The Promise of a Cure: Why Are We Still Failing People with HCV?

Hepatitis C virus (HCV) infection affects millions of Americans, contributing to thousands of preventable deaths each year. While a cure for HCV, in the form of direct-acting antiviral (DAA) medications, has been available for over a decade, achieving widespread treatment access has been a persistent challenge. This challenge is particularly acute among younger adults, who experience the highest rates of new HCV transmissions, often associated with injection drug use.

Historically, the high cost of DAAs led many state Medicaid programs to implement restrictive coverage policies, limiting treatment access based on factors like liver disease severity, sobriety, and prescriber specialty. In 2022, CANN highlighted in a blog post, these policies not only created barriers to care but also undermined public health efforts to interrupt HCV transmission. Advocacy and legal action have played a crucial role in dismantling these restrictions, as evidenced by the Center for Health Law and Policy Innovation's (CHLPI) successful litigation efforts in 13 states, which served as a model for similar efforts nationwide.

While this progress is encouraging, the fight to eliminate HCV as a public health threat is far from over. We must address the remaining barriers to care, particularly those that continue to disproportionately impact people who use drugs and those that persist within managed care organizations.

The Promise and Progress of HCV Treatment

Direct-acting antivirals represent a monumental advancement in HCV treatment. These medications offer cure rates of 95% or higher, achieving sustained virologic response in the vast majority of people treated. The benefits of DAA treatment extend far beyond individual health outcomes. Expanding access to these curative therapies holds immense promise for improving public health by reducing HCV-related mortality, interrupting transmission chains, and generating long-term cost savings.

The Centers for Disease Control and Prevention (CDC) has estimated that approximately 14,200 HCV-related deaths occurred in the United States in 2019 alone, a stark reminder of the urgent need for effective treatment. Treating HCV not only saves lives but also prevents ongoing transmission of the virus. When a person achieves sustained virologic response, they are no longer able to transmit HCV to others. Furthermore, a study published in JAMA Network Open found that HCV treatment is associated with reduced healthcare costs in the long term, as cure prevents the need for expensive interventions related to managing complications like cirrhosis and liver cancer.

The dismantling of restrictive Medicaid policies has been instrumental in increasing treatment access. A JAMA Health Forum study analyzing data from 39 state Medicaid programs found that easing or eliminating restrictions on DAAs led to a significant increase in treatment uptake. Specifically, these policy changes were associated with an increase of 966 DAA treatment courses per 100,000 Medicaid beneficiaries per quarter compared to states that maintained restrictions. This finding underscores the tangible impact of removing barriers to care.

Further progress is evident in the growing trend of states removing prior authorization requirements for DAAs. The 2024 National Snapshot Report from CHLPI and National Viral Hepatitis Roundtable (NVHR) reveals that, for the first time, more states have eliminated prior authorization for most patients than those that still require it. This shift toward streamlining access represents a critical step in ensuring timely treatment initiation.

Persistent Barriers to HCV Treatment Access

Despite the progress made in expanding HCV treatment access, significant barriers remain, particularly for people who use drugs. The 2024 National Snapshot Report from CHLPI and NVHR reveals that nine states still impose substance use restrictions, requiring sobriety or counseling as a prerequisite for DAA treatment. These restrictions are not only medically unnecessary but also demonstrably harmful, as the JAMA Network Open study found a significant association between sobriety requirements and reduced HCV treatment rates. The HealthHIV State of Harm Reduction survey further underscores this point, with respondents reporting that stigma and community resistance pose substantial obstacles to accessing drug user health services, including HCV care.

Retreatment restrictions present another hurdle for people seeking HCV care. According to the 2024 National Snapshot Report, 15 states impose stricter criteria for retreatment than for initial therapy, often denying access based on factors like adherence challenges or previous treatment failure. These policies fail to recognize the complex social and structural factors that can contribute to reinfection or treatment interruptions, particularly among people who use drugs.

Furthermore, disparities in treatment rates among Medicaid recipients persist. The CDC's Vital Signs report found that Medicaid recipients who are Black were 7% less likely to initiate timely DAA treatment compared to White recipients. These disparities reflect the systemic inequities that permeate the healthcare system and demand targeted interventions to ensure equitable access to care.

Discrepancies between state Medicaid policies and managed care organization (MCO) practices present an additional layer of complexity. While many states have eased restrictions on DAAs, the JAMA Health Forum study revealed that these policy changes did not translate into increased treatment uptake in states where DAAs were predominantly reimbursed by MCOs. This finding aligns with the 2022 National Summary Report from CHLPI and NVHR, which found that MCOs often impose more restrictive criteria for HCV treatment access than their fee-for-service counterparts.

These persistent barriers raise serious ethical concerns. Denying treatment based on substance use or adherence challenges perpetuates harmful stereotypes and undermines the principles of patient autonomy and healthcare equity. As Jen Laws argues, "We don't get to tell patients how to prioritize their care based on a payer or provider's biases." The HealthHIV harm reduction survey echoes this sentiment, with respondents emphasizing the importance of meeting people "where they're at" and respecting their right to make informed decisions about their health.

Other administrative barriers, such as requirements to fill prescriptions at specialty pharmacies, further complicate access. The 2022 National Summary Report highlights the challenges posed by specialty pharmacies, which often impose additional restrictions and logistical hurdles that can delay or prevent treatment initiation, particularly for people experiencing homelessness or housing instability.

Harm Reduction and HCV Elimination: A Holistic Approach

Achieving HCV elimination requires a holistic approach that goes beyond simply removing treatment restrictions. We must recognize that HCV treatment access is inextricably linked to broader harm reduction efforts. As Jen Laws aptly stated, "If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what's working and what's not." This means embracing a comprehensive strategy that addresses the social, economic, and structural factors that contribute to HCV risk and disparities.

A 50-state survey of harm reduction laws conducted by the Network for Public Health Law revealed significant variations in the legal landscape surrounding syringe access and naloxone distribution. These variations underscore the need for a coordinated national effort to expand access to these life-saving interventions. The HealthHIV State of Harm Reduction survey further highlights the importance of harm reduction in HCV prevention and care, with respondents emphasizing the need for services that prioritize their safety and well-being.

A truly comprehensive approach to HCV elimination must encompass the following key elements:

• Removal of All Remaining Medicaid Restrictions: Eliminating all restrictions based on substance use, retreatment history, and other arbitrary factors is essential for ensuring equitable access to DAAs.

• Ensuring Parity Between State Medicaid Policies and MCO Practices: States must strengthen oversight and enforcement mechanisms to ensure that MCOs adhere to state Medicaid policies and do not impose additional barriers to HCV treatment.

• Expanding Access to Harm Reduction Services: Increasing the availability of syringe exchange programs, naloxone distribution, and other harm reduction services is critical for preventing new HCV transmissions and connecting people who use drugs to care. However, even in states that do have syringe exchange programs, access can vary widely, with many programs facing funding limitations, geographic restrictions, and community resistance. For example, a 2017 report indicated that 26 states had either no syringe exchange programs or limited these services to one or two major cities. Research suggests that existing programs meet only a fraction of the estimated need, highlighting the need for continued advocacy and policy reform.

• Addressing Social Determinants of Health: HCV elimination efforts must address the underlying social and economic factors that contribute to HCV risk and disparities, such as poverty, homelessness, and lack of access to healthcare. The HealthHIV harm reduction survey found that inadequate housing and transportation were significant barriers to clients engaging in care. Investing in housing, transportation, and other social support services is necessary for creating a more equitable and effective HCV response.

The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing many of these challenges. The plan's key elements include a subscription-based payment model for medications, investment in rapid point-of-care testing, and increased federal support for community-based healthcare infrastructure and provider training. However, as CANN CEO Jen Laws emphasizes, successful implementation requires more than just affordable drugs. The plan must prioritize reinvestment of cost savings into public health systems, support community-based testing and integrated treatment models, and address logistical barriers to care. Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would further strengthen the plan's foundation.

Conclusion

While significant progress has been made in expanding HCV treatment access, the fight to eliminate HCV as a public health threat demands a sustained and multifaceted effort. The Biden Administration's proposed plan offers a promising roadmap, but its success hinges on congressional budget approval and addressing the systemic barriers that continue to impede progress.

To effectively combat HCV, we must move beyond a narrow focus on medication access and embrace a holistic approach that prioritizes harm reduction, addresses social determinants of health, and ensures equitable access to care for all. CANN’s latest HIV/HCV Co-Infection Watch report provides a valuable resource for understanding the current landscape of HCV treatment access and harm reduction programs across the United States, empowering advocates and communities to push for meaningful change. Together, we can translate the promise of a cure into a reality for all Americans affected by HCV.

Equitable and Data-Driven Viral Hepatitis Quality Measures

Viral hepatitis remains a significant public health threat in the United States, affecting approximately 3.3 million people with chronic hepatitis B and C infections. In 2021, there were 12,715 reported cases of chronic hepatitis B (HBV) and 117,105 reported cases of chronic hepatitis C (HCV). Despite the availability of effective treatments, these infections disproportionately impact marginalized communities, including people who inject drugs, those experiencing homelessness, and Black and Indigenous populations. This reality underscores the urgent need for a comprehensive and equitable approach to viral hepatitis care.

Recognizing this challenge, the U.S. Department of Health and Human Services’ (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) has issued a call for public comment on proposed viral hepatitis quality measures for Medicaid. This initiative, aimed at supporting the nation's goal of eliminating viral hepatitis by 2030, focuses on a crucial measure: hepatitis C screening and treatment initiation.

OIDP's call for public comment presents a critical opportunity to advance health equity, strengthen data-driven decision-making, and foster collaboration to accelerate progress towards eliminating viral hepatitis as a public health threat. Engaging in this process is essential for ensuring that the final measures effectively address disparities, improve care, and ultimately save lives.

The Landscape of Disparities and the Need for Action

The urgency for action is amplified by the significant disparities that exist in HCV care. Research consistently demonstrates that Black, Indigenous, and people of color, as well as those with lower socioeconomic status, face significant barriers to timely diagnosis and treatment. A study of Medicare beneficiaries found that while disparities in Direct-Acting Antiviral (DAA) use between Black and White patients narrowed by 2016, socioeconomic disparities persisted, with those receiving a Part D low-income subsidy less likely to access these life-saving medications. As the researchers noted, "DAA use among Medicare patients remained far below the level needed to eradicate HCV. The black-white gap in HCV treatment was closed by 2016, but disparities by patient socioeconomic status remained."

These disparities are deeply intertwined with social determinants of health. Factors such as poverty, limited access to healthcare, inadequate transportation, and low health literacy create significant obstacles to receiving quality HCV-related care. As one study aptly pointed out, "A variety of elements contribute to lower quality of care in rural areas, including shortages of medical equipment and services, poor health literacy, lack of transportation, and travel time and long distances."

Quality measures offer a vital tool for dismantling these barriers and fostering health equity. By tracking screening rates, treatment initiation, and outcomes across different populations, quality measures can illuminate where disparities exist and guide targeted interventions. They provide a data-driven framework for holding healthcare systems accountable for providing equitable care and for measuring progress towards eliminating viral hepatitis.

Analyzing the Proposed Measures

At the heart of OIDP’s proposal lies the HCV screening and treatment initiation measure. This measure, designed to track the percentage of Medicaid beneficiaries who receive both timely screening and treatment for HCV, is structured with a clear numerator and denominator. The numerator encompasses those Medicaid members who are screened for HCV and, if diagnosed, initiate treatment within a specified timeframe. The denominator includes all adult Medicaid enrollees within a defined age range, excluding those with evidence of Medicare or third-party insurance coverage.

This measure, viewed through an equity lens, holds immense potential for dismantling the barriers that prevent marginalized communities from accessing life-saving HCV care. By promoting universal screening, the measure encourages a proactive approach to diagnosis, reaching people who might otherwise remain unaware of their infection until they experience serious complications. Furthermore, the focus on timely treatment initiation is crucial for addressing disparities in treatment access. By tracking this metric, healthcare systems can be held accountable for ensuring that all patients diagnosed with HCV receive prompt and effective treatment, regardless of their background or socioeconomic status.

The transcript from HHS’s Viral Hepatitis Quality Measures Technical Consultation Meeting provides compelling insights into how similar measures have been leveraged at the state level to advance health equity. Dr. Su Wang, a clinician and advocate deeply involved in hepatitis care, shared her perspective, stating, "We really believe, those of us who have been doing this clinical work and also advocacy work, that quality metrics can really help us achieve hepatitis elimination by 2030." This sentiment is echoed by the experiences of states like Michigan, which has implemented a suite of HCV quality measures, including those focused on screening during pregnancy and medication adherence. These measures have not only helped Michigan track progress towards elimination but have also provided valuable data for identifying and addressing disparities in care.

Data Considerations

The success of this measure hinges on the feasibility of data collection and the robustness of the data sources used. While claims data, readily available through Medicaid programs, offer a practical starting point for tracking screening and treatment initiation, this source has limitations. Claims data primarily capture billing codes, which may not fully reflect the nuances of clinical encounters or capture social determinants of health that influence care access.

Electronic Health Record (EHR) data, on the other hand, hold a wealth of clinical information that can provide a more comprehensive picture of patient care. As noted during the technical consultation meeting, "There's a lot more information, digitally available through EHRs, health information exchanges, etc. that are readily available and allows us to get closer to real-time measurement and response." Leveraging EHR data could enhance the measure's accuracy and timeliness, enabling more rapid identification of disparities and interventions. However, widespread use of EHR data for quality measurement faces challenges, including variations in EHR systems, interoperability issues, and privacy concerns.

Additionally, capturing the influence of social determinants of health requires going beyond traditional clinical data sources. Integrating data from community organizations, social service agencies, and patient surveys could provide valuable insights into the social and economic factors that shape health outcomes. This multifaceted data approach, while complex, is essential for developing a truly equitable and effective hepatitis C quality measure.

Collaborative Action

The successful implementation of the HCV quality measure demands a collaborative approach that transcends traditional silos and brings together a diverse array of stakeholders. Public health agencies, Medicaid programs, healthcare providers, community organizations, and, most importantly, patients themselves must be actively engaged in the process.

The transcript from the technical consultation meeting showcases inspiring examples of collaborative action from states at the forefront of viral hepatitis elimination efforts. In Pennsylvania, the Department of Human Services (DHS) and the Department of Health (DOH) forged a strong partnership to drive their elimination plan, recognizing the critical role of Medicaid in reaching those most impacted by HCV. As Lauren Orkis, HBV supervisor at the Pennsylvania DOH, emphasized, "Our Medicaid partners are absolutely critical in our elimination planning efforts, statewide. So we made the partnerships strong between DHS and DOH in Pennsylvania from the get-go as we got our elimination plan underway."

Similarly, Washington State's Bree Collaborative, a legislatively mandated group focused on quality improvement for Medicaid, exemplifies the power of multi-stakeholder engagement. This collaborative, which includes representatives from various sectors, has been instrumental in developing and recommending quality measures for a range of health issues, including HCV. By bringing diverse perspectives to the table, these collaborative models foster innovation, ensure buy-in from key stakeholders, and pave the way for effective implementation.

Conclusion

OIDP's call for public comment on proposed viral hepatitis quality measures presents a defining moment in the fight against this silent epidemic. By engaging in this process, we have the power to shape measures that not only track progress but also drive meaningful change, reduce disparities, and improve the lives of millions. Let us seize this opportunity to advocate for equity, data-driven decision-making, and collaborative action.

Submit your comments, raise your voice, and join the movement to eliminate viral hepatitis. Together, we can ensure that quality measures become powerful tools for achieving health equity and creating a future where viral hepatitis is no longer a threat to our communities. The path to elimination is within reach, and quality measures, shaped by our collective voice, can light the way.

HCV Cases Down, But Not Out

The Centers for Disease Control and Prevention (CDC) recently released data analysis from 2022 indicating a 6% decrease in new viral Hepatitis C (HCV) infections, a revelation that leaves infectious disease specialists cautiously optimistic. Yet, despite the existence of a cure, thousands of Americans still die needlessly from this disease each year. Systemic barriers – restrictive insurance policies, inefficient testing, and neglect of marginalized communities – prevent many from accessing the lifesaving treatment they need. These failures fuel a public health crisis, with over 14,000 Americans dying from HCV complications in 2020 alone. The most vulnerable suffer the worst consequences, including young people, people impacted by substance use and the justice system, and those experiencing homelessness. While experts remain cautious, this decline after a decade of steady increases could signal a turning point. "We've had a decade of bad news…I am cautiously encouraged," said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable. "This could be a sign the tide has turned."

Systemic Barriers to HCV Care

Despite the existence of a cure, a shockingly low percentage of those with HCV achieve viral clearance. Systemic barriers rooted in insurance practices, fragmented testing, and neglect of marginalized communities prevent countless Americans from accessing the treatment they need.

Insurance Roadblocks

Insurance restrictions present a formidable obstacle to HCV treatment, often creating a maze of administrative hurdles. State Medicaid programs frequently require proof of months-long sobriety, specialist-only prescriptions for treatment, or evidence of existing liver damage before approving care. These arbitrary restrictions fly in the face of medical best practices and delay treatment, increasing the risk of liver failure, liver cancer, and even death.

Even those with commercial insurance face barriers to HCV care. Despite the high cost of HCV medications, many insurers impose prior authorization requirements. These delays, coupled with restrictive formularies and high copays, discourage patients and providers. The fact that only about 50% of commercially insured patients in a recent CDC study achieved viral clearance speaks volumes about how deep-seated this issue is, impacting people regardless of their insurance status.

The Burden of Diagnosis

A shocking number of people live with Hepatitis C without knowing it, with the CDC estimating over 40% of those infected are unaware of their status. This highlights a problem of insufficient screening and inefficient testing procedures. The current multi-step diagnostic process, requiring separate blood draws for the initial HCV antibody check and subsequent confirmation, creates logistical barriers. Many face issues like needing multiple appointments, additional travel costs, or potential delays in results.

Populations most impacted by HCV, including young people, those experiencing homelessness or substance use, and people who are incarcerated, often face additional challenges accessing even basic healthcare. Routine HCV screening within prisons, expanded outreach testing in underserved communities, and integration of HCV screening into substance use treatment programs are essential to reaching those at heightened risk.

Modern medicine offers rapid point-of-care tests for many conditions, including HIV. Similar technology exists for HCV, yet approval and widespread use lag behind. Streamlining the diagnostic process through rapid, single-visit testing would revolutionize care by connecting people to treatment far earlier, minimizing disease progression and preventing transmission.

How Barriers Foster Disparities

HCV treatment disparities highlight a system that consistently fails our most vulnerable populations. Cure rates are lowest among those without insurance and people on Medicaid, a stark reflection of restrictive insurance practices and a lack of support to navigate complex healthcare systems. The disease disproportionately impacts marginalized communities, including:

• Young People: Driven by the opioid crisis, new HCV cases have surged among millennials and Gen Z, with over 60% of new chronic infections found in these younger populations. This highlights the need for increased prevention and treatment efforts tailored to this age group.

• People Experiencing Homelessness: Lack of stable housing leads to missed appointments, medication storage issues, and prioritization of immediate survival over long-term health concerns.

• Incarcerated People: An estimated 13% of those moving through prisons and jails annually have HCV, yet treatment is rarely offered. Post-release, they face navigating insurance and accessing care with limited support.

• Those with Substance Use Disorders: Stigma and outdated treatment requirements often bar this population from receiving HCV care. Integrated treatment models, combining HCV care with substance use treatment and harm reduction services, are vital to reaching this underserved population.

Untreated HCV is a Public Health Threat

The systemic barriers discussed – restrictive insurance practices, the cumbersome diagnostic process, and inadequate outreach to marginalized communities – contribute to a critical public health issue: a significant portion of people living with HCV remain undiagnosed and untreated. This compromises their health and increases the risk of unknowingly transmitting the virus through unprotected sex or sharing drug paraphernalia. Ensuring equitable access to HCV testing, treatment, and care is essential to protecting public health. By dismantling these barriers and ensuring everyone has the opportunity to be diagnosed and cured, we can protect those most vulnerable and achieve a future free from HCV.

Cost of Inaction

The human and economic toll of failing to address HCV is staggering:

• Deaths: More than 14,800 Americans died from HCV-related complications in 2020.

• Liver Cancer: HCV is a leading cause of liver cancer, with rates of new cases rising 38% between 2003 and 2012.

• Economic Burden: The Biden Administration's proposed HCV elimination plan projects that over 10 years, it would prevent 24,000 deaths and save $18.1 billion in healthcare costs.

National Strategy & the Biden Plan

The persistent low cure rates, widening health disparities, and the staggering human and economic cost of untreated HCV reveal that relying on any single solution won't achieve elimination. A coordinated national strategy is essential to overcome existing systemic failures and ensure that no one falls through the cracks. The Biden Administration's proposed HCV elimination plan offers a transformative framework for addressing these challenges, but its success hinges on learning from the lessons of past initiatives.

Key Elements of the Biden Plan:

• The "Netflix Model": To address insurance barriers, this model proposes a subscription approach, where the government negotiates a fixed price with drug companies to provide treatment for vulnerable groups (uninsured, Medicaid, incarcerated, and others). This simplifies coverage and ensures those who need it most can access life-saving medication.

• Rapid Testing & Community Focus: Investment in rapid point-of-care testing would enable same-day diagnosis and treatment initiation, revolutionizing care. Federal funding to support expanded testing in non-traditional settings, like mobile clinics, prisons, and substance use treatment centers, would directly reach the populations most impacted by HCV.

• Federal Support & Coordination: Centralized guidance, resources, and funding for healthcare providers are crucial for expanding screening, streamlining care models, and educating both providers and communities.. This investment in public health infrastructure would create a ripple effect, increasing capacity for effective HCV treatment long-term.

Subscription models like those piloted in Louisiana and Washington have demonstrated the potential to reduce medication costs. However, as Jen Laws, CEO of CANN, highlights, even with affordable drugs, systemic shortcomings remain a significant barrier to care. The Biden Plan must recognize that:

• Price isn't the only issue: Drug costs are a major factor but investment in community-based healthcare infrastructure, provider training, outreach programs, and addressing logistical barriers to care and testing are just as crucial.

• Reinvestment of savings is key: The substantial cost-savings generated from the "Netflix model" must be reinvested directly into strengthening public health systems, ensuring long-term success.

• Policy-driven solutions are essential: Federal legislation mandating opt-out HCV screening in hospitals, universal screening in prisons, and cost-sharing limits on commercial insurance plans would provide a powerful foundation to support and guide the Biden Plan.

Addressing Disparities

The Biden Plan's focus on equity directly confronts the health disparities highlighted earlier. By specifically targeting uninsured and Medicaid populations, it helps ensure that financial barriers don't translate into needless deaths. The emphasis on community-based testing and integrated treatment models is crucial for reaching marginalized populations like:

• Young People: Increased outreach and testing aligned with this age group is vital to curbing the surge of new infections fueled by the opioid epidemic.

• People Experiencing Homelessness: Integrating HCV screening and care into supportive services for this population is essential to address their often complex healthcare needs.

• Incarcerated People: By treating HCV within prisons, not only would patient health outcomes improve, but it could also help prevent transmission within facilities and in communities upon release.

• Those with Substance Use Disorders: The plan's support for harm reduction strategies and integrated treatment models recognizes the need to address HCV without discriminatory sobriety restrictions.

The Cost-Benefit Argument

The Biden Plan isn't just compassionate; it's a sound fiscal investment. Projections indicate it would save 24,000 lives and $18.1 billion in healthcare costs over ten year. By preventing long-term HCV complications like liver failure, cancer, and transplants, we can reduce the significant future economic burden of this preventable disease.

Despite a small, yet significant decrease in new HCV infections, there remains the staggering toll of untreated HCV. The promise of the Biden Plan demands immediate action, according to advocates, because it addresses preventable deaths, widening health disparities, and the economic strain of a solvable public health crisis. It will take a larger, systemic approach to remove many of the barriers impending the elimination of Hepatitis C in the United States.

Improving Liver Health for People Who Inject Drugs

A recently published study in the Annals of Internal Medicine found that providing Hepatitis C treatment to people who inject drugs (PWID) showed significant improvement in liver health outcomes when provided with community-based access to care and treatment. The study, which drew its cohort from Baltimore and collected data from 2006 to 2019, found a particular value to participants in low-barrier access to care – a mainstay of harm reduction advocates.

The qualifying condition for participants was a chronic HCV diagnosis, with the majority of participants being Black, assigned male at birth, and not having an HIV diagnosis. Within the last 6 months of the participants’ lives prior to study enrollment, 54% had injected drugs and 27% were on methadone. 56% of participants also scored as having had severe, harmful, or hazardous alcohol use. The initial rate of cirrhosis was 15%, rising to 19% in 2015 and dropping dramatically in 2019 to 8%, with the rate of detectable HCV RNA reducing from 100% in 2006 to 48% in 2019. Self-reported treatment also increased from 3% to 39% across the study period. Some of the most significant findings of the study were specific to broader outcomes – those with undetectable HCV RNA were 72% less likely to develop cirrhosis and were at 46% lower risk of all-cause mortality. While 430 of the participants died across the span of the study, 394 had chronic HCV and 36 had no detectable HCV RNA. 29% of those deaths were categorized as from drugs or trauma, 41% from chronic illness, and 6% from liver disease/cirrhosis.

The study itself did not depend on distribution of treatment to patients but rather, it sought to assess how patients engaged in care in community-based settings and what accessing services through these settings means for patient health outcomes. The study’s findings aren’t particularly surprising for anyone familiar with providing services to communities which are often marginalized. Indeed, for communities and patients experiencing poverty or living in health care deserts, also coinciding with red-lined neighborhoods and thus associated with Black communities, access to “traditional” health care settings is limited or not meaningfully existent. Trust of traditional health care and even public health services is equally limited due to historical traumas, including forced sterilization, concerns for law enforcement engagement, and – perhaps most directly – due to provider bias. Community-based, low-barrier care in light of these realities and lived-experiences are simply…more welcoming.

In recognizing a sense of welcoming, observers should also recognize the sense of safety patients to these settings feel – that trust in tangible for patients. It’s also important to recognize a particular failure in federal funding focuses in entities that may claim being based in a particular community but are not necessarily required to hire providers or staff from the service area or served populations. Indeed, during a recent O’Neill Institute call, this distinction was of particular complaint. Funding is typically awarded to larger entities rather than smaller ones and holds no particular requirement for staff to be reflective of the patient population. For those larger entities, they tend to also be stuck in programming with limited creativity, are explicitly tied to specific clinical outcomes, and extraordinarily strict and onerous reporting requirements. Those requirements can and do translate into administrative barriers for patients and limit the creativity that may also translate less directly or immediately to measurable health outcomes. The complaints were broad, generally stating a need to take a more diverse approach that looked at longer-term investments into patient health through relationship building.

Those relationships are critical to the success of patients and introducing the ideas behind “harm reduction”. Another barrier to successful harm reduction can be found in particular state and federal policies which may run contrary to the best practices identified by academics and advocates. In this, the details matter. For example, most “good Samaritan” laws maintain a carve out of exception for drug dealers in reporting overdoses – even if they wanted to help, they could be prosecuted for homicide if a person dies, discouraging intervention from the course. For states with syringe exchanges (now facing conservative backlash by way of moralizing substance use rather than viewing substance use as a health condition), many still maintain paraphernalia laws which means patients engaging with syringe exchange programs can be arrested and charged either going to or coming from accessing services at syringe exchange sites.

Community Access National Network’s HIV-HCV Co-Infection Watch monitors certain state-level harm reduction measures in an effort to provide a resource to advocates and our Annual Monitoring Report discusses these nuances. Advocates know well the positive health outcomes for patient and communities when public health programs are designed with long-term investments are made and comprehensive approaches are taken. State and federal law and policy makers would do well to reconcile the conflicts between these and strive to achieve a policy environment which fosters the development of creative, safe, low-barrier care and reduces risks to people who inject drugs.

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.

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.