Absence of Effect of Menopause Status at Initiation of First-Line Antiretroviral Therapy on Immunologic or Virologic Responses: A Cohort Study from Rio de Janeiro, Brazil

Abstract

ObjectiveTo compare the effectiveness of first-line combination antiretroviral therapy (cART) between premenopausal and postmenopausal women.MethodsART-naïve women initiating cART between January 2000/June 2010 at the Instituto de Pesquisa Clínica Evandro Chagas Cohort were studied. Women were defined as postmenopausal after 12 consecutive months of amenorrhea. CD4 cell counts and HIV-1 RNA viral load (VL) measurements were compared between pre- and postmenopausal at 6, 12 and 24 months after cART initiation. Women who modified/discontinued a drug class or died due to an AIDS defining illness were classified as ART-failures. Variables were compared using Wilcoxon test, χ2 or Fisher’s exact test. The odds of cART effectiveness (VL<400 copies/mL and/or no need to change cART) were compared using logistic regression. Linear model was used to access relationship between CD4 change and menopause.ResultsAmong 383 women, 328 (85%) were premenopausal and 55 (15%) postmenopausal. Median pre cART CD4 counts were 231 and 208 cells/mm3 (p = 0.14) in pre- and postmenopausal women, respectively. No difference in the median pre cART VL was found (both 4.8 copies/mL). Median CD4 changes were similar at 6 and 12 months. At 24 months after cART initiation, CD4 changes among postmenopausal women were significantly lower among premenopausal women (p = 0.01). When the analysis was restricted to women with VL<400 copies/mL, no statistical difference was observed. Overall, 63.7% achieved cART effectiveness at 24 months without differences between groups at 6, 12 and 24 months.ConclusionMenopause status at the time of first-line cART initiation does not impact CD4 cell changes at 24 months among women with a virologic response. No relationship between menopause status and virologic response was observed.

Perspectives on menopause and women with HIV

“… 67 Similarly, in a prospective cohort study of 383 antiretroviral-naïve, HIV-infected women in Brazil (85% premenopausal and 15% postmenopausal), menopausal status had no effect on treatment response at 24 months post-initiation of therapy. 68 Pre- and postmenopausal women, with similar baseline CD4 counts (231 cells/mm 3 compared to 208 cells/mm 3 , P =0.14), were equally likely to achieve virologic suppression. Interestingly, postmenopausal women had a lower median CD4 response than premenopausal women at the 24-month postantiretroviral therapy (ART) time point (184 cells/mm 3 vs 273 cells/mm 3 , P =0.02); however, when this analysis was restricted to the women who achieved a viral load <400 copies/mL, there was no longer a difference in CD4 response ( P =0.27).…”

“…More recent studies have generally yielded promising results, finding that menopausal status itself does not influence response to antiretroviral treatment. 67 , 68 In 267 treatment-naïve women living with HIV, 47 of whom were postmenopausal, CD4 and viral load response to antiretroviral initiation did not differ between those who were pre- and postmenopausal. 67 Postmenopausal women were able to maintain viral suppression through a 96-week follow-up period.…”

“…Interestingly, postmenopausal women had a lower median CD4 response than premenopausal women at the 24-month postantiretroviral therapy (ART) time point (184 cells/mm 3 vs 273 cells/mm 3 , P =0.02); however, when this analysis was restricted to the women who achieved a viral load <400 copies/mL, there was no longer a difference in CD4 response ( P =0.27). 68 …”

Determinants of Restoration of CD4 and CD8 Cell Counts and Their Ratio in HIV-1–Positive Individuals With Sustained Virological Suppression on Antiretroviral Therapy

“…The peak in CD4 response in women coincides with the mean age of natural menopause, but studies have found no evidence for a difference in CD4 cell count response after ART initiation between premenopausal and postmenopausal women with a virological response. 38,39…”

Age Differences by Sex in Antiretroviral-Naïve Participants: Pooled Analysis from Randomized Clinical Trials

“…Similarly, a study of 383 ART-naïve HIV-infected women conducted in Brazil compared ART response in 55 post-menopausal women to 328 pre-menopausal women. At 24 months after treatment initiation, the authors reported CD4+ T cell median changes among postmenopausal women that were significantly lower compared to premenopausal women, but the difference was attenuated when restricting the analysis to women with HIV RNA levels lower than 400 copies/mL (Calvet et al, 2014).…”