The rates of adverse pregnancy outcomes for women who conceive whilst being treated with antiretroviral therapy (ART) may be increased but studies to date have been conflicting. The authors randomised asymptomatic HIV-infected, non-breastfeeding women with pre-ART CD4+ T cell counts ≥400 cells/mL who started ART during pregnancy to either continue or discontinue ART. Study sites covered Argentina, Botswana, Brazil, China, Haiti, Peru, Thailand and the US. Women who were randomised to discontinue ART were recommended to restart if a subsequent pregnancy occurred or for clinical indications. Subsequent pregnancies occurred in 17% of the 1652 women recruited. A pregnancy outcome was recorded for 96% of these women, with a median age of 27 years and median CD4+ T cell count of 638 cells/mL. In the intention-to-treat analysis, when spontaneous abortions and stillbirths were combined, there was a significant difference in events, with 23.6% occurring in the continue ART arm and 11.9% in the discontinue arm (relative risk [RR] 2.0, 95%CI 1.1-3.5). However, in the as-treated analysis the RR to 1.4 was reduced and was no longer statistically significant. Therefore women who are randomised to continue ART and who subsequently conceive may be more likely to have spontaneous abortion or stillbirth compared to women randomised to stop ART.
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