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.
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.
Addressing the Intersection of HIV and Methamphetamine Use
A recent convening, hosted by the O’Neill Institute, found government representatives, service providers, and community advocates discussing methamphetamine use among gay/bisexual men, transgender women, and transgender men under the lens of exploring stigma, sexual health, and HIV. The intersectionality between HIV and Methamphetamine, commonly known as “meth”, is significantly associated with greater risk for HIV transmission and numerous co-morbidities for people living with HIV.
Attendees received updates on existing data and policy relevant to methamphetamine use. Often overshadowed by the opioid epidemic, wherein the “gaps” in epidemiological data explicitly on meth use were glaringly obvious and largely dependent on supplemental data gathered during HIV outreach activities or related to broader assessments of substance use. Similarly obvious were the reasons why these data would be challenging to gather: law enforcement. According to the Substance Abuse and Mental Health Data Archive (SAMHDA), in 2019, more than 400,000 people who use methamphetamine were arrested and booked into jail for at least one time during the previous twelve (12) months. While the convening focused on gay, bisexual, and other men who have sex with men (MSM), transgender women, and transgender men, federal data found similar rates of methamphetamine use among heterosexual men and MSM. Additionally, there was no statistical difference in methamphetamine use between heterosexual women and lesbian-identified women. There was however an increase in self-reported methamphetamine use among bisexual women. Data provided did not distinguish between cisgender and transgender people, an issue explained as participants in data gathering were not asked necessarily asked questions regarding their sexual or gender identity, rather this information was largely assumed unless a participant disclosed otherwise.
Following the data sharing, patient advocates and service providers discussed their perspectives on what to consider in assessing policy and federally funded programs. Presenters highlighted their own lived-experiences as influencing their ideas on where policies and programs have succeeded and failed – largely coming to an unspoken consensus that we must do at least something differently than we are today. One presenter stated existing funding structures tend to reward large entities which is perceived to be at the expense of small service entities, which may or may not be trusted by people who use substances. Another focused on the contrary policy priorities being voiced by the Biden Administration between supporting harm reduction and supporting law enforcement – giving an explicit voice from community advocates that law enforcement often poses a threat of harm to drug users. Presenters also pointed out the need to distinguish between recreational use, misuse, and addiction, as the stigma associated with substance use often conflates these experiences with one another, when the reality is very, very different. For my part, I shared the idea that existing funding designs associated with HIV, where substance use harm reduction is largely aligned both on issues advocacy and service provision, may perpetuate social stigma by prioritizing the experiences and work of health care providers over that of patients – especially with regard to metrics of “success”. A reworking of funding and program designs and incentives that look at addressing health disparities from a human rights lens is necessary. Envisioning Ryan White programs as workforce development and community investment programs in addition to being public health programs, recognizing the potential detriment of a consolidating provider market and the need to incentivize provider diversification, and shifting funding and goals to better reflect efforts to meet the needs of communities as those communities define them.
Lastly, presenters shared honest assessments of “on the ground” perspectives and what programs are working. With meaningful geographic and demographic diversity represented on the final panel, confirming sentiments of the previous one, presenters discussed novel (and often underfunded) approaches to ensuring affected communities are receiving high quality sexual health education, linkage to care, and low-barrier interventions for those people are seeking them. Panelists discussed the need for policy makers and funding to reinforce those novel programs which do work and to consider novel metrics to better capture these successes. From reinvestments in the Ballroom scene as a safe and empowering space of expression to the successful effort from affected Latino communities in Texas to engage with their state health department, educating health care administrators and providers on the necessity of harm reduction, these programs which originate from the priorities of communities, rather than from the dictates of statehouses are already doing more and going farther than traditional programming.
So…why don’t we have more of this?
To learn more about the initiatives of the O’Neill Institute at Georgetown University, click here.
Biden Drug Policy Agenda: NIH Invests in Harm Reduction
On December 29th, 2021, the National Institute of Health (NIH) issued two new requests for application (RFA), one for the establishment of a “Harm Reduction Network” and another for a data coordination center in support of the network. The idea the NIH proposes is to develop and test new harm reduction strategies, examining the efficacy of existing harm reduction models, effective implementation of harm reduction strategies, and examining new models targeting diversified settings and delivery models of harm reduction services. The data coordination center will focus on meeting with relevant stakeholders, defining common metrics, developing research and clinical practice models, and otherwise analyzing the landscape of harm reduction across the nation. This move represents the “investigative” phase of the Biden Drug Policy Agenda.
Of note, the NIH very specifically cites interest in exploring the impacts of decriminalization and safe consumption sites as harm reduction policies and syringe service programs (including vending machines and mail programs), community based infectious disease services and prevention programs (specifically mentioning HIV and HCV), naloxone programs, and fentanyl testing strip programs.
In discussing decriminalization as a policy, much existing work is focused on marijuana decriminalization (either for medical or recreational use) in which several states have progressed in passing legislation in recent years. However, few of these pieces of legislation address people who are incarcerated currently or previous criminal records or restitution to these people for imprisonment related to possession, use, or distribution of marijuana. This has left an extraordinarily inequitable landscape with regard to marijuana as an industry – white guys are getting rich for what Black men and women are being imprisoned for. But none of this speaks to the motivation of NIH in these RFAs: reducing fatal and non-fatal overdose deaths and marijuana isn’t typically associated with these types of outcomes. Rather, state drug paraphernalia laws may be more apt at addressing these issues. For example, Louisiana’s statute outlines anything used to test a substance’s “purity” as prohibited and criminal. Decriminalization efforts should be broadly construed for applications and not just focus on particular illicit substances but also the items substance users may access to consume products safely. Indeed, being able to “test” a substance is a well-established mechanism for users to reduce potential harms.
Similarly, safe consumption sites have long faced an uphill battle in the United States due to the “crack house” provision of the Controlled Substances Act (CSA), exemplified by the legal fight Safehouse of Pennsylvania is currently facing. Safehouse argues the relevant provision of the CSA doesn’t apply to them; the language makes it a crime to own or operate a property meant for the consumption of illegal or illicit substances, Safehouse argues they operate for the purposes of saving (a religious calling protected by the Religious Freedom Restoration Act), not drug consumption. The most effective way to save lives is by offering services where they’re needed most, including overdose reversal, housing and recovery linkage to care, syringe exchange, and HIV screenings. The Office of National Control Policy has expressed support for safe consumption sites, generally speaking, but refuses to address the legal issues Safehouse is facing. The clear lack of alignment between OFNCP and the Department of Justice has left advocates more than a tad frustrated. What’s important to note about the CSA’s “crack house” provision is the reason users gather is often related both to enjoyment of experience but also safety; they’re “unsanctioned” consumption sites, as users have until recently had to rely upon their own networks for safety. Like with any issue of access to care, sanctioned safe consumption sites pose the potential to further existing health disparities. As states warm up to the idea of supervised consumption as a service to the community, policy makers and program planners need to consider those areas which exist as medical deserts may very well be the same areas in which safe consumption sites need to exist.
Biden’s drug police agenda has numerous other items of note, including strengthening protections for people with substance use histories in the labor market under the Americans with Disabilities Act, addressing the illicit and illegal drugs supply in the country, and preventing youth from engaging in drug use. Arguably, a key component missing in much of these discussions is how to protect the interests of drug users and strengthen families struggling with substance use disorder. Under the existing punitive approach, drug users are isolated from their families by way of criminal and family courts, isolating them from a core source of social support. A common refrain in recovery, “addiction is a disease of isolation”, also has decent behavioral science research support. Separating people from their families, when those families are generally well-situated to provide necessary support, operates in direct contrast to addressing the needs of a drug user and only sets them up for failure. The Biden administration needs to evaluate family strengthening policies and incentives, including education directives and best policy practices to family courts and child protection agencies as part of this effort and the NIH initiatives should consider qualifying and quantifying how policies in these areas intersect with other harm reduction efforts.
While these initiatives and this funding opportunity is a good start. The Biden administration has a long way to go to fulfilling campaign promises and we’re already twenty-five percent of the way through his first term.