Breakthroughs in HIV Research from CROI 2024

This month, the global health community convened at the Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, spotlighting groundbreaking advancements in HIV research and treatment. This year's conference highlighted significant progress in long-acting HIV therapies and innovative strategies for pediatric HIV care, pointing towards a future where HIV management is more effective and less burdensome.

Key discussions focused on the success of long-acting treatments like Cabenuva (cabotegravir and rilpivirine), which have demonstrated remarkable efficacy in clinical trials, offering new hope for those challenged by daily medication regimens. These developments promise to enhance adherence and improve the quality of life for millions living with HIV.

Advancements in HIV prevention were also notable, with the introduction of once-weekly oral treatments and the confirmation of safety for HIV prevention methods during pregnancy. These innovations expand the tools available to combat HIV transmission and emphasize the need for accessible and inclusive prevention strategies.

Additionally, the conference highlighted the importance of addressing co-occurring conditions such as liver disease and cardiovascular risks in people living with HIV. The exploration of pediatric HIV treatment also showed promising paths towards ART-free remission in children, potentially leading to a cure for young patients.

The role of community-engaged research was underscored, ensuring that the developments reflect the needs and voices of those most affected by HIV. The insights from CROI 2024 mark a path forward in the HIV fight, characterized by innovation, collaboration, and a commitment to enhancing the lives of those impacted by the virus.

Advancements in Long-Acting HIV Treatments

The landscape of HIV treatment and prevention is undergoing a significant transformation, heralded by the advent of long-acting therapies. These innovations promise a new era of convenience and efficacy, potentially changing the lives of millions of people living with HIV (PLWH) worldwide.

At the forefront of this shift are long-acting injectable treatments, such as Cabenuva (cabotegravir and rilpivirine), which have demonstrated remarkable success in clinical trials. A new study reveals that "These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking." This statement underscores the potential of long-acting injectables to revolutionize HIV treatment by alleviating the daily burden of pill-taking, with more than 90% of participants receiving their injections on time.

The development of ultra-long-acting formulations, such as the cabotegravir injection for HIV prevention, represents another leap forward. With a predicted half-life significantly longer than existing formulations, these treatments offer the promise of even greater adherence and convenience, potentially reducing the frequency of dosing to just 3 times a year.

Moreover, the integration of broadly neutralizing antibodies (bnAbs) with long-acting antiretrovirals is opening new avenues for more durable treatment options. As Liz Highleyman summarizes, "Broadly neutralizing antibodies appear to work well with lenacapavir or cabotegravir in long-acting regimens for HIV treatment, but studies are still in early stages." This collaboration between bnAbs and long-acting antiretrovirals has shown promising results, with studies reporting up to 95% of participants maintaining viral suppression.

Apart from injectable treatment options, the introduction of a once-weekly oral HIV treatment presents another long-acting option for patients who prefer treatment without needles. The convenience of a once-weekly regimen cannot be overstated, with one researcher emphasizing the importance of such developments: "Developing once-weekly treatment options could help meet the needs of each person, aiming toward maximizing long-term outcomes for people with HIV." This approach has demonstrated remarkable efficacy, with over 90% of participants maintaining viral suppression, showcasing the potential of once-weekly treatments to significantly enhance adherence and, consequently, the effectiveness of HIV treatment.

Breakthroughs in HIV Prevention

In addition to advancements in treatment regimens, significant progress has been made in ensuring the safety of HIV prevention methods during pregnancy. The use of the vaginal ring and oral PrEP has been thoroughly evaluated, with findings affirming their safety for pregnant women—a critical consideration given the increased vulnerability to HIV infection during pregnancy. Remarkably, "95% of deliveries were at term and 4% were preterm, with no study participants acquiring HIV," highlighting the effectiveness and safety of these prevention tools in protecting both mothers and their unborn children from HIV.

Furthermore, the Together Take Me Home project has made significant strides in expanding access to HIV prevention through the distribution of HIV self-test kits. In just nine months, the project saw over 181,558 orders placed, with 337,812 tests distributed, many to people who had never tested for HIV or had not tested in over a year. Sixty percent of all orders contained enough information to describe participants, with 61% from men reporting male partners in the past 12 months, 10.7% from gender-diverse persons, and 10% from Black women. This initiative underscores the importance of meeting people where they are, providing accessible and confidential testing options. As Dr. Neblett Fanfair noted, "This shows how impactful this is to meet people where they are with what they need to be met with. We’re really excited that it’s not just about HIV self-tests, but it also opens the door to STI testing and PrEP as well," highlighting the project's role in broadening the reach of HIV prevention efforts.

Addressing Co-Occurring Conditions

The intersection of HIV with other health conditions underscores the complexity of care required for people living with HIV. Recent research has brought to light significant advancements in addressing co-occurring conditions, such as liver disease and cardiovascular risks.

A groundbreaking study on the use of semaglutide has shown promising results in reducing the severity of metabolic dysfunction-associated steatotic liver disease (MASLD) in people living with HIV. MASLD, characterized by excessive fat accumulation in the liver, poses a significant risk of progressing to more severe liver diseases. The introduction of semaglutide, a medication initially used for diabetes and weight management, into the treatment regimen for PLWH has marked a notable advancement, with participants experiencing "an average 31% reduction in liver fat." This significant decrease highlights semaglutide's potential as a therapeutic agent in managing liver health in people living with HIV.

Furthermore, the issue of cardiovascular health in PLWH has been brought to the forefront by recent findings indicating that current tools may significantly underestimate the risk of cardiovascular events in this population. Notably, "Cardiovascular event rates were higher overall, with cisgender women experiencing about two and a half times more events than predicted." This discrepancy underscores the need for more accurate assessment tools and tailored prevention strategies to mitigate the elevated risk of cardiovascular diseases among people living with HIV.

Additionally, research into prostate cancer screening among men with HIV has revealed a concerning "screening gap." According to a study, men with HIV were significantly less likely to receive PSA screening prior to diagnosis, leading to a higher incidence of advanced prostate cancer at the time of diagnosis. This gap in screening and early detection highlights the need for increased awareness and proactive screening measures for men living with HIV, to ensure timely diagnosis and treatment of prostate cancer.

Innovations in Pediatric HIV Treatment

Pediatric HIV treatment is witnessing remarkable innovations, particularly in the areas of early treatment and the exploration of long-acting therapies. These advancements are not only enhancing the quality of life for children living with HIV but also paving the way toward potential remission and a future where daily medication may not be necessary.

In a new study highlighted in POZ and further discussed on HIV.gov has brought to light the significant potential of initiating ART within the first days of life. This approach has led to ART-free remission in some cases, with "four of the six children achieving ART-free remission." Such findings are groundbreaking, as they suggest that early intervention can drastically alter the course of HIV in children, offering a glimpse into the possibility of a cure or long-term remission. The impact of these results cannot be overstated, as they represent a monumental step forward in the quest to end HIV as a lifelong condition.

Further extending the scope of pediatric HIV treatment, recent research has also explored the benefits of long-acting HIV treatments for adolescents. Long-acting, injectable antiretroviral therapy has been found safe and effective in adolescents with HIV viral suppression. This study marks the first instance where adolescents with HIV have an alternative to daily pills for treatment, showcasing very encouraging outcomes. All participants in the study remained virally suppressed, and none experienced serious adverse events related to the drug regimen. This advancement is particularly significant as it addresses one of the major challenges in adolescent HIV care—adherence to daily medication. By providing a less frequent dosing schedule, long-acting treatments can significantly ease the treatment burden on young patients and their families.

Community-Engaged Research and Future Directions

These groundbreaking advancements in HIV research and treatment are increasingly being achieved thanks to community-engaged research. This approach not only enriches the research process but ensures that the outcomes are more aligned with the needs and realities of those most affected by HIV. Dr. LaRon Nelson's insights underscore the critical role of community involvement: "If we don’t have community voices or engaged communities, we aren’t going to be asking the right questions." This perspective highlights the indispensable value of incorporating diverse community experiences and insights into the research process, ensuring that the studies conducted are both relevant and impactful.

A prime example of the success of community-engaged research is the implementation and study of Doxy-PEP (doxycycline post-exposure prophylaxis) for the prevention of sexually transmitted infections (STIs) alongside HIV. Research and real-world application in San Francisco have demonstrated remarkable outcomes, with bacterial STIs decreasing by nearly 60% in less than a year at the San Francisco AIDS Foundation’s (SFAF) clinic. This significant reduction showcases the potential of community-engaged approaches in addressing public health challenges effectively. The collaboration between researchers, healthcare providers, and community members facilitated the rollout of Doxy-PEP, leading to substantial public health benefits.

Furthermore, the ongoing exploration of HIV vaccine research represents another frontier where community engagement is vital. As discussed in HIV.gov’s updates from CROI 2024, the development and testing of HIV vaccines are critical to the future of HIV prevention. Engaging communities in this research not only helps in designing more effective studies but also in building trust and ensuring broader acceptance and uptake of future vaccines.

Conclusion

CROI 2024 showcased significant progress in HIV research, highlighting innovations in long-acting treatments, prevention strategies, and care for co-occurring conditions and pediatric HIV. These advancements signal a shift towards more effective, less burdensome HIV management, tailored to meet diverse needs. They not only aim to improve the lives of millions living with HIV but also to significantly reduce new infections.

These developments are the culmination of years of research, collaboration, and community engagement, emphasizing the crucial role of community-involved research in addressing the real needs and voices of those affected by HIV.

To fully leverage these breakthroughs, continued research investment and stronger community partnerships are vital. We're at the cusp of a new era in HIV care, characterized by innovative treatments and comprehensive prevention efforts, all geared towards improving the lives of those living with or at risk for HIV. While these innovations are welcomed, necessary, and exciting, we must also recognize the policy landscape that affects access to care. In order to End the Epidemic, we must ensure consistent, open, equal access to individualized care and medications.

Payer-Denied PrEP Fails Black Women and Marginalized Communities

In the battle against HIV, Pre-exposure Prophylaxis (PrEP) stands out as a transformative defense, significantly lowering infection risks for those most vulnerable. However, this critical protection remains alarmingly out of reach for many, especially Black women, due to insurance payers' denial of coverage. This systemic neglect transcends a mere healthcare gap; it's a stark reflection of the health disparities that exist in the United States’ healthcare construct.

Recent findings from IDWeek 2023, led by Li Tao, MD, PhD, confirm: obstacles to PrEP, particularly insurance denials, are directly linked to rising HIV diagnoses. The research, spanning January 2019 to February 2023, exposes a distressing reality where people with rejected PrEP claims encountered a 95% higher likelihood of new HIV diagnoses compared to recipients of the medication.

Moreover, delays in PrEP dispensing due to these denials correlated with approximately a 20% increased HIV contraction risk, emphasizing the urgency of immediate PrEP access. This isn't just a postponement; it's a life-threatening denial disproportionately affecting marginalized communities. The study highlights the necessity of prompt PrEP access to prevent new HIV infections, especially for those with rejected or abandoned claims.

Further analysis showed the lowest HIV diagnoses among cisgender men with dispensed claims, contrasting with the highest rates among transgender women and men with abandoned claims. Individuals with sexually transmitted infections in the rejected or abandoned groups also faced elevated HIV diagnosis rates.

These insights "emphasize the dire need to eliminate PrEP access barriers to halt HIV transmission," the researchers concluded.

Empowering People: The Psychological Benefits of PrEP

PrEP's impact extends beyond physical health, offering significant psychological relief. A recent study in Pharmacy Times illustrated that PrEP usage enhances the confidence of people in having safer sex, reducing HIV transmission anxiety. This security is crucial, especially for communities burdened by the constant dread of HIV. It represents not just a medical breakthrough but an empowerment tool, allowing people to regain control over their sexual health without looming HIV fears.

The study, conducted over 96 weeks, encompassed participants from various backgrounds, including men who have sex with men, transgender women, and cisgender women. It found that those on PrEP experienced less anxiety and more comfort during sexual activities, confident in their reduced HIV risk. This mental health benefit was consistent across all groups, highlighting PrEP's universal advantage beyond its physical protective effect.

"PrEP is more than a medical solution; it's a source of hope and assurance for those at elevated risk of HIV," the researchers noted. They suggested that this confidence might encourage adherence to the medication, strengthening prevention efforts.

However, when such empowering medical solutions are restricted, it doesn't just withhold a health service; it robs people of the mental peace that accompanies protection. This added psychological strain compounds the systemic injustices that marginalized communities endure, deepening disparities.

Global Perspectives on HIV Prevention

While the U.S. struggles with healthcare inequities, other countries are advancing in the HIV fight. For example, Australia has made significant strides by implementing a comprehensive HIV prevention approach. A pioneering study in The Lancet HIV demonstrated that integrating HIV treatment-as-prevention (TasP) with PrEP significantly reduced new HIV cases among gay, bisexual, and other men who have sex with men (GBM).

This extensive research in New South Wales and Victoria, Australia's most populous states, indicated a substantial rise in the population prevalence of viral suppression, accompanied by a corresponding decline in HIV incidence. The findings advocate for continuous investment in holistic HIV prevention strategies, suggesting that even slight enhancements in treatment and prevention access and adherence can drastically reduce new HIV cases.

However, Australia's success highlights a stark contrast in healthcare access and strategy in the U.S., especially impacting Black women and marginalized communities. The effectiveness of Australia's model stems from its inclusivity, guaranteeing extensive coverage and straightforward access to diagnostic and treatment services. This strategy encompasses not just broad PrEP availability but also a robust focus on TasP, ensuring a high treatment rate among those diagnosed with HIV, thereby lowering their viral load and transmission risk.

In contrast, the U.S. healthcare system's piecemeal strategy, characterized by payer denial for PrEP and other preventive measures, hampers these all-encompassing prevention methods. A Health Affairs study unveiled severe disparities in PrEP access and costs. In 2018, populations such as gay, bisexual, and same gender loving men (GBM), heterosexual women and men, and people who inject drugs encountered the most significant financial barriers. Insurance plays a crucial role in healthcare access, yet it's grossly inadequate regarding PrEP coverage. According to a 2022 study, numerous people encountered administrative barriers, including outright PrEP claim denials. These systemic shortcomings resulted in uncovered costs totaling an astonishing $102.4 million annually, a financial burden that individuals had to shoulder in 2018 alone.

These uncovered costs represent tangible hurdles, keeping potentially life-saving medication inaccessible for many at-risk individuals. The systemic obstacles that Black women face, as outlined in a KFF Health News report, emphasize the grave repercussions of this neglect. Economic challenges, healthcare exclusion, and biased marketing strategies limit PrEP access, leaving this community exposed and overlooked.

The current state demands an immediate reassessment of the U.S. HIV prevention strategy. It's not solely about PrEP accessibility; it's about a comprehensive approach that encompasses effective treatment for people living with HIV/AIDS (PLWHA). This strategy involves not just advocating for PrEP insurance coverage but also pushing for extensive healthcare reforms that guarantee all-encompassing coverage, including TasP methods.

Australia's success story provides clear evidence: with the proper dedication and strategic approach, we can substantially lower new HIV transmissions and work towards eradicating the HIV epidemic. However, this achievement requires a collective resolve to seek a healthcare system that serves everyone, not just a privileged minority.

It's time to hold payers and policymakers responsible, to shame them for their role in a system that continues racial and socioeconomic health disparities. Their inaction costs more than money; it costs lives. The U.S. must learn from global success stories and adopt an inclusive, comprehensive HIV prevention strategy that recognizes and caters to the unique needs of all communities, including Black women and other marginalized groups.

The Plight of Black Women

The situation becomes even more tragic when we consider Black women's struggles, especially those identifying as cisgender. Despite bearing a disproportionate burden of the HIV epidemic, Black women face numerous systemic barriers, from healthcare alienation and biased marketing to economic hardships, all limiting their PrEP access, as detailed in a KFF Health News report.

One personal story, that of Alexis Perkins as featured in a PBS NewsHour article, illustrates these challenges. Perkins, a 25-year-old nurse, encountered difficulties in obtaining PrEP despite her proactive health efforts. During her visit to her OB-GYN’s office, Perkins sought a prescription for PrEP but encountered several obstacles. The medical assistant who initially greeted her was not only unfamiliar with PrEP but was uncomfortable discussing it. Furthermore, her provider, though aware of PrEP, did not feel confident prescribing it due to a lack of sufficient knowledge about the medication. Her experience reflects a broader systemic problem where healthcare providers often lack PrEP knowledge or are reluctant to prescribe it, failing to meet Black women's health requirements. "It's not something that's being marketed to us," Perkins expressed in the article, indicating the absence of information directed at Black women.

These systemic barriers extend beyond mere neglect; they inflict direct harm. The research points out exclusionary marketing tactics, where PrEP promotional efforts frequently miss Black women, resulting in misunderstandings and unawareness about PrEP's relevance to their lives. This issue is aggravated by the gender disparity in FDA-approved PrEP medications' accessibility, with some treatments tested solely on male participants, restricting their use for women.

While manufacturers have begun addressing these disparities in marketing materials and clinical trial design for emerging therapies, stigma, radical judicial activism, and lack of strengthened or continued investment in public health all threaten our ability to meet our goals in Ending the HIV Epidemic.

Economic barriers, more common among Black communities, exacerbate these challenges, making consistent PrEP usage difficult. The necessity for regular medical appointments and HIV testing, along with high initiation costs and logistical hurdles, presents significant obstacles. As the PBS article elaborates, these economic and logistical barriers, particularly for those in poverty, are daunting and often insurmountable, barring Black women from the healthcare they deserve.

Addressing this healthcare inequality demands a comprehensive strategy. Economic and social empowerment, community-focused health campaigns, and policy and research initiatives are essential. Improving access to quality employment, healthcare, and stable housing can empower Black women to make informed health decisions. Customized health messaging and community dialogues, as well as policy and research efforts like those by the Centers for Disease Control and Prevention (CDC) and Gilead Sciences, are vital steps toward closing these gaps.

Alexis Perkins' story is not unique; it reflects the experiences of many individuals navigating a healthcare system that consistently fails them. As we face these harsh truths, we must acknowledge that this crisis goes beyond medicine; it's a moral issue. The barriers preventing access to PrEP for the most at-risk communities are not mere oversights; they are expressions of a societal hierarchy that deems certain lives less worthy.

This is more than a health disparity; it's a measure of our societal values. Will we maintain a system that actively undermines the health and futures of its most vulnerable? Or do we possess the collective bravery to demand change?

Change is achievable; it's been proven. Nations like Australia have adopted inclusive, forward-thinking, and compassionate public health policies, dramatically reducing HIV transmission and new diagnoses. Their methods show that with sufficient commitment, we can revolutionize healthcare delivery.

Reflecting on the stories of people like Alexis Perkins, let's contemplate our role in this narrative. Will we be passive observers in a system that discriminates and excludes, or will we become advocates, championing a future where healthcare is a right, not a privilege determined by socioeconomic status? The decision is ours, and it's one we must make now. Because with every moment we delay, every moment we choose inaction, we become silent co-conspirators in a system that tallies casualties instead of champions. In a country that boasts freedom and justice for all, how long will we allow these injustices to determine who gets to live, prosper, and contribute to our society?

Stigma: ‘The PrEP Penalty’

Since the beginning of the HIV Epidemic in the United States, advocates have worked to combat HIV-related stigma, and the populations most affected by it. That stigma, in no small part, originates from the messaging and official positions from the country’s foremost public health institutions and the government itself. Starting with the Reagan Administration’s labeling of affected communities under four specific categories, now referred to as the “4-H Club” (homosexuals, hemophiliacs, Haitians, and heroin users), some of those perpetuated by the Clinton and W. Bush Administrations, eased under the Obama Administration, and weaponized by the Trump Administration. Despite each of these past leadership regimes coordinating programing and funding to address the domestic HIV epidemic, they have all participated in certain furthering in stigma by policy, position, or language.

In response, advocates have largely targeted efforts to address social attitudes, with some effort to address policy issues which might define that stigma. One of the challenges of addressing stigma is appropriately defining the real-life experiences of people living with HIV and where, having been diagnosed with HIV, that stigma influences institutional assumptions and wherein power is exercised to affect a person’s life. Much advocacy combating stigma has been focused on modernizing state HIV criminalization laws. Advocates can and should be thinking more broadly, and specifically, around other areas in which people living with and at risk of acquiring HIV might be affected.

In February 2021, this blog published a piece defining that stigma in terms of family courts and child welfare systems and where advocates might find themselves involved in policy work to better protect families affected by HIV from adverse rulings or actions involved in custody and child welfare matters. This is but one example of where specific advocacy, leveraging existing protections, can and does dramatically affect the lives of people living with HIV for the better. Additional advocacy is necessary, including pressure on professional standards, continuing education, and licensing organizations to eliminate stigma and protect people living with HIV interacting with these systems. For example, what might it look like for the American Bar Association to promulgate ethics rules or specifically define that mentioning someone’s HIV status (or gender identity) in a child custody hearing is a breach of professional ethics worth sanctioning? In 1992, the Association of Family and Conciliation Courts warned of high-conflict parents trying to incite biases and assumptions of family court judges with making claims around their ex’s HIV status. These professional associations and those like them have incredible sway and should be realized as an opportunity for advocates to identify new allies.

One tool analyzing these concepts of stigma, and as a result identifying areas of opportunity for advocates to combat same, comes from Doron Dorfman, a law professor at Seton Hall University. In Dorfman’s paper, published in March 2021, The PrEP Penalty, the professor examines how stigma is institutionalized by various agents and agencies of the government as well as the attitudes (and stereotypes) behind the qualifiers of stigma. I got the chance to speak to Professor Dorfman on Thursday, March 30. It just so happened that morning, Judge Reed O’Connor issued a judgment in Braidwood v. Becerra which would gut the Affordable Care Act’s mandate for coverage of pre-exposure prophylaxis (PrEP) with no cost-sharing.

“If you look at the ruling itself, you can see clearly this isn’t about PrEP, per se, but about how O’Connor and the plaintiffs view PrEP as something that ‘encourages homosexuality’,” Professor Dorfman said, speaking to core of what drives stigmatization of PrEP. Recounting initial insurer refusal to cover PrEP and continued problems in ensuring payers are covering both the medication and related, required laboratory screenings for PrEP maintenance, Professor Dorfman argued these positions really center on a ”de-medicalization” of HIV prevention. This concept removes the nature of preventative tools as a medical necessity and conflates engaging protective measures with “enabling” “risk taking” or that patients are engaged in “risk compensation” – compensating behavior to mitigate negative health outcomes while still engaging in activities which are moralized as “undesirable”. Indeed, in his ruling, O’Connor ruled the Religious Freedom Restoration Act claims had standing and were legitimate because the plaintiffs argued providing insurance with PrEP coverage “facilitates and encourages homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman.” This argument failed to recognize that HIV can and does pose a risk between married, heterosexual, sero-discordant couples. O’Connor also flatly rejected that the government has a “substantial interest” in preventing new HIV transmissions – or the public health argument. The fact that the government has an interest in preventing new transmissions of an infectious disease of any kind is indisputable and this end of O’Connor’s judgment is likely the weakest of an already weak ruling.

Instead, Professor Dorfman says that patients utilizing PrEP should be appreciate for assessing a risk and working to mitigate the potential negative outcomes. Penalizing PrEP engagement due to these rather naked biases creates a “chilling effect”, discouraging people and whole communities from seeking out necessary medical care. Dorfman compared this to the anti-gay stigma around prostate and colon screenings, wherein heterosexual, cis gender men might avoid seeking out recommended screenings because “getting something put up my butt makes me gay”.

These stigmatizing attitudes and stereotyping are universal around “sexually charged preventative measures”; we see it when people are charged for solicitation as a prostitute because they carried condoms on them, around access to the morning after pill and abortion, and certainly we’ve seen these attitudes around the human papilloma virus vaccine. These attitudes are so pervasive that providers sometimes refuse to prescribe PrEP and, when they are, they may find themselves avoiding doing so for patients in their teens for fear of a parent acting out as a result.

While the Americans with Disability Act 9ADA) and related guidance and rulings have offered some protection for people living with HIV, those protections are not offered to people utilizing PrEP – but they could be, with some creative thinking, in part, because the ADA protects people from stereotypes related to an “assumed” disability. If a situation arose where PrEP use was specifically assumed to mean someone is likely to develop or already has an HIV diagnosis, the ADA protects patients from harmful stereotyping. But that would be extraordinarily specific. Instead of trying to make that stretch, Professor Dorfman thinks seeking out state or federal legislation which prohibits medical discrimination more broadly than disability status could be useful. Similarly, guidance and policies which apply a personalized assessment of risk, tied with scientifically accurate information may also be useful. For example, a personalized assessment in evaluating people for blood donation, rather than a categorical (though, now more limited) ban might create a sense of equity between potential donors and address some of the stigmatizing assumptions that come from the policy.

Professor Dorman has another, forthcoming paper, Penalizing Prevention, which includes case studies – one wherein a parent’s engagement with PrEP was one factor used against them in a child custody matter – that assesses how preventative care is adversely treated by various institutions.

Advocates should consider what it means to define “stigma” and evaluate what comes next. Such as, what are potential policy answers as well as identifying private, professional organizations with power to influence the persons exercising those biases as potential partners in addressing HIV stigma. Invested policymakers should consider a variety of ways, including legislation, regulatory guidance or rulemaking, and requirements attached to grants as a means of combating stigma and promoting a more robust public health landscape. Lastly, funders should consider what it means to have an active and effective strategy for addressing stigma beyond “education” - which of your grantees and partners are getting creative in changing our environment for good? More specifically defining stigma allows us to identify ways in which to address that stigma and make tangible improvements in people’s lives and we should not shy away from exploring these potentials.

Analysis: Biden’s Budget Request Emphasizes HIV, HCV Goals

On March 9th, President Joe Biden released his proposed budget. As with all Presidents, in all years, and in all sorts of political climates, it outlines what can generously be called a “wish list”. Rarely, even under unified control of the government, does a President’s budget request get a full match. Most often, the budget Congress passes and the budget a President proposes are dramatically different. In 2022 (and in decades past), Biden attributed a quote to his father: “Don’t tell me what you value. Show me your budget – and I’ll show you what you value.” To that end, Biden’s budget proposal has a few notable areas of interest with regard to HIV, hepatitis C, public health in general, and with regard to priorities that might affect various stakeholders along the chain from manufacturing medications to patients.

In a call to advocates, just prior to the full court press release of the President’s budget, White House staff touted a proposed expansion of the Inflation Reduction Act’s (IRA) drug price negotiation provisions to include more medications up for government control of list prices as part of a “savings” counterbalance to expenditures in the proposed budget. It’s important to note no specific medications have yet been proposed under the IRA, any proposed “savings” the government expects to see have not been tested, and, yet again, these potential “savings” are not required to be passed down to patients or even back to the government as a public sponsor of affected plans. Similarly, on the call, officials said the proposed budget would stop “subsidizing” pharmaceutical manufacturers and, immediately thereafter, stated a priority in the budget would be to incentivize innovation as part of the administration’s “Cancer Moonshot”.

There are several HIV-related provisions in the budget request as well. First up, the proposal seeks to expand funding for the Ending the HIV Epidemic initiative started under the previous administration by about $313 million. These dollars would be bolstered by a $90 million increase for HIV prevention activities at the Centers for Disease Control and Prevention (CDC) and a $15 million increase for associated CDC programming around pre-exposure prophylaxis (PrEP) for the prevention of HIV. Notably, these same funds are a portion of dollars Tennessee will be rejecting later this year. Right along with these increases, Biden’s budget seeks to increase Ryan White HIV/AIDS Program funding by $125 million in order to better ensure those already living with HIV have better access to care and treatment.

One of the crowning jewels of the request includes funding for a national PrEP program to the tune of $9.7 billion over 10 years. That particular request may get passed and have some funding, but it is not likely to be funded at this level…or anywhere near sufficiently to meet the need. As it stands, relatively few people who would benefit from PrEP are taking the medication and that number, based on preliminary data for 2022, might be falling again. Largely, PrEP is being used by white men who have sex with men, who are already highly activated, while fewer Black Women and Black men who have sex with men are accessing the medication. A national program may help on this front, but only if it’s handled correctly and carefully. To that end, the CDC has been making a concerted effort to urge primary care providers to adjust their comfort level with prescribing PrEP and having conversations with patients about their sexual activities.

The proposal, however, did not include an increase in funding for Housing Opportunities for People with AIDS (HOPWA), a particular priority of advocates.

Biden’s proposal also includes an increase in funding for the Indian Health Service to better address HIV and Hepatitis C by about $5 million.

In line with these efforts, the Administration unveiled the financial cost of a national Hepatitis Elimination Program (HEP): $11 billion (over 10 years). Now, effort has been in the works for a while, benefitting from a boost of interest from advisor Francis Collins. Biden’s team is already working hard blunt the shock of the request, arguing that making the investment now would, in that same timeframe, actually only amount to about $5.2 billion, thanks to savings realized by a reduction of costs associated with treating long-term impacts of Hepatitis C, including certain cancers. The program would aim to save 100,000 lives by 2050, if goals are achieved.

Of these ideas, HEP likely has the best chance of getting closer to its goal (though, not nearly as close as the Administration or advocates might like), in part, because the idea is largely modeled after cost savings realized in Louisiana and Washington after implementing a “subscription” model of drug purchasing for public programs. While these programs have indeed saved monies for those states, and would do so for the country at large, and increased the number of people accessing curative direct acting agents, they have also stagnated in reaching their goals. That lack of progress after making a giant leap can be attributed to several factors, of which both Ending the HIV Epidemic and a national Hepatitis Elimination Program will face.

Let’s break those factors down real quick by highlighting the Hepatitis C program, which focuses on medication cost and access among at-risk communities near exclusively.

A report from the CDC released last year found just 1 in 3 insured patients who need access to curative treatment for Hepatitis C received it. These are patients whose coverage is already guaranteed. Barriers included payer administrative burdens, including prior authorization requirements, and, likely most importantly, providers just not…providing; not screening, not referring patients for diagnostic testing, not prescribing curative medications for patients (hoping the virus will clear on its own), and not following up to ensure sustained virologic response. And that’s for well connected and engaged patients. Hepatitis C thrives among populations which are routinely hardly reached – people who use drugs, poorer populations, imprisoned people, persons experiencing homelessness, a whole host of folks who need a whole awful lot of help. While the Administration’s proposals would look at encouraging using local pharmacies as points of access and investing in innovative screening tools, like rapid tests, none of those things speak to identifying and treating people most affected by Hepatitis C and HIV. And none of those things would incentivize private providers to increase their frequency of screening for and treating Hepatitis C and HIV.

These lofty goals are admirable. And frankly, they’re achievable. We would also need these tools already mentioned, certainly. But without baseline investments in making HIV and Hepatitis C screening a standard of care, a mandatory inclusion in annual wellness checks, requiring prisons and jails to screen, report to state health departments, and provide curative care on both intake and release, without ensuring clinics are sufficiently funded to have staff to do street outreach, we’re gonna keep missing the mark. Reaching communities that are hardly reached means spending more money per patient in order to reach each patient, not less.

So yes, this is a great start. Yes, these investments need to be made. Yes, this is a great starting point. No, it’s not enough.

Advocates would be well-served to fine tune messaging that thanks allies in power for supporting these tools while also emphasizing that we haven’t yet used all of the tools still in our toolbox. We need to continually re-invest in the foundation of this work while also growing and innovating. Medication is but one tool and without the support for patients to even get to a provider who is willing to screen and treat them, all the medication in the world won’t help.

We need to invest in our own “Yes, and…show me your values…” as we meet with each other, our partners, law makers, policy makers, and the Administration.

Special Interests Favor S.4395, but Patients Oppose It...Here's Why

This blog post is a collaborative piece, co-written by Brandon M. Macsata, CEO of ADAP Advocacy Association, and Jen Laws, CEO of Community Access National Network.

The very first words of the Ryan White HIV/AIDS Treatment Extension Act of 2009 read, “An Act to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS.” These words reflect the true legislative intent of the Act, which is to provide life-saving care and treatment for people with HIV/AIDS (PLWHA). For over thirty years, these words have represented a contract between our government and PLWHA, reflecting a commitment to patients. The Ryan White HIV/AIDS Program (RWHAP), as the payor of last resort, has literally served as the only lifeline for hundreds of thousands of patients in some of the most marginalized communities. That is why the ADAP Advocacy Association and the Community Access National Network (CANN) have led a national advocacy campaign to thwart any effort to undermine the legislative intent.

A proposed bill, S.4395 (otherwise known as the "Ryan White PrEP Availability Act"), would, for the first time in the 32-year history of this life-saving contract, open the Act to divert programmatic funding from PLWHA to people who are not living with HIV. The legislation is not only ill-conceived, it is potentially very dangerous. The special interests behind this legislation, as well as their inside-the-beltway lobbying tactics, do not reflect the general sense of the much broader HIV patient advocacy community. 

In fact, nearly 100 national, state, and local organizations joined the ADAP Advocacy Association and Community Access National Network in submitting a sign-on letter to Congress expressing the HIV patient advocacy community's collective concerns over the legislation. The sign-on letter was sent to Chair and Ranking Member of the Senate Committee on Health, Education, Labor & Pensions (HELP), Chair and Ranking Member of the House Committee on Energy & Commerce (E&C), and the Co-Chairs of the Congressional HIV/AIDS Caucus. Several of these offices applauded our efforts upon acknowledging receipt of the letter.

David Pable, who has been deeply embedded in South Carolina's patient advocacy community, expressed strong sentiments against the legislation. Pable said, "For almost 20 years, Ryan White has been a lifeline for me, and it was truly the safety net that saved my life. Ryan White-funded medical care, case management, and mental healthcare services have transform my life and the lives of countless others to survive and thrive." Pable's views are shared by nearly all PLWHA who learn about the potential danger lurking behind S.4395.

Over the years, Pable had the opportunity to be involved in many planning meetings for prevention services, including the need for an adequate PrEP program with dedicated funding. According to Pable, never in any of those meetings was it discussed as a good idea to funnel funding from the Ryan White Program to pay for PrEP. "Treatment, care and prevention make up three sides of the triangle," he said. "Together they each hold up the other, but take one piece away to support the other and eventually it will all fall apart." 

S.4395 would authorize the Health Resources & Services Administration (HRSA) to divert already limited resources away from providing care and treatment for PLWHA. The legislation reads, in part, "Any eligible area, State, or public or private nonprofit entity that receives a grant under part A, B, C, or D may use program income received from such a grant to provide to individuals who are at risk of acquiring HIV... drugs and biological products for pre-exposure prophylaxis (PrEP)... medical, laboratory, and counseling services related to such drugs and biological products...and referrals and linkages to appropriate services for the prevention of HIV."

The legislation is extremely ill-advised for numerous reasons. Amending the Ryan White Program (Pub.L. 101-381) would:

• Open-up the law, (which is currently unauthorized) and thus subject it to potentially harmful changes in a hyper-partisan political environment.

• Change the purpose of the law, in that the purpose of the Ryan White Program is serving people living with HIV/AIDS.

• Create yet another access barrier for the approximately 400,000 PLWHA who are not in care.

• Further isolate PLWHA who are already disproportionally impacted by homelessness, hunger, substance use disorder, and undiagnosed and/or untreated mental health conditions.

• Impede Ending the HIV Epidemic's efforts to both increase enrollment and expand services for low-income PLWHA, especially since discretionary funding is already limited.

Unfortunately, special interests continue to push false narratives in their efforts to shove the harmful legislation through the Congress. Probably one of the most egregious claims, “The bill’s intent and text doesn’t take money from people living with HIV.” This is false! 

Indeed, legislative language reads, “To allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV.” While subsection “B” of the legislation entitles the program as “voluntary” and to not allow federal grant dollars for the use of funding PrEP or PrEP services, it would allow federal grant dollars to be used for referrals – explicitly providing funding for people not living with HIV.

Photo Source: oncnursingnews.com

More concerning, special interests supporting the legislation conflate programmatic revenue as not grant dollars, as a somehow meaningful distinction. There is no difference in this distinction because each funded RWHAP recipient and subrecipient is required under current law to use their programmatic revenue to support providing services included in the grant – for people living with HIV. The design of these programs are significantly dependent on revenues generated from the 340B Drug Discount Program (340B) in order to meet the goals outlined in each of the grants. 

And that gets to the heart of the issue here. 340B's intent was “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program, amid much criticism, allows federal grants funding public health programs count on 340B revenues in order to show they can operate a sustainable program.

Let's be clear: S.4395 would divert RWHAP programmatic revenues – including 340B dollars – away from providing services and supports to PLWHA who are living at or below 400% of the federal poverty level (the income threshold for qualifying as eligible for receiving RWHAP funded services). It is important to remember that more than 50% of the patients receiving care from the State AIDS Drug Assistance Program are living at or below 100% of the federal poverty level. More than 250,000 patients, or approximately one quarter of all the estimated people living with HIV in the United States are earning less than $13,000 per year. 

Kathie Hiers, President & CEO of AIDS Alabama argued, "The HIV community needs to get its act together around funding for PrEP.  We have been told by the Director of the Office of National AIDS Policy that our messaging is not cohesive. At AIDS Alabama, we understand that stable PrEP programs are absolutely necessary if we ever hope to end HIV as an epidemic. However, raiding the Ryan White Program to fund prevention is not the answer, particularly as the needs of an aging HIV-positive population continue to grow."

As it stands, gaps in care still remain for too many marginalized communities. It isn't uncommon for patients to fall out of care because they have to prioritize work, or child care, or buying food, or finding affordable housing, or finding transportation. Funding to meet the needs for these patients is already stretched way too thin and the current inflationary pressures have only made things harder for far too many PLWHA. There are tens of thousands of people living with HIV who have no roof over their heads when they try to find a safe spot to sleep tonight.

Photo Source: debralmorrison.com

Robbing Peter to pay Paul is not the solution to funding HIV prevention efforts in the United States. A better option to meet the needs of people who would benefit from PrEP, and that is additional HIV prevention funding. This approach would allow patient choice in medicines and support for ancillary services, provider education and outreach. Additionally, HIV prevention funding could be directed to communities that are most in need of prevention medicines and services, thereby providing more equitable access. This approach would also use and could strengthen the existing HIV prevention infrastructure.

One local health department official (who asked to remain anonymous) in Florida said the people behind the legislation did not understand the nuances between funding for HIV prevention and HIV treatment. We couldn't agree more!

The HIV+Hepatitis Policy Institute's Carl Schmid summarized, "It's not an issue of not wanting clinics that receive Ryan White Program funding to be engaged in PrEP, we think they are the perfect places for PrEP to be delivered. It is an issue of taking funding generated from caring and treating for people living with HIV away from the intended purpose of the Ryan White Program – to provide for people living with HIV. With so many people with HIV living longer, who are not in care or have fallen out of care, you would think that these Ryan White grantees would devote that money to people who are living with HIV, as it was intended."

With more than a decade of science to back the position that effectively treating PLWHA, ensuring viral suppression both empowers positive health outcomes for PLWHA and prevents new transmissions. One of the most startling and, frankly, concerning shifts in the public policy conversation regarding Ending the [domestic] HIV Epidemic is a move away from focusing on the needs of PLWHA in favor of PrEP. The policy issues at hand, including the necessary funding, should not be proposed as an “either/or” situation, but an “and” situation. The same things that make a person vulnerable to contracting HIV are the same things that are killing people already living with HIV. 

While the U.S. Centers for Disease Control and Prevention (CDC) 2020 Surveillance data found 70% of white PLWHA were virally suppressed, only 60% of their Black/African American peers were virally suppressed. Additionally, while the U.S. Department of Housing and Urban Development (HUD) reported a general homelessness rate across the country as about 0.2% of the population, the CDC’s 2019 data found that PLWHA among communities of color were experiencing homelessness at a rate of 11%. It cannot be understated how the power RWHAP dollars hold to address these disparities specifically affecting patients. Failing to do so not only betrays the contract at the center of the legislative intent, it perpetuates injustices levied against our peers, our family, and our community. Raiding precious dollars from this program is nothing short of consenting to the unjust neglect of our communities.

Said Murray Penner, U.S. Executive Director for Prevention Access Campaign: "The Ryan White Program is crucial for people living with HIV, providing treatment and supportive services to keep people healthy and undetectable so they will not sexually transmit HIV. With over 400,000 people living with HIV in the U.S. who are not virally suppressed, there is significant unmet need for additional services. S.4395 would move money out of the Ryan White Program, potentially leaving people without the crucial treatment and services that keep them healthy and prevent new transmissions. Ensuring that the Ryan White Program is fully funded is critical for us to improve the quality of life for people living with HIV and thus improve our country's viral suppression rate and help us end the HIV epidemic."

A cornerstone of the HIV patient advocacy community's success over the last 40 years has been its desire to come together for a common purpose, which has centered around the notion of do no harm! S.4395 and the special interests and inside-the-beltway lobbyists pushing it have failed to meet that test. Raiding Ryan White programmatic funding for PrEP would negatively impact patients. Trying to authorize or amend an already underfunded program, when there is still so much unmet need in its originally intended population, undermines the goals of the program. If we try to be everything to everyone, we will end up failing on all fronts. The powers that be in Congress have assured us that this legislation "ain't going anywhere" this year!

Access Issues Remain: Protecting and Providing PrEP

Last week, I got to tackle the intersections of medication access and the issues of abortion and transgender health care. In doing so, I brought up one of the court cases I’m watching closely (and you should be too) as the next great attack on the Affordable Care Act (ACA). Kelly v. Beccera asks courts to strike down a portion of the ACA that outlines a requirement of services, care, and medications recommended by the United States Preventative Services Task Force (USPSTF) are required to be covered, with no “cost-sharing” to beneficiaries of a health insurance policy (or at no out-of-pocket cost to patients enrolled in a covered plan). Specifically, petitioners in the case object to the requirement because USPSTF gave a “Grade A” recommendation for preexposure prophylaxis for the prevention of HIV infections (PrEP).

The recommendation, originating with the USPSTF recommendation issued in 2019, and culminating in federal guidance offered in 2021, most insurers were put on notice to begin offering coverage for PrEP and support services at no cost to patients. However, according to an analysis by HIV + Hep Policy Institute, more work needs to be done to ensure payers were complying with the requirements of the law. State and federal regulators are tasked with evaluating benefit design, ensuring compliance, and enforcement when compliance fails. However, those regulators are deeply dependent upon patients and providers to initiate complaints about their experiences in payers who refuse to cover PrEP and the associated services necessary to maintain proper program adherence at no cost to patients. Successfully getting a complaint heard is time consuming and often difficult. Some payers have taken to a tactic of blaming providers for improper coding and billing as to why claims and coverage are being denied to patients. And while the law requires coverage of PrEP, it doesn’t stop insurers from implementing utilization management tactics, like prior authorizations (PAs), in which the insurer prefers a lower-cost generic medication over a higher-cost brand name medication. PAs are a deny and delay effort from payers that generally frustrate the process of a patient accessing the medication and care the patient and their provider has already determined to be of best interest to a patient’s health.

Sometimes, PAs can be an abusive. For example, one state’s public payer program required a PA in order for a patient to receive coverage for Cabenuva (Cabenuva is the treatment sister medication to Apretude, ViiV Healthcare and Janssen Pharmaceutical’s long-acting PrEP product). In this situation, the payer required patients to both be virally suppressed and have trouble swallowing their current oral medication – a complete contradiction to the medical science of HIV treatment. In terms of preventative medications, requiring a patient to fail their current treatment would necessarily mean requiring a patient to risk acquiring HIV unnecessarily – or worse yet to actually acquire HIV, negating the value of PrEP in the first place. Despite all of the value advancing pharmaceutical products and medication modalities may offer us, payers prioritizing costs over benefits realized by patients threatens to undermine the modern gains in the fight against HIV.

This point moves from acute to near painful when considering one pillar of the Ending the HIV Epidemic effort is prevention, the Department of Health and Human Service’s Ready, Set, PrEP program, and President Biden’s push to invest nearly $10 billion into PrEP and other HIV-related programing. But between payers limiting provider networks, provider bias leaving PrEP prescription largely to specialists rather than general practitioners, and the patient costs of navigating a complex payer effort to deny coverage at every turn, our highest ideals of accessible care come to a screeching halt.

Federal and state regulators must go beyond “calling” on payers to cover PrEP and the associated provider and lab services at no cost-sharing. They must refuse to certify payers without comprehensive PrEP coverage policies and practices as managed care organizations (MCOs) for Medicaid, marketplace plans, and qualified employer sponsored plans. If the practices of a payer substantially challenges a patient or provider from accessing PrEP, they are necessarily behaving in a discriminatory fashion. Regulators could require more proactive action on the part of payers to assume eligibility for particular PrEP medications, they could also require payers to “lock-in” medications and services meeting the USPSTF recommendation requirement without ability for mid-year adjustment, particularly with regard to formulary design, they could require payers receiving federal subsidy engage in patient satisfaction surveys as a meaningful engagement of patients and reflection of patient-realized access, they could simply make the penalties for failing to adhere to the law so painful as to not engage in these tactics. Much could be done to curb payer avoidance of covering necessary preventative care and we, as advocates, should readily challenge why these changes haven’t yet been made. And we’ll still have to tackle issues of access for our uninsured peers, often living at the intersections of greatest risk, we’ll still have more work to do to overcome provider bias and social stigma.

Making sure our regulatory structures meaningfully empower and enforce our legal protections as patients is an excellent first step in that process.

How One FQHC is Advancing Health Communication

Earlier this month, new outlets got a hold of a local (to me) treasure: NoiseFilter. Local health heroes, Dr. MarkAlain Dery and Dr. Eric Griggs, have been hosting Noise Filter since the beginning of the COVID-19 pandemic as an innovative way to educate the public about pressing health issues. The show started as a podcast, moved to live streams on Facebook, and has recently found a niche in animated shorts designed to engage and entertain patients. One of the latest episodes, titled Test, Treat, Cure, focuses on explaining Hepatitis C and curative treatments.

Before we go further, you can check out other Noise Filter animated videos here and you really should. They’re fun! At a recent virtual event aimed at educating stakeholders on the issue of HIV criminalization, after reviewing the science behind Undetectable Equals Untransmittable (U=U) and other access to care issues, Dr. MarkAlain played this episode for the audience. The audience happened to include Centers for Disease Control and Prevention Division of HIV Prevention Director, Dr. Demetre Daskalakis, who may or may not have chair danced with the end of the video. They really are that exciting!

This isn’t Dr. MarkAlain’s first foray into utilizing broadcasting platforms to reach patients as audience members. In 2014, the good doctor helped found local radio station WHIV (102.3FM). Staffed by volunteer hosts and DJs and focused on issues of social justice, human rights, and community health, WHIV titles itself as “…not a radio station with a mission…a mission with a radio station.” The station’s programming digs into issues of policy, politics, faith, entertainment, and more.

Both Doc Griggs and Dr. MarkAlain and both programs are tied to one of Louisiana’s largest Federally Qualified Health Center networks, Access Health Louisiana. AHL is actively involved in the state’s health planning activities and has been one of the mobile testing providers even before the COVID-19 pandemic and was one of the state’s first at-home testing providers (for HIV screenings), positioning the entity well in terms of already having infrastructure in place to mobilize and having Doc Griggs’ astounding communications talent for breaking down complex health issues, setting patients at ease, and empowering communities to activation makes the entity accessible and flexible in meeting the needs of served communities.

In many ways, both Noise Filter and WHIV seek to speak to patients as whole people, with whole lives, living in whole communities.

We need more of that. We need more of this.

Improvements to Public Health Guidelines, Despite Covid-19

2022 is off to a roaring Covid-19 start with both mainstream news and scientific outlets focusing on variant development, diversifying vaccines, and the impacts of the pandemic on various aspects of our lives. Last year, Community Access National Network opened our blog with discussing Covid-19’s Impact on HIV, HCV, and Substance Use Disorder and the theme crawled through our public policy discussions of the last year. While the topic is likely to set the frame for all variety of public health and policy throughout 2022, there is a necessity to discuss the developments in our space in spite of the distractions COVID has to offer.

Early 2021 found the Biden administration rescinding the “axe” the previous administration gave to the so-called “X” waiver, a requirement for providers to seek specified training in order to administer buprenorphine based medication assisted treatment for patients experiencing opioid use disorder. While providers and advocates hailed eliminating the X-waiver as a move toward advancing care, reports stated administration officials found problems with the rule as written, calling it “premature”. The Department of Health and Human Services (HHS) would later update treatment guidelines by way of formal notice posted to the federal register on April 28th, expanding eligibility of providers to administer the treatment when they “intend” to treat fewer than 30 patients a year. What enforcement looks like around the word “intent will be an area to watch as this area of public policy develops.

Later in the year, the Centers for Disease Control and Prevention (CDC) updated their Sexually Transmitted Infections Treatment Guidelines, the first overhaul since 2015. While the most significant updates to the guidelines are focused on the treatment of gonorrhea, an area of focus given the bacteria’s penchant for developing resistance to treatment, other highlights include aligning the guidelines with the CDCs 2020 recommendation for universal Hepatitis C screenings and adoption of the Advisory Committee on Immunization Practices (ACIP) recommendation for Human Papilloma Virus (HPV) “catch-up” vaccination schedules for people assigned male at birth. These and other additional updates were made, in part, because the CDC’s 2021 annual report found the United States facing the 6th consecutive year of STI increases.

Among ACIP’s many accomplishments in a year that found the panel meeting nearly twice as often as usual, a November meeting overshadowed by the endorsement of recommending Covid-19 vaccines for 5-11 year olds provided also found ACIP recommending universal adult Hepatitis B vaccination.

In a similar vein to the aforementioned updates (and with much rejoicing from advocates), the White House Office of National AIDS Policy “turned the lights back on” with the appointment of Harold Phillips as Director. Mr. Phillips provided an update to the National HIV/AIDS Strategy, announced in December with a focus on acknowledging structural barriers to achieving goals, including racism, stigma, and violence against transgender women. The plan, however, does not specifically outline ways to address these particularly challenging, systemic issues. President Biden also recognized World AIDS Day with a characteristically frank review of the history this country has with HIV and AIDS and the obstacles we still face in working to Ending the HIV Epidemic.

One of the last developments of 2021 included the CDC updating its clinical practice guidelines for pre-exposure prophylaxis for the prevention of HIV (PrEP). The update shifts language in such a way to encourage providers to more openly bring up the issue of PrEP with all patients rather than solely seeking to target “high-risk” populations. This move falls in-line with the efforts to reduce PrEP stigma among the broader public and, specifically, among providers. This was a particularly exciting development in light of the Food and Drug Administration’s (FDA) approval of cabotegravir (branded as Apretude) for PrEP. The long-acting injectable was first approved for the treatment of HIV in early 2021 and poses an extraordinary advancement in the potential for medication delivery mechanisms, improving adherence, and, ultimately, advancing efforts to End the Epidemic. Of note, pharmacy benefit managers, specifically CVS, anticipated this move as much as advocates and patients have. Despite a supposed commitment to investing in health equity with regard to HIV, CVS’ own “payor solutions” site boasts of the methods the entity will use seeking to delay or deny access to this and other innovative care under the need to “balance cost” with effective or curative treatments.

Looking into the new year, HHS’ annual policy report indicates the agency will seek to strengthen protections afforded to LGBTQ patients and more appropriately define discrimination in plan design, affecting patients living with HIV and HCV.

While these changes in direction and advancements in treatment are quite thrilling, advocates should be prepared to compete for space to be heard and anticipate familiar “foes” continuing to refuse to engage or finding ways to blockade access to care. Be they based in political ideal or industry priority or even from providers, patients and advocates would be better served when those who have traditionally disfavored advancing equity and access engaged in discussions on how to find the win-win for all parties. Community Access National Network remains committed to engaging stakeholders across interests in this space and looks forward to the good-faith efforts of those who seek to move these adversarial relationships to partnerships and even friendships.