One Shot or Two? Necessity of COVID-19 Vaccination Among People Living with HIV and/or Chronic Liver Disease

At the time of this writing, the United States’ Food and Drug Administration (FDA) has provided Emergency Use Authorizations (EUAs) to 3 COVID-19 vaccines, with Novavax’s product potentially leading the race to become the fourth. While some have fretted over “which vaccine” is “the best”, governors and clinicians have resoundingly adopted a simple answer: “which ever vaccine you can get”. While President Biden has pushed to expand eligibility to all adults in the US by May 1st, as we’re all too familiar with in patient advocacy, eligibility does not necessarily equate to access and, in this respect, demand still vastly outstrips vaccine supply domestically.

The debate on who should get a vaccine and when began well before the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations in December 2020. ACIP’s recommendations focused primarily on constructing an ethical model based on hospitalizations and mortality, with an eye toward those performing duties most necessary to meet the health care demands of the moment. Ultimately, outside of this job-based prioritization, ACIP gave top priority via age-based allocation and then ascertaining those at-risk for these outcomes based on pre-existing conditions. Most states adopted some version of these prioritized populations. The debate on the efficacy of this model continues to rage on – what about those in marginalized communities more impacted by COVID-19 than more affluent communities? What about younger people with comorbidities? Which health conditions should be prioritized?

Regardless of where one’s local government falls on this debate, evidence catalogued by the CDC indicates a very real need for people living with HIV and those with chronic liver diseases to seek a vaccine as readily as possible as these cohorts are at increased risk for complications related to a COVID-19 infection. Studies have found PLWH experiencing an acute COVID-19 infection may see as much as 50% drop in CD4 T-cells compared to their historical levels, a condition known as lymphopenia – of which, is also an indicator for severe COVID-19 and protracted recovery or death. Additionally, the same study found key clinical metrics used to measure inflammation were similarly increased among PLWH. Another study out of Wuhan, examining people with chronic, yet controlled Hepatitis B infections may see a reactivation of viral activity and/or potentially face significant progression of liver cirrhosis during and after a COVID-19 diagnosis. Another study found SARS-CoV-2 may target certain cells in the bile tract and cause focused damage to the systems serving a person’s liver, with another study suggesting the need for health care providers to emphasize liver repair post COVID diagnosis.

While Janssen ensured PLWH were enrolled in phase 3 clinical trials for their product, none of the currently authorized products included solid organ transplant recipients in their trials. While the American Society of Transplantation notes COVID-19 vaccine administration recommendations for solid organ transplant recipients remains the same as other vaccines (either completed at least 2 weeks prior to transplant or initiated at least 1 month after transplant). Which may pose a problem according to a study published in March showing transplant recipients having received the first shot in the series mounted an antibody response just 17% of the time. While antibody responses are not necessary to confer immunity, they are the leading indication of an immune response. The authors of this study will be seeking to answer that question later this year.

Furthermore, additional research is needed in assessing post-acute COVID-19 infections and the implications of “long COVID”. Most research at this moment on long-COVID is tied to assessing symptom presentation and frequency of health care needs. However, there is a minor bit of information regarding organ function post-hospitalization with COVID-19 – none of it is “good news”. In particular, people experiencing chronic liver diseases were almost 2 times as likely to experience “major adverse events” after being released from the hospital due to COVID-19.

All of this information culminates with a sense of urgency some states are heeding in expanding vaccine access “ahead of schedule” to include people living with HIV or specific programming targeted to provide vaccines to these communities.

Brandon Macsata, CEO of ADAP Advocacy Association, recently penned a blog addressing any hesitancy among people living with HIV around getting their vaccines: “Vaccines are an important element of the journey, along with proven public health strategies (i.e., wearing masks, remaining social distant, washing hands). For the HIV-positive community, it is even more important for us to do our collective part to protect ourselves, as well as the people around us. Get your Covid-19 vaccine!”

With the CDC’s guidance on prioritizing our communities in vaccination schemes, I couldn’t agree more.

Novel Developments: Merck & Gilead Partner on New ARVs

On March 15th, 2021, Merck and Gilead Sciences announced a partnership in development of their novel products, Islatravir and Lenacapavir – both currently in clinical trial phases. The partnership isn’t limited to these investigative products – both, if successful, would establish new classes of antiretrovirals each. The agreement allows an option by either manufacturer to investigate potential combination therapies with the other’s already established products. Additionally, while current trials for these medications are focused on oral administration and injectable application, Merck is investigating the potential for Islatravir as PrEP via an annual implant.

Let’s take a moment to acknowledge the remarkable nature of these proposed products. Gilead’s Lenacapavir is aimed at addressing those with multidrug resistance and – here’s the kicker – with a potential to be effective for as long as 6 months via subcutaneous injections. While Merck’s Islatravir has been described as “potent”, it’s so strong that in order for it to be taken once daily, it must be “lightly sprayed” onto a doravirine tablet (the partner medication for Islatrvir in current studies). Which is great for that aim at being a once weekly therapy.

With these two potential first-in-class medications inching closer to the finish line of approval, this partnership also stands to benefit advocates in a another direct way. Merck has been an exceptionally strong advocacy partner, edging into nuanced regulatory territories and working hard to ensure patients lead those discussions and the company’s positions. Gilead is savvy in their marketing, contracting, and programming; from flashy commercials on targeted tv platforms and innovative radio campaigns to the ease in which their products become “preferred” on some formularies to providing 10-day “sample” bottles – which some providers have used to initiate same day treatment for newly diagnosed people living with HIV without ever having to leave the provider’s office.

Merck and Gilead’s partnership here is…interesting to say the least. Prior to January 19, 2021, when the Supreme Court of the United States refused to hear Merck’s appeal, these two pharmaceutical behemoths were engaged in a legal fight over patent rights to hepatitis C medications, Harvoni and Sovaldi, since 2016.

When you work in HIV and Hepatitis patient advocacy, these kinds of things are our soap operas in their own way. We love our contacts within these companies and often share a great deal of our personal lives with them. That type of relationship is tinged, like most familial relationships, when we have conflicts of interest with our friends – where our priorities diverge from those of the corporation’s. The issue of patents and anti-competitive contracting are some of these hot button issues. All of that said, despite the faux-shock theatrics some advocates have used to enjoy the spotlight, our friends in pharmaceutical manufacturing are also some of the strongest supporters of our work (read: the largest share of corporate funding supporting advocacy).

Thankfully, the vast majority of these relationships are dynamic. Advocates enjoy space to call-out practices we find detrimental, direct funding to programs and priorities in alignment with our values, and provide feedback on nuanced areas like clinical designs and regulatory structures. One might say our greatest allies pay us to argue with them. And there’s good logic to such a scheme; a team grows stronger when the weaknesses are evaluated, addressed, and turned into strengths.

Indeed, this partnership, with its expansive nature to include development, manufacturing, and marketing, holds both great promise and great concern for our communities. Gilead is already learning from its failure with Descovy trials to include people assigned female at birth (AFAB) – including cisgender women in clinical trials for Lenacapavir as a long acting injectable (for both treatment and prevention) to begin later this year; though Gilead should note: “people of trans experience” won’t all fit neatly into the clinical trial including cisgender men. To be fair, Merck’s Gardasil commercials still refer to “males and females” rather than the simpler “everyone”.

Sincerely, the trans guy writing this blog.

Taken as a whole, this team poses the potential to be “The Dream Team” in both treatment and prevention and as partners to advocates. We’ll need to see the best of them, not the worst and we’ll need to keep a close eye on how those relationships we’ve come to rely upon may change in light of this new partnership.

In the meantime, (I’m going to say this for the first time a year with a humorous intent rather than a morbid one) pass the popcorn. This season is going to be fantastic!

Covid-19: How Far We’ve Come & How Far We Have to Go

Unraveling a tangle of yarn can be maddening. Pull here, threads get tighter. Pull there, you’ve created another knot. Now, imagine having to weave with the same tangle – “undo” a well-organized mess and make it something functional, beautiful even. The fragile public health system in United States during the Covid-19 pandemic is much like that tangled yarn.

This dual task is very much an oversimplified explanation of where the American health care landscape exists in this moment. Like most collective traumas, this stage isn’t the “undoing” stage, it’s the stop the damage stage. In writing the first blog of the year, tracking site Worldometers reported 20 million confirmed COVID-19 cases in the United states and about 345,000 COVID-19 deaths. As of the time of this writing, the same site is reporting more than 30 million confirmed COVID-19 cases in the US and about 550,000 COVID-19 deaths. Daily case counts continue to remain high at around 50 thousand confirmed cases a day and around 1,100 deaths per day on average. While the introduction of 3 vaccine products has brought hope and another tool to our COVID toolkit, and daily new cases and deaths are far below their height, the pandemic still rages on.

Which is…concerning for the entirety of the health care spectrum and especially so for those spaces that have been historically underserved or needing additional protection or funding. From the Centers for Disease Control report at the Conference on Retroviruses and Opportunistic Infections (CROI) the United States performed at least 700,000 fewer HIV screenings and 5,000 fewer new diagnoses in the first 6 months of the pandemic (compared to the same time in 2019) to the extraordinary implications of COVID among vulnerable populations to Senators Grassley and Klobuchar introducing legislation to allow drug importation (despite very clear warnings about why this is not a great idea) to the Biden Administration issuing a formal disapproval of Medicaid work requirements, to say information is coming at “break neck speed” may well be as much of an understatement as a tangled ball of yarn.

With an emerging “surveillance gap” for both HIV and HCV, a startling HIV outbreak in West Virginia, overdoses increasing as a result of COVID, some of greatest tools gained in combating this pandemic, even those advocated for by the CDC, have already started to go away as states begin to “open up”. Indeed, Congress has already begun taking up old questions regarding telehealth restrictions and payment systems designs, this time with an eye for permanency.

While President Joseph R. Biden’s American Rescue Plan, recently passed by Congress and signed into law, offers a great deal of funding to address the needs of certain entities and programs to tackle COVID and even offers the most meaningful adjustments to the Affordable Care Act by expanding subsidies, the existing needs of the health care ecosystem have largely been neglected for the last year. Well…far longer…but I digress. Like any trauma, our need to strengthen patient protections and access, incentivize quality of care over quantity of services, and meaningfully reduce health disparities have been the ends of thread tightening around the knot of COVID. This pandemic did not create these disparities and the needs outlined above – but not having a plan for a pandemic, not addressing structural inequities and these burning policy needs with the urgency they so deserve absolutely made us more vulnerable to the most devastating impacts of any pandemic.

This isn’t “the end”, certainly. For advocates, this has always been our “normal”. We need those who have hung on our every word and insight through this emergency to stay at the table – we’re not done yet. Everything you were outraged by (and may still be enraged by thanks to vaccine access scarcity) remains and will continue to loom just over our shoulders, waiting to be exploited by an opportunistic disaster.

Indeed, the ghost of Scott County may well continue to haunt us for some time to come. This is, after all, a very big ball of very tangled yarn.

What About Us? Reflections on What the Global Covid-19 Vaccine Means to HIV

A year ago, the world turned its eyes to a justifiably disparate race to find any possible treatment, cure, or prophylactic for COVID-19. The collective experience was familiar to veterans of the fight against HIV – though, for some, the feeling was tinged with dulling hope and cynicism. Afterall, the first HIV vaccine trial began in 1987. A near 35 years later and we’ve yet to find an effective and safe protective vaccine.

The COVID-19 effort spurred extraordinary and sometimes bizarre theories, with journalists soaking up non-peer-reviewed pre-prints with the abandon of a starving person. From theories on hormone replacement therapies to reduce blood clotting risks to the now-infamous hydroxychloroquine episodes to convalescent plasma to repurposing our own antiretroviral therapies, many, if not most, of these failed the test of time. Something HIV advocates and researchers are all too familiar with. As a result of the pressure and need, the Trump Administration initiated one of the largest scale federal research funding initiatives in history: Operation Warp Speed, promising to deliver a vaccine for the novel coronavirus in record time.

The resulting skepticism was understandable. Previously, the fastest any modern vaccine had been developed was about 5 years, with the current mumps vaccine. The difference this time, though, was vaccine tools that had failed elsewhere, in the fights against cancer, Ebola, and other diseases, had provided us the opportunity to “practice” for such an incident – expanding the unused tools in the toolbox as it were. Included among these was a near 50 year old theoretical approach, using messenger RNA to teach our bodies how to fight this new pathogen. Moderna and Pfizer did indeed produce such a product in December 2020.

While the world praised these developments, HIV also took an exception to the announcements. We’ve been waiting nearly 40 years for the same technological miracle. With more than 75 million known transmissions, approximately 32 million having died from AIDS related complications, and 38 million people currently living with HIV, since the start of our pandemic, it’s understandable to ask “what about us?” Where was this “warp speed” effort in 1995 when AIDS was the leading cause of death among 25-44 year-olds in the United States?

It’s important to note: coronaviruses and HIV are two very different types of viruses. Coronaviruses maintain a greater integrity in their reproduction processes and HIV’s “copy writers” are known for making “mistakes”, developing mutations and resistance to medications. As such, coronaviruses “mutate” at a much slower rate than HIV. Despite the very warranted concerns on SARS-CoV-2 variants, most vaccine products coming to market are showing promise in beating back these emerging threats. Whereas HIV is also known to “hide” viral reservoirs within a person’s body – merely waiting to be activated, thwarting certain progress.

Still, technology moves forward and hope springs eternal. Moderna has already announced intentions to use mRNA vaccine technology to produce more accurate vaccines for influenza, personalized vaccines for certain cancers, and HIV. Scribbs Research has also recently announced a phase I trial utilizing “germline targeting” technology to stimulate the exact B-cell responses for a body to develop HIV neutralizing anti-bodies.
Additionally, in a remarkable find, Abbott has recently identified an extraordinary occurrence of elite controllers, those with HIV antibodies but no or undetectable viral load without the use of antiretroviral therapies, in the Democratic Republic of Congo (DRC). With a prevalence of 2.7-4.3%, as opposed to 0.1-0.2% elsewhere in the world, researchers believe this population provides us an opportunity to investigate what is essentially a natural occurring immunity to HIV, something medicine doesn’t currently understand well enough to replicate. Abbott was able to identify this population through surveillance activities, as its screening tools are used in about 60% of the world’s blood supply donations, where information gathered is also used to identify emerging diseases – in particular “new” strains of HIV and viral hepatitis. Abbott’s findings state this occurrence of elite controllers is extends as far back as 1987, prior to the advent of antiretroviral therapies, at “similarly elevated levels”.

Regardless of the promise (read: hope) of a protective or therapeutic vaccine for HIV, any effective product is bound to face the same persistent issues of equity COVID vaccines are currently facing. From trial design by and inclusion of the most affected communities to equitable distribution outside of western countries, we absolutely run the risk of perpetuating existing global health disparities. Manufacturers, governments, and researchers will need to better align their actions with our moral and ethical obligations in order to truly end HIV for all, instead of just some.

Painting Roses in the Desert: Despite Medicaid Expansion, Gaps Remain in Arizona

[Editor’s Note: This blog is, in part, a replication of a blog hosted by the ADAP Advocacy Association. Supplementary policy analysis on hepatitis treatments continues in this blog]

It shouldn’t be a surprise to anyone that many AIDS Drug Assistance Program advocates are in favor of Medicaid expansion. Indeed, as noted here, those same advocates view Medicaid expansion as an opportunity to strengthen health care access for the most vulnerable people living with HIV, meet needs unaddressed by a state’s ADAP coverage, and help ADAPs remain financially stable. For ambitious advocates (I’m talking about myself), when sufficient support exists to support those at or below the expanded Medicaid eligibility threshold of 138% of the federal poverty level, state ADAPs could consider expanding income eligibility above 400% of the federal poverty level. Indeed, Louisiana is one such state.

However, like all health care policy, the details matter.

In Arizona, the state’s Medicaid formulary is restrictive and slow to adapt to the needs of qualified people living with HIV, shifting financial pressure to the state’s ADAP and requiring the most impoverished clients to manage interacting programs in order to achieve coverage of certain medications. As the payer of last resort, when ADAP clients have other coverage (ie. Medicaid), conflicting payment processes are most often felt at the point of medication delivery or when a client gets told, inadvertently, their medication is not paid for. The process of correcting this mistake can take a matter of days or weeks, depending on a pharmacy’s experience with co-occurring payers.

In that time, patients can fall out of care, drastically reducing their likelihood of achieving an undetectable viral load.

For ADAP formulary advisory committees, for states that have them, the process of adding and adjusting formularies is sometimes relatively expedient. Relatively, in part, because those medical experts and community experts understand the need and nature for ensuring access to an expansive list of antiretroviral medications and modern advancements. Arizona’s Medicaid formulary lacks several single tablet regimens and, in the opinion of Glen Spencer, executive director of Aunt Rita’s Foundation, favor outdated “cocktails” (or multi-tablet regimens), complicating daily care for people living with HIV and accessing Medicaid, often subjecting clients to greater experiences of toxicity, and ultimately interjects an unnecessary interruption in both patient choice and provider care.

In aiming to impress the need of Arizona’s Medicaid formulary to expand in both supporting the sustainability of the state’s ADAP and meeting national initiatives Mr. Spencer stated, “It is critically important that Arizona’s Medicaid program include all single-tablet regimens on its formulary to offer patients the right medication for them, and to provide medical providers with the flexibility they need to prescribe the right medication for each patient.”

To this end, Aunt Rita’s advocacy efforts are also expanding with proposed legislation addressing the failure of Arizona’s Health Care Cost Containment System (AHCCCS) to take up the issue. According to Mr. Spencer, the bill is not likely to make it out of committee this year and lacks any great deal of interest for legislators battling over other budgetary and policy concerns and does not currently have a companion bill in the state Senate. On the other hand, the bill is sponsored in the Arizona House by a bipartisan coalition of 9 legislators.

“In order to end the HIV epidemic, both the patient and provider community will need all therapies available to them to support persons living with HIV, save lives, and get patients to an undetectable viral load.” Mr. Spencer added, “This policy not only promotes patients’ ability to lead a robust life, but also prevents new infections given the science behind U=U.”

The state’s ADAP and Medicaid formularies also present a similar situation for medications used to treat Hepatitis C, leaving a critical gap in available health care services and treatment for those at risk of contracting Hepatitis C. While the state’s ADAP coverage includes most direct acting agents, Arizona’s Medicaid formulary only covers Epclusa, Mavyret, Ribovirin, and Peginterferon.

Arizona’s situation offers a critical reminder that even with the value of Medicaid expansion, in order to achieve the greatest reach of ADAPs, tackle the absolutely critical inclusion of treatment and retention in prevention efforts, and to eliminate viral hepatitis, the details matter and advocates will need to adapt old fights to new environments.

Modeling Navigation: Hepatitis C Toolkit for Improving Care for People Who Use Drugs

In September 2020, our friends at the National Association of State and Territorial AIDS Directors announced the launch of a new hepatitis C toolkit and navigation model to improve care for people who use drugs (PWUD) and other impacted populations. NASTAD, in partnership with the New York City Health Department, spent 8 years developing this model of care navigation and the associated toolkit and has made an informational training video available to preview the program for interested health departments, providers, and community-based organizations.

The model builds upon what’s now common knowledge: clients often need help navigating complex systems of care, an influx of information, and available support. NASTAD’s training video walks viewers (and prospective partners) through nearly every aspect of the model, from staffing needs to potential funding sources. While standard roles are as expected, including program managers and data personnel, rather than strictly relying on peers, the toolkit specifically delineates between “peer navigators” and “patient navigators”, including suggested job descriptions and distinctions on educational requirements. Notably, the peer role works to support the activities of the patient navigator role (as opposed to supporting case management work directly, as seen in many HIV peer programs). Entities considering the model should note: combining these roles may weaken the efficacy of the program and, given role descriptions, overburden staff assigned to the task. Further, for these roles to be effective, providers will need to be comfortable with an active navigator advocating for and with a client. Those same providers should also note, both navigators are designed to support positive health outcomes for clients and to work in tandem with a client’s provider, including medication adherence support, follow up with provider instructions, and to ensure appointments are attended.

NASTAD’s model envisions a comprehensive approach of assessment beginning at the time of contact (either during outreach or testing activities) and throughout the care continuum. From education to treatment preparedness, the model’s training curriculum and suggested documents prompt both types of navigators to consider their language, a client’s needs in housing, stress management, co-occurring health issues, and encourage actively linking clients to resources that are not necessarily medically based. The model supports this approach from the very design of the program – highlighting the success of (and need for) syringe services programs (SSPs), medication assisted treatment (MAT), addressing maintenance of contact with a client regardless of housing status, and instructing administrators on the necessity of a robust referral network.

The virtual training includes recognition of barriers and evaluation of a case study during COVID. NASTAD notes stigma, access to care, language access, and medication prior authorization are the most common barriers to engagement, retention, and success in care. Challenges include, as we previously noted, a COVID-associated plummet in HCV testing, changes in working hours, the need to access facilities with ever changing rules of access, and technology barriers, especially for homeless clients. Successes include easier access to treatment thanks to flexibilities in insurance approvals, more easily tracking down and following up with clients thanks to “stay-at-home” orders, and easier contact tracing.

Resources at the end of the training materials are either national or based in/from New York City and prospective partners will need to consider adding to or substituting this resource list with their own, more local resources. NASTAD encourages accessing the program’s technical assistance and capacity building assistance teams and those of partners involved in developing program materials (also found in the resources section of the materials).

This model poses an opportunity that may only be limited by the will power of funders and willingness to collaborate in an environment where community-based organizations are encouraged to be everything to everyone. Funders should take note of the extraordinary potential NASTAD’s model offers and support both entities seeking to implement it and those entities implementing partners would need to rely on in order to fulfill the wrap around nature of care and navigation the model envisions.

Jen’s Half Cents: Family Courts, Child Welfare Services & Missed Opportunities for Intervention and Linkage to Care

One of the things I often relate in HIV advocacy and health care advocacy is the remarkable nature of the work we do. Yeah, we can absolutely get bogged down in the nuances of payment policies and necessary regulatory functions, but that’s not what motivates us. What truly drives us is a desire to improve the lives of those around us. And, as is the nature of any community built on shared trauma, HIV advocacy is unique in how it bonds us to one another. There’s little quite like it, regardless of the stakeholder. “On the ground”, we share about everything – our relationships, our hobbies, our sex lives, our triumphs and struggles, and, yes, our families. So nearly a decade into this work, it wasn’t a surprise–when I sought some emotional support—to find I could console with my colleagues as friends upon finding myself wrapped up in a complex custody battle. It brought me a great deal of comfort to receive advice on playing a supportive role to my partner as a parent and to share things like holiday photos and craft projects.

What did surprise me was coming to understand with great intimacy how family court and child welfare systems fail to consider their roles in family health, especially with regard to multi-generational poverty and behavioral risks. On February 6th, 2020, I was sitting in a court room awaiting a hearing while another parent’s case was being heard. The parent was seeking a change to a custody arrangement because the mother of his children had experienced a mental health break, was very likely to face homelessness, and he was making a concerted effort to both keep her involved in their children’s lives and to do so in a way that set her up for success. After his hearing concluded, he respectfully asked if the hearing officer or the court social worker could recommend resources for his ex to navigate public assistance and benefit applications. The response he received was, “we don’t know, we just don’t do that,” and I was shocked—truly and remarkably shocked—the court was unprepared for this request. It can’t possibly be an uncommon one. As he got up to leave, I politely stopped him and gave him information for a local federally qualified health center, Access Health Louisiana, which happens to be Ryan White funded.

This incident incited a shift in my perspective and self-education regarding issues of health, HIV-status, and family court and child welfare issues. A 2003 report from the ACLU’s AIDS Project found providers reporting clients having lost custody, denied visitation with their children, or having been barred from being foster or adoptive parents due to their sero-status. Indeed, parents have had their custody arrangements negatively impacted by merely associating with PLWH. In 2015, POZ Magazine covered the story of Donna Branum, a mother in Kansas who temporarily lost custody of her children because her fiancé’s HIV-status. While Branum was ultimately granted the right to return to a joint custody arrangement, the issue came to the attention of the court because Branum’s ex-husband petitioned the court, claiming Ms. Branum’s fiancé posed a “health risk” to the children. The ACLU’s 2003 report appropriately describes this type of stigma and lack of foundational, basic HIV-related education as discriminatory.

Thanks to a Supreme Court decision in 1998, HIV status, including “asymptomatic” cases, is covered under the protections offered by the Americans with Disability Act (ADA). While Bragdon v. Abbott centered on a dentist refusing to provide care for Sydney Abbott based upon her HIV status, the ruling contributed to the Department of Justice specifically mentioning HIV (twice) as a covered disability in its August 2015 guidance on the rights of parents and potential parents and technical assistance document regarding family courts and child welfare agencies:

Excerpt:

3. Who do Title II of the ADA and Section 504 protect in child welfare programs?

Answer:  Title II of the ADA and Section 504 protect qualified individuals with disabilities, which can include children, parents, legal guardians, relatives, other caretakers, foster and adoptive parents, and individuals seeking to become foster or adoptive parents, from discrimination by child welfare agencies and courts.  Title II also protects individuals or entities from being denied or excluded from child welfare services, programs or activities because of association with an individual with a disability. For example, Title II prohibits a child welfare agency from refusing to place a child with a prospective foster or adoptive parent because the parent has a friend or relative with HIV.

A 2013 UNAIDS report, entitled Judging the Epidemic, describes denying parents with HIV custody and visitation rights as “arbitrary, disproportionate and ineffective” with regard to any public health interest and urges courts to consider “actual” risk to a child’s welfare rather than “theoretical” risk. UNAIDS recognizes both children’s best interests and the rights of parents living with HIV as human rights issues needing careful address. However, even back in 1992, the book, AIDS Agenda: Emerging Civil Rights Issues, recognized family court matters provided an opportunity for “…the worst characteristics of litigants [to] emerge, with divorcing parents raising issues based on prejudice rather than on concerns of parenting ability – out of their own bias, anger, or an attempt to appeal to the anticipated biases of judges.” Both sources cite the American Bar Association’s position defending the rights of parents living with HIV and legal precedents in which parents living with HIV needed to employ medical experts to explain what’s commonly understood in medical circles: it is impossible to transmit HIV via casual, household contacts.

I’d be remiss not to mention a growing area of study currently gaining more attention: how—both psychological/emotional and physical—abusers use family court processes to exert control over their intended victims. At the intersection of family court processes being abused and parents living with HIV is the decade-old Centers for Disease Control report on domestic/intimate partner violence as “…both a risk factor for HIV, and a consequence of HIV.” This area deserves more attention than it gets; the least of which being a follow-up and more recently updated data than is provided in the CDC report.

In fact, despite attention to educating children and families and providing a holistic approach to outreach and linkage to care, the National HIV Strategy doesn’t mention family courts or child welfare agencies even once. With the HIV epidemic disproportionately impacting Black Women, family courts and child welfare agencies have a very unique opportunity as non-traditional partners to impact the public health of their communities. However, to even begin doing this, family court judges and child welfare agencies would need to begin addressing policies and procedures that essentially penalize poverty (often confusing poverty with negligence), rather than assisting families in need.

“We recognize the lives of PLWH are often impacted by people not working in HIV,” Louisiana’s implementation of their Ending the HIV Epidemic plan, Get Loud Louisiana, states. The plan is the first (to my knowledge) to include activities to engage family courts, social workers, and child welfare agencies to educate and change policies to better serve this public health interest.

Like all issues surrounding HIV, this is an intersectional one. Well-established is the role and social support of family for people living with HIV, and family court’s primary mission is the health and well-being of families; policies and procedures for resource-sharing are of paramount importance in meeting both of these sets of needs. To end the epidemic, to set families up for success, to address stigma, to help keep PLWH engaged in care, and so much more, we must begin to engage these critical stakeholders. We cannot afford to continue to miss this opportunity.

Ongoing Viral Hepatitis Outbreaks: Systemic Interventions

Viral Hepatitis outbreaks, namely Hepatitis A and Hepatitis B, have been in the news quite a bit during the last year. Could COVID-19 have contributed to them?

Annual surveillance data for the state of Florida found the 2017 Hepatitis A outbreak has shifted location from primarily South Florida to the Pensacola area, in Escambia County. Florida isn’t alone with persistent Hepatitis A outbreaks. According to the CDC’s Hepatitis A outbreak dashboard, as of February 5, 2021, almost 40,000 cases of Hepatitis A have been confirmed related to the outbreak beginning in 2017, with more than 25 states still in an active outbreak status. Florida, Indiana, Kentucky, Ohio, Tennessee, and West Virginia top the list for the most cases reported since the outbreak began.

These outbreaks are primarily attributed to an increase in homeless populations and populations experiencing housing instability and lack of access to sanitary conditions. Hepatitis A is primarily transmitted in close-contact settings by way of ingesting blood or stool particles from a person carrying the disease. While the disease is not always deadly, it can be. Indeed, the 2017 multi-state outbreak has resulted in at least 354 deaths, according to the CDC.

Additionally, in late 2020, Vermont reported outbreaks of Hepatitis A and B, with Vermont Health Commissioner, Dr. Mark levin, said the state had been anticipating an eventual outbreak because of existing outbreaks in New Hampshire and Massachusetts. Hepatitis B, much like Hepatitis C, is often attributed to injection drug use, long-term health care settings, and contact with bodily fluids containing the virus, including blood and semen.

In response to these outbreaks, the CDC has encouraged states to engage in more active community education and vaccination programs. Both Hepatitis A and Hepatitis B are preventable and post-exposure vaccine administration may be appropriate in some situations. However, as the COVID-19 pandemic has reminded us, other interventions are necessary to address both risk factors to infectious diseases and reduce barriers to care. Addressing the nation’s housing and homelessness crisis could potentially provide one, extraordinarily significant structural intervention to address these and other public health crises.

President Joe Biden made campaign promises relating to need for more equitable housing policies and expanding affordable housing to address social justice needs as well as health-related needs and is already working to establish a fairer housing environment for the country. From extending the eviction moratorium to ensuring housing protections are extended to all Americans regardless of sexual identity or gender orientation (a reversal of the previous Administration’s policies), first steps are already being laid in order to meet well-known housing needs. And none too soon, as we don’t yet have a full picture of exactly how the COVID-19 caused economic recession will impact rates of homelessness, but one study issued a rather dire warning last month, saying this recession would likely cause double the rate of homelessness than the 2008 crisis.

From Hepatitis A and B to COVID-19 and the Opioid Crisis, housing has become (always was) a preeminent intervention that remains largely inadequately addressed. Federal funding and state programming must move to invest in housing as a prevention strategy in order to get ahead of these outbreaks and stop the chains of transmission. Housing is not just a human necessity; it is a public health necessity and must be embraced with the vigor the moment demands.

For the most up-to-date information from the National ADAP Working Group (NAWG), Hepatitis Advocacy, Education, and Leadership blog, and the quarterly HIV-HCV Co-infection Watch Report, sign up for our listserv here.

The Future is Now: Welcome to the Age of Injectables

For years, HIV advocates have anticipated injectable antiretroviral therapies (ART) – often with a level of excitement. I recall listening to robust discussions between advocates and officials in statewide meetings, reviewing candidate treatments, discussing labor and staffing needs for providers, potential regulatory changes needed to ensure programs could cover the actual syringes associated with injectable ART, given state-based restrictions. The excitement extended from a sense of no longer needing daily tablets (pills) in order to maintain adherence and thus an undetectable viral load, extend quality of life for those experiencing barriers to care like homelessness, and otherwise welcome a new age of treatment – if only by new method of delivery.

In late 2019, we seemed on the edge of such an accomplishment. ART focused pharmaceutical manufacturers Glaxo Smith Kline subsidiary, ViiV, and Johnson & Johnson subsidiary, Janssen, had paired up in an effort to provide the world with its first long-acting ART via injection. However, the Food and Drug Administration (FDA) refused to grant the companies an approval for the dual shot regimen of cabotegravir and rilpivirine (together, “Cabenuva”) due to concerns related to “Chemistry Manufacturing and Controls”. Thirteen months later, on January 21, 2021, Janssen and ViiV announced FDA approval of Cabenuva.

ViiV Healthcare understands the transformative nature of Cabenuva and the many “firsts” associated with a provider-administered injectable therapy for HIV. We will be educating HCPs on how to identify appropriate patients who may prefer or benefit from an option other than daily, oral therapy. Two key considerations are that patients agree to the required monthly dosing schedule and understand the importance of adherence to scheduled dosing visits. We also will be helping educate people living with HIV about Cabenuva and these commitments. - ViiV

According to the product monograph, Cabenuva is a dual intramuscular injection protocol (requiring one shot of cabotegravir and one shot of rilpivirine) monthly, administered by a health care provider. Prior to starting the monthly injections, providers should test tolerability via “oral lead-in” via once daily tablets of both cabotegravir and rilpivirine with a meal. If consumers expect to miss a monthly injection by more than 7 days, once daily oral tablets of cabotegravir and rilpivirine may be used to replace the injections for up to two injection cycles (or 2 months). Contraindictions include any known or suspected resistance to either or both drugs and any intolerability of components of either or both drugs. The injections cannot, at this time, be self-administered.

Despite all of the antici…pation and data showing a higher level of satisfaction than with current regimens among trial participants, some advocates are still cautious and concerns remain regarding logistical accessibility. Regarding financial accessibility, ViiV has already launched its patient assistance program for Cabenuva through ViiVConnect. Florida advocates and members of Florida HIV/AIDS Advocacy Network, Ken Barger, Joey Wynn, and David Brakebill, discussed in…spirited detail varying perspectives on rural access.

Wynn advocated for diversifying public funds, if rural health departments couldn’t meet the demand of a once monthly injection protocol, “If a rural health department can’t do a monthly injection [for ART], when they do injections for all sorts of other disease states, they need to give their money to providers who can.” Barger and Brakebill pointed out that for many rural counties, the health department may be the only provider in the area that’s accessible, with a highlight on concern regarding capacity. Wynn suggested the need for investment in better planning and preparation – not just for injectables, but for situations of natural disasters which have been known to disrupt access to medications and care in the state regularly.

When asked about these concerns, ViiV acknowledged the challenges and provided the following commitment to invest in ensuring more equitable access to care: ViiV Healthcare is also dedicated to improving how HIV treatment and care are delivered in the “real-world” environment through our Implementation Science program. One example of this focus is a study evaluating how improvements in transportation and use of digital tools can help get people living with HIV to their healthcare providers on a regular basis, which if successful we’ll look to implement on a broader scale

---

This week’s HEAL blog wouldn’t have been possible without the coverage of and reporting on treatment developments in this and other therapeutic areas by Liz Highleyman.

Quotes attributed to ViiV Healthcare are direct and were provided by Robin Gaitens, Product Communications Director.

Highlights from the Viral Hepatitis National Strategic Plan

On January 7th, the Department of Health and Human Services announced publication of an updated plan to eliminate viral hepatitis in the United States.  This “roadmap” coincides with HHS’s release of the first Sexual Transmitted Infections (STI) National Strategic Plan on December 18th, 2020, and an update to the HIV National Strategic Plan on January 15th, 2021.

Notably, these documents reference one another and specifically call for integrated efforts to tackle these syndemics across stakeholder groups, specifically including substance use-disorder as part of a “holistic” cohort. Additionally, each contains a near identical vision statement:

- The United States will be a place where new viral hepatitis infections are prevented, every person  knows their status, and every person with viral hepatitis has high-quality health care and treatment and lives free from stigma and discrimination.

- The United States will be a place where new HIV infections are prevented, every person knows their status, and every person with HIV has high-quality care and treatment and lives free from stigma and discrimination.

- The United States will be a place where sexually transmitted infections are prevented and where every person has high-quality STI prevention, care, and treatment while living free from stigma and discrimination.

All three vision statements end with the following: This vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, religion, disability, geographic location, or socioeconomic circumstance.

Each plan addresses a limited but indefinite list of social determinants of health such as socio-economic burdens impeding access to care, including racism, intimate partner violence (IPV), and stigma and acknowledges discrimination against sexual and gender minorities (SGM). COVID-19 is mentioned repeatedly as underscoring and providing a highlight to the United States’ excessive health disparities, giving a nod to the unfortunate…”opportunity” the pandemic has provided health care advocates working with or as a part of these highly affected, highly marginalized communities. “The pandemic has exacerbated existing challenges in the nation’s public health care system, further exposing decades, if not centuries, of health inequities and its impact on social determinants of health.” Plans also acknowledge personnel and resources from programs addressing STIs, viral hepatitis, and HIV have been heavily redirected toward efforts to address COVID-19.

All plans call for better data sharing across providers and reporting agencies and an increase in surveillance activities, with an emphasis on local-level efforts to rely on local data, rather than national-level trends. Each plan also calls for expanded testing, interventions, linkage to care, provider and community education, and access to treatment, including incarcerated populations. The Viral Hepatitis National Strategic Plan (VHNSP) described “poor quality and a paucity of data” as clear impediment to meeting the goals of the plan. Sparring no stakeholder with access, the plan highlights a need for data sharing among correctional programs, health insurers, public and private health systems, mental and behavioral health, public health entities, and more.

The VHNSP also acknowledges opportunities to take lessons from the fight against HIV and the need to integrate “treatment as prevention” as a powerful tool in combating new HBV and HCV infections.

The Viral Hepatitis Strategy National Plans notes the following key indicators:

• On track for 2020 targets:

  • HBV deaths

  • HCV deaths

  • HCV deaths among Black People

• Trending in the right direction:

  • HBV vaccine birth dose (87% for people born between 2015-2016 by 13 months, WHO recommends 90% by 13 months)

  • HBV vaccine among health care personnel

  • HBV-related deaths among Black people

  • HBV-related deaths among people over the age of 45

• Not on track:

  • New HBV infections

  • New HCV infections

  • New HBV infections among people 30-49 years of age

  • HBV-related deaths among Asian Americans and Pacific Islanders

  • New HCV infections among people of 20-39 years of age

  • New HCV infections among American Indians and Alaska Natives

The plan recognizes an 71% increase in HCV infections in reporting years 2014-2018 and points toward a strong data correlation between these new infections and the opioid epidemic, based on local area reporting data. Care related challenges include lack of personal status knowledge, perinatal transmission, and cost of curative treatment.

The plan states ideal engagement in various activities across an astoundingly broad scope of stakeholders including faith-based organizations for outreach and education, stigma and anti-bias training among all client-facing personnel, the opportunity to engage comprehensive syringe services programs as an outlet to provide HCV medication and more traditional services like referral for opioid-use disorder, educating providers and employers about federal protections for people with viral hepatitis, increasing awareness through school education programs – specifically culturally sensitive and age-appropriate sex education programs.

From issues of criminalization laws to lack of cohesive data collection, overall, the plan is very welcomed, comprehensive approach toward addressing viral hepatitis. With the STI and HIV plans mirroring very closely.

While the plans call stakeholders to address economic barriers to care and other social determinants of health, specifics are lacking. Stakeholders may wish to consider some of the priorities in the Biden administration’s public health approach including hiring from affected communities (including reducing or allowing alternative education requirements like live-experience or consideration of on-the-job training opportunities). These lofty goals may also require regulatory changes in order to implement and realize them fully (i.e. mechanisms incentivizing correctional facilities and the Veterans Administration to share data with local or state health departments and establish linkage to care programs). Private funders would be wise to take advantage of this opportunity and fund innovative, comprehensive pilot or demonstration projects. Advocates would be wise to leverage these documents when seeking state-level regulatory changes and advocating for federal funding and program design.

HCV Screenings: An Evolving Blind Spot Amid Covid-19

A recent study in the Journal of Primary Care & Community Health highlighted the impact of COVID-19 on routinized Hepatitis C (HCV) screening in ambulatory care settings. (Press release and summary of study findings by the Boston Medical Center can be found here.)

Before we dig into the findings, some background:

On April 10, 2020, the Centers for Disease Control and Prevention issued expanded recommendations regarding Hepatitis C Virus screenings to include universal screening for adults aged 18 and over at least once in a lifetime and all pregnant persons – except in settings where HCV prevalence is less than 0.1%. The recommendations also calls for periodic screening among people who inject drugs (PWID).

Prior to this update, the previous recommendations (2012) for HCV screenings was primarily limited to an age cohort focused on Baby Boomers (adults born between 1945 and 1965, regardless of risk factors) and certain risk factors including potential for occupational exposure.

These recommendations came on the back of the CDC’s Viral Hepatitis Surveillance Report (2003-2018), indicating a rise in acute HCV infections among all age cohorts except those under the age of 19, with PWID representing the leading risk factor for new HCV infections (72%). However, data collection on both acute HCV infections and risk factors is sorely lacking. The 2018 surveillance report notes Alaska as having no statutory or regulatory reporting requirement, Hawaii did not report data to the CDC for any year of the report, and 6 other states merely indicated as “data unavailable” (most typically for all reporting years). Finally, no state reported a sero prevalence below 0.1%.

In a report entitled Beyond Baby Boomers, the CDC notes the surge in new HCV infections was dramatically impacted by the opioid crisis – a driving cause in new infections among younger cohorts.

Despite these recommendations, health care providers and traditional health care settings like primary care providers and hospitals routinely miss opportunities to identify PWID and offer HCV screening. This leaves emergency rooms and comprehensive syringe service providers as the most critical partners in identifying new HCV infections, with a priority in op-out screening as a means to increase surveillance, linkage to care, and stigma-reducing education.

All of this makes the Boston Medical Center study that much more alarming. The COVID-19 pandemic, while bringing much to us in the way of innovative health care access, has drastically decreased HCV screening in ambulatory care settings in part because of the leading innovation: telemedicine. Authors observed a hospital-wide reduction in HCV screenings by 50% and diagnoses of HCV by 60%. The finding was even more striking in primary care settings at 72% decrease in HCV screenings and a 63% decrease in new diagnoses. While HCV screenings are not the only preventative care to suffer, as noted by the authors, this is particularly concerning because of the nature of infectious disease impact on public health and because chronic HCV is the leading cause of hepatic illness in the United States.

The blind spot on the horizon is our less than proactive approach in directing resources and programing. Primarily, as many are learning thanks to COVID-19, data collection is historical in nature and offers a limited ability to predict where these necessary resources should be targeted, both geographically and demographically. Data collection efforts may need to consider other metrics in addition to screening and surveillance data in reviewing where resources and programs should focus as we move through the pandemic (i.e. fatal and non-fatal opioid overdose data). Given the CDC’s acknowledgement of the role the opioid crisis has had in driving new HCV infections, the agency’s December 2020 press release indicating an increase in overdose deaths associated with COVID-19 is all that more concerning.

Finally, advocates working at varying intersections of addiction, harm reduction, HCV, HIV, and overall health care could aim their efforts at state and federal policy influencers associated with the Centers for Medicare and Medicaid Services (CMS) to call for including HCV screening as a standard of care for all ambulatory care providers, either by incentive or penalty, as applied to approved Marketplace plans. Other avenues for this strategy should include other state insurance regulatory bodies.

We cannot afford to allow COVID-19 to detract from efforts to address existing syndemics.

What a Narrowly Divided Senate Means for Health Policy

On January 5th, Reverend Raphael Warnock and Jon Ossoff defeated Senators Kelly Loeffler and David Perdue in the Georgia Senate run-off elections, respectively. Democrats narrowly winning both Georgia Senate seats also means Democrats have narrowly won the Senate, dividing seats 50-50 between members who caucus with Democrats and Republicans with Vice President-elect Harris empowered to cast any tie-breaking votes and handing the incoming Biden administration a unified government.

While those with lofty ambitions on policy and legislative issues are cheering, there’s good reason to consider the need for moderating what can be expected from the 117th Congress: Democrats aren’t always on agreement on major issues like direct payment amounts as part of COVID relief or Medicare For All. The Biden administration will likely need to rely heavily on the regulatory powers allowed to federal agencies – which makes the prospective appointment of Xavier Becerra to lead Health and Human Services make more sense than it perhaps did on the surface. After all, who appoints an attorney to lead a health care agency?

The Trump administration made dramatic regulatory moves with regard to health care, targeting non-discrimination rules in health care, the Affordable Care Act including attempting to get the legislation declared unconstitutional by the Supreme Court, drug pricing, and championed legislative changes eliminating individual mandate penalty. While a judge has already temporarily blocked Trumps’ effort to tie drug prices to that of other nations’ prices and the Supreme Court has given the green light to recently-revived Food and Drug Administration rules on abortion pill access, these issues are regulatory in nature. The Biden administration could simply choose not to defend these moves in court change these regulations. While state push back is likely, a lack of Congressional challenge against these moves may help smooth the way for institutional changes.

It’s largely expected that among Biden’s first moves regarding health care will include expanding COVID relief measures and vaccine distribution plans, rescind the Mexico City policy (also known as the “Global Gag Rule”), “expand[ing] access to high-quality health care for Lesbian, Gay, Biden, Transgender, and Queer+ individuals” (or moving quickly to rescind the “Provider Conscience” rule), and reversing the 23% rate cut to 340B entities. With the help of a unified House and Senate, among Biden’s first accomplishments may be a legislative “fix” to the Affordable Care Act challenge awaiting ruling from the Supreme Court. Other campaign promises from Biden include seeking legislation to end HIV criminalization and increasing research into harm reduction models, expanding syringe services programs, and substance treatment funding – an issue Biden has evolved on and largely due to bearing witness and supporting his son through.

Other moves to watch for:

Strengthening the Affordable Care Act:
                - A regulatory move recalculating and increasing subsidies for Marketplace plans
                - Restoring Marketplace Navigator funding
                - Returning the open enrollment period to 90 days
                - Rescinding a proposed rule on 1332 waivers allowing states to opt-out of the Marketplace
                - Changes to regulations regarding short-term policies and association health plans (including reduced allowable coverage periods and requiring coverage of pre-existing conditions, including pregnancies, HIV, HCV, and transgender identity among others)
                - Reduce documentation burden for subsidies and Special Enrollment Periods
                - Expand the definition of qualifying life events and rules regarding special enrollment periods
                - Enforce mental health and substance abuse coverage parity
Strengthening Medicaid:
                - Rescind, reject, and stop defending 1115 waivers seeking work requirements
                - Encourage 1115 waivers to include the impacts of increasing coverage
                - Revise increased eligibility verification for Medicaid
                - Encourage policies regarding presumptive eligibility outside of hospitalization and emergency situations
                - Review and revise reimbursement schedules for Rural Hospitals
LGBTQ Health Equity:
                - Issue guidance and seek funding to address mental health services and support staff in schools
                - Reinstitute and/or strengthen Obama era guidance regarding transgender students and Title IX protections
                - Revise and strengthen Affordable Care Act, Section 1557 non-discrimination rules protecting women, Lesbian, Gay, Bisexual, Transgender, and Queer people, and people living with pre-existing conditions like HIV or HCV (in which the Trump administration would allow payers and providers to refuse care
                - Rescind the Trump era ban on transgender people serving in the military
                - Reverse or rescind Trump era “religious conscience” applying to civil rights laws – use regulatory power to include Lesbian, Gay, Bisexual, Transgender, and Queer people in civil rights protections in health, housing, and labor
                - Expanding data collection policies to include sexual and gender identities

While some may view the heads of regulation making agencies as “unelected officials”, in many ways, who we elect to be the executive is very much choosing who leads the agencies that impact our lives on a daily basis. There is much work to do for the Biden administration on the regulatory front and unified, carefully crafted legislation speaking to these issues may well help cement these changes beyond political party ping pong.

Too Good to be True: Drug Importation

“Never let a good crisis go to waste.”

Most famously attributed to Winston Churchill (or Saul Alinksy, depending on which rumor you follow), this phrase is as apt for politicians, activists, and scam artists alike. In general, the former two groups mean “seize an opportunity to move forward an agenda,” while the latter focuses solely on personal gain at a cost to the well-being of others. There are few more fertile fields for those scam artists to seize the moment than counterfeit products. The United States has worked hard to combat counterfeit scams across a variety of industries on international, federal, and state levels: forming investigative agencies, imposing high fines, and establishing consumer protection and reporting entities charged with receiving complaints and notifying the public of fake and potentially harmful consumer items.

The COVID-19 pandemic offered a fresh chance for a scheme that gained notoriety in the 1980’s: fake medicines. For much of the United States, COVID-19 became “real” on March 13th, 2020. As soon as March 19th, the FBI issued warnings over fake testing kits, making the problem of fake medicines, treatments, cures, tests, and even personal protective equipment (PPE) a front-and-center issue in the fight against COVID-19.

Counterfeit medicines have long plagued the chronic illness space. From insulin and cancer medications to anti-retrovirals and hepatitis medicines. Notably, the FDA participates in Interpol’s Operation Pangea, a global effort to crack down on counterfeit medicines and collaborative work to ensure supply chain safety. Operation Pangea specifically targets illicit websites claiming to be “pharmacies”. In 2017 alone, the collaborative work resulted in more than 400 arrests and the seizure of more than $51 million in potentially counterfeit drugs.

Despite nearly three decades worth of work fighting this dangerous practice, it continues to plague patients, their families, and our communities. While not as much a news item these days, counterfeit opioids remain an issue, having resulted in at least 42 deaths in the United States this year. As recently as December 23rd, 2020, manufacturer, Janssen, issued an alert regarding counterfeit Symtuza and, in July, the Department of Justice secured admissions in federal court on a pair of men pushing fake cancer and hepatitis treatments.

The problem is growing. In 2018, Operation Pangea identified and took down 465 websites illegally selling potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers. It’s not just direct consumers these potentially dangerous actors target, the FDA sent a warning letter in 2019 to CanaRx, an entity that contracts with self-funded health care plans.

Most disturbingly, despite many of these online websites masking themselves as “Canadian pharmacies”, in the waning days of the Trump administration, HHS has issued a final rule that would allow states, tribes, pharmacists, and wholesalers to import medications from Canada. While already facing legal challenges from industry and advocates, the final rule does not outline specific measures of safety – rather it forces states and manufacturers to take on the cost of ensuring a safe drug supply – and does not point to any specific evidence importation will reduce costs to consumers.

The issue of defending (or not) or further defining the rule will fall squarely on the shoulders of the Biden administration as the legal and logistical challenges work their way through their respective processes.

The American drug supply already faces an uphill battle to remain safe in an ever-evolving environment with increasingly sophisticated and predatory bad actors. Those most vulnerable to exploitation are not served (and the dangers of counterfeit medicines are not diminished) with unproven notions and a lack of safeguards. Whether in treatment of disease states with which we are long familiar or in the case of a novel virus, the American public deserves both to be able to afford their medications and to trust them.

For providers, BeSafeRX, an FDA resource page.

For patients seeking assistance in affording your medications, PAN Foundation may be able to help.

Covid-19’s Impact on HIV, HCV, and Substance Use-Disorder

“New Year, new you!” Or so the saying goes.

Every effort moving forward must evaluate past and current circumstances in order to be successful. A year ago, states and local jurisdictions were moving through planning processes for updates to the Viral Hepatitis National Strategic Plan and working toward finalizing their Ending the HIV Epidemic plans. Many advocates were cautiously excited to move forward with innovative and integrated planning. Even the CDC’s February, 2020 EHE funding announcement allowed entities to use up to 10% of their EHE funds for integrated viral Hepatitis and STI activities. Few involved in state-level work were listening intently for news of the novel pneumonia we would come to call a pandemic merely 2 months later.

As of this writing, the data collection site Worldometers is reporting almost 20 million confirmed COVID-19 cases and 345,000 COVID-19 related deaths…in the United States alone. A slew of federal agencies introduced extraordinary flexibilities across the health care landscape; from cross-state licensing recognition to expanded telehealth allowances for most providers to flexibilities in programmatic spending and supplemental RWHAP in the CARES Act passed in March. In many ways, these changes ushered in an “uncontrolled”—yet welcome—“test atmosphere” for policies and programmatic flexibilities advocates have historically championed.

Ryan White clients across the country were able to recertify via phone or video conference for the first time. A Kaiser Family Foundation report evaluating Ryan White providers in the age of COVID-19 found an increase in providers offering telehealth services (22%-99%) and 89% are offering multiple month ARV fills (more than half attributing to COVID related policy changes).

However, not all changes have been positive. Despite the CDC’s guidance encouraging programs to offer HIV self-tests in lieu of offering on-site or mobile rapid testing, many Ryan White providers and STI clinics have had to shutter programs or reduce testing availability and disrupt PrEP services. Telehealth access, while wonderful in overcoming transportation barriers to care, does not address the need for actual testing. A study published in the Journal of Primary Care and Community Health found community hospitals and primary providers saw a significant drop in HCV testing from January 24 through August 17, 2020. Another study found instituting HIV testing as a standard of care and elimination protocol for COVID-19 screenings in hospitals saw an increase in new and acute HIV diagnoses for certain hospitals in the Chicago area. While it’s almost certain this is indicative of a certain transference of where clients are receiving services, we don’t yet know how many of these community members would have sought these testing services outside of a hospital or emergency setting.

COVID-19 has also clearly highlighted the impact of social determinants of health and health disparities of which HIV and HCV advocates have long been aware. One of the most unfortunate examples is lack of care and lack of policy and program attention to the incarcerated population. A report from the Hepatitis Education Project and National Hepatitis Corrections Network found incarcerated populations have a 12-35% Hepatitis C prevalence, with less than 1% of prisoners having received treatment. Similarly, COVID-19 has ravaged prison populations in the United States and, as of yet, FDA recommendations for vaccine distribution do not include prisoners as a “priority population”.

At the intersection of COVID-19 impacts on HIV and HCV policy and programs is the looming issue of humanity – the very thing that increases our risks of contracting a deadly respiratory illness: a need to connect. KFF reported significant increases in depression, anxiety, and substance and alcohol use due to job loss, income insecurity, and other stresses related to COVID-19 and COIVD-19 related restrictions. As Tuyishime Claire Gasamagera so aptly put, The COVID-19 Pandemic Is a Perfect Storm for People With Substance Use Disorders and Addiction. While traditional recovery programs and medication-assisted treatment have had similar disruptions to services, reduced outreach, and a need to shift to virtual platforms as HIV and HCV programs, some local health departments are using their syringe services programs to overcome these barriers by distributing larger quantities of supplies and delivering supplies to clients. Still, some officials have already reported an increase in overdose related deaths during the pandemic.

The incoming Biden administration has high hopes to tackle some of the most pressing immediate and long-standing health issues facing the nation. While the Biden transition team has already named a COVID-19 task force, promised to re-establish the Office of National AIDS Policy, and named Rochelle Walensky as his pick to lead the CDC, there’s also a number of executive actions the incoming administration could take to re-shape the health care landscape and work to fill these gaps.

We need to focus on these “wins” and unintended consequences in order to ensure our federal representation and local implementation are equally as mindful of the gaps created by well-meaning policies.

Hindsight and 2020 and all that.

__________

Disclaimer: HIV-HCV Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HIV-HCV Blogs might be graphic due to the nature of the issues being addressed in it.

Advocacy in 2021…and Beyond

The last four years seem to have passed in bit of blur. The events in public health and the related healthcare advocacy world have been driven by the fall-out from dysfunctional political chaos. The growing political divisions that prevented compromise, and thereby any progress on resolving overarching problems in our national life, have forced the Community Access National Network (like most national nonprofit organizations) to re-evaluate its approach to patient advocacy. In fact, democracy itself seems to look rather beaten up, even perhaps slightly damaged.

The advocacy priority landscape has changed in the last three decades that CANN has been a part of it, not to mention the almost four decades that I have spent in this field, personally. The mission of access to care and treatment in the HIV and viral hepatitis space for all regardless of their socio-economic capabilities clearly remain, but the world that started with no tools and no policies has expanded into a veritable constellation of potential policy changes, treatment improvements, and technological tools with which to work. The possibilities for improvement are a far cry from what was available in 1985. 

Clearly, some advocacy priorities and tactics have evolved over time. HIV/AIDS is mainstreamed and routine even, close to “normal” if measured by expected life expectancy. Daily advocacy commitments for many individuals have been superseded by the ability to live a normal life. Remaining holes in the HIV/AIDS “safety net” are often local issues, which require local advocacy actions to correct.

As recent polling has shown us, crystal balls do not guarantee accurate predictions, but I think some areas bear watching. They include:

1. The Biden-Harris Administration shows signs of serious policy work. Most are likely to be issues we would support, such as improvements in the Affordable Care Act to cover a bigger piece of the currently uninsured U.S. population. It will be quite the contrast from what we have witnessed since January 2017.

2. Issues around changes in the 340B drug discount program, which might impact access to care for the HIV-positive (and other) demographics.

3. Changes in various state Medicaid eligibility levels, which can be a major factor in access to care and treatment for the uninsured.

4. Ongoing work will continue to be needed on issues like HIV-criminalization, health-related stigma, and the myriad phobias and bigotries circulating about drug additions, nontraditional sexual identity, racial and ethnic communities.

5. Importation safety for prescription drugs not now part of our FDA oversight and supply chain distribution safety oversights.

6. The costs of prescription drugs, most importantly to our HIV populations, in terms of insuring that out-of-pocket costs, deductibles, tier pricing and similar marketing ploys do not result in exceeding the ability of the patient to pay – regardless of their income level – thus leaving the medication on the pharmacy shelf.

All of the above points (and many others) will be in play in the background (and likely foreground) circulation as an incoming President-Elect Biden, Vice-President-Elect Harris, and a new Congress take office in January 2021. All in the context of damage from COVID-19 to the body politic and renewed human rights focus especially in the context of further defining the rights of racial, ethnic, cultural, religious, geographic, gender, sexual identity, religious desires for inclusion, diversity, economic equality. Our hope is we can collectively achieve a better state of fairness, equality and liberty. In short – the promise of “the American Dream”, our founders tried their best to articulate.

The ongoing need for civil discourse, actually policy changes and improvement is likely to be quite strong, which might actually predict substantive policy changes, political compromise, and a desire to rectify past errors that can no longer be ignored.

The goals of advocacy and education will be as important as ever in educating our political leaders at levels from local towns all the up through our national leadership in Washington, where there will be many new faces and new staffs. Firstly, to ensure that the folks we endeavor to speak for do not lose the hard-won gains of the last three decades, but also that their voices are heard in the debates and discussions that we hope will result in productive changes in policies at all levels of government.

As with every organization, change is inevitable. CANN has already started to make some changes in preparation for January 20th, when our country can collectively turn the page. As evidenced by the launch of our new microsite as the repository of information for our acclaimed HIV/HCV Co-Infection Watch, we will be building upon the good work done in this area over the last five years under the stewardship of our policy consultant, Marcus J. Hopkins. And Marcus, thank you for all of your hard work!

In anticipation of the issues surrounding the 340B drug discount program resurfacing in the next Congress, CANN welcomes its new policy consultant, Jen Laws. Jen’s community level knowledge about 340B’s impact on Ryan White providers and engaging patients on strategic communications and data analysis will play a central role in our work on HIV/HCV co-infection moving forward. And Jen, welcome aboard!

As we have since 1996, CANN hopes to continue as a constructive voice in the multiple process we’ll face in the next four years. Advocacy and education activities in person, by organizations, in multiple coalitions will be as important as they have been for the last three decades – perhaps even MORE important – as the cheeseboard of political life now has more movable pieces than ever and specific policy changes affect many different stakeholders.

__________

Disclaimer: HIV-HCV Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HIV-HCV Blogs might be graphic due to the nature of the issues being addressed in it.