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.
Reducing Medication Abandonment; Improving Retention in Care
In early 2021, Riley Johnson, the community co-chair for Florida’s Comprehensive Planning Network, and Kim Molnar, the Director of The AIDS Institute’s Center for Convening and Planning, reached out to me to discuss a more and more pressing issue the state’s pharmacies were noticing: medications patients weren’t picking up. Their primary concern was understanding the scope of the problem and developing interventions appropriate to ensure the state’s Ryan White clients were getting the medications they needed. How does this problem fit into the state’s Integrated Plan and Ending the HIV Epidemic efforts?
The question of scope is one highlighted in a recent report from the trade organization known as PhRMA (Pharmaceutical Research and Manufacturers of America). The report focuses on how medication abandonment is a symptom and measure of health equity (or inequity, as is the case). Comparing the rise in high cost-sharing commercial insurance plans and medication abandonment from between 2016 and 2020, there’s a clear association. Not only did medication cost-sharing increase on new brand name medications, the out-of-pocket costs of many existing brand name medications increased and with those rises in costs came a rise in medication abandonment.
Insurers set the prices end-user patients have to pay at the pharmacy counter and increasing these costs effectively allow for these payers to defer expenses on care. When out-of-pocket costs reached $125 at the pharmacy counter, medication abandonment increased from 40% in 2016 to 58% in 2020. Across all prescriptions, medication abandonment only rose by 4% for the same timeframe, from 10% to 14%. It’s important to note these high cost-sharing medication because they’re often those assigned to chronic conditions, like diabetes, HIV, and hypertension, in which generic options aren’t’ as effective, have difficult to manage side effects, or aren’t even available. Indeed, our providers prescribe particular medications because those medications are appropriate to our individual and personal care.
Digging in further, PhRMA recognized an immediate disparity in who was not picking up their medications. On average, Black patients were 7% more likely to abandon new medications than their white peers. The disparity was particularly high among patients seeking pre-exposure prophylaxis for the prevention of HIV (PrEP) with Black patients 41% more likely to abandon a new fill compared to their white counterparts. Similarly, when a medication’s out-of-pocket cost rose to $125 per fill, PrEP again out paced other medication classes with a 34% disparity between Black and white patients. On the issue of income, between patients who earn less than $50,000 per year (lower-income) and those earning more than $100,000 per year (high-income), lower-income patients were 16% more likely to abandon their medications compared to their high-income peers, in an overall analysis.
PhRMA offers a few policy solutions to help overcome the cost-at-the-counter barrier; 1. Sharing the rebate and discount savings offered to pharmacy benefit managers and health insurers by manufacturers directly with the patients, 2. Covering particular medications from “day one” of benefits, rather than requiring a separate pharmacy benefit deductible to paid first, and 3. Ensuring all value of manufacturer patient assistance programs be credited toward patient deductibles, copays, and out-of-pocket maximums. The report also urges investment in better understanding the root causes of medication abandonment, as one of the limitations of the review includes not being able to account for factors like stigma, the effects of racism, education, or other social determinants of health.
In even this brief, yet national, review of medication abandonment, the necessity of intervention is obvious. That last bit, accurately understanding the “why” and offering an opportunity to intervene is exactly why Louisiana’s Ending the HIV Epidemic plan includes improving data sharing agreements and aims to reach beyond Ryan White funded entities to include the state’s Medicaid program and encourages appropriate coordination for the benefit of patients who need some extra help. When a patient has failed to pick up a medication, it’s the first sign a patient may not yet be ready to start a particular therapy or other barriers to care are pressing enough they’re prime to drop out of care. Improving retention in care by utilizing real-time data or software tools to notify an interventionist, be they case managers or peers, when a patient is struggling to pick up their medications would allow for programs to reach-out, identify the particular barrier a patient may be struggling with and empower or assist them in navigating that barrier. Data collected from these engagements is critical to better understanding and actively quantifying various barriers to care and better targeting individual and community wide interventions.
Medication abandonment is but one issue in which creative solutions, better data sharing while appropriately protecting patient data, and thoughtful considerations from the patient perspective can drive meaningful change.