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.
All Together Now: West Virginia’s HIV Outbreak
On April 5th, 2021, Washington’s “Most Important Man”, Senator Joe Manchin, submitted a Congressional Inquiry to the Centers for Disease Control regarding the well-publicized HIV outbreak in Kanawha County, West Virginia. The CDC has called the West Virginia HIV outbreak “the most concerning” in the United States, with an unprecedented growth in new diagnoses related to intravenous drug use (IDU). For context, in 2018, the county reported just two new HIV diagnoses related to IDU compared to at least thirty-five new diagnoses related to IDU reported in 2020 – New York City, with a population almost forty-five times that of Kanawha County, reported thirty-six new HIV diagnoses related to IDU in 2019.
A. Toni Young, founder and executive director of Community Education Group and Rural Health Services Provider Network, said, “We kinda saw this coming, unfortunately. The state has been facing a Hepatitis C outbreak for years now [related to substance use] and the lack of coordinated response between stakeholders, specifically providers, with different areas of expertise has kept us siloed and limited in our response – we’re approaching this as multiple epidemics rather than a syndemic.”
Dr. Demetre Daskalakis, the CDC’s Director of HIV Prevention, told a news outlet, “It is possible the current case count represents the tip of the iceberg.” Young echoes this sentiment, “I think we have a state-wide outbreak.” They’re not wrong to believe this outbreak extends across the state, given a 2020 presentation on the Cabell County outbreak, also citing the state’s long fight against opioid use. Though, improvement in the outbreak in Cabell County has already begun, thanks, in large part, to a syringe exchange program – a situation near the mirror opposite of Kanawha County, where a similar county-run program closed its doors in 2018 after city officials and first responders complained about used syringes being improperly disposed of.
Local officials, however, seem steeped in their “moral panic” and rebuffed the CDC’s assessment of the outbreak and requested a federal inquiry into the data provided by the CDC.
While local, volunteer-lead program, Solutions Oriented Addiction Response (SOAR) has stepped in to fill the syringe exchange need, problems have plagued the organization. In January, while under police investigation – which found no wrong-doing on the part of the organization – the program paused operations. During that time, co-founder Sarah Stone, said clients requested bleach in order to clean syringes, even while volunteers advised those same clients such a practice would not guarantee safety.
All while this is transpiring, the state legislature is considering a bill that will significantly impact how syringe services programs operate. SB 334 would give county health departments more freedom to shut down SSPs, require clients provide identification in order to receive services, and require SSPs to obtain a special permit to operate. Opponents of the bill call it a move that may drastically harm community trust and willingness to engage the programs, give leeway to local political pressure as opposed to proven public health interventions, and potentially prevent these community-based programs from operating all together.
Young has a different perspective. “Ok. If this is the way we have to go, show me the data. Let’s use this chance to see exactly how much this move will cost or save the state in terms of all resources – I’m talking money and lives. We cannot forget people’s lives are stake here.” Young goes further and credits the state’s health department operations in their response to COVID-19 as successful – proof the state is able to response appropriately to a public health emergency, when provided enough resources. Young specifically cites resources to include financial of rural hospitals, community-based programming and services, and, rightly, the people-power to enact these services.
In order to meaningfully address the syndemic nature of the state’s situation, Young calls on public health officials and both federal and state legislators to prioritize a holistic, coordinated response to addressing HIV, HCV, SUD, and COVID-19. “Listen, we can do this. It’s just a matter on if we want to do this. We need MAT [medication assisted treatment] providers, addiction services providers, HCV screeners, Ryan White providers, county health departments – all of us need to be at the same table and seeing our clients, our community, as the same people. We cannot split a single person into multiple ‘problems’, we shouldn’t be treating our residents’ needs as if they can be split apart.” Indeed, the National HIV Strategy calls for this type of coordination. “We need an integrated plan – an integrated workgroup,” Young added.
Mirroring a sentiment other advocates have voiced, Young also thinks public health metrics should shift to be more reflective of the client experience, rather than the service provider’s experience, “A referral is not care and it shouldn’t count as care.”
“I’m not gonna sugar-coat this,” Young concluded, “we need money and people and the investment into meaningful, collaborative infrastructure to meet the needs of this community.”