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Gender-affirming hormones and antiretroviral therapy: implications on adherence and clinical outcomes Asa Radix, MD, MPH, FACP Director of Research and.

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Presentation on theme: "Gender-affirming hormones and antiretroviral therapy: implications on adherence and clinical outcomes Asa Radix, MD, MPH, FACP Director of Research and."— Presentation transcript:

1 Gender-affirming hormones and antiretroviral therapy: implications on adherence and clinical outcomes Asa Radix, MD, MPH, FACP Director of Research and Education, Callen-Lorde Community Health Center Clinical Associate Professor of Medicine, NYU

2 Conflict of Interest No conflicts of interest to declare

3 Outline What are gender affirming medical interventions?
What impact does provision of hormones have on HIV prevention, treatment and care? What additional considerations exist for the use of hormone therapy and ART?

4 Gender-Affirming Medical Treatments
Hormone therapy, androgen blockers Surgeries Speech therapy Hair removal Image source: Callen-Lorde Community Health Center, New York, New York

5 Medical Transition Feminizing Masculinizing Hormones (estrogen)
Androgen blockers Breast augmentation Vaginoplasty & labiaplasty Orchiectomy Tracheal shave Facial bone reduction Rhinoplasty Hormones (testosterone) Chest masculinization hysterectomy, salpingo- oophorectomy Phalloplasty Metoidioplasty Vaginectomy Scrotoplasty Urethroplasty Testicular prostheses

6 Early Medical Treatment*
Methyltestosterone 1935 Diethylstilbestrol 1938 Conjugated estrogens1941 Ethinyl estradiol 1943 *No longer used for medical transition

7

8 Feminizing Regimens Anti-androgen * Starting Dose Average Dose
Maximum Dose Spironolactone, oral 25mgday 150mg/day 400mg/day Finasteride, oral 1mg/day 1-5mg/day 5mg/day Cyproterone, oral 50mg/day 100mg/day Goreselin, sc 3.6 mg/month or mg/3 months Leuprolide acetate, im 3.75 mg/month Estrogen Estradiol valerate oral 2mg/day 4mg/day 8mg/day Estradiol valerate 20mg IM q 2 wks 20-40 IM q 2 wks 40 mg IM q 2 wks Estradiol patch (preferred over 45) 25 mcg/day 50 mcg/day 200mcg/day Adapted from Hembree, JCEM 2009, 94(9):3132–3154 Royal College of Psychiatrists, 2015

9 Feminizing Regimens Breast development Redistribution of body fat
Reduced muscle mass & stamina Reduced body hair (not facial) Reduced erectile function Reduced size of testes Lower sperm count Image source: Callen-Lorde Community Health Center, New York, New York Hembree, JCEM 2009, 94(9):3132–3154

10 Masculinizing Regimens
Hormone Starting Dose Average Dose Maximum Dose Testosterone (cypionate or enanthate) im Depo-Testosterone® 50 mg q 2w 200 mg q 2 w 200 mg q 2 Transdermal Testosterone 1% 25 mg daily 50 mg daily 100 mg daily Testosterone patch 1-2.5g daily 4-5g daily 7.5-8 g daily Testosterone undecanoate im 750 mg/10 weeks Measure testosterone levels between injections Goal: ng/dL Adapted from Hembree, JCEM 2009, 94(9):3132–3154

11 Masculinizing Regimens
Facial and body hair Redistribution of body fat Increased muscle mass Deepened voice Male-pattern baldness Cessation of menses Clitoromegaly Atrophic vaginitis Hembree, JCEM 2009, 94(9):3132–3154

12 Hormones also… Improve quality of Life
Reduce perceived stress, anxiety, depression Improve social functioning Improve sexual function Reduce in cortisol levels Gorin-Lazard A, et al. J Sex Med. 2012 Newfield E,et al. Quality of Life Research. 2006 Gómez-Gil E, et al. Psychoneuroendocrinology. 2011 Meier SLC, et al. Journal of Gay & Lesbian Mental Health. Costantino A, et al J Sex Marital Ther. 2013 Colizzi M, et al. J Sex Med Dec

13 Antiretrovirals & Hormone Therapy

14 Transgender Women and ART
HIV+ Less likely to receive ART More likely to report lower adherence More likely to have detectible viral load Higher HIV-related mortality HIV- Lower rates of PrEP uptake Lower adherence to PrEP Melendez et al, APJH 2005 Sevelius et al, JANAC, 2010 San Francisco DPH HIV/AIDS, 2008 Deutsch MB, et al. Lancet HIV. 2015 Wilson E, et al PLoS One. Sevelius JM, et al. Glob Public Health. 2016

15 Ryan White HIV/AIDS Program Services Report, 2015
Retention in Care Viral Suppression Total population N= 531,816 Total Transgender Population, N=6020 (1.1%) Percent Percent Ryan White HIV/AIDS Program Annual Client-Level Data Report Ryan White HIV/AIDS Program Services Report (RSR)

16 Why less likely to adhere?
Prioritization of transition-related medical care over HIV care Fears about drug interactions between hormones and HIV Lower adherence self-efficacy Negative experiences with providers/health systems Fear of stigma & discrimination Sevelius J, et al. J Assoc Nurses AIDS Care ; 21(3): 256–264 Sevelius J, et al. AIDS Care August ; 26(8): 976–982 Chung, et al Transgender Law Center

17 Why less likely to adhere?
Prioritization of transition-related medical care over HIV care Fears about drug interactions between hormones and HIV Lower adherence self-efficacy Negative experiences with providers/health systems Fear of stigma & discrimination Sevelius J, et al. J Assoc Nurses AIDS Care ; 21(3): 256–264 Sevelius J, et al. AIDS Care August ; 26(8): 976–982 Chung, et al Transgender Law Center

18 Antiretrovirals & Hormones
Data based on studies with oral contraceptives (ethinylestradiol) Estrogens metabolized by cyp3A4 Protease inhibitors & NNRTI interactions possible - Avoid using unboosted fosamprenavir with estrogens – APV Cmin decrease 20% DHHS. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 2016 Radix A et al. JIAS 2016, 19(Suppl 2):20810

19 Check estradiol levels may need to decrease dose
Radix A et al. JIAS 2016, 19(Suppl 2):20810

20 Check estradiol levels may need to increase dose
Radix A et al. JIAS 2016, 19(Suppl 2):20810

21 Hormone access improves engagement
Hormones are a primary motivator for seeking medical care, improves retention Adherence to hormone therapy predicts high ART adherence When HIV providers are hormone prescribers, improves ART adherence Sevelius, J. Ann Behav Med February ; 47(1): 5–16 Sevelius J, et al. J Assoc Nurses AIDS Care ; 21(3): 256–264 Sevelius J, et al. AIDS Care August ; 26(8): 976–982 Deutsch M, et al NHPC.

22 Gender Identity Engagement Integrating hormones into HIV care
Gender-affirming care environment Knowledge about ART/HT Competent providers/systems Trans staff Gender Identity Engagement Stigma and discrimination Provider mistrust Lack of provider awareness Fear about drug interactions Social marginalisation

23 Steps to Improve HIV Prevention & Care
Co-locate/integrate HIV services & hormone care Train providers to deliver hormone therapy Antiretrovirals – discuss safety with hormones Trans inclusive materials Hire trans staff

24 Acknowledgements Callen-Lorde Trans Ops Team Peter Meacher, MD
Pedro Carneiro, MPH William Nazareth

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