Background:
Dolutegravir (DTG) and tenofovir alafenamide(TAF) have been associated with incident hypertension (HTN), but limited data exist in pregnant and postpartum women. We performed a post-hoc analysis of blood pressure (BP) data collected in IMPAACT 2010 to characterize by-arm incidence of elevated BP and hypertensive disorders during pregnancy and postpartum.
Methods:
Women with HIV were randomized at 14-28 weeks gestational age (GA) to start DTG+emtricitabine(F)/ TAF, DTG+F/tenofovir disoproxil fumarate(TDF), or efavirenz (EFV)/F/TDF. Incident gestational HTN was defined by ≥2 BPs ≥140/90 (mild) or ≥160/110 (severe) at ≥20 weeks GA with resolution by 12 weeks postpartum. We also characterized incident HTN from antepartum to 50 weeks postpartum defined by ≥2 values in the following categories (and not meeting the definition of gestational HTN): elevated BP 130-139/80-89, mild HTN 140-159/90-99, moderate HTN 160-179/100-109, or severe HTN ≥180/110 mmHg, with the most severe reading defining the category. The Cox proportional hazard model was used for by-arm comparisons of incident HTN, defined as either elevated BP or gestational or non-gestational HTN, with and without adjustment for time-varying weight.
Results:
626 participants were included: 211 in DTG+F/TAF, 208 in DTG+F/TDF, and 207 in EFV/F/TDF (11 were excluded for HTN at entry). Baseline medians were: age 26.4 yrs, GA 21.9 wks, HIV RNA 938 cp/mL, CD4 cell count 472 cells/uL, BMI 24.6 kg/m2. Incident elevated BP or HTN (mild+) was high overall (55%) and more common with DTG+F/TAF (59%) and DTG+F/TDF (56%) relative to EFV/F/TDF (51%). Moderate and severe HTN occurred in 1.6% of women (Table). 12 women had pre-eclampsia and 1 had eclampsia, with no apparent pattern by arm. While the estimated difference between DTG arms was small, there was a trend toward an increased hazard of incident elevated BP or gestational or non-gestational HTN for DTG+F/TAF vs EFV/F/TDF (HR 1.26, 95%CI 0.98, 1.64) and DTG+F/TDF vs EFV/F/TDF (HR 1.18, 95%CI 0.9,1.53); results adjusted for time-varying weight were similar.
Conclusions:
Our data are consistent with findings that DTG-based ART may be associated with incident HTN, largely represented by numerically more women with BP ≥130-139/80-89mmHg in this cohort of young, pregnant and postpartum women. Our findings should be confirmed with additional studies. Pending further data, efforts should focus on early identification and management of hypertensive disorders in pregnant and postpartum women on DTG.
