Few studies have prospectively captured pregnancy outcomes among women living with HIV (WLHIV) who conceive on antiretroviral treatment (ART).
IMPAACT 2010 (VESTED) enrolled 643 WLHIV at 14-28 weeks gestational age in 9 countries. Women were randomized to start ART with dolutegravir (DTG) plus emtricitabine (FTC)/tenofovir alafenamide (TAF); DTG+FTC/tenofovir disoproxil fumarate (TDF); or efavirenz (EFV)/FTC/TDF. Due to recommendations at the time, women who did not wish to take effective contraception following delivery were required to switch from DTG to another antiretroviral (usually EFV) during the 50 weeks of postpartum study follow-up. We describe adverse pregnancy outcomes in women who became pregnant during postpartum follow-up (subsequent pregnancy): spontaneous abortion (<20 weeks), stillbirth (?20 weeks), preterm delivery (<37 weeks), small for gestational age (SGA; <10th centile) and neonatal death (?28 days).
Nineteen (3%) of 643 women had 20 subsequent pregnancies on-study and were taking the following ART at conception: DTG+FTC/TAF (3), DTG+FTC/TDF (2), EFV/FTC/TDF (11, 1 woman with 2 pregnancies), non-study ART (2) and no ART (1). Only 12/20 (60%) subsequent pregnancies resulted in live birth; 4/20 (20%) spontaneous abortions, 3/20 (15%) stillbirths, and 1/20 (5%) induced abortion. Three (25%) liveborn infants were preterm (24, 26 and 36 weeks’ gestation). Thus, at least one adverse pregnancy outcome occurred in 11/20 (58%) subsequent pregnancies, more frequently with EFV/FTC/TDF at conception (8 [67%] of 12 pregnancies) than with DTG-ART at conception (1/4 women) [Figure]. Our sample size was too small to formally test differences in outcomes of subsequent pregnancies by regimen. Of the 7 women who experienced spontaneous abortion or stillbirth in the subsequent pregnancy, 4 had experienced a stillbirth and 1 a neonatal death as outcomes of the earlier index pregnancy (the pregnancy at enrolment to the VESTED trial).
Adverse pregnancy outcomes were very common in this cohort of WLHIV who conceived on ART in the VESTED trial, particularly in women with recent prior pregnancy loss (potentially at higher risk for repeat adverse pregnancy outcome), however numbers were small. This finding should be considered in analyses of incident pregnancies occurring in trial participants. Data from larger similar cohorts of women are needed, to elucidate factors associated with adverse pregnancy outcomes in WLHIV.