Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV

Considerations for Antiretroviral Use in Special Populations

Transgender People With HIV

Introduction

Because transgender and nonbinary people bear a disproportionate burden of HIV, it is important for HIV care providers to be knowledgeable about the specific HIV care needs of these individuals.

Terminology

Transgender people are broadly defined as those whose gender identity differs from their assigned sex at birth.^1-3 The terminology used to describe transgender identities continues to evolve over time and across geographical and cultural contexts.^3,4 The terms cisgender, cis man, and cis woman are used to describe people who identify with their assigned sex at birth. The terms used to describe women who were assigned male at birth include transgender women, trans women, transfeminine individuals, and women of transgender experience. The terms for men who were assigned female at birth include transgender men, trans men, transmasculine individuals, and men of transgender experience. Some individuals identify outside the gender binary of man or woman, describing themselves as gender diverse, gender nonbinary, genderqueer, or gender nonconforming. Other individuals may not have a fixed sense of their gender and may move back and forth among different gender identities; these individuals are described as gender fluid. Gender fluidity refers to the nonfixed, adaptable nature of gender identity and expression that can occur and is commonly seen during adolescence.⁵ Agender people do not identify with having any gender and can use other terms, such as null gender or neutrois.

Gender affirmation describes processes whereby a person receives social recognition, value, and support for their gender identity and expression.⁶ Gender affirmation is often described across several dimensions, including social (e.g., social support and acceptance, use of pronouns, names, or clothing that align with their gender identity), medical (e.g., use of hormones or surgery), legal (e.g., legal name change or changing gender markers on identity documents), and psychological (e.g., the degree of self-acceptance and comfort with their gender identity).⁷ Medical gender affirmation has been shown to improve mental health outcomes and measures of well-being in transgender individuals.^8,9

Epidemiology

National surveys indicate that 1.14% of the U.S. adult population, representing 3 million people, identify as transgender.¹⁰ Data from the Pew Research Center suggests that gender diversity is more commonly reported among adolescents and young adults, with approximately 5% of young adults (aged 18 to 29) expressing a gender that is different from the sex on their original birth certificate, compared to 0.3% of older adults (aged 50 or older).¹¹ Meta-regression modeling suggests that the number of people who are willing to report that they are transgender and/or gender nonbinary is likely to increase in the future.¹²

The most recent estimate of global HIV prevalence among transgender people is 19.9% among transgender women and 2.6% among transgender men.¹³ In the United States, the highest prevalence was found among Black and Latina transgender women¹⁴, although data among transgender men are more limited.¹⁵ Data on HIV prevalence among nonbinary individuals is scant. Of 164 nonbinary adults who completed nationally representative LGBTQ surveys between 2016 and 2018, 3% self-reported having HIV; however, results should be interpreted with caution due to the small sample size.¹⁶ In 2022, HIV diagnoses among transgender people accounted for approximately 2% of all diagnoses. Of transgender and nonbinary people diagnosed in 2022, 31% were aged 13 to 24 years.¹⁷ HIV diagnoses increased among transgender and nonbinary people while remaining stable among other gender groups, and transgender women were the only gender group to experience an increase (20%) in HIV-related deaths since 2018.¹⁷

The Centers for Disease Control and Prevention (CDC) surveillance reports indicate that 83% of transgender and nonbinary people with HIV diagnosed at year-end 2022 had received some aspect of HIV medical care, and 67% were virologically suppressed, which is well below the National HIV Strategy goal of 95% viral suppression for all people with HIV. Transgender women were the gender group with the lowest percentage of receipt of care and viral suppression.¹⁸ In 2022, the Ryan White HIV/AIDS Program (RWHAP) provided services for 11,085 transgender people, representing 2.8% of RWHAP clients.¹⁹ Of these transgender clients, 2.3% were transgender women, 0.3% transgender men, and 0.2% with another gender identity (e.g., nonbinary). Among RWHAP participants, retention in care (73.5%) and viral suppression (86.4%) for transgender adults and adolescents were lower than the national averages (77.5% and 89.6%, respectively). Overall, existing data are limited and likely underrepresent the proportion of transgender people due to a lack of systematic collection of gender identity and possible reluctance to disclose transgender identities because of social stigma.²⁰

HIV Care Continuum

Some studies have reported that transgender women with HIV are less likely than cisgender men to receive antiretroviral therapy (ART), be adherent to ART, and achieve viral suppression.^21-27 However, data from a large multisite cohort study suggest that transgender women who are effectively engaged in care may have similar, if not better, HIV outcomes than cisgender people in HIV care.²⁸ Another retrospective study of Medicare beneficiaries with HIV found that transgender beneficiaries had greater care engagement than cisgender beneficiaries.²⁹ These results suggest that once transgender people are linked to care, they are as likely to achieve positive HIV outcomes as cisgender people.

However, transgender people may experience numerous barriers to health care access and viral suppression.^30-32 The CDC Medical Monitoring Project found that transgender women diagnosed with HIV were more likely than cisgender men with HIV to have unmet subsistence needs (e.g., housing, transportation).³³ Unmet needs for services were negatively associated with higher levels of ART nonadherence (adjusted prevalence ratio [aPR]: 1.39; 95% confidence interval [CI], 1.13–1.70) and detectable viral loads (aPR: 1.47; 95% CI, 1.09–1.98). Among transgender and nonbinary participants in RWHAP, retention in care was lowest among those with temporary (68.3%) or unstable (67.5%) housing, and viral suppression was lowest among people with unstable housing (73.6%).¹⁹ For a more detailed discussion on social determinants of health and adherence to HIV health care appointments and medications, clinicians should refer to Adherence to the Continuum of Care.

Barriers to HIV Care and Treatment

Transgender people may avoid the health care system due to stigma and past negative experiences (e.g., being called the wrong name or pronoun, being verbally harassed, being asked invasive questions about being transgender, or having to educate their providers about transgender people).^14,31,34-37 For many transgender people, gender-affirming therapy (e.g., feminizing hormones) is a greater priority than HIV treatment and care.^38,39

Concerns about adverse interactions between antiretroviral (ARV) drugs and gender-affirming hormone therapy are common among transgender people.³⁸ One study found that 40% of transgender women with HIV did not take their ARV drugs as directed due to concerns about drug–drug interactions, yet less than half had discussed this concern with their providers.⁴⁰

Facilitating HIV Care Engagement

Gender Affirmation

Individuals are more likely to engage in HIV care when gender affirmation needs are met.^6,35 A national study of transgender people with HIV found that participants who work with HIV care providers who affirm their gender (e.g., providers who use their chosen name and pronoun) were more likely to be virologically suppressed.³⁹ Adherence to hormone therapy correlates with adherence to ART.^41,42 However, making access to hormone therapy contingent upon ART adherence is associated with a lower likelihood of viral suppression.³⁹

Integration of HIV Care With Gender Care

According to research on transgender youth³⁵ and adults,³⁸ integrating HIV care with gender care facilitates treatment and is associated with higher rates of viral suppression. In addition to minimizing the number of provider visits and potentially stressful clinical interactions, care integration makes it easier to discuss concerns about drug–drug interactions between HIV treatment and gender-affirming medications. In instances where integrated care is not feasible, the ART prescriber should refer the individual to an appropriate hormone therapy prescriber. Collaboration between these two care providers may enhance the quality of care.

Peer Navigation

Peer navigation has been found to improve the likelihood of sustained viral suppression among key populations, including among transgender women.⁴³ Research including youth and adults suggests that having visible transgender staff in the clinical environment also facilitates engagement in care.³⁵

Gender-Affirming Clinical Settings

HIV care services should be provided within a gender-affirmative care model to reduce potential barriers to ART adherence and to maximize the likelihood of achieving sustained viral suppression (AII). Concrete steps that clinicians can take include ensuring that registration forms and electronic medical records are inclusive of transgender and gender nonbinary identities, preferably using a two-step method that records both gender and sex assigned at birth.^44,45 A self-reported, electronic approach may facilitate the disclosure of gender identity. Clinicians should also ask people with HIV about their gender identity, chosen names, and pronouns, using developmentally appropriate language. However, before including these items in the electronic health record, clinicians should discuss with people with HIV the possibility of inadvertent disclosure to others, such as parents or guardians.⁴⁶

Example of an affirming way to ask about chosen names and pronouns:

“My name is Dr. Smith. I use she/her pronouns. What name would you like me to use for you? What pronouns do you use?”

Clinicians and staff should avail themselves of resource lists, brochures, and other materials that meet the specific needs of transgender people with HIV.

Integrating hormone therapy with HIV services is the recommended practice; this requires HIV providers to become knowledgeable about hormone therapy and other aspects of gender-affirming services. When integration of HIV and transgender services is not possible, the individuals should be referred to clinicians who are knowledgeable in the field of transgender medicine. Both the World Professional Association for Transgender Health (WPATH) and GLMA: Health Professionals Advancing LGBTQ+ Equality (previously known as the Gay & Lesbian Medical Association) have provider directories that list endocrinologists, primary care providers, and psychiatrists who have expertise working with transgender populations.

Pharmacological Considerations

Hormone Therapy

Hormone therapy is an important aspect of gender-affirming care for many transgender individuals. Hormones facilitate the acquisition of the secondary sex characteristics that are associated with the affirmed gender. Several guidelines for hormonal treatment of transgender people have been published, including guidelines from the Endocrine Society⁴⁷ and WPATH.³ Clinical outcomes, potential adverse effects, treatment goals, and the person’s current hormone levels should be taken into account when determining the appropriate doses of hormone and androgen blockers. A clinician should be aware of the typical doses and routes of administration for all the hormones and androgen blockers that the person is taking, whether these medications are prescribed or not. All additional interventions (such as gonadectomy) should be documented. These interventions could potentially increase the risk of ART-related adverse effects on cardiovascular and bone health. Table 16a provides a list of gender-affirming hormone therapies (GAHT) that are commonly used in practice.

Feminizing regimens that are used by transgender women and others who were assigned male at birth usually include estrogens and androgen blockers. Feminizing regimens result in breast growth, redistribution of body fat, softening of the skin, and a decrease in muscle mass.³ These regimens do not reduce facial (beard) hair or change the voice. In the United States, oral, parenteral, or transdermal preparations of 17-beta estradiol, or, less often, conjugated estrogens, are the mainstay of gender-affirming medical care for transgender women. Spironolactone, a mineralocorticoid receptor antagonist with anti-androgen properties, is normally used for androgen blockade; alternatives include gonadotropin-releasing hormone (GnRH) agonists (e.g., goserelin acetate and leuprolide acetate). Cyproterone acetate is a steroidal anti-androgen that is frequently used outside of the United States. 5-alpha reductase inhibitors that decrease the production of dihydrotestosterone (e.g., finasteride or dutasteride) may be used to reverse scalp hair loss. Some people may request progesterone to assist with breast growth; however, this has not been proven to be effective.⁴⁴ When using feminizing regimens, the goal is to suppress the testosterone level to <50 ng/dL and reach a serum estradiol level in the physiologic cisgender female range of 100 pg/mL to 200 pg/mL.⁴⁷

Masculinizing regimens for transgender men and others who were assigned female at birth involve parenteral or transdermal testosterone preparations. These regimens are designed to stimulate the growth of facial and body hair, increase muscle mass, and deepen the voice; use of these regimens also results in clitoral enlargement, vaginal atrophy, and amenorrhea.⁴⁷ When using masculinizing therapy, the target testosterone levels are recommended to be 400 ng/dL to 700 ng/dL.⁴⁷

Hormones and Antiretroviral Therapy

Studies that have examined interactions between exogenous estrogens and ART have predominantly focused on combined oral contraceptive use in cisgender women.⁴⁸ The data from these studies have been used to make predictions about the direction and extent of drug–drug interactions (see Table 16b). However, there are known differences between the pharmacologic characteristics of ethinyl estradiol, which is used in contraceptives, and 17-beta estradiol, which is used for gender affirmation. These differences may influence the accuracy of the predictions about the interactions between feminizing hormonal regimens and ART.⁴⁹

Other Hormonal Therapy Considerations

Bone Health

Bone metabolism is influenced by sex hormones. Current recommendations for osteoporosis screening are based on age and sex and have not been studied in transgender populations, which include people who have used hormone therapy and/or undergone removal of their gonads. Studies investigating bone mineral density (BMD) changes in transgender women have shown inconsistent results, with the use of estrogens being associated with both elevations and declines in BMD.^50-52 In one study, transgender women had high rates of osteopenia even before initiating hormones, possibly due to low levels of physical activity and low vitamin D levels.⁵⁰ Transgender men receiving testosterone appear to maintain adequate BMD.⁵³ The risk for osteoporosis increases after gonadectomy for both transgender men and transgender women, especially if hormone regimens are stopped. Consequently, clinicians should consider early BMD screening in this setting. The use of GnRH agonists to delay puberty is associated with a reduction in BMD. Although BMD has been shown to improve after these agents are stopped and/or gender-affirming hormones are initiated, peak bone mass attainment may be reduced.^54,55

When using the FRAX^® tool, which requires a sex designation, expert consensus is that assigned birth sex should be used, because transgender people who initiate hormones in early adulthood have generally already achieved peak bone mass.^47,56 Transgender people with HIV should be screened for osteoporosis by age 50 using dual-energy X-ray absorptiometry, in accordance with current primary care recommendations.⁵⁷

Since the use of tenofovir disoproxil fumarate (TDF) has been associated with reductions in BMD in people with HIV, TDF should be used with caution in transgender people with risk factors for osteoporosis, or in those with established osteoporosis.

Interpretation of Laboratory Values

Interpretation of laboratory results requires special attention when reference ranges vary by sex. The sex listed on laboratory requisition forms typically corresponds with the gender listed on the insurance forms and may not reflect the person’s current anatomical or hormonal configuration. Reference ranges have not been established for transgender individuals who are receiving gender-affirming hormonal or surgical interventions. Interpretation of laboratory results is dependent on the person’s physiology, dose and duration of hormone therapy, and the specific test being performed.⁵⁸

Renal Concerns

Gender-affirming hormones can affect estimates of glomerular filtration rates (eGFR) that rely on serum creatinine due to changes in muscle mass. In a systematic review assessing the impact of gender-affirming hormones on kidney function, transgender men showed a mean increase in serum creatinine levels of 0.15 mg/dL (95% CI, 0.00 to 0.29) at 12 months after GAHT initiation, compared to a decrease of -0.05 mg/dL (95% CI, -0.16 to 0.05) among transgender women.⁵⁹ Creatinine-based eGFR calculations may therefore overestimate glomerular filtration rates (GFR) in transgender women and underestimate it in transgender men using GAHT. Obtaining a measured GFR or using cystatin C–based eGFR calculations may be considered for people with marginal renal function who are taking gender-affirming hormones.

Cardiovascular Disease Risk

Transgender individuals may have elevated cardiovascular disease (CVD) risk due to both traditional risk factors and cardiometabolic effects associated with hormone use.⁶⁰ Rates of tobacco use are higher among transgender people than in the general population,⁶¹ and exogenous testosterone has been associated with increased levels of low-density lipoprotein (LDL) and decreased levels of high-density lipoprotein (HDL) among transgender men.⁶² Transgender women have a higher risk of venous thromboembolism and ischemic stroke, primarily associated with the duration of estrogen use.⁶³ Transgender women on estrogens may show an increase in serum levels of triglycerides and HDL and a decrease in levels of LDL.⁶² The implications of these differences are unclear. For example, one small study found transgender women with HIV have altered biomarkers associated with systemic inflammation and CVD when compared to matched cisgender men with HIV.⁶⁴ Yet, another small study of people with HIV found that subclinical CVD pathophysiology was not elevated in transgender women taking estrogen when compared with matched cisgender controls.⁶⁵

Assessment of cardiometabolic risk among transgender people with HIV can be complicated by hormone-induced changes in lipid levels, as well as sex-specific variations in levels of homocysteine and high-sensitivity C-reactive protein.⁶⁶ American Heart Association (AHA) guidelines recommend using sex-specific calculators to determine cardiovascular risk and guide interventions;^67,68 however, AHA guidelines do not provide guidance for transgender people whose assigned sex at birth may differ from their hormonal and/or anatomical sex.⁶⁹ The WPATH Standards of Care, Version 8, recommends clinicians use their professional judgment to tailor such calculators to the needs of transgender and gender-diverse people, taking into consideration the duration of hormone use, dosing, serum hormone levels, current age, and the age at which hormone therapy was initiated.³

Providers should take CVD risk into consideration when selecting both ART regimens and GAHT regimens. For transgender people with an elevated CVD risk or a history of CVD events, ARV drugs that are associated with CVD should be avoided whenever possible. See Table 20 for a list of ARV drugs that are associated with an increased risk of CVD. See Table 21 for alternative ARV agents to use in individuals with CVD. In transgender women who have an elevated risk for CVD or who have experienced a CVD event, transdermal estradiol may be the safest option for hormone therapy, because it carries a lower risk of thromboembolism than other routes of administration.⁷⁰ Of the 7,769 people with HIV in the recent Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE), 127 (1.6%) were identified as transgender.^71,72 However, sub-analyses by gender identity have not been published. For guidance on the use of statins in people with HIV based on the REPRIEVE results, please see Recommendations for the Use of Statin Therapy as Primary Prevention of Atherosclerotic Cardiovascular Disease in People With HIV.

Pregnancy Potential

Important information on contraception, drug–drug interactions between ARV drugs and hormone therapy drugs, and pregnancy is provided in Women With HIV and in the Drug–Drug Interactions tables of the guidelines. Much of this information also applies to transgender and nonbinary individuals. Below are specific ART considerations for transgender and nonbinary people of childbearing potential. Clinicians who care for pregnant people should also consult the current Perinatal Guidelines for a more in-depth discussion and guidance.

Some transgender individuals use exogenous hormones and/or undergo gonadectomy for gender affirmation. Understanding exactly what interventions someone has undergone and the timeline for these interventions will clarify the person’s potential for pregnancy. Transgender individuals without a uterus (by birth or by hysterectomy) do not have pregnancy potential. Ovulation may continue in the presence of hormone therapy in transgender people with a uterus and ovaries, and these individuals may retain their fertility.¹ Gender-affirming surgeries do not impair fertility unless the uterus, ovaries, and vagina are removed.^73,74

All transgender people who have a uterus and ovaries and engage in sexual activity that could result in pregnancy should receive a pregnancy test prior to initiating ART (AIII). All ART-naive persons who are pregnant should be started on ART for their health and to prevent perinatal transmission. Transgender people of childbearing potential should be counseled about ARV drug use during pregnancy, and clinicians should consult the Perinatal Guidelines when designing a regimen (AIII).

Testosterone Exposure in Transgender Persons With Ovaries

Testosterone alone is not a reliable form of contraception, and pregnancies have been reported in transgender men following prolonged testosterone treatment. Testosterone is a teratogen and it is contraindicated in pregnancy. Clinicians should assess the reproductive desires and fertility potential of their transgender clients and provide accurate information on contraceptive and reproductive options.⁷⁵

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