MELISSA BADOWSKI, PHARMD, MPH, BCPS, AAHIVP

Gender-affirming care consists of comprehensive services including medical, surgical, mental health, and social services to support and affirm an individual’s gender identity.

 Gender identity refers to a person’s individual experience of gender.

 A transgender, gender nonconforming, gender nonbinary, or genderqueer person’s gender identity differs from the sex they were assigned at birth.

In 2019, approximately 1 million individuals living in the United States identified as transgender or gender nonconforming.

Transgender individuals made up approximately 2% of all new HIV diagnoses that year.

 Transgender persons are at high risk for acquiring HIV, with approximately 14% of trans women and 3% of trans men already living with HIV and even higher rates among racial minority transgender persons.

 Transgender individuals may prioritize gender-affirming hormone therapy (GAHT) over antiretroviral therapy (ART) if they perceive ART to decrease efficacy of GAHT.

 Previous literature suggests provision of gender-affirming care to persons living with HIV improves quality of life as well as engagement and retention in care.


GAHT therapy consists of administration of exogenous hormones and suppression of endogenous hormone production, with the goal of obtaining characteristics more congruent with an individual’s gender identity.

 Currently, there are several clinical practice guidelines to inform gender-affirming care, but it is important to note that data to guide treatment decisions in persons living with HIV specifically are scarce.

In general, goals of GAHT should be individualized to each patient and target acquisition of secondary sex characteristics that better align with the patient’s gender identity.

 Some may prefer limiting hormonal effects or maintaining a mix of feminine and masculine characteristics.

 Therefore, recommendations for specific serum level monitoring targets herein are based on cisgender adult normal ranges to avoid long-term complications of supratherapeutic levels, with the goal of total feminization or masculinization.


Estrogen is the cornerstone of feminizing hormone therapy (FHT). However, because estrogen therapy alone is not enough to suppress testosterone levels, FHT also typically consists of an antiandrogen and sometimes progestogen and/or gonadotropin-releasing hormone (GnRH) agonist.


There are several preparations of estrogen available: oral conjugated estrogens, ethinyl estradiol (EE), and oral or sublingual, injectable, or transdermal 17β-estradiol. 17β-Estradiol is biochemically identical to the estrogen released from the ovary and is preferred to EE and oral conjugated estrogens because of its more favorable safety profile. EE is commonly formulated into oral contraceptives and increases risk for venous thromboembolism. In addition to venous thromboembolism risk, conjugated estrogens also increase cardiovascular (CV) risk.

 The transdermal formulation is thought to have the least thromboembolic risk of all preparations.

Sublingual administration of micronized tablets and the injectable formulations have been found to have variable pharmacokinetics and higher serum concentrations, as they bypass first-pass metabolism.

 Injectable estradiol can result in peak levels of 250 pg/mL and troughs of 50 pg/mL; decreasing the dosing interval between injections may decrease these fluctuations in levels.

 The most common adverse effects of 17β-estradiol preparations are mood swings, migraines, hot flashes, and weight gain.

 Dosing and considerations for monitoring can be found in 

. Studies comparing the efficacy of the agents look primarily at postmenopausal women, with no 1 formulation more efficacious than the others for all outcomes. Moreover, the desired effects in the study population differ from the desires of transgender persons.

 Therefore treatment decisions should be based on patient preference.

Monitoring parameters for 17β- estradiol therapy include maintenance of serum estradiol levels between 100 and 200 pg/mL and serum testosterone less than 50 ng/dL. Timing of monitoring is further described below in 

. Conjugated and synthetic estrogens cannot be evaluated via blood testing and are not recommended for use as GAHT.

Estrogen therapy is also associated with increased triglycerides (TG) without significant effects on high- and low-density lipoproteins (HDL and LDL).

 Ritonavir- and cobicistat-boosted ART, efavirenz, and tenofovir alafenamide (TAF) are also associated with dyslipidemias.

 Prior to initiating estrogen therapy in individuals taking these antiretrovirals (ARV), providers should discuss interventions tailored to decrease CV risks, such as smoking cessation and lifestyle modifications.

 Currently, there is conflicting evidence regarding the risk of CV events with abacavir. Nonetheless, abacavir should be used with caution in patients taking estrogen, especially those with CV risk.

Ritonavir-boosted protease inhibitors, efavirenz, etravirine, and nevirapine are expected to decrease serum concentrations of estradiol. Therefore, the US Department of Health and Human Services (DHHS) guidelines recommend increasing the dose of estradiol in patients taking these medications concomitantly to achieve desired clinical effects. These ARVs are no longer commonly prescribed in the United States but may still be used in other countries. Because of conflicting information provided in the DHHS guidelines, it is unclear the effect of cobicistat-boosted regimens may have on estradiol concentrations.

 Current evidence has investigated only the impact of these regimens on EE exposure, showing decreased EE exposure with boosted darunavir and elvitegravir but no difference with boosted atazanavir.

Closer monitoring of serum estradiol levels may be required to achieve desired clinical effects.


Antiandrogens suppress production of testosterone and suppress male characteristics. These medications include spironolactone, GnRH agonists, and 5-α reductase inhibitors.

Spironolactone is a potassium-sparing diuretic with androgen receptor–blocking properties at high doses as well as dose-dependent gynecomastia.

 Doses of 200 to 400 mg daily have been reported without negative effects.3 Total daily doses greater than 50 mg should be divided into 2 doses.

 Hyperkalemia rarely occurs and is more likely in patients with impaired renal function or concomitant use of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or sulfamethoxazole-trimethoprim.

 Because of its diuretic effect, hypotension can occur and patients may experience self-limiting polydipsia and polyuria.

GnRH agonists, such as histrelin and leuprolide, block the release of follicle-stimulating and luteinizing hormones, leading to full gonadal blockade.

 Histrelin is a surgically inserted implant that lasts 12 to 36 months, whereas leuprolide requires injections ranging from daily to every 3 to 4 months.

 Although more commonly used to delay puberty in adolescents, these medications may be used in combination with estrogen to lower testosterone levels.

 Redistribution of body fat toward the affirmed gender can occur; however, most studies simply report an increase in body fat and decrease in muscle mass, which may or may not be desired.

 Effects of GnRH agonists on bone mineral density (BMD) have not been well studied but may be of less concern when used as an adjunct to estradiol. Exogenous estrogen therapy has been shown to be sufficient in maintaining normal BMD.

 Because tenofovir disoproxil fumarate (TDF) has been associated with a decrease in BMD, it should be used with caution in transgender patients who are at higher risk for osteopenia and osteoporosis, including those on GnRH agonists in the absence of hormone therapy.

 Hypertension has also been reported with GnRH agonists.

Lastly, 5-α reductase inhibitors block the conversion of testosterone to dihydrotestosterone. Because they do not suppress testosterone production or activity, these inhibitors have less of an antiandrogen effect when compared with GnRH agonists. Dutasteride is more selective of the pilosebaceous unit compared with finasteride and therefore may have more feminizing effects. These agents are a good option for patients seeking only partial feminization or experiencing hair loss after total androgen blockade.

 Normal dosing in gender-affirming care is finasteride 1 to 5 mg daily and dutasteride 0.5 mg daily. Both are associated with decreased libido and ejaculation disorders.

Boosted ART is expected to increase concentrations of these agents. Conversely, efavirenz, etravirine, and nevirapine may result in decreased 5-α reductase inhibitor concentrations; therefore, increased doses may be required to achieve desired clinical effects.


To date, evidence from well-designed trials for progestogens as FHT is lacking. Nevertheless, progestogens are thought to improve breast development, mood, and libido without evidence to suggest harm.

 Commonly used progestogens include micronized progesterone 100 to 200 mg at bedtime or medroxyprogesterone 2.5 to 10 mg at bedtime.

 Depot medroxyprogesterone acetate is less common in transgender women but may be used in transgender men to induce amenorrhea.

Physical changes with FHT can be expected between 3 and 12 months after treatment initiation. Decreased sexual desire and spontaneous erection may occur within 1 to 3 months of starting hormone therapy. Within 3 to 6 months, redistribution of body fat, decrease in muscle mass, skin softening, breast growth, and decrease in testicular volume can be expected. Finally, after 6 to 12 months, terminal hair growth declines.


The general approach to masculinizing hormone therapy (MHT) is the administration of exogenous testosterone, with the goal of developing male secondary sex characteristics and suppression or minimization of female sex characteristics.


Testosterone is available in injectable and transdermal formulations, which are all thought to be equally efficacious. Dosing is summarized in Table 1. Adverse effects of injectable formulations include acne, polycythemia, sleep apnea, and dyslipidemia, whereas transdermal formulations (including the patch) may also cause skin irritation and hypersensitivity.

According to the Endocrine Society guidelines, the normal male range for total testosterone levels is between 320 and 1000 ng/dL, but reference values may vary by assay.

 If patients experience decreased libido and mood, testosterone should be uptitrated to target midrange values. Further uptitration to the upper end of the reference range is unlikely to produce further masculinizing results and is not recommended.

 Depot medroxyprogesterone acetate 150 mg every 3 months may be used in transgender men to induce amenorrhea until full effects of testosterone are seen.

Physical changes with MHT expected to occur within 1 to 6 months of the initiation include the cessation of menstruation, increased libido, increased body and facial hair, increased muscle mass, and redistribution of body fat. Deepening of the voice, clitoromegaly, and sometimes male pattern baldness can be expected within 12 months of testosterone therapy.

Testosterone therapy has a similar drug interaction profile to that of 5-α reductase inhibitors regarding ART. Boosted ARVs are expected to increase concentrations of testosterone, whereas efavirenz, etravirine, and nevirapine may result in decreased concentrations; therefore, increased doses of testosterone may be required. Exogenous testosterone also increases LDL and TG while decreasing HDL in transgender men. Therefore, caution should be used when initiating boosted ART, efavirenz, abacavir, and TAF.

CONSIDERATIONS FOR PRE-EXPOSURE PROPHYLAXIS


The CDC and the United States Preventive Services Task Force recommend use of preexposure prophylaxis (PrEP) in all high-risk individuals, including transgender persons.

 Small pharmacokinetic studies have found lower serum concentrations of emtricitabine (F)/TDF and F/TAF in transgender women. However, these lower concentrations were still within the expected ranges for patients taking these medications and above the levels necessary to confer 90% protection from HIV infection.

 F/TDF has no effect on serum levels of gender-affirming hormones, more specifically testosterone and estradiol.

 Long-acting injectable cabotegravir (CAB) is not expected to have any drug-drug interactions (DDIs) with GAHT and was found to be superior to oral PrEP for prevention of HIV infection.

 Therefore, F/TDF and CAB can each be safely used as PrEP in the setting of GAHT. F/TAF is expected to remain efficacious in transgender women on FHT, but it is currently not approved for transgender men.


Modern ARV regimens have few, if any, expected DDIs with GAHT, including agents used for PrEP. Clinicians should discuss the benefits of adherence to agents used for HIV treatment and prevention, as well as the minimal risk for DDIs with GAHT.



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Articles

Gender-affirming hormone therapy (GAHT) therapy consists of administration of exogenous hormones and suppression of endogenous hormone production, with the goal of obtaining characteristics more congruent with an individual’s gender identity. Here is a review of these therapies and consideration for PrEP and the risks associated with HIV in this diverse population.

Gender-Affirming Care in Persons Living With HIV

In 2016, an estimated 2.3 million people living with HIV were coinfected with chronic hepatitis C virus (HCV).

 Of the coinfected population, more than half were intravenous drug users (IVDUs).

 One meta-analysis of the HIV/HCV coinfection literature found that more than 80% of the coinfections were in IVDUs.

 Yet, while it is established that persons who inject drugs make up a large part of this HIV/ HCV coinfected population, these patients are not clearly identified in the major HIV/HCV coinfection trials. Although this can be a difficult patient population to manage, they are a high priority from a population health standpoint. Eradication of HCV, in addition to complete viral suppression of HIV, would substantially decrease overall transmission of these viruses if these high-risk behaviors continue.

Initiation of antiretroviral therapy (ART) is recommended for all patients testing positive for HIV infection. In the coinfected population, this is even more important, as untreated HCV in HIV leads to more rapid liver disease progression and increases both morbidity and mortality.

 In patients with HIV/ HCV coinfection, the choice of ART should take into consideration the potential need for concurrent HCV treatment. Other considerations include the ability to adhere to therapy, cost or insurance coverage of medications, hepatitis B virus status, and progression of liver disease or cirrhosis. Each of these factors can further dictate the medication regimen for both disease states.

 outlines the recommended first-line and alternative direct-acting antiviral (DAA) medications for the treatment of HCV from the American Association for the Study of Liver Diseases (AASLD) and takes into consideration appropriate, as well as inappropriate, concomitant antiretroviral agents.

Patients with HIV should always be screened and evaluated for HCV treatment. If they meet the criteria, therapy with a DAA should then be initiated based on HCV genotype and severity of disease.

 The currently available DAA regimens result in high HCV cure rates, as measured by sustained virologic response (SVR). SVR is achieved in the HIV/HCV coinfected population at a similar rate as those with HCV monoinfection.

 The trials investigating many of the DAA agents in the HIV/HCV coinfected population are outlined in 

 (available at contagionlive.com). Some of the data on glecaprevir/ pibrentasvir have been presented, but the full trial has not yet been published. No articles on the efficacy of the newest agent, sofosbuvir/velpatasvir/voxilaprevir, are available yet in this specific patient population. However, the phase 3 trials for this medication, published as the POLARIS series, have shown SVR rates comparable with those of the agents listed below in HCV monoinfected patients. In treatment-naïve patients, 8 weeks of treatment with sofosbuvir/velpatasvir/voxilaprevir resulted in an SVR of 95%. In previously treated patients without cirrhosis, the SVR was as high as 99%.

 Because of the high SVR in this population and the already well-established first-line agents, sofosbuvir/velpatasvir/voxilaprevir will be seen clinically primarily in patients who have failed prior therapy.

Although HIV/HCV coinfection is common in IVDUs, these patients are not commonly mentioned in clinical trials, despite making up a large portion of the real-world HIV/HCV coinfected population. In fact, IVDU is a common exclusion criterion for trials, especially those in which treatment adherence and follow-up are directly correlated to efficacy. For example, the C-EDGE and ION-4 trials list clinically relevant drug or alcohol abuse or a history of abuse within 12 months of screening as an exclusion criterion.

 In the PHOTON-1 trial, persons who inject drugs were not explicitly excluded, however, if any participant had a positive urine drug toxicology screening, he or she could not participate in the study.

 The ledipasvir/sofosbuvir trial, the National Institute of Allergy and Infectious Disease’s ERADICATE trial, inclusion criteria states that if patients were opioid dependent, they had to participate in supervised treatment while in the study.

 Other studies give even less detail but state generally that anything that could affect adherence should be an exclusion criterion at the principal investigator’s discretion.

When treating a person who injects drugs with newly diagnosed HIV/HCV co-infection, as with all patients, medication therapy for both infections should be initiated as soon as possible to prevent the progression of liver disease and decrease the transmission of the viruses. HIV viral load suppression should be obtained first, followed by the addition of HCV treatment. An ideal combination for a patient presenting with an HIV/HCV coinfection would be a regimen such as dolutegravir/abacavir/lamivudineand glecaprevir/ pibrentasvir. If a patient is eligible for HIV treatment with dolutegravir/abacavir/lamivudine (namely HLA-B*5701 negative and without cardiovascular disease), glecaprevir/pibrentasvir can be safely added to this regimen with minimal risk of drug—drug interactions. Furthermore, as a pan-genotypic agent, glecaprevir/ pibrentasvir has shown efficacy for all HCV infection genotypes. Perhaps most important for this patient population is that in individuals without cirrhosis, treatment is only 8 weeks, potentially increasing the likelihood of adherence.

Starting at diagnosis and continuing with each health care encounter, it is important to address and evaluate the patient’s illicit drug use. Studies have shown that in the HIV populations, ART is equally efficacious for IVDUs and non-IDVUs when patients are not actively using drugs.

 Illicit drugs have been linked to depression and anxiety, which is a strong predictor of poor adherence and potentially poor treatment outcomes. Persons who inject drugs and have HIV have lower rates of ART if they also have additional risk factors such as recent incarceration or lack of access to rehabilitation programs. Therefore, management of substance use disorders is often necessary to successfully eradicate HCV and appropriately manage HIV.

It is important to build a relationship of trust with these patients and not only provide medical support for their HIV/ HCV infections but also assist in getting them connected for their other comorbidities that affect patient adherence to medication therapies. This primarily includes a multidisciplinary approach to treating the patient’s substance abuse disorders. In addition to medication therapy, it is prudent to stabilize these patients through treatment of psychiatric illnesses and substance abuse treatment. Further harm-reduction measures such as connecting patients with needle exchange programs and clinics to provide sexually transmitted infection screenings and free condoms are also important.

In a patient population that is commonly lost to follow-up, it is also pertinent to engage, link, and retain these patients from the community into care. This could be done through co-management of patient’s infectious diseases in substance abuse programs or methadone clinics. As this is a high-risk population for transmission of HIV and HCV, population screening should also be provided to ensure adequate treatment for all individuals.

HIV/HCV treatments can be provided only if these patients are identified. With overlapping modes of transmission and affected populations, meeting these patients in the community is the first step for control of these conditions. With new medications being developed for both HIV and HCV, as clinicians we need to remain up-to-date on safety profiles, drug interactions, and clinical pearls for each medication. Armed with this knowledge, we can treat this unique population with the most targeted and multifaceted approach. 

Dr. Badowski is a clinical associate professor at the University of Illinois at Chicago (UIC), College of Pharmacy in Chicago, Illinois. She completed a PharmD at Midwestern University, Downers Grove, Illinois, an MPH at UIC, School of Public Health, and residencies at the University of Maryland Medical Center and College of Pharmacy in Baltimore. Her current practice setting is an interdisciplinary telemedicine clinic where she manages people living with HIV in the correctional setting for the state of Illinois.  

Dr. Murdock is a PGY2 ambulatory care pharmacy practice resident at the University of Illinois at Chicago, College of Pharmacy (UIC) in Chicago, Illinois. She completed a PharmD at the University of Kentucky and a first-year pharmacy residency at UIC. 

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Unique considerations are called for when caring for intravenous drug users with newly diagnosed HIV/HCV coinfections.

MELISSA BADOWSKI, PHARMD, MPH, BCPS, AAHIVP

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