Baseline Characteristics Explain Differences in Effectiveness of Randomization to Daily Oral TDF/FTC PrEP Between Transgender Women and Cisgender Men Who Have Sex With Men in the iPrEx Trial

Mehrotra, Megha; Westreich, Daniel; McMahan, Vanessa; Glymour, M. Maria; Geng, Elvin; Grant, Robert M.; Glidden, David V.

doi:10.1097/qai.0000000000002037

Cited by 12 publications

(9 citation statements)

References 22 publications

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“…These results support current recommendations for PrEP dosing using regimens that contain TDF [24]. Although men who have sex with men and TGW are different in multiple important respects, dosing recommendations are similar based on findings that trends in differences in efficacy in the intentionto-treat subgroup analyses did not reach statistical significance (P = .09), that the relationships between blood concentrations and protective benefits are similar, and that baseline characteristics explain trends in observed efficacy [5,6]. These findings of comparable accumulation kinetics in these 2 groups support application of similar dosing recommendations across these groups.…”

Section: Discussionsupporting

confidence: 75%

“…The subgroup analysis of iPrEx revealed that TGW were less likely than men who have sex with men to have protective concentrations of PrEP medications in an intention-to-treat analysis, especially if they also reported using feminizing hormone therapy [5]. In a subsequent, more sophisticated transportability analysis, PrEP efficacy among TGW was comparable to efficacy among cisgender men (CGM) who have sex with men when adjusted for the following baseline factors: depression score (using Center for Epidemiologic Studies in Depression Scale [CESD]), number of partners in the previous 3 months, any condomless receptive anal intercourse in the previous 3 months, living situation, any history of transactional sex in the previous 6 months, and any sexually transmitted infection diagnoses in the previous 6 months [6].…”

mentioning

confidence: 99%

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Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study

Grant

Pellegrini

Defechereux

et al. 2020

Clinical Infectious Diseases

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Background Pilot studies showed lower tenofovir plasma concentrations during PrEP use among transgender women (TGW) using feminizing hormones compared with cisgender men (CGM). Tenofovir diphosphate (TFV-DP) concentrations in TGW and transgender men (TGM) using gender affirming hormones and on directly observed dosing of PrEP have not been studied. Methods TGM and TGW on at least 6 months of stable sex hormone therapy containing testosterone or estradiol (respectively) were enrolled in a 4-week study of directly observed dosing of daily oral co-formulated emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). TFV-DP in dried blood spots and sex hormones in serum were measured at weekly intervals. TFV-DP was compared with 2 and 4 week samples from DOT-DBS (NCT02022657). Results From May 2017 to June 2018, 24 TGM and 24 TGW were enrolled; one TGM withdrew prior to 4 weeks of PrEP. Ethnicity (non-exclusive) was 27 (57%) white, 10 (21%) black, and 15 (32%) latinx. The median age was 31 (IQR 28 to 40). Of TGW, 9 (38%) took spironolactone in addition to estradiol. Testosterone (total and free) and estradiol concentrations were comparable before and after 4 weeks of PrEP use in TGM and TGW respectively. Historical controls comprised of 17 cisgender women (CGW) and 15 CGM. TFV-DP concentrations at week 4 were comparable between TGW and TGM (mean difference -6%; 95% CI -21% to 12%; P=0.47), comparable between TGW and CGM (mean difference -12%; 95% CI -27% to 7%; P=0.21) and were lower among TGM compared with CGW (mean difference -23%; 95% CI -36% to -7%; P=0.007). All persons in all groups were projected to reach the TFV-DP threshold that has been associated with high protection from HIV. There were no associations between serum estradiol or free testosterone concentrations and TFV-DP. Conclusion CGM, TGM, and TGW had comparable TFV-DP concentrations in DBS after 4 weeks of directly observed daily FTC/TDF PrEP use. Serum hormone concentrations were not affected by FTC/TDF PrEP use.

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Section: Discussionsupporting

confidence: 75%

mentioning

confidence: 99%

Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study

Grant

Pellegrini

Defechereux

et al. 2020

Clinical Infectious Diseases

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“…Furthermore, a secondary analysis of iPrEx trial data showed that significant differences in baseline characteristics between transgender women and cisgender MSM (e.g. depression, transactional sex in the last 6 months) explained the heterogeneity of oral PrEP efficacy [51]. These findings show that we need to go beyond simply including transgender participants in research to increase our understanding of the specific needs and characteristics of transgender people.…”

Section: Resultsmentioning

confidence: 99%

Global scoping review of HIV prevention research with transgender people: Transcending from trans‐subsumed to trans‐centred research

et al. 2021

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Introduction: Globally, transgender populations are disproportionally impacted by HIV and effective HIV prevention interventions targeting these populations are critically needed. Such interventions require research focused on the specific needs and experiences of transgender people. This methodological review aims to determine the extent to which HIV prevention research has included transgender participants by subsuming them into non-transgender populations, or by centring them either in comparison with other groups or as the sole focus of research. Methods: We searched five electronic databases (e.g. SCOPUS) for empirical studies that focused on HIV prevention and included transgender participants, published through 31 December 2020. For each study, we extracted information on: (a) types of inclusion of transgender participants; (b) total sample size and number/percentage of transgender participants; (c) country(ies) where study was conducted; (d) HIV research topics; (e) methods (i.e. quantitative, qualitative or mixed-methods research) and (f) gender identity of transgender participants. Results and discussion: Of 667 HIV prevention studies included in the review, 38.5% subsumed transgender participants into cisgender populations (most frequently combining transgender women with cisgender men who have sex with men), 20.4% compared transgender and cisgender participants and 41.1% focused exclusively on transgender populations. Our global scoping review also revealed that these three types of transgender inclusion in HIV prevention research vary greatly over time, place and thematic areas. Transgender women are the focus of the majority of reviewed studies, whereas transgender men and gender expansive people are rarely included as participants. Conclusions: Inclusion of transgender persons as participants in HIV prevention research has significantly increased, particularly in the last decade. Further research centred on transgender participants and their experiences are needed to develop effective HIV prevention interventions for transgender populations. We advocate for HIV prevention research to move from subsuming transgender people, to trans-centred research that asks questions that focus on their specific needs and experiences. We provide recommendations to move from trans-subsumed to trans-centred HIV prevention research.

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“… 10 , 11 Other studies indicated that seroconversions among TGW were probably related to adherence issues and different baseline characteristics rather than to potential interactions between FHT and tenofovir disoproxil fumarate/emtricitabine. 12 , 13 Given the mixed results shown by studies to date, the clinical significance of drug interactions between tenofovir disoproxil fumarate/emtricitabine and FHT among TGW remains unclear. 14 We aimed to evaluate the impact of FHT on tenofovir disoproxil fumarate/emtricitabine pharmacokinetics (PK) among TGW in the context of the PrEParadas demonstration study.…”

Section: Introductionmentioning

confidence: 99%

Impact of feminizing hormone therapy on tenofovir and emtricitabine plasma pharmacokinetics: a nested drug–drug interaction study in a cohort of Brazilian transgender women using HIV pre-exposure prophylaxis

Cattani¹,

Jalil²,

Torres³

et al. 2022

Journal of Antimicrobial Chemotherapy

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Objectives Potential interactions between feminizing hormone therapy (FHT) and pre-exposure prophylaxis (PrEP) may be a barrier to PrEP use among transgender women (TGW). We aimed to assess the impact of FHT on PrEP plasma pharmacokinetics (PK) among TGW. Methods This was a PK substudy of the effects of FHT on tenofovir disoproxil fumarate/emtricitabine nested to a trans-specific PrEP demonstration study (NCT03220152). Participants were assigned to receive PrEP only (noFHT) or standardized FHT (sFHT; oestradiol valerate 2–6 mg plus spironolactone 100–300 mg) plus PrEP for 12 weeks, after which they could start any FHT (aFHT). Short- and long-term PK assessment occurred at Weeks 12 and 30–48, respectively (plasma samples prior and 0.5, 1, 2, 4, 6, 8 and 24 h after dose). Non-compartmental PK parameters of tenofovir and emtricitabine were compared as geometric mean ratios (GMRs) between noFHT and PrEP and FHT (sFHT at short-term PK; aFHT at long-term PK) participants. Results No differences in tenofovir and emtricitabine plasma PK parameters were observed between the short-term PK of noFHT (n = 12) and sFHT participants (n = 18), except for emtricitabine Cmax [GMR: 1.15 (95% CI: 1.01–1.32)], or between noFHT short-term PK and aFHT long-term PK (n = 13). Most participants were on oestradiol valerate 2 mg at the short-term PK (56%) and 4 mg at the long-term PK (54%). Median (IQR) oestradiol levels were 56.8 (43.2–65.4) pg/mL at short-term PK (sFHT) and 44.8 (24.70–57.30) pg/mL at long-term PK (aFHT). No participants in this analysis seroconverted during the study. Conclusions Our results indicate no interaction of FHT on tenofovir levels, further supporting PrEP use among TGW using FHT.

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Baseline Characteristics Explain Differences in Effectiveness of Randomization to Daily Oral TDF/FTC PrEP Between Transgender Women and Cisgender Men Who Have Sex With Men in the iPrEx Trial

Cited by 12 publications

References 22 publications

Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study

Sex Hormone Therapy and Tenofovir Diphosphate Concentration in Dried Blood Spots: Primary Results of the Interactions Between Antiretrovirals And Transgender Hormones Study

Global scoping review of HIV prevention research with transgender people: Transcending from trans‐subsumed to trans‐centred research

Impact of feminizing hormone therapy on tenofovir and emtricitabine plasma pharmacokinetics: a nested drug–drug interaction study in a cohort of Brazilian transgender women using HIV pre-exposure prophylaxis

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