Impact of Vaginal Estradiol on the Genitourinary Syndrome of Menopause, Vaginal Microbiome and Mucosal Immune Mediators in Women With HIV.

BACKGROUND

Women with human immunodeficiency virus (HIV, WWH) experience early onset menopause and symptoms may impact antiretroviral therapy (ART) adherence. Vaginal estradiol is safe and effective for treatment of the genitourinary syndrome of menopause (GSM) but has not been studied in WWH. The study objective was to test whether vaginal estradiol would improve GSM symptoms in menopausal WWH.

METHODS

Menopausal WWH were randomized 1:1 to 12 weeks of open-label vaginal estradiol (n = 25) versus no treatment (n = 26). Participants had at least 1 GSM vulvovaginal symptom in the month prior (dryness, itching, irritation, soreness, or dyspareunia) and clinical atrophy. The primary outcome was difference in mean symptom severity (scale 0-3) defined by the composite vaginal symptom index (VSI) between baseline and week 12. Changes in severity of participants' most bothersome symptom (MBS), vaginal maturation index (VMI), vaginal microbiome, and mucosal immune mediators were assessed. Results were compared by paired t test or Wilcoxon signed rank tests; a mixed effect model examined differences in VSI improvement between groups.

RESULTS

Mean age was 59 years, 78% self-reported as Black, and all were on ART. Both groups had significant reductions in VSI, however the magnitude was significantly greater in the estradiol group (P < .0001). Estradiol and younger age were associated with VSI improvement. VMI and MBS improved significantly only in the estradiol group. There were no significant changes in the microbiome or mucosal mediators.

CONCLUSIONS

The favorable response to estradiol suggests that treatment perhaps initiated earlier may be beneficial for GSM in WWH and should be studied in larger clinical trials.