at 6 months, and another study in which mothers were not encouraged to wean (NVAZ). In NVAZ, the mean breast-feeding duration was 732 days compared with 183 days mean overall breast-feeding in PEPI. In PEPI probability of gastroenteritis peaked to 13.1% at 9 months of age, when 77 of 590 infants had reported incidents.
Hospitalization for gastroenteritis in the PEPI study was 10- to 30-fold higher than in the study in which women were not encouraged to wean abruptly.
“Once we looked at mortality associated with the PEPI study, we noticed a significant increase after the time of weaning in gastroenteritis mortality, as well as overall mortality in infants in the PEPI study,” said Michael C. Thigpen, MD, of the National Center for HIV, Viral Hepatitis, STD and TB Prevention, CDC.
Thigpen and colleagues called for urgent counseling strategies to aid mothers in safe post-weaning food preparation and nutrition in developing countries. – by Kirsten H. Ellis
For more information:
- Coovadia H. Prevention of HIV Transmission from Breast-feeding, Plenary.
- Sinkala M, Kuhn L, Kankasa C, et al. No benefit of early cessation of breast-feeding at 4 months on HIV-free survival of infants born to HIV-infected mothers in Zambia: The Zambia Exclusive Breast-feeding Study. 74LB,.
- Onyango C, Mmiro F, Bagdena, et al. Early breast-feeding cessation among HIV-exposed negative infants and risk of serious gastroenteritis: findings from a perinatal prevention trial in Kampala, Uganda. Poster #775.
- Kafulafula G, Thigpen M, Hoover D, et al. Post-weaning gastroenteritis and mortality in HIV-uninfected African infants receiving ARV prophylaxis to prevent MTCT of HIV-1. Poster #773.
- All presented at: 14th Conference on Retroviruses and Opportunistic Infections; Feb. 25-28; Los Angeles.