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SUBSEQUENT PREGNANCY OUTCOMES IN WOMEN DURING FOLLOW-UP IN PROMISE 1077HS
Jose H. Pilotto1, Sean Brummel2, Risa M. Hoffman3, Paula Britto2, Gaerolwe Masheto4, Linda Aurpibul5, Nahida Chakhtoura6, Karin Klingman7, Judith S. Currier8
1Oswaldo Cruz Fndn/Fiocruz & HGNI, Rio de Janeiro, RJ,2Harvard T.H. Chan SPH, Boston, MA,3David Geffen Sch of Med at Univ of California Los Angeles, Los Angeles, CA,4Harvard Univ, Gaberone, Botswana,5Chiang Mai Univ, Chiang Mai, Thailand,6NICHD, Bethesda, MD,7DAIDS , NIAID/NIH , DHHS, Bethesda, MD,8Univ of California Los Angeles, Los Angeles, CA
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.