Integrating HIV Treatment with Gender-Affirming Care
In our pursuit of health equity, it's critical to focus on the specific needs of transgender people living with HIV, particularly regarding the safe and effective use of antiretroviral therapy (ART) alongside gender-affirming hormone therapy (GAHT). A groundbreaking study conducted by Thomas Jefferson University and the National Institutes of Health (NIH) has significantly advanced our understanding of ART with GAHT for transgender people, specifically women, living with HIV. This research, a direct response to the previously identified gaps in knowledge, offers concrete evidence on the safety of such co-administration, marking a shift in how healthcare providers can approach treatment plans for their transgender patients.
Until now, the apprehension to combine ART and GAHT has led a significant portion of the community to modify their treatment regimens due to fears of adverse interactions. A 2017 study in LGBT Health reveals the depth of this issue, noting that among study participants 40% reported not taking ART (12%), GAHT (12%), or both (16%) as directed due to drug-drug interaction (DDI) concerns. The recent study, published in Clinical and Translational Science, directly addresses these concerns by analyzing the pharmacokinetic interactions of doravirine, tenofovir (key components of ART), and estradiol (a common estrogen used in GAHT). The findings reveal that these medications, when used together, do not significantly impact each other's effectiveness, providing a much-needed evidence base to support the concurrent use of ART and GAHT.
For transgender women living with HIV, the integration of ART and GAHT is essential not only for managing their HIV status but also for affirming their gender identity. This aspect of their healthcare journey underscores the need for clear, evidence-based guidelines that address the co-administration of these treatments without compromising their efficacy or safety. The recent study's findings mark a significant advancement in our understanding, challenging previous assumptions about potential DDIs.
Safety of Co-administration
The study, "Bidirectional pharmacokinetics of doravirine, tenofovir, and feminizing hormones in transgender women (IDentify): A randomized crossover trial," examines the pharmacokinetic parameters—essentially, how the body absorbs, distributes, metabolizes, and excretes a drug—of doravirine and tenofovir (two key antiretroviral medications) when administered alongside estradiol, a common estrogen used in GAHT.
The findings are significant: the co-administration of these ART medications with estradiol does not significantly alter the effectiveness of each drug. Specifically, the study observed that the levels of doravirine, tenofovir, and estradiol remained stable when used together, indicating that these medications can be safely combined without diminishing their ability to treat HIV or support gender transition.
This research addresses a critical gap in healthcare for transgender women living with HIV, who have historically faced uncertainty about combining ART with GAHT. By demonstrating that these medications do not interfere with one another to a clinically significant degree, the study reassures patients and healthcare providers alike that pursuing both HIV treatment and gender affirmation simultaneously is both safe and viable.
Furthermore, this study lays the groundwork for more informed healthcare practices. It underscores the importance of considering the unique needs of transgender people in HIV treatment plans and encourages ongoing research to explore the interactions between various ART and GAHT regimens. Ultimately, this evidence supports the development of comprehensive care models that fully address the health and well-being of transgender women living with HIV, ensuring they receive effective, affirming care without compromise.
Advancing Guidelines and Communication for Integrated Care
For providers, this new data addresses the concerns expressed in a prior literature review in the Journal of the International AIDS Society, which noted the "insufficient data to address DDIs between ART and feminizing hormone regimens." Now, with fresh insights available, the emphasis can shift to using this updated information to craft and apply comprehensive guidelines and to kickstart education campaigns for providers and the community that align with these new findings.
The urgency now is to convert this research into practical, accessible guidelines that assist healthcare providers and transgender women in navigating the safe use of ART alongside GAHT. It's critical to update healthcare providers with the latest evidence, ensuring they are well-equipped to guide their patients through informed treatment choices. This means integrating new research findings into professional development programs and encouraging open, knowledgeable conversations between healthcare professionals and their patients about the combined use of these treatments.
Expanding the Scope: Inclusive Research for Transgender Men and Non-Binary People
While significant strides have been made in understanding the co-administration of antiretroviral therapy (ART) and gender-affirming hormone therapy (GAHT) for transgender women, our knowledge remains limited when it comes to transgender men and non-binary people living with HIV and seeking gender affirming care. With the completion of this major study by Thomas Jefferson University and the NIH, the next step is to expand our research efforts to encompass the full spectrum of transgender experiences, ensuring that future studies are as inclusive and comprehensive as possible.
Transgender men and non-binary people face unique healthcare challenges that are often overlooked in medical research. This oversight not only perpetuates health disparities but also leaves significant gaps in our understanding of how ART interacts with testosterone and other aspects of gender-affirming care utilized by transgender men and non-binary people. To ensure that all members of the transgender community receive comprehensive and affirming care, it is imperative that future studies specifically investigate these interactions.
The call for research extends beyond the pharmacokinetic interactions to encompass the physiological, psychological, and social outcomes of combining HIV treatment with gender-affirming care across all gender identities. Such studies should aim to provide a holistic understanding of treatment efficacy, safety, and the overall well-being of gender diverse patients, regardless of their specific gender identity or the nature of their gender-affirming treatments.
By advocating for and conducting research that includes transgender men and non-binary people, we can move towards a healthcare model that truly embraces diversity and inclusivity. This approach not only enriches our collective knowledge but also ensures that healthcare practices and guidelines are reflective of the needs of the entire transgender community. It is through this comprehensive understanding that we can improve care, enhance treatment adherence, and ultimately support the health and well-being of all transgender people living with HIV.
Mobilizing for Inclusive Healthcare Reform
The recent advancements in understanding the co-administration of antiretroviral therapy (ART) and gender-affirming hormone therapy (GAHT) represent a significant step forward. However, the journey towards fully supporting the health and well-being of all transgender people living with HIV continues. We must intensify our efforts in advocacy, education, and policy reform to ensure equitable treatment for everyone. Here's how different stakeholders can contribute:
For Healthcare Providers:
Educate Yourself: Actively seek out and participate in continuing medical education (CME) opportunities focused on the latest research in ART and GAHT co-administration. Utilize resources from reputable organizations such as the World Professional Association for Transgender Health (WPATH) and the Centers for Disease Control and Prevention (CDC).
Practice Inclusive Care: Implement guidelines and practices in your clinical setting that respect and address the unique needs of transgender patients. Ensure that your staff is trained in cultural competency regarding transgender health issues.
For Researchers:
Fill the Research Gaps: Prioritize studies that explore the long-term health implications of ART and GAHT co-administration, especially for underrepresented groups within the transgender community, such as transgender men and non-binary people.
Collaborate with the Community: Engage with transgender communities to ensure that research is inclusive, relevant, and respectful. Consider community-based participatory research (CBPR) approaches to involve community members in the research process.
For Policymakers:
Develop Evidence-Based Guidelines: Work with medical experts and advocates to create and enforce guidelines that facilitate the safe co-administration of HIV medications and gender-affirming therapies. These guidelines should be based on the latest research and best practices.
Support Access to Care: Advocate for policies that remove barriers to accessing both HIV treatment and gender-affirming care. This includes ensuring coverage by insurance providers and addressing legal and systemic obstacles that transgender people face.
For Advocates and Community Leaders:
Raise Awareness: Use your platforms to disseminate accurate information about the safety and importance of integrating ART with GAHT. Highlight stories and data that underscore the positive impact of affirming care.
Mobilize Support: Organize campaigns to advocate for improved healthcare policies, increased research funding, and greater awareness of transgender health needs. Collaborate with healthcare providers, researchers, and policymakers to amplify your efforts.
Together, we can bridge the gaps in care and knowledge, creating a future where every transgender person living with HIV has access to the treatments they need, free from stigma and barriers. Let's commit to a healthcare environment that celebrates diversity, champions inclusivity, and ensures comprehensive care for all.
DEA Proposed Rules Risk Harming Access to Care
Since the beginning of the COVID-19 pandemic, the United States Drug Enforcement Administration (DEA) has held certain relaxed or waived rules regarding prescribing of controlled substances. On January 30th, President Biden announced his administration would end the public health emergency (PHE) declaration related to COVID-19 in May of 2023, after one, last renewal in February. Part of what’s being called an “unwinding” of the PHE includes returning to “normal” operations for executive entities like the DEA. But times have changed dramatically in terms of healthcare access since the beginning of the COVID-19 pandemic, most notably around the issue of telehealth. Thus, on February 24th, the DEA announced two proposed rules regarding permanent telehealth access and prescribing related to controlled substances.
The DEA’s controlled substances list is…controversial, to say the least. The five category list includes those which the agency has deemed to have the “potential for abuse or dependency” characterization. Schedule “V” (five) having a “low” potential for abuse relative to other levels and having sufficient medical value, resulting in quantity limits but, typically, not more than that in terms of regulatory impact. These medications include certain cough medicines and an anti-diarrheal medication, among others. Schedule “I” (one) substances as having been deemed to have “no” medicinal value, a high potential for abuse, and a lack of accepted safety for use even under medical supervision. These substances include marijuana, “ecstasy”, LSD, and peyote. In between these, you’ll find certain pain killers, treatment for attention deficit disorder (ADD), anabolic steroids, and medications used to treat opioid use disorder (OUD). The DEA’s proposed telehealth rules (here and here) would allow for a provider who has never conducted an in-person assessment of a patient to only prescribe up to a 30-day supply of schedule III-V non-narcotic medications and a 30-day supply of buprenorphine. In order to get a refill or maintain treatment, a patient would have to then arrange for an in-person assessment. For patients referred by a provider who has already conducted an in-person assessment in the last year or for providers who are directly prescribing the medication and have already had an in-person assessment in the last year, the limitations on telehealth would not apply.
Particularly, in the rules, the DEA argues medications used to treat OUD are at risk of diversion and misuse, despite evidence that misuse is relatively rare and declining and despite the fact that only about 11% of the population which could benefit from medication assisted treatment (MAT) have access, according to a report from the Substance Abuse and Mental Health Services Administration (SAMHSA). Reasons for limited access are slowly being addressed. Most notably, the “X-Waiver”, a program which limited which prescribers could offer buprenorphine and other MAT and how many patients they could treat. The “X-Waiver” requirements were repealed in Section 1262 of the Consolidated Appropriations Act of 2023 (otherwise known as the Omnibus). Another giant barrier to prescribing MAT is provider stigma. This stigma against people who use drugs (PWUD) often leads to patients having an exceptionally hard time finding a provider willing to help them, when they need it. Years of prescribing limits and the vagueness of the DEA requiring pharmacies to report “suspicious” orders (the DEA does not define what’s constitutes “suspicious”), has also left pharmacies, wholesalers, and distributors exceedingly cautious as not gaining the DEA’s ire. With these proposed rules, the biggest barrier to President Biden’s plan to expand access may be the bureaucracy he enabled as a Senator and Vice President (Politico details more here).
Additionally, some states are attempting to ban access to gender-affirming care; not just for minors but for anyone accessing public payer programs and even attempting to forbid private, commercial plans from offering gender affirming care. While these would not necessarily impact access to care for transgender women seeking out-of-state telehealth, it would adversely affect transgender men because testosterone is a schedule III controlled substance. Thus, under these rules, transgender men would have to have in-person assessment with a provider in order to begin or continue accessing prescribed testosterone replacement therapy. Where this is a bit of a “come uppins” moment for President Biden is in his historical record of championing the Anabolic Steroid Control Act of 2004, making testosterone and anything related to it a controlled substance. The law rose to a certain popularity because of major sports leagues in the United States insufficiently addressing steroid use among professional athletes. The world has changed greatly since then and most, if not all, of those entities have adopted tight controls and regular screenings of athletes (which do need some update to appropriately reflect the endocrinological variety the human species offers). A carve out in the law would allow for the DEA to exempt medications which “does not present any significant potential for abuse.”
Chronic pain patients, disability advocates, harm reduction advocates, and advocates for access to gender-affirming care are sufficiently outraged to see their life-saving care being ripped from the ease of telemedicine. Leo Beletsky, a law professor at Northwestern University said, “The fallout is going to be measured in lives lost.” Dr. Brian Hurley, the president-elect of the American Society of Addiction Medicine said, “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion.” “forcing people with disabilities who are immunocompromised or high-risk to choose between potential COVID exposure and forgoing vital medications is ableist and dangerous,” said Madeline T. Morcelle of the National Health Law Program. Adult ADHD patients are already fighting a shortage on their medications and providers who will prescribe them. And with the rural health care crisis limiting access to providers for queer people, disabled people, and PWUD, this rule will strip them of the only time they’ve seen their access to care expand in decades.
A bi-partisan, bi-cameral group of legislators have written a letter to the DEA cautioning against these rules and Senators Warren (D-MA) and Ed Markey (D-MA) have also written a letter to the U.S. Department of Justice, U.S. Department of Health and Human Services, and the DEA about de-scheduling testosterone. Neither letter has been answered yet. Orion Rummler of 19th News recently asked for an update and will be following up on the status of a response from the Biden Administration and executive agencies.
With these massive concerns on finding and accessing care, patients may well turn to the black market or grey market to self-manage the life-saving medications they need. This not only defeats the purpose of the DEA’s rules in attempting to prevent diverse by artificially creating a market for illicit trade, it exposes patients to risks of infections, counterfeit medications, and other safety hazards.
Patients should not have to risk their lives and even incarceration in order to access life-saving medications they have readily enjoyed over the last three years. The DEA should engage providers, advocates, and patients more than any other stakeholder from law enforcement to approach promulgation of these rules in a way that aligns with public health instead of carelessly chasing after ways to limit access to life-saving medications.
The proposed rules aim to come into effect in November. The public comment period ends on March 31, 2023. We encourage our partners, including those not directly involved in issues of substance use or production of controlled substances, to comment in support of adjustments to the proposed rules that would maintain telehealth access to care, meet the stated public health goals of the Biden Administration, and, most directly, maintain access to the life-saving medications patients depend upon. The public may submit comments here and here.