Gender-affirming hormones and antiretroviral therapy: implications on adherence

Gender-affirming hormones and antiretroviral therapy: implications on adherence

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 #IAS2017 | @IAS_Conference #IAS2017 | @IAS_conferenc Conflict of Interest No conflicts of interest to declare #IAS2017 | @IAS_conferenc 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? #IAS2017 | @IAS_conferenc Gender-Affirming Medical Treatments Hormone therapy, androge blockers Surgeries Speech therapy Hair removal #IAS2017 | @IAS_conferenc Medical Transition Feminizing

Masculinizing Hormones (testosterone) Chest masculinization hysterectomy, salpingooophorectomy Phalloplasty Metoidioplasty Vaginectomy Scrotoplasty Urethroplasty Testicular prostheses

Hormones (estrogen) Androgen blockers Breast augmentation Vaginoplasty & labiaplasty Orchiectomy Tracheal shave Facial bone reduction Rhinoplasty #IAS2017 | @IAS_conferenc Early Medical Treatment* Methyltestosterone 1935 Diethylstilbestrol 1938 Conjugated estrogens1941 Ethinyl estradiol 1943

*No longer used for medical transition #IAS2017 | @IAS_conferenc #IAS2017 | @IAS_conferenc 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 50mg/day 100mg/day

Goreselin, sc 3.6 mg/month or 11.25 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 Adapted50 frommcg/day Hembree, JCEM 2009, 94(9):31323154 25 mcg/day 200mcg/day Royal College of Psychiatrists, 2015 #IAS2017 | @IAS_conferenc

Feminizing Regimens Breast development Redistribution of body fat Reduced muscle mass & stam Reduced body hair (not facia Reduced erectile function Reduced size of testes Image source: Callen-Lorde Community Health Center, New York, New York Lower sperm count Hembree, JCEM 2009, 94(9):31323154 #IAS2017 | @IAS_conferenc Masculinizing Regimens Hormone Starting Average Dose Maximum

Dose 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 Measure testosterone levels between injections Goal: 320-1000 ng/dL 750 mg/10 weeks Adapted from Hembree, JCEM 2009, 94(9):31323154 #IAS2017 | @IAS_conferenc 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):31323154 #IAS2017 | @IAS_conferenc Hormones also Improve quality of Life

Reduce perceived stress, anxiety, depression Improve social functioning Improve sexual function Reduce levels Gorin-Lazard A,in et al. cortisol J Sex Med. 2012 Newfield E,et al. Quality of Life Research. 2006 Gmez-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. 2013 Dec Antiretrovirals & Hormone Therapy #IAS2017 | @IAS_Conference

#IAS2017 | @IAS_conferenc 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 Melendez et al, APJH 2005 et al, JANAC, 2010 Lower adherence to PrEPSevelius San Francisco DPH HIV/AIDS, 2008 Deutsch MB, et al. Lancet HIV. 2015 Wilson E, et al. 2015. PLoS One. Sevelius JM, et al. Glob Public Health. 2016 14 Ryan White HIV/AIDS Program Services Report, 2015

80.6 80 78.7 84.3 80 77.3 en de r Tra ns g ve ral l

HA PO en de r Tra ns g ve ral l PO HA RW Viral Suppression 60

60 Ryan White HIV/AIDS Program Annual Client-Level Data Report Ryan White HIV/AIDS Program Services Report (RSR) https://hab.hrsa.gov/sites/default/fil es/hab/data/datareports/2015rwha pdatareport.pdf 100 Percent Retention in Care RW Total Transgender Population, N=6020 (1.1%)

Percent Total population N= 531,816 100 #IAS2017 | @IAS_conferenc 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. 2010 ; 21(3): 256264 Sevelius J, et al. AIDS Care. 2014 August ; 26(8): 976982 Chung, et al. 2016. Transgender Law Center

#IAS2017 | @IAS_conferenc 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. 2010 ; 21(3): 256264 Sevelius J, et al. AIDS Care. 2014 August ; 26(8): 976982 Chung, et al. 2016. Transgender Law Center #IAS2017 | @IAS_conferenc 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-1infected adults and adolescents. 2016 Radix A et al. JIAS 2016, 19(Suppl 2):20810 18 Check estradiol levels may need to decrease dose Radix A et al. JIAS 2016, 19(Suppl 2):20810 Check estradiol levels may need to increase dose Radix A et al. JIAS 2016, 19(Suppl 2):20810 #IAS2017 | @IAS_conferenc

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. 2014 February ; 47(1): 516 Sevelius J, et al. J Assoc Nurses AIDS Care. 2010 ; 21(3): 256264 Sevelius J, et al. AIDS Care. 2014 August ; 26(8): 976982 Deutsch M, et al. 2015 NHPC. #IAS2017 | @IAS_conferenc

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

Social marginalisation #IAS2017 | @IAS_conferenc 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 https://www1.nyc.gov/assets/doh/downloads/pdf/ah/transgenderwomens-health-booklet.pdf 23 #IAS2017 | @IAS_conferenc Acknowledgements Callen-Lorde Trans Ops Team

Peter Meacher, MD Pedro Carneiro, MPH William Nazareth [email protected] @aeradix @callenlorde

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