Biden’s State of the Union: Bold Promises on Public Health

On March 1st, President Biden delivered his first State of the Union Address to both chambers of Congress and the American people at large. Amid a slew of foreign and domestic policy proclamations, particular attention should be afforded to the statements and commitments made about addressing the COVID-19 pandemic and public health, more broadly. Championing the landmark legislation that was the American Rescue Plan, the President laid out how the legislation’s programming reduced food pantry lines, increased employment, and how expansion of the Affordable Care Act’s subsidies resulted in lower insurance premiums for many Americans. In addressing the COVID-19 pandemic, Biden also recognized a sobering outcome that will shake the nation: within the next few weeks, the United States’ official COVID death toll will surpass one million people. Though the President misstated the moment in that those empty seats at dinner tables will be more than a million; on average each COVID death has impacted 9 other people, including orphaning children across the country. Biden then shifted the address, citing the Centers for Disease Control and Prevention’s recent announcement of adjust masking guidelines and metrics of risk, trying to signal a much-needed political win in the fight against COVID. However, immediately following these statements, the President also focused on providing the country with another round of free at-home COVID-19 tests and implementing a tactic already well-known in the HIV space: test-to-treat, with added bonus of the program following the COVID vaccine model and having no out-of-pocket expense for patients.

The program ideals outlined in the days that followed found some confusion, need for clarity, and even some professional association bickering. Public health professionals who have long advocated for more robust responses to the pandemic took to news outlets to vent their frustrations and the American Medical Association drew derision on social media for their statement discouraging pharmacists prescription and provision of COVID antivirals. Pharmacists have long been a target for HIV advocates, especially in terms of increasing pre-exposure prophylaxis (PrEP) access and decreasing test to treat initiation delays. Wouldn’t it be nice if this COVID program provided a model outside of vaccination in which pharmacists could also serve a more robust role in facilitating seamless treatment and prevention? The meaningful hiccups the administration and advocates should keep a close eye on in this regard is the labor shortage of pharmacists, closing of more rural locations for chain pharmacies, and any developments around anti-competitive practices of pharmacy benefit managers (PBMs) associated with pharmacies. Consequences of these will extend beyond immediate COVID programming and ideal HIV programming.

The President also made statements referring to medication costs and price controls and needing to make sure more Americans could afford their care. However, details were lacking and if any recent effort is indicative, singularly focusing on manufacturer list prices won’t address patient costs or get much anywhere. Buyer beware, some proposals in the apparently sunk Build Back better legislation would also cut provider compensation in public payer programs, a dire consequence as the nation struggles with health care staffing shortages. Those shortages should be noted in detail because the American Rescue Plan provided funding meant to supplement the financial demands of staffing a pandemic and there’s good reason to suspect administrators, rather than providers, enjoyed the fruits of that labor. Further, most Americans experience their out-of-pocket costs of care due to the benefit design of their insurer (and PBM), not the manufacturer list price. Indeed, the Biden Administration appears to eb as insurer friendly as the Obama admin. To impact the costs facing patients more meaningfully at the pharmacy counter and other burdens in accessing medication, the Biden administration should focus more on developing patient protections via the regulatory process, limiting the aggressive utilization management (or deny-first coverage) policies, increasing formulary restrictions, and discriminatory plan design. Some of the tools for doing so already exist, but the federal government has yet to curb the tactics of payers in avoiding their responsibilities under the ACA’s medical-loss-ratio rules or ensure payers are not inappropriately applying cost-sharing for qualifying preventative medications and services.

The President also became the first to mention “harm reduction” in a State of the Union Address. Urging Congress to pass the Mainstreaming Addiction Treatment Act (MAT Act), President Biden is seeking to fulfill his commitments to address the opioid epidemic and move toward modernizing domestic drug policy. In a sign of acknowledgment of the scope and size of substance use epidemic in the country, Biden endorsed recovery programs and recognized the more than 23 million people struggling with addiction in the country. Immediately following the MAT Act mention, the President moved on to address of a lesser defined but equally important need in encouraging commitment to a robust set of policy ideals aimed at meeting the mental health needs of the country.

All these good things can easily be outweighed by what wasn’t mentioned. President Biden did not mention any interest in extending another round of stimulus payments, despite the program resulting in one of the largest reductions in poverty in US history. And while there was focus on rebuilding the nation’s health care staffing, no mention was afforded to rebuilding the nation’s public health infrastructure. Meanwhile, we’ve known for quite some time poverty as a notable association with HIV and decreasing poverty also decreases HIV risks and prevalence, data remains in the decline with regard to HIV and STI screenings, Hepatitis C rates are still on the rise, and inconsistencies in PrEP usage during the height of initial COVID waves likely foretells a more diverse at-risk community. Even the government’s own HIV.gov webpage dedicated to the State of the Union fails to mention any HIV or HCV specific programming efforts associated with the address.

While there’s much to celebrate about the President’s COVID goals, advocates should be cautious about projecting those goals onto other public health efforts. Afterall, COVID proved we could provide more up to date reporting than the 2 year delays we typically see in HIV and HCV surveillance, but we haven’t. COVID-related telemedicine expansion was welcomed by patients across the nation but Congress is poised to claw back those gains. For many of us, while the state of the union is improving coming out of the Omicron wave of the COVID-19 pandemic, much work remains. Including reminding this administration that it is empowered to protect patients, access to and affordability of care, an obligation to invest in public health programs beyond COVID and has committed to advancing efforts to End the HIV Epidemic.

Return of the Flu: Flurona, a Co-occurring Infection that is NOT

The beginning of 2022 brought about an ominous rise in COVID-19 cases as the Omicron variant began to ravage the United States in earnest, with the Centers of Disease Control and Prevention reporting about 1.3 million new cases on January 10th. While this report is inclusive of a weekend backlog, representing the majority of states’ reporting for 2 days, rather than 1, this kind of report for any respiratory transmission is truly startling. In the background, another virus with a respiratory transmission mode, influenza, had been crushed to near non-existence during the 2020-2021 season, according to the CDC’s FluView surveillance report. Indeed, on the surface, what appears to stop COVID transmission, stops flu transmission even better. But with the relaxing of mitigation measures, “pandemic fatigue”, and society eagerly looking to move on, the flu has begun to mount its seasonal return.

In comes the frightening shadow of “flurona”! Social media sites buzzed with the dire warning experts had given in 2020: a ghastly winter with two very dangerous, highly communicable diseases ripping through the nation. The difference in late 2021 and early 2022, compared to the year before, is obvious: wide access to COVID-19 vaccinations (in the United States, at least) and a continuation of annual influenza vaccination availability. This co-occurring infection, however, isn’t new. Indeed, the United States likely experienced some combined infections during the early days of the COVID pandemic in 2020, prior to the wide availability of diagnostic COVID tests, and again in the 2020-2021 flu season. While the instances may have been relatively rare due to the decrease in influenza transmission, the situation was not entirely unknown. It was, after all, the CDC’s FluView surveillance that shaped our initial tracking of community transmission of SARS-CoV-2 (the virus that causes COVID-19); the surveillance program tracks weekly reports from health care providers and local and state health departments of influenza like illness (ILI) incidence and the results of flu screenings in order to ascertain key metrics of public health response.

Let’s pause for a moment to acknowledge just how remarkable the 2020-2021 flu season was. A key measure in tracking influenza is pediatric mortality. In both the 2018-2019 and 2019-2020 flu seasons, the CDC reported 144 and 199, respectively, pediatric deaths attributed to the flu. In the 2020-2021 season, the CDC reported only 1 pediatric flu death (CDC data application). The total national percent positivity (or number of reactive tests relative to total tests administered) for influenza during the 2020-2021 flu season never crested the national baseline for the season of 2.6% positivity compared to only being about half way through the season this year and already having crested the national baseline (2.5%) for the last 5 weeks. In the 2019-2020 flu season, percent positivity for the flu crested the national baseline (2.4%) for 22 weeks.

We shouldn’t be dismissive of influenza. It is still a serious illness that hospitalizes many, especially vulnerable populations. National vaccination programs have done a great deal to help curb the potentially deadly impacts of influenza, though, schools have been known to be shut down due to flu outbreaks, including in early 2019. The idea of selective mitigation efforts coming and going in order to address outbreaks, isn’t new.

So here we are with Flurona – an incidence which may well have been happening this whole time, but because we don’t specifically track this particular co-occurring infection, we can’t say for sure. While there’s limited data on what to expect with a co-occurring flu and COVID infection, that data is a tad concerning; mortality did not necessarily increase but the symptomology of this type of situation did require frequent use of mechanical ventilation.

The catchy combined name of these viruses went…well…viral, even if only for a short period of time. As the project director for CANN’s HIV-HCV Coinfection Watch, the idea of a co-occurring viral infection didn’t surprise me. And it probably doesn’t surprise many of our readers here. The fact that it did surprise many members of the public, even after Dr. Anthony Fauci and other officials had previously mentioned the possibility, is indicative, inditing even, of how information is delivered and disseminated in today’s world. Numerous studies have been done on the amount of stress and anxiety people are experiencing in light of the COVID-19 pandemic. The CDC has also dedicated a page to “Coping with [pandemic-related] Stress” and many states have adopted mental health helplines for residents to dial into. The relationship between the public, experts, and news media is deeply damaged by practices of all parties – a busy public less interested in reading longer, more detail articles, a news media competing for clicks and attention in order to fund their outlets, and experts competing for space and importance because of outlet bias and lack of vetting have all harmed our ability to cohesively respond to the COVID-19 pandemic.

I’m not usually one to say “can’t we all just get along”, my job, in fact, is often about digging deep into spaces of disagreement or interest conflict and hammering out mutually beneficial concessions. This place we’ve found ourselves in as a society, where we’re all operating out of scarcity and competition at all costs is ultimately how we all “lose”; be it this pandemic, the next, or even in combatting long standing ills already needing address. Patient advocates and public health officials having to divert time and resources to educate patients and the public when a panic-inducing headline aimed at derailing the reader’s tasks is, in fact, derailing to multitudes of efforts to better the world around us if by sheer inability to focus on our tasks at hand.

If you’re struggling with coping with stress of the pandemic, flurona headlines, COVID variant headlines, any headlines, please, take a moment to review the National Alliance on Mental Illness (NAMI) COVID Resource and Information guide, or give them a shout on their hotline to be directed to area specific resources by calling 800-950-6264 or by clicking “chat with us” at the bottom of this page.

There’s little in this world that can’t be made a tiny bit more manageable with a snack, a nap, or a hug. Check those boxes, take a deep breath, and know you’re not alone.

HIV & Covid-19: A Story of Concurrent Pandemics

On September 20th, Johns Hopkins’ COVID data tracker totaled the “confirmed” (note: not “official”) number of deaths from COVID-19 in the United States to surpass 675,000 – or the estimated number of deaths in the US due to the 1918-1919 H1N1 influenza pandemic (colloquially called the “Spanish flu” because Spanish media were more willing to discuss the pandemic than most other countries). Forbes, STAT, and other large news outlets ran headlines like “Covid-19 overtakes 1918 Spanish flu as deadliest disease in American history” or included statements in their articles like “It was the most deadly pandemic in U.S. history until Monday, when confirmed coronavirus deaths overtook the death toll for the Spanish Flu.”

Which, as Peter Staley pointed out, isn’t factually accurate.

Image: Twitter.com - @peterstaley (Sep 20, 2021) “Um, HIV/AIDS?  700,000 U.S. deaths (and counting), according to the http://HIV.gov https://hiv.gov/federal-response/ending-the-hiv-epidemic/overview”

Staley would quickly admit COVID-19 would or already has likely overcome the death toll of HIV in the United States. While I agree with this analysis, I would add “for now”.

The very nature of HIV has made finding a “cure” or vaccine for the virus an oft sought after “holy grail” in pharmaceutical development. While that grail may have been snatched away by the attention COVID-19 is justly generating, this isn’t the first concurrent pandemic HIV has run alongside. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) both refer to the H1N1 influenza outbreak of the 2009-2010 flue season a “pandemic”. The problem of course isn’t just how deadly COVID-19 is, its’ how botched the domestic and global responses have been to the disease.

Viruses, after all, are opportunistic. They have a singular purpose: reproduce. As such, viruses thrive in environments – ecosystems, if you will – that are sorely neglected, lack coordinated responses, and are largely inequitable. But we knew that. We’ve known that with regard to global and domestic health disparities data for decades. As with personal health, emerging, urgent issues in public health reduce our capacity to address existing issues effectively.

As I mentioned in previous blogs, and has been recently noted by the Global Fund, COVID-19 has drastically reduced the efficacy of existing HIV, HCV, STI, and SUD programs. Even still, Global Fund’s report proves a rather interesting point – when meeting the demands of advocates for programs to provide patients with multi-month supplies of medications, meeting people in their own neighborhoods rather than in clinics, and providing at-home testing kits, communities can be activated in care at an exceptional level. Despite the COVID-19 pandemic raging, the needs of the HIV pandemic didn’t stop. And while meeting those needs faltered some (with 4.5% fewer mothers receiving vertical transmission prevention medications, an 11% drop in prevention programming, and a 22% reduction in testing services), in some areas meeting those needs thrived. Global Fund’s report found South Africa was able to increase the number of people receiving antiretroviral therapies by more than three times the baseline, even while fighting on two fronts.

Dr. Sioban Crowley, Head of HIV at the Global Fund, pointed out these program designs are not exclusive to HIV, “If we can keep 21.9 million people on treatment, we can probably deliver them a COVID test and a vaccine.”

Indeed, with the United States’ (and the world’s) response relying heavily on expertise gained in the fight against HIV, one can reasonably ask “If we know how to beat this, why aren’t we…just doing that?”

“That” being what advocates have long asked for: a more dedicated, equitable landscape and adequate support of our public health systems. As with COVID-19, a vaccine won’t “cure” us of HIV if the rest of the world cannot access it. As with HIV, if preventative services, adequate testing, and necessary education are not readily made available to people where they are, we will continue to fail in both fights. If we don’t wish to repeat the losses we’ve already experienced in the fight against HIV, then we cannot keep making the same mistakes of kicking the costs of these investments down the road and maybe, eventually “getting to it”.

As has been said many times through the latest pandemic, “the best time to do the right thing was yesterday. The next best time to do the right thing is today.” It’s time for us to do the right thing and stop allowing backbone public health programs to fall by the wayside in the face of the next emergency. Today, for the next few years, it’s COVID. We don’t need to “wait” for that to end. There’s two pandemics occurring, it’s time we act like it.

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.

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.

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.

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.

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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.