Degrees of Separation: Social & Spatial Networks of HIV & HCV

In 1929, Frigyes Karinthy posited a theory many of us might attribute to Kevin Bacon: everyone on the planet is but six degrees of separation (or less) from one another. Depending on how one would measure a connection, that metric is likely far less than it was in 1929. Beyond social media marketing, connecting these networks of friends and friend-of-friends has been pretty important to the concepts of “partner testing and notification” utilized by disease intervention specialists to disrupt chains of transmission in terms of STIs and HIV. What’s been less well understood is the geographic relationship between areas experiencing outbreaks or “clusters” or the specific venues in which transmission occurs – social-spatial networks.

A study performed in New Delhi sought to better understand the relationship between social circle and gathering venue among “hard to reach populations” homeless people and/or, particularly, people who inject drugs. Originating recruitment from within community, asking community to propel recruitment, and paying particular attention to the “mutuals” between otherwise unconnected participants, the researchers sought to better understand the relationship of “risk” of transmission not just in behavior or large geographic area but in specific places in which specific behaviors are part of the culture – the community standards, if you will - of that venue. Researchers found 65% of participants had HCV antibodies, of which 80% had an “active infection” and most were unaware of their HCV status. Similarly, of those participants living with HIV, 65% were directly connected with another participant living with HIV. Researchers did not specify these connections to be causative – those connected did not necessarily transmit either virus to one another. Further, researchers found partaking at the most popular venue was associated with a 50% greater likelihood of a participant having an HIV or HCV diagnosis. Even if a participant did not access the most popular venue, if they associated with someone who did, their likelihood for being diagnosed with HIV or HCV was 14% higher. And the more degrees of separation a participant had from someone who accessed the most popular venue, the less the likelihood of a diagnosis.

The researchers conducting the study were hoping to identify methods of understanding that would allow for effective interventions that reach beyond the individual level. Can group behavior be influenced beyond recruitment and toward changes? Can harm reduction strategies or housing programs find greater efficacy, a better stretch of our dollars, by better understanding where these networks exist and how they operate?

Or is this association merely a by-product of sharing certain characteristics society has deemed unworthy of care? Those social ills that drive disparities in health and poverty and addiction may also drive those experiencing these harms of bias and negligence to seek a social network that at least understand their struggles. To be a little less alone in these struggles.

As is the nature of most things, a better understanding of behavior doesn’t always lend itself to building positive interventions. The same ability to navigate networks in areas where people living with HIV are discriminated against and people who inject drugs can easily be criminalized, rather than connecting to care. With molecular surveillance generating the ire of HIV advocates over fear of this kind of detailed knowledge being used by law enforcement, advocates should also keep a keen eye on how networks may be weaponized as well.

Understanding the spatial relationship within a social network could be a powerful public health tool that shifts our focus from individual intervention to far more meaningful interventions, so long as we can keep the focus of this type of research and the information gathered from it squarely aimed at building up the “public” part of public health rather the continuing to push the responsibility of public health on individual behavior.

Potentially Powerful Tools: A Vaccine in the Fight Against HCV

In 1989, Sir Michael Houghton helped discover the Hepatitis C Virus. Last year, he was awarded the Nobel Prize in Medicine for this same discovery. Now, he’s aiming to create a vaccine against the virus.

Just a few weeks ago, Houghton announced an effort at the University of Alberta’s Li Ka Shing Applied Virology Institute that could have a adjuvanted recombinant vaccine ready for global deployment by 2029. Both new mRNA and viral vector vaccines, used in the COVID-19 vaccines currently authorized by the Food and Drug Administration under an emergency use authorization, have the potential strength to produce multiple kinds of antibodies, solving a long-held problem in the search for an HCV vaccine.

A couple of words of caution: A recent study, using two viral vectors, while successful producing HCV specific T-cells, failed to prevent chronic HCV infection. The last decade has seen several attempts at developing an HCV vaccine but few have made it to human trial, specifically because of evasive properties of the virus’ genotypes to behave differently or escape the body’s natural defenses.

If Houghton and his team are successful, a 2029 launch would likely still have much of the globe well behind the World Health Organization’s 2030 goals but adding a clear, definitive prevention tool stopping chains of transmission would, in theory, help countries playing “catch-up”. With complications from Hepatitis C killing more than 400,000 people annually – and possibly more in the coming years due to COVID-19-related disruptions in care – a vaccination effort could very easily save millions of lives and save billions in public health and health care funding. Houghton suggested Canada alone could see a reduction in HCV-related costs of 98%, or $20 million as opposed to $1 billion – annually due to the high costs of direct acting agents, which are the current gold standard in HCV care and can be curative.

However, if global access to COVID-19 vaccine difficulty and notable vaccine distrust and failure to uptake have taught us anything, having the technology is not the same as having the technology. COVID-19 doesn’t appear to be slowing down, despite recurrent waves, and supply demand on shared vaccine ingredients could find HCV deprioritized.

Additionally, there’s other potential complications to consider. While the United States has seen an increase in Hepatitis B vaccine acceptance, in part thanks to an infant vaccination schedule inclusive of HBV, a study published last year found waning immunity over the years post-vaccination. Now, the CDC’s information page does not recommend HBV boosters and technology may differences may naturally boost efficacy of vaccines but anything that needs additional follow up, like multi-stage vaccines or boosters, are always prone to follow-up failures. And – yet again – COVID-19 provides an excellent case study in this (and all other hidden asterisks). With “anti-vax” sentiments rising at exceptional rates, especially associated with “new” technologies, adding yet another vaccine to the schedule may find barriers in acceptance other common vaccines haven’t run into, at least not on this scale.

Nevertheless, a successful HCV vaccine that answers the challenges of the virus, the conspiracy, and the supply would be a game-changer (to use an unfortunately over-used phrase).

If advocates and policy makers have learned anything, being well prepared for an ever-changing environment in terms of technological advancements, the advancement of anti-science sentiments, and a whole host of other challenges is to our benefit. Analyzing the years between now and, hopefully, 2029, perfecting routine vaccination programs and ensuring actual global equity in access and distribution are critical to making sure this kind of discovery doesn’t go to waste.

Community Roundtable Emphasizes Impacts of Covid-19

In late June, Community Access National Network hosted a virtual Community Roundtable on Covid-19’s Impacts on HIV, Viral Hepatitis, Sexually Transmitted Infections, and Substance Use Disorder. CANN’s policy consultant (yours truly) was joined by A. Toni Young, founder and executive director at Community Education Group, and Kenneth Westberry, senior manager of policy and government relations at the National Coalition of STD Directors, in discussing the wide-reaching impacts of the Covid-19 pandemic and subsequent public health emergency on the nation’s longest and most well-funded public health service providers…so far. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmseutical companies, and federally or state funded service providers from 20 states and the District of Columbia. The event was sponsored by ADAP Advocacy Association, ViiV Healthcare, Abbvie, Merck, and Janssen Pharmaceutical Companies of Johnson & Johnson.

Toni started off a whirl wind of information with making direct comparisons between the previous year’s overdose death rates and this year’s and emphasizing the plight of West Virginia by comparing the nation’s increases to the state’s. This opened the roundtable with a clear message that would ring through with every new data point: the pandemic’s impacts are not equal. Building upon the point made in a blog post earlier this year, Toni pointed to a stark decrease in HCV screening and, more pointedly, reviewed available data on HCV medication access – showing a decrease of 37-48% during the first few months of the public health emergency. She warned listeners not view initial lower incidence rates as optimistic, rather these findings should be viewed under a lens of a lack of access to screening and services. She further stressed the lack of SUD services accessed at the beginning of the pandemic resulting in alarming increases in injection drug use-related HIV diagnoses as a year over year trend with 2021 looking even more worrisome. Rounding out this segment of the roundtable, Toni cautioned attendees: we have good reason to believe screenings will not necessarily return to their pre-pandemic levels in a speedy fashion or without additional effort and funding.

I followed Toni’s dynamic presentation, picking up with the Centers for Disease Control and Prevention surveillance reports for 2015-2019 – reminding the audience federal level data often lags by two years and the CDC has already presented data for 2020 on fewer HIV tests being performed. This portion of the presentation highlighted disparities in HIV along geography, racial and ethnic lines, as well as sex assigned at birth. I needed to note: gender identity is not uniformly collected data in HIV surveillance. The CDC’s pre-exposure prophylaxis data was similarly…unfortunate. With right around 10% for Hispanic/Latino people identified as living at risk for HIV receiving PrEP services and medication in 2018 and just over 6% of African American/Black people living at risk for HIV receiving PrEP services and medication in the same year. Similarly, people assigned male at birth were more likely than people assigned female at birth to have access to PrEP. Looking to the pandemic, I cited two Kaiser Family Foundation reports one on the similar disparate impacts between HIV and Covid-19 among racial and ethnic communities compared to their white peers and the other on Covid-19’s impact on Ryan White service providers. The KFF reports showed service providers reporting an increase in patients without insurance or receiving Medicaid, some clinics reporting a decrease in patient retention and other reporting increases in patient retention, and clinics reporting a decrease in patient demand for HIV screenings and accessing PrEP services.

The final presenter, Kenneth Westberry, began by giving a brief overview of the state of STI’s as public programming: a steady increase year over year in reported STI incidence, a lack of significant funding increases in the last 15 years, and nearly 40% of clinics reporting a decrease in hours or closing entirely during the height of Covid-related restrictions. Of the particular burdens, Covid-19 brought state and local health departments, nearly 80% redeployed their staff from STI programming to Covid-19 programming, reducing capacity to manage STI caseloads, and facing an unprecedented lack of testing supplies as manufacturers also refocused on making Covid-19 tests. Kenneth then reviewed the findings of NCSD’s surveys seeking to evaluate the state of STI programs (phase I, phase II, and phase III) showing many health departments are still behind in terms of having enough staff to meet the needs of both Covid-19 as a public health emergency and regular STI programs.

Moving onto the nuts and bolts of the federal response to Covid-19, Kenneth highlighted the role of disease intervention specialists historically and in response to Covid-19, answering the “why” the Biden Administration’s change in stature toward the pandemic was critically necessary. Particularly, the American rescue Plan Act added $1.13 billion to expand and sustain current DIS and the President’s budget request includes an increase in funding for STI programs in addition to current spending levels.

The three panelists then spent a brief amount of time discussing the funding weaknesses exposed by Covid-19 diverting resources. In a particular “shot across the bow”, Toni stated “Health departments and appropriators have learned Ryan White dollars aren’t sacrosanct anymore. If the emergency is big enough, they can grab those monies,” urging advocates to keep on their toes and watch actions at the state and local as much as they do at the federal level. Each panelist also mentioned a need for greater collaboration between “silos” in order to reach the nation’s lofty public health goals with regard to HIV, HCV, STI’s, and SUD.

Panelists wrapped up by highlighting upcoming events for each organization, sharing resources, and once again thanking each other, attendees, and sponsors. The slide deck can be downloaded here.

Future events will be hosted to ensure we’re “tracking what’s on the ground” and connecting community partners with pertinent resources and information.

Rising Morbidity: Viral Hepatitis Co-Infection with HIV and Age All Associated with Increased Rates of Liver Cancer

In February, researchers associated with numerous universities across Canada and the United States published one of the most comprehensive data reviews thus far conducted on the incidence rates of the most common type of liver cancer among people living with HIV/AIDS (PLWHA) and PLWHA co-infected with viral hepatitis. The study reviewed data collected as part of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), conducted between 1996 and 2015, with clinical data from 109,283 participants. Conclusions from the study were fairly straight-forward: the combination of HIV status (mono-infection), co-infection with viral hepatitis (HBV and/or HCV) and age all correlated with an increased chance of developing liver cancer (hepatocellular carcinoma [HCC]). The hope of researchers, as evidenced in the study’s introduction was to “inform expectations for other regions with a substantial burden of HIV and HBV-HCV coinfection but with delayed cART [combination antiretroviral therapy] scale-up and limited access to viral hepatitis treatment”.

While most research papers wait to include study limitations at the end, I prefer to open with them as prefacing allows for contextualizing data. The first and primary limitation on the review is clinical information reviewed was necessarily from those people linked to care and correlations provided by the data in the study cannot be applied to the diagnosed-but-not-in-care or undiagnosed population. Second, researchers note, information on relevant, individual health factors were missing from significant portions of participants data (example: smoking and drinking habits, natural clearance of HCV, fibrosis score, and HIV exposure risk). Additionally, data collection was not uniform across all participating entities at the time of linkage to care, though a quality analysis was used to help even things out and ensure the integrity of data comparisons. This lack of uniform protocol also included certain sites not administering or participants not receiving HCV or HBV screening. The last, though likely most significant limitation of the study is the data were collected prior to the advent of curative direct acting agents (DAAs) for HCV, and conclusions cannot be made on the potential positive impacts of readily available DAAs.

A limitation not mentioned and data unassessed is any reference between older ART regimens and newer ones, in which toxicity and tolerability is commonly known to be considerably improved with newer regimens. Liver health monitoring is fairly standard, among other relevant patient labs, for PLWHA because of a relationship between ART and liver health. While it’s understandable researchers who generally enjoy significant funding from manufacturers may wish to avoid broaching this topic, not mentioning the issue, even to say “we can’t make any conclusions on cART tolerability and toxicity as an indicator for adherence or risk of developing HCC” misses an incredibly important elephant in the room for researchers, providers, and patients alike.

Instead, researchers chose to focus on cART “eras” (1996-2000 [A], 2001-2005[B], and 2006-2015[C]), in which there’s a positive correlation between age and era; or those aging with HIV were more likely to be diagnosed with HCC. Highest rates of HCC diagnosis by cART area are as follows: A – between 50 and 60 years-old (HBV co-infection with HIV), B – lower end 70-80 (HCV co-infection with HIV), and C – upper end 70-80 (HCV and HBV co-infection with HIV). This data is particularly valuable on its own, however, as the associated risk cohort shift appears to be very closely related to age (ie. those in the upper end of the C “era” are also those to first receive effective cART and the 20-year age gap between the C and A cART eras).

Ultimately, PLWHA were more than 3 times as likely as the general population to develop HCC and more than 20 times more likely to develop HCC if co-infected with viral hepatitis. HCC incidence among study participants fell along rather predictable lines in terms of HIV related clinical monitoring metrics; those with higher viral loads and lower CD4 counts were more likely to develop HCC.

The study’s finding highlight the need for ensuring access to DAAs and HBV vaccines, ready ART uptake upon linkage to care, and strengthening the integrity of AIDS Drug Assistance Programs, Medicaid Programs, and care provided to incarcerated persons – specifically, ensuring the inclusion of coverage of DAAs in these.

Advocates, providers, and patients can review DAA coverage inclusion in ADAPs and Medicaid and harm reduction policies impacting HIV and HCV with Community Access National Network’s quarterly HIV-HCV Co-Infection Watch report.

Medicaid Access: HCV Medication Stalls

In November 2015, the Centers for Medicare and Medicaid Services (CMS) issued a stark warning to state managers of Medicaid programs regarding restrictive limits on accessing newly developed and emerging direct acting agents (DAAs) for the therapeutic and curative treatment of Hepatitis C. Since then, Harvard’s Center for Health Law and Policy Innovation (CHLPI) has steadily tracked the three most impactful methods of restricting access to DAAs in Medicaid programs: fibrosis restrictions, sobriety requirements, and prescribing provider requirements.

Briefly, fibrosis restrictions require a patient to have advanced in the amount of liver damage to a specific degree in order to qualify for care, sobriety requirements restrict access to DAAs based on a person’s self-attested stated or clinically documented sobriety, and prescribing provider requirements restrict recognition of “medical necessity” to that of a specialist or with consultation of specialist in order to receive coverage of a particular DAA. CHLPI’s most recent survey of Medicaid programs outlines progress of the policies of restriction by state. As of the date of the survey, 4 states maintain fibrosis restrictions, 13 states require some period of abstinence/sobriety with an additional 15 states requiring a patient to participate in some level of alcohol and/or drug screening and counseling, and 18 sates have some level of specialist prescriber requirements. Additionally, Community Access National Network’s quarterly HIV-HCV Coinfection Watch Report details which states cover which Hepatitis C therapies and DAAs under their Medicaid preferred drug lists (PDLs).

Of particular note, the 2015 CMS notice specifically highlight the practices of fibrosis stage and sobriety requirements as running counter to various provisions under Section 1927 of the Social Security Act. A 2020 legal review by CHLPI’s Phil Waters describes various case law and potential enforcement mechanisms in which to combat these restrictions, which may prove prescient for federal enforcement agencies and advocates alike. Of particular note, Waters argues the Americans with Disability Act (ADA) presents a “novel” approach in addressing the most caustic and immediate barrier to accessing DAAs by Medicaid recipients: sobriety restrictions/abstinence requirements. Waters notes opposition to this method of seeking enforcement may argue such policies “benefit” the class of persons affected by same. While 2018 guidance from the Department for Health and Human Services (HHS) recognizes substance use disorder as a disability, the same guidance specifically exempts people currently using illicit and illegal drugs from the protections afforded by the ADA.

As we referenced in a blog earlier this year, the Centers for Disease Control and Prevention (CDC) Hepatitis C surveillance data indicates an extraordinary increase in new HCV diagnoses relative to the opioid epidemic. Arguably, requiring an otherwise qualified Medicaid client to undergo additional, non-emergency treatment or engage in non-medical activities in order to gain coverage of a live saving therapy is necessarily discriminatory. After all, a particular Medicaid pharmacy and therapeutics committee cannot evaluate the degree of limitations a person’s experience with substance use disorder causes and imposing additional requirements that specifically target this particular is counter to best practices. Indeed, requiring a person to “get clean” before receiving life-saving medical care is the exact opposite of managing substance use recovery. Relieving pressures of medical need, housing, and other negative pressures related to determinants of health are what set people up for success in combating substance use.

In order for the Biden administration to fulfill its promises with regard to combating the opioid epidemic, for states to fulfill their responsibilities under the National Viral Hepatitis Strategy, and to meaningfully address the intersection of these syndemics, federal agencies tasked with enforcement of these rules and Medicaid directors should consult and act in alignment with advocates with lived experience and best practices in combating both the opioid epidemic and resulting infectious disease outbreaks and diagnosis, including HIV and Hepatitis C. Just as with strategic, culturally competent approaches to combatting HIV and STIs focus on sex-positive education and access to resources, including prevention and treatment interventions, barrier reduction is critically necessary in order to succeed in this fight. As it stands, Medicaid programs present one of the best opportunities to ensure and enact meaningful access to care in an effort to eliminate Hepatitis C. These access limiting policies also present the biggest barriers to achieving that goal.

Global & National Perspectives on HIV & HCV Co-Infection

On April 26, UNAIDS issued a report briefly detailing the state of HIV and Hepatitis deaths, globally, taking particular note of the issue of coinfection among people who inject drugs. Here in the United States, multiple jurisdictions have declared new HIV and ongoing Hepatitis C outbreaks, all combined with a surge in overdose deaths.

Domestically, federal public health initiatives have long sought to understand and address intersections of these issues, offer guidance, and shifted – albeit slowly – to understand HIV, HCV, and SUD exist as syndemics. And I want to talk about this language.

Syndemic, in general, means two or more linked health problems, interacting synergistically, and contributing to the disease burden of a given population; operating in a fashion that feed one another. To prevent or treat a syndemic, entities must not only treat each health problem but also the social ills that bridge these health problems.

This distinction is important – if we are to meet any of our public health goals on any of these, we need expertise, advocates, and structural support that both address the singular nature of each and the intersections, un-siloed from one another. Unique expertise in designing solutions is as valuable and necessary as expertise with the vision to see the whole system.

As we move through the COVID-19 pandemic, well-publicized discussion on the conflicts between national strategies and local actions mirrors fights patient and policy advocates have been fighting for four decades and continue to fight today. Even as we’ve made progress in ensuring direct acting agents (DAAs) are included in AIDS Drug Assistance Program (ADAP) formularies, at least one state has set an unchallenged precedent of denying this basic care to incarcerated people based on budgets and the Democratic mayor of the city with the “most concerning” HIV outbreak in the nation has back tracked on commitments to work with local public health experts.

This quarter’s HIV-HCV Coinfection Watch Report highlights some progress in syndemic-oriented policy changes and some more…unfortunate changes. While the American Rescue Plan, passed earlier this year, provides for more funding to address state budgets harmed by COVID-19 related revenue decreases, a few states have instituted – and currently maintain – restricted services. For example, while Georgia’s ADAP maintains DAAs on the formulary, payment for same is halted due to funding and Texas’s ADAP has removed all HCV medications, except one DAA from the formulary. Positive notes from earlier this year include Kentucky’s Medicaid program moving to a universal preferred drug list (PDL).

Of the space that has the greatest amount of room to progress and needing nuanced advocacy changes is harm reduction policies. Well-established federal policy and laws only reach so far if state and local laws act in direct opposition to those model positions or even merely lack the funding to establish comprehensive programs. One such space is the near universal adoption of “Good Samaritan Laws”, wherein, generally speaking, if a person, regardless of capacity, does their level best to help another, they cannot be held liable. However, several states have amended their “Good Samaritan Laws” or criminal codes to remove that liability protection from people who distribute illicit substances – disincentivizing reporting of overdose incidents and calling for medical help as they happen. Along the same lines, doctor shopping laws are aimed at preventing patients from seeking multiple prescriptions or seeking multiple providers if one is unsatisfied with their care. However, many states rely upon “lock-out” programs administered by insurance providers or managed care plans to implement under the guise of preventing “drug seeking behavior”. As Alison Gaye stated in a recent presentation to Louisiana’s Commission on HIV, AIDS, and Hepatitis C Education, Prevention, and Treatment, “drug seeking behavior often looks like care seeking behavior, subject to the personal biases of the examining provider”.

Harm reduction policies are in dire need to evolve and delve into the difficult nuanced spaces currently unaddressed if we’re to meaningfully work to end the syndemics of HIV and HCV. Far, far too often the solution found by policy makers in addressing public health needs has been to incarcerate those among us who need help. Driven by stigma, whether the issue is HIV criminalization or lack of access to standard HCV care or refusing adequate insurance coverage for recovery programs, shoving people into prisons has not served this country well on any front.

As we step into the next phase of our advocacy, evaluating existing programs, practices, and priorities cannot include a carceral mindset if we are to effectively reduce the harm caused by these syndemics and our past policies.

SCOTUS Sets Dangerous Precedent for Incarcerated People Needing Care

The 8th Amendment to the United States Constitution reads as follows:

“Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.”

Long standing precedent, Estelle v. Gamble, sets one standard of “cruel and unusual punishment” as “deliberate indifference” to the medical needs of incarcerated people. Additional precedents include an affirmative need to evaluate these medical needs on an individual basis, cannot be excused as mere neglect when an incarcerated person is at “substantial risk of harm” if that need is not met, and that providing care that is “grossly inadequate as well as by a decision to take an easier but less efficacious course of treatment” are also considered measures of “deliberate indifference”.

In August 2020, the US Court of Appeals for the 6th Circuit added an asterisk: “…if the state decides it can afford to…” provide the care required under the 8th amendment [paraphrasing].

Last month, the Supreme Court of the United States refused to hear the appeal of Atkins v. Parker, where a group of incarcerated people alleged their 8th amendment rights were violated because the state was rationing their HCV related care. In the 6th Circuit appeal, the state argued, successfully, that rationing care was “reasonable” due to budgetary constraints supposedly outside the control of the prison system.

Coverage of both appeals referred to a 2018 settlement in Michigan, wherein the state’s Medicaid program, after suit, expanded coverage to include direct acting agents. However, in a lone descent, Judge Gilman drew more direct parallels in other SCOTUS and 11th Circuit rulings regarding prison overcrowding and access to AZT (case was in 1991) for incarcerated people, ruling in part “The fast moving status of research and medical advances in AIDS treatment is continually redefining what constitutes reasonable treatment.”, respectively. Indeed, in Atkins, the state’s position boils down to “new drugs are too expensive” to be “reasonable” for incarcerated people to have access to. The majority argued because Tennessee’s Department of Corrections Medical Director, Dr. Williams, had only recently restructured the state’s rationing of DAAs and individual assessments, the state had fulfilled its obligations, within budgetary constraints. Judge Gilman correctly argued the state’s medical administrator for the prisons was obligated to request appropriate funding to meet these needs in order to fulfill the state’s 8th amendment requirements – of which, no evidence was presented to prove Dr. Williams did make such a request. Judge Gilman closes the descent with well-established citation that treating HCV early reduces overall costs of care compared to delayed or denied care.

That said, with SCOTUS refusing to hear the appeal, affected people in prisons are facing a dangerous precedent of state officials shirking their Constitutional responsibilities to provide a basic standard of care to the people in their custody. Legislatures merely need to neglect increasing a budget, as we’ve seen in other state-run health care programs, in order to avoid meeting their Constitutional duties.

Interestingly, also in April, the Department of Justice filed a statement of interest in a case in the Georgia, where an incarcerated transgender woman has been subject to violent attacks and refusal of care. The Biden administration’s position here is denying incarcerated people gender affirming medical care is a violation of the 8th amendment’s protections and is thus “deliberate indifference” to the person’s medical needs.

There’s an intersection between Diamond and Atkins that cannot be missed. While the timing of Atkins didn’t favor intervention by the current administration, this administration must also recognize the precedent set forth by Atkins, fight for appropriate funding measures to meet the medical needs of incarcerated people, and update Federal Bureau of Prisons HCV guidance to with regard to prioritization not justifying rationing of care. As with nearly every infectious disease, prisons are both a “canary in the coal mine” of the local community and the ideal environment for manifesting new diagnoses.

The most startling statistic in Atkins is even after DAAs were available, at least 109 incarcerated people had died due to HCV complications. Death by neglect, by rationing is still a death sentence.

Even as I write this, President Biden argued “health care should be a right, not a privilege.”

As it turns out, according to the 6th Circuit, it’s a right, with a large asterisk.

To ensure this injustice is answered for, advocates must remember the courts do not always find justice and our advocacy must reach every level of government. If we don’t, the asterisks will continue to add up.

Checking-In: 100 Days of the Biden Administration

Advocates in public health and addressing HIV, viral hepatitis, and substance use disorder will affirmatively tell anyone the race to win these fights is a marathon, not a sprint. Globally, despite the devastation, COVID-19 is likely to be much the same with most experts anticipating COVID-19 to become endemic for a variety of reasons. And while every administration takes extraordinary efforts to brand their term with lofty promises of what “starts” in the first 100 days of a presidency, the Biden administration is making some tentative progress in some of those named goals.

Maintaining the brand that arguably helped him win the 2020 general election, Biden’s press team has focused on the sympathetic messaging while delivering policy appeals. One remarkable example likely to please disability and care giver advocates is Biden’s commitment to include an expansion of community and home-based services and better pay, benefits, and the right to unionize in the American Jobs Plan. Indeed, Biden’s infrastructure plan goes far outside of more traditional notions of “infrastructure” and seeks to initiate or expand several initiatives directly addressing to the gaps COVID-19 has highlighted with idea that infrastructure is the economic ecosystem supporting the country, regardless of industry. All of this is on the back of Biden’s American Rescue Plan, which expanded subsidies established by the Affordable Care Act and moves like recently announced renewed funding for Marketplace Navigators for 2022, extension of a universal school lunch program, and expansion of syringe services funding, among others.

The administration detailed further in the President’s Discretionary Budget Request for Fiscal Year 2022, priorities in further spending, namely requesting additional funding for the Ending the HIV Epidemic, reforms to the criminal justice system related to racial inequities and substance use treatment for incarcerated persons, addressing the opioid epidemic with – as some advocates have called – a “reformist” mindset rather than a penalty mindset. While these efforts are a solid move in the right direction and arguably a good down payment on Biden’s campaign promises, they do fall short of some of the funding goals advocates have long sought. And that’s just the beginning of the problems in finding the money to meet those lofty goals. For example, the United States is facing a new height to the overdose crisis and advocates have long argued to meaningfully tackle this epidemic funding needs to answer to the tune of $125 billion. Even if the president were to get his wish list funding of $10.7 billion in addition to the $4 billion provided for in the ARP, this still falls incredibly short of that advocate driven funding goal.

Much of the Biden administration’s priorities are likely to find similar fates and advocates should be prepared to both take their wins and lick their wounds. COVID-19’s havoc isn’t the only thing standing in the way of progress. With the exceptionally narrow divide in the House and Senate, the man seemingly wielding the power of majority leader, Senator Joe Manchin’s dedication to maintaining the filibuster, Democrats have an uphill battle in helping their party deliver on the promises sold to the country. Whether the issue is Nancy Pelosi’s (D-CA) desire to maintain ACA subsidy expansion or an entirely opaque drug pricing policy overhaul or expanding the age eligibility of Medicare, Democrats have promised to go big and if they don’t, they can very likely look forward to “going home”, either in the midterms or 2024.

Meanwhile, COVID-19 has very likely pared back minimal gains made in the South with regard to fighting the HIV epidemic in the United States, HIV and STI health care workers are burning out at extraordinary rates due to having to pull double duty for the last year, studies are finally digging into the hepatitis and HIV related health disparities among transgender people, and every other issue of health equity prior to pandemic has lost ground. Biden’s Health Equity Taskforce should absolutely take into consideration the nuances of emerging data on these existing disparities and advocates should seize this moment and pathway provided by engaging the taskforce on addressing these issues. After all, we’ve argued all along COVID-19 is merely thriving in these long neglected communities and it’s not unique for COVID-19 manifest disparate impacts among marginalized peoples, every other epidemic has.

It’s a marathon, not a sprint.

The Most Meaningful Public Health Intervention: Housing

A note on the language used in this article: Some housing advocates reference a difference between “homelessness” and “houselessness” with exceptional, nuanced conversations on individual experiences with housing instability, connection to community, and personal autonomy. While some advocates may opt to consider a frame of “home is where the heart is” as an issue of empowerment, I, as an author and advocate, use these distinctions because of well-established links between housing instability and uncertainty in situations of domestic violence. A roof does not necessarily a “home” make. For the stakeholder targets of this blog, the link between intimate partner violence/domestic violence and HIV is so notable, the Department of Housing and Urban Development has recently announced funding opportunities for joint demonstration projects between HOPWA and VAWA (Housing Opportunities for People with AIDS and the Violence Against Women Act, respectively).

For 30 years, people living with HIV have advocated “housing is health (care)” religiously. A drumbeat of nearly every action, the inevitable topic of any roundtable or meeting, even if housing isn’t an agenda item – or especially if housing isn’t an agenda item. Arguably, when it comes to issues of “social” Justice and policies impacting the notion of equity, outpacing even health care is housing. Housing is the lone sustainable investment any person or family in the United States can make and, generally, expect to last well beyond their own time. Housing is the basis of both defeating and maintaining systems of inequity and oppression. Housing is such a significant factor in individual and collective outcomes it had its own carve out, separate and apart from the Ryan White Care Act, via the program known as Housing Opportunities for People with AIDS.

Indeed, the housing’s impact on health care is so exceptional, in 2019, the American Medical Association built upon limited calls to improve identification access for people experiencing houselessness and expanded their policy position for more comprehensive and collaborative resources aimed to bring care to this population and called for decriminalizing houselessness. In the same year, the Department of Housing and Urban Development’s annual “point in time” data estimated about 568,000 people were experiencing houselessness on any given night in the United States, a near 10% increase of “unsheltered persons” from the prior year.

Late last month, the University of Bristol published in The Lancet a systemic review and meta-analysis of housing instability and houselessness finding among people who inject drugs (PWID), recent houselessness and housing instability were associated with a 55% and 65% increase in HIV and HCV acquisition, respectively. Additional findings include of the global 15.6 million PWID, over 1 in 6 have acquired HIV and over half have acquired HCV at some point and an astounding estimation that half of PWID in North America actively experiencing houselessness or housing instability.

None of the studies included data collect prior to the start of the COVID-19 pandemic. While several states near immediately began introducing short-term eviction moratoriums and the CARES Act provided for federally backed mortgage holders to seek forbearance or deferment, these protections were short-lived, with many states looking toward the federal government for guidance. As with many issues, the summer of 2020 brought the country little comfort due to a lack of cohesive and coordinated public health response to the emergency. A paper published by housing heavy-weight, Emily Benfer, and HIV champion, Gregg Gonsalves, among others, found this failure to uphold and maintain meaningful and enforceable state-based eviction moratoriums contributed to racial health inequity and cited research finding that lifting moratoriums prematurely, triggering displacement, is associated with an additional 10,700 preventable COVID-19 deaths and 433,700 excess cases. In fact, an organization Benfer serves with, Eviction Lab, rates nearly every state in the country as “one star” in terms of housing protections for renters.

Under this frame, tens of millions of people in the United States are at extraordinary risk of contracting COVID-19. Which is part of why the Centers of Disease Control attempted to flex some public health muscle by issuing an eviction moratorium for public health purposes in October, 2020. Like with other investments made in the fight against COVID, the move was bittersweet for public health advocates at the intersection of housing and HIV, HCV, and SUD syndemics – where was this before now?

“Among the Biden administration’s first priorities is the advancement of racial equity and support for underserved communities,” Benfer said. “This requires redress of the structural and systemic discrimination in housing. As an immediate measure, the federal government should bolster the nationwide moratorium on evictions to apply to all stages of eviction, all forms of eviction, and all renters who face housing instability. At the same time, to prevent an avalanche of evictions and protect small property owners from harm once moratoria lapse, policy makers must provide the rental assistance necessary to address the accumulating back rent and sustain renters, state and local governments, and the housing market—and direct it to the communities at the greatest risk of housing instability.”

“Preventing COVID-19 eviction alone could save the U.S. upwards of $129 billion in social and health care costs associated with homelessness,” Benfer added.

However, the CDC’s moratorium is on shaky ground and implementation/access is not automatic – those seeking to use this protection most pro-actively notify their landlords and express intent to seek cover of the moratorium in eviction court. Several states and localities have not evenly implemented the moratorium or setting up “eviction kiosks” to expedite the process, because so many cases were in que, and some going so far as to list children as defendants in eviction actions. Which, according to Benfer, is not an uncommon occurrence. And due to the lack of protections for tenants and outdated credit reporting associated with eviction judgements, these legal actions can and often do follow people for at least a decade, compounding barriers to housing and drastically increasing the risk of houselessness. Because state-based protections have ended, Texas is allowing evictions to resume and the 6th Circuit Court of Appeals has recently allowed a challenge to the authority expressed by the CDC for the moratorium to move forward, even as some landlords are openly exploiting loopholes in the moratorium.

Landlords aren’t the only abusive persons seeking to take advantage of weaknesses in our housing protections. An unfortunate side-effect of the moratorium actions and our lack of investment in ensuring adequate resources for people experiencing intimate partner violence is perpetrators exploited stay-at-home orders and survivors, who are already at exceptional risk of housing instability, with an estimated 26% increase in domestic violence abuse calls made in some cities across the US during the strictest of those orders.

Additionally, with more people facing a lack of houselessness, even more are now at risk for “mobile homelessness” – or a lack of car to sleep in – an issue which may be masking just how many people are experiencing houselessness and housing instability, due to the design of some point in time surveys are conducted. And with an estimated 49% increase in chronic homelessness expected as a result of COVID-19 over the next 4 years, the potential exacerbation of the existing housing crisis in the US may well likely become an even larger, permanent feature without extraordinary action from all levels of government and, or even especially, private stakeholders. To put this figure into context, this would twice as much homelessness as was caused by the 2008 housing recession.

In The American Eviction Crisis, Explained, Benfer suggests there’s some basic policy moves to be made for longer-term successes:

“In the long term, federal, state, and local policymakers must reform the housing market in a way that provides equal access to housing, thriving communities, and areas of opportunity. Rental subsidies, new construction or rehabilitation, home ownership, and investment in long ignored communities would increase long-term affordable housing. Government-Sponsored Enterprises (GSEs) must remedy the current market conditions that can be traced to racially discriminatory lending policies. This means GSEs must address disparities in asset accumulation and the persistence of discrimination in mortgage lending and the siting of homes.

Where eviction is absolutely necessary, the eviction system itself must be reformed. Evidence-based interventions, such as providing a right to counsel, diversion programs, ‘just cause’ and ‘clean hands’ policies, as well as altering the eviction process, and sealing or redacting identifying information from eviction records, can prevent or mitigate the harm of eviction.”

That long-term investment is well past-due in addressing the needs of people living with and affected by HIV, HCV, and substance use disorder.

Benfer added, “Eviction prevention and the right to safe and decent housing must be the priority. As President Biden said while signing executive orders directed at ending housing discrimination: ‘Housing is a right in America, and homeownership is an essential tool to wealth creation and to be passed down to generations.’ It’s time the U.S. fulfilled the promises of the 1944 Economic Bill of Rights, which includes a right to a decent home, and the 1949 Housing Act that set the national housing goal: ‘the realization as soon as feasible of the goal of a decent home and a suitable living environment for every American family.’ Ultimately, our policies and budgets reflect our humanity and morality as a nation, and nothing could justify the continued denial of basic human needs and access to opportunity. If we are ever to call our society humane or just, we must finally redress housing disparities and discrimination and secure every American’s right to a safe and decent home.”

For far too long, housing as been placed on a shelf as an “unreachable” necessity in actionable advocacy. We cannot afford to “kick this can down the road” any longer. We’ve long known housing is one of the most effective interventions in prevention and in patient care. The oft-touted “it’s too expensive” excuse has manifested a broken dam with lives sifting through the cracks. We already pay for housing for PWID, it’s just most often manifested in the form of imprisonment. A far more meaningful investment in a person’s recovery and success, regardless of recovery, and in community health and in Ending the HIV Epidemic and in ending violence against women and interrupting cycles of generational poverty and answering our most sacred, moral promise and…and…and… would be to address the issue squarely: it’s time to invest in housing.

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.

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.

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.

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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.