Hypertension in a randomized trial of dolutegravir- versus efavirenz-based antiretroviral therapy in pregnant and postpartum women with HIV

Abstract Introduction We performed an analysis of incident hypertension in a randomized trial comparing dolutegravir(DTG)+emtricitabine(F)/tenofovir alafenamide(TAF) vs DTG+F/tenofovir disoproxil fumarate(TDF) vs efavirenz(EFV)/F/TDF in pregnant and postpartum women with HIV. Methods Women were randomized at 14-28 weeks gestational age (GA) to start DTG+F/TAF, DTG+F/TDF, or EFV/F/TDF and followed through 50 weeks postpartum. The composite incident hypertension outcome was defined as initiation of antihypertensive medication or ≥2 elevated blood pressures categorized as: elevated (130-139 and/or 80-89mmHg), mild (140-159 and/or 90-99mmHg), moderate (≥160-179 and/or ≥100-109mmHg), severe (≥180 and/or ≥110mmHg). Incident gestational hypertension was defined by initiation of antihypertensive medication or ≥2 blood pressures ≥140 and/or ≥90mmHg at ≥20 weeks GA with resolution by 12 weeks postpartum. Cox proportional hazard models were used for by-arm comparisons of the composite outcome and to look for the effect of weight change within arm. Results Of 626 women without baseline hypertension (median age 26.6 years), the composite incident outcome occurred in 49% (n=308), predominantly due to the incident elevated category of elevated blood pressure, with no significant differences by arm, although hypertension was numerically more likely in the DTG arms. Each additional 5kg of weight was associated with an 8-17% higher hazard of the composite hypertension outcome. Twenty-seven participants (4.3%) had gestational hypertension with no apparent differences between arms. Conclusions Our data contribute information regarding the safety of DTG-based ART and TAF in pregnant and postpartum women and highlight the importance of monitoring weight and performing hypertension screening as part of maternal health care for young women with HIV.