Rates of adverse pregnancy outcomes for women who conceive on antiretroviral therapy (ART) may be increased, but data are conflicting.
In PROMISE 1077HS, asymptomatic HIV+, non-breastfeeding women with pre-ART CD4 cell count ≥400 cells/mm³ who started ART during pregnancy were randomized up to 42 days after delivery to continue (cART) or discontinue ART (dART). LPV/RTV with TDF/FTC or ZDV/3TC was the preferred study regimen. Sixty sites in Argentina, Botswana, Brazil, China, Haiti, Peru, Thailand and the US participated between 12/2011-11/2014. Women randomized to dART were recommended to restart if a subsequent pregnancy occurred or for clinical indications. This analysis includes outcomes for all subsequent pregnancies that occurred prior to offering all women ART in 7/2015. We compared subsequent pregnancy outcomes among women in the cART versus dART arm using Fisher’s exact test (post hoc analysis).
Subsequent pregnancies occurred in 277/1652 (17%) women (cART: 144/827, dART: 133/825). A pregnancy outcome was recorded for 266 women with median age 27.4 years (IQR 23.7, 31.1) at pregnancy diagnosis, and median CD4 688 cells/mm³ (IQR 529, 867) recorded at 2 months prior to pregnancy diagnosis. Two hundred (75%) live births were included, 40 (15%) spontaneous abortions (<20 weeks gestation), 18 (7%) induced abortions (<20 weeks gestation) and 8 (3%) stillbirths (≥20 weeks gestation). At 12 weeks prior to pregnancy diagnosis, 86% (120/140) in the cART group were on a boosted/non-boosted PI regimen versus 6% (8/140) NNRTI. In the dART arm, 19/126 (15%) restarted ART prior to pregnancy diagnosis: 74% (14/19) were on a PI regimen versus 26% (5/19) NNRTI. After pregnancy diagnosis (first regimen during pregnancy), there was frequent use of PIs in the cART arm (89% (124/140) PI versus 7% (10/140) NNRTI) and among those restarting ART in the dART arm (53% (67/126) PI versus 27% (34/126) NNRTI). Spontaneous abortions were more common in the cART arm (cART: 19.3% (27/140), dART: 10.3% (13/126); p=0.06), as were stillbirths (cART: 4.3% (6/140), dART: 1.6% (2/126); p=0.29). When stillbirths and spontaneous abortions were combined, there was a statistically significant higher rate in the cART arm (cART: 23.6% (33/140), dART: 11.9% (15/126); p=0.02).
Women randomized to continue ART after their index pregnancy who subsequently conceived were more likely to have spontaneous abortion or stillbirth compared to women randomized to stop ART.