Pregnancy outcomes and birth defects from an antiretroviral drug safety study of women in South Africa and Zambia.

Objective: To evaluate the safety of combination antiretroviral therapy (ART) in conception and pregnancy in different health systems.

Design: A pilot ART registry to measure the prevalence of birth defects and adverse pregnancy outcomes in South Africa and Zambia.

Methods: HIV-infected pregnant women on ART prior to conception were enrolled until delivery, and their infants were followed until 1 year old.

Results: Between October 2010 and April 2011, 600 women were enrolled. The median CD4 cell count at study enrollment was lower in South Africa than Zambia (320 vs. 430 cells/μl; P < 0.01). The most common antiretroviral drugs at the time of conception included stavudine, lamivudine, and nevirapine. There were 16 abortions (2.7%), one ectopic pregnancy (0.2%), 12 (2.0%) stillbirths, and 571 (95.2%) live infants. Deliveries were more often preterm (29.7 vs. 18.4%; P = 0.01) and the infants had lower birth weights (2900 vs. 2995 g; P = 0.11) in Zambia compared to South Africa. Thirty-six infants had birth defects: 13 major and 23 minor. There were more major anomalies detected in South Africa and more minor ones in Zambia. No neonatal deaths were attributed to congenital birth defects.

Conclusions: An Africa-specific, multi-site antiretroviral drug safety registry for pregnant women is feasible. Different prevalence for preterm delivery, delivery mode, and birth defect types between women on preconception ART in South Africa and Zambia highlight the potential impact of health systems on pregnancy outcomes. As countries establish ART drug safety registries, documenting health facility limitations may be as essential as the specific ART details.