Maternal Events and Pregnancy Outcomes in a Cohort of HIV-Infected Women Receiving Antiretroviral Therapy in Sub-Saharan Africa (MEP) (CDC/PEPFAR)

Overview

This multi-country study was one of the first in sub-Saharan Africa to evaluate maternal and infant outcomes in women receiving antiretroviral treatment (ART) at time of conception and during pregnancy as part of routine HIV service delivery. The primary study objectives were to describe both the frequency of severe adverse events including major congenital defects, adverse pregnancy outcomes, and death among infants or fetuses born to mothers exposed to ART during conception and pregnancy and these events within a section of the general population, regardless of maternal or infantile HIV‐1 infectivity status. A secondary objective of the study was to describe the distribution of major congenital defects, adverse pregnancy outcomes, and infant death by various ART regimens being used in resource‐limited countries.

The study involved the observational surveillance of a cohort of HIV-positive pregnant women that were taking combination ART before becoming pregnant in South Africa and Zambia. In each country, 300 mothers were enrolled in the cohort. Infants born to these women were examined for major congenital defects at birth or as soon as possible thereafter, and until one year of age. Data on prevalence of major congenital defects and adverse pregnancy outcomes within the general population were abstracted from facility records during the same time period as data from the cohort was collected. Data collection is ongoing, and the study is anticipated to finish in early 2013 once all children in the cohort have been followed to one year of age.

With the expansion of the use of ART in pregnancy both for treatment and infant prophylaxis, it is critical that the safety of these drugs in women and their infants be evaluated in the African context. Outcomes of how ART protects infants from HIV infection in the actual ART program setting also will be determined. Data from this initial pilot will provide the building blocks for further wo