The Mma Bana Study has revealed that administering Highly Active Antiretroviral Therapy (HAART) to pregnant and breastfeeding women lowers transmission to the infant.
An overall 1% transmission from mother to child was recorded through 6 months, the lowest MTCT rate ever recorded in Africa or for a breastfeeding population.
The Mma Bana Study is a randomised trial comparing HAART for Virologic Efficacy and the Prevention of Mother To Child HIV Transmission (PMTCT) among breastfeeding women in Botswana.
The study enrolled 730 women. Five hundred and sixty of the enrolled women did not need long term HAART and 170 needed long term HAART. The study was conducted at 4 clinical sites in Botswana as a collaboration between the Harvard School of Public Health and the Botswana government.
The study was a first of its kind as no randomized trial has previously compared HAART regimens in pregnancy or during breastfeeding.
The investigators randomised 560 HIV-positive pregnant women with CD4 cell counts above 200 cells/mm3 to take one of two antiretroviral regimens between weeks 26 and 34 of pregnancy.
This treatment was continued until weaning six months after giving birth.
Women in the first arm were provided with a combination of drugs that comprised the three nucleoside reverse transcriptase inhibitors (NRTIs) 3TC, abacavir and AZT, dosed as Trizivir.
Nevirapine-based ART is unsuitable for women with CD4 counts above 250 due to an increased risk of liver toxicity, so alternative regimens need to be identified to enable treatment in pregnancy to be extended to women with higher CD4 counts.
Women in the other arm were treated with the protease inhibitor lopinavir/ritonavir (Kaletra) in combination with 3TC and AZT (dosed as Combivir).
The 170 women with lower CD4 counts who required treatment for their own health were observationally enrolled and received anti HIV drugs, including AZT, 3TC with Nevirapine/Combivir.
Dr. Roger Shapiro, one of the
investigators and a WHO expert panelist on PMTCT, stressed that the Botswana guidelines were adhered to during the study and medication due to the women was administered.
“Any woman who got sick and qualified by government was put on HAART,” he said.
Shapiro also said that a two-year follow up was ongoing for the women. He said that Viral load suppression was also noted through the study, adding that, at birth, Arm A viral load suppression was at 96%, 93% for arm B and the observational arm registered at 95%.
Throughout breastfeeding, the reduction of the HIV virus for arm A was 92%, 93% for arm B and 95% for the observational arm. Only 8 transmissions were registered among 709 live born infants.
Of the 8 transmissions, 2 were breastfeeding transmissions and four were confirmed transmissions during pregnancy while 1 was a probable transmission during pregnancy.
The investigations also reveal that maternal HAART from early in the third trimester of pregnancy through 6 months of breastfeeding is a safe and very effective strategy for preventing MTCT while allowing for the benefits of breastfeeding.
The Botswana Project Director for the Botswana Harvard Partnership, Dr. Joseph Makhema, said that the study was one of the best they had conducted.
“Mma Bana is one study in a series of mother to child transmission to be conducted; we are at no stage to reveal what the Ministry of Health will do with the findings of the study.”
He added, “They are our partners, we worked with them.”
The Director in the Department of HIV Prevention and care in the Ministry of Health, Dr. Khumo Seipone, commended the participants in the study and said she will communicate any steps the ministry takes regarding the findings of the study.