Addressing the High Burden of HCV in HIV-Positive MSM
The threat of Hepatitis C (HCV) co-infection casts a long shadow over the lives of men who have sex with men (MSM) living with HIV, demanding a swift and decisive response. Globally, 7% of this group also faces chronic HCV infection—a disproportionately high burden compared to the estimated 1% prevalence in the general population. A recent meta-analysis published in Health Sciences Reports, which synthesized data from 56 studies across various countries, also revealed a 9% global prevalence of hepatitis B virus (HBV) among MSM living with HIV, further highlighting their vulnerability to viral hepatitis co-infection.
While highly effective direct-acting antiviral (DAA) therapies offer a cure for HCV, access to these life-saving medications remains uneven, perpetuating health disparities and undermining global elimination efforts. This disparity is driven by a complex interplay of factors, including shared transmission routes for HIV and HCV, persistent stigma surrounding both viruses, and structural barriers such as poverty, homelessness, and lack of access to healthcare.
To dismantle these barriers and chart a path towards HCV elimination and health equity, we need a comprehensive strategy. This includes expanding ADAP coverage of DAA therapies, streamlining convoluted authorization processes, and implementing tailored interventions that address the unique needs and vulnerabilities of MSM living with HIV.
The Case for DAAs
The advent of direct-acting antiviral (DAA) therapies has revolutionized HCV treatment, offering a cure for a disease that was once considered a chronic, debilitating condition. DAAs are now the standard of care for HCV, providing a safe and effective cure for most people within a relatively short treatment duration, typically 8 to 12 weeks.
The benefits of DAA treatment extend beyond curing HCV. Studies have demonstrated a profound impact on long-term health outcomes, including a lower risk of both liver and non-liver complications. A large, real-world analysis published in JAMA Internal Medicine found that DAA therapy was associated with a remarkable 57% reduction in all-cause mortality among patients with chronic HCV. This underscores the life-saving potential of these medications and the importance of ensuring timely access for all who need them.
The Economics of DAAs
Despite the high initial cost of DAAs, concerns about affordability are countered by the substantial long-term cost savings they generate. A 2022 study in the Journal of Managed Care & Specialty Pharmacy demonstrated that treating HCV with DAAs in the Veterans Affairs (VA) system resulted in $7 billion in savings over a lifetime compared to pre-DAA treatments. These savings are achieved through reduced healthcare utilization, as fewer patients experience the costly complications of advanced liver disease. The study further highlighted that DAAs become less expensive than both pre-DAA treatments and no treatment within just five years, demonstrating a rapid return on investment.
The budgetary impact of expanded HCV treatment extends beyond individual payers like the VA. The Congressional Budget Office (CBO) has reported that increased HCV treatment leads to net budget savings for the federal government due to averted healthcare spending. Even a modest 10% increase in Medicaid treatment rates could save $700 million over 10 years, according to the CBO's estimates. This underscores the fiscal responsibility of investing in HCV elimination efforts, as treating the disease upfront prevents more costly interventions down the line.
Furthermore, the CBO highlights the importance of considering the long-term budgetary impact of HCV treatment, particularly the savings that accrue beyond the typical 10-year budget window. As HCV is a slow-progressing disease, the full economic benefits of treatment may not be realized within a decade. By taking a longer-term perspective, policymakers can better appreciate the true value of investing in HCV elimination and the potential for significant cost savings over time.
The Consequences of Limited Coverage
Despite the transformative potential of DAAs and the compelling evidence for their cost-effectiveness, access to these life-saving therapies remains uneven for people living with HIV (PLWH). A significant barrier is the limited coverage of HCV therapies by some state AIDS Drug Assistance Programs (ADAPs). CANN's HIV/HCV Co-Infection Watch for April 2024 reveals that only 47 out of 56 ADAPs in the United States offer some form of coverage for HCV treatment, meaning that a substantial number of PLWH, particularly those who rely on ADAPs as a safety net, face significant financial barriers to accessing the care they need.
This echoes the challenges faced within Medicaid programs, where restrictive policies driven by cost concerns have historically limited HCV treatment access. A 2024 study published in JAMA Health Forum analyzed data from 39 state Medicaid programs and found that easing restrictions related to liver disease severity, sobriety, or prescriber specialty led to a substantial increase in DAA utilization. Specifically, these policy changes were associated with an increase of 966 DAA treatment courses per 100,000 Medicaid beneficiaries each quarter. This evidence strongly suggests that similar policy shifts within ADAPs could significantly expand access to curative therapies for PLWH.
The consequences of limited ADAP coverage are far-reaching. Without access to DAAs, PLWH face a higher risk of progressing to advanced liver disease, experiencing debilitating complications, and ultimately succumbing to HCV-related mortality. This not only jeopardizes patient health outcomes but also undermines public health efforts to control and eliminate HCV. Furthermore, the financial burden imposed by limited coverage exacerbates existing health disparities. People of color, low-income persons, and those living in rural areas are more likely to rely on ADAPs and also experience higher rates of HCV infection. Denying them access to curative treatment perpetuates a cycle of inequity, further entrenching health disparities and undermining the goal of achieving health justice for all.
Policy Barriers and Provider Discouragement
The path to HCV treatment for MSM living with HIV is fraught with obstacles, a tangled web of restrictive policies and a healthcare system that often fails to prioritize their needs. Compounding the challenges of limited ADAP coverage are state-level restrictions that create a patchwork of barriers, disproportionately impacting vulnerable populations. Stringent eligibility criteria, complex authorization processes, sobriety requirements, and limited provider networks—often justified by cost concerns—prioritize short-term budget considerations over the long-term health and well-being of PLWH.
These policy barriers intersect with personal and systemic biases to create a system that perpetuates inequities in HCV care. A 2019 study published in the International Journal of STD & AIDS revealed that Medicare enrollees and patients with drug abuse diagnoses were significantly less likely to initiate DAA treatment, highlighting the impact of cost-sharing requirements and stigma. Stigma surrounding substance use can discourage patients from seeking treatment or disclosing their drug use history, while providers may harbor biases about the effectiveness of DAAs in this population.
This complex landscape also contributes to provider discouragement, further limiting access to HCV care. The administrative complexity of ADAPs, with their varying formularies, eligibility criteria, and authorization processes, creates a confusing and burdensome system for providers. Many providers also lack familiarity with newer DAA regimens and the latest treatment guidelines, particularly those who primarily focus on HIV care. Persistent stigma surrounding HCV and substance use can also lead to provider fatigue and bias, compounding these challenges.
Moving Towards Equitable HCV Care and Elimination
The evidence is clear: MSM living with HIV face significant and unjust barriers to accessing life-saving HCV treatment. We must act decisively to dismantle these barriers and create a healthcare system that prioritizes equity, accessibility, and the well-being of all PLWH.
Achieving this vision requires a bold policy agenda that addresses the systemic issues driving disparities in HCV care. We must demand action from policymakers and hold them accountable for creating a more just and equitable healthcare system.
Policy Changes are Needed:
Mandate DAA Coverage for All ADAPs: Every state ADAP must be required to cover all FDA-approved DAA regimens for HCV treatment, ensuring that no PLWH is denied access to a cure based solely on their geographic location.
Streamline Prior Authorization Processes: The administrative burden of navigating complex and inconsistent prior authorization processes within ADAPs discourages both providers and patients. We must demand a streamlined, standardized system, ideally with a single prior authorization form that can be used across all payers, including ADAPs and Medicaid, as recommended by NASTAD. Better yet, remove the need for prior authorizations all together.
Increase Funding Allocations for ADAPs: ADAPs are a lifeline for PLWH, yet these programs are chronically underfunded. We must advocate for increased federal and state funding allocations, ensuring they have the resources to provide comprehensive HCV care, including DAA treatment, without imposing undue restrictions.
Expand Financial Assistance Programs for Medicare Enrollees: Medicare's cost-sharing requirements create a significant financial barrier to DAA access for many PLWH. ADAPs must expand financial assistance programs to cover out-of-pocket costs for DAA treatment for Medicare enrollees with HIV/HCV co-infection.
These policy recommendations are concrete steps that can be taken to create a more just and equitable healthcare system for PLWH. By advocating for these changes, we can dismantle the barriers to HCV treatment, improve health outcomes, and move closer to eliminating HCV.
Tailored Interventions: Addressing the Unique Needs of MSM Living with HIV
While expanding ADAP coverage and addressing cost concerns are crucial, policy changes alone are insufficient to achieve equitable HCV care. We must also invest in tailored public health interventions that address the unique needs of MSM living with HIV.
This includes:
Targeted Testing and Linkage to Care: MSM living with HIV should be routinely screened for HCV, with a focus on re-engaging those who have fallen out of care or disengaged from traditional healthcare settings. Implementing targeted testing programs in community-based organizations, substance use treatment facilities, and MSM-centric settings, coupled with robust linkage to care services, is essential.
Peer Support Programs: Peer support programs, led by MSM living with HIV who have successfully navigated HCV treatment, can be powerful tools for addressing stigma, providing emotional support, and promoting adherence to DAA regimens.
Provider Training and Education: Provider training programs are necessary for addressing implicit bias, promoting harm reduction, and fostering patient-centered communication. These programs should equip providers with the knowledge, skills, and attitudes necessary to provide equitable and compassionate care to all PLWH, regardless of substance use history or other social challenges.
By investing in these tailored interventions, we can create a more responsive and equitable healthcare system that meets the unique needs of MSM living with HIV. Combining policy reform with targeted programmatic efforts will empower PLWH to access life-saving HCV treatment, improve health outcomes, and advance our shared goal of eliminating HCV.
A Shared Responsibility for Health Equity
The disproportionate burden of HCV among MSM living with HIV is a reminder of the persistent health disparities that plague our healthcare system. We have the tools to eliminate HCV, yet systemic barriers and inequities continue to impede access to life-saving treatment for many vulnerable populations.
Addressing HCV co-infection among MSM living with HIV is critical for improving patient health outcomes and essential for achieving broader public health goals, including the Ending the HIV Epidemic (EHE) initiative. Eliminating HCV among PLWH will reduce liver-related morbidity and mortality, improve overall health, and contribute to reducing HIV transmission.
Achieving HCV elimination and health equity for all PLWH is a shared responsibility. Policymakers must enact bold reforms that expand access to DAAs, simplify authorization processes, increase funding for ADAPs, and address systemic inequities. Healthcare providers must embrace patient-centered care, commit to ongoing education, and actively dismantle stigma and bias. Communities must mobilize to advocate for change, support peer-led initiatives, and create a culture of support and empowerment for PLWH.
The time for action is now. By working together, we can create a healthcare system that upholds the dignity and well-being of all PLWH, ensures equitable access to life-saving HCV treatment, and paves the way for a future free from the burden of this devastating disease.
Painting Roses in the Desert: Despite Medicaid Expansion, Gaps Remain in Arizona
[Editor’s Note: This blog is, in part, a replication of a blog hosted by the ADAP Advocacy Association. Supplementary policy analysis on hepatitis treatments continues in this blog]
It shouldn’t be a surprise to anyone that many AIDS Drug Assistance Program advocates are in favor of Medicaid expansion. Indeed, as noted here, those same advocates view Medicaid expansion as an opportunity to strengthen health care access for the most vulnerable people living with HIV, meet needs unaddressed by a state’s ADAP coverage, and help ADAPs remain financially stable. For ambitious advocates (I’m talking about myself), when sufficient support exists to support those at or below the expanded Medicaid eligibility threshold of 138% of the federal poverty level, state ADAPs could consider expanding income eligibility above 400% of the federal poverty level. Indeed, Louisiana is one such state.
However, like all health care policy, the details matter.
In Arizona, the state’s Medicaid formulary is restrictive and slow to adapt to the needs of qualified people living with HIV, shifting financial pressure to the state’s ADAP and requiring the most impoverished clients to manage interacting programs in order to achieve coverage of certain medications. As the payer of last resort, when ADAP clients have other coverage (ie. Medicaid), conflicting payment processes are most often felt at the point of medication delivery or when a client gets told, inadvertently, their medication is not paid for. The process of correcting this mistake can take a matter of days or weeks, depending on a pharmacy’s experience with co-occurring payers.
In that time, patients can fall out of care, drastically reducing their likelihood of achieving an undetectable viral load.
For ADAP formulary advisory committees, for states that have them, the process of adding and adjusting formularies is sometimes relatively expedient. Relatively, in part, because those medical experts and community experts understand the need and nature for ensuring access to an expansive list of antiretroviral medications and modern advancements. Arizona’s Medicaid formulary lacks several single tablet regimens and, in the opinion of Glen Spencer, executive director of Aunt Rita’s Foundation, favor outdated “cocktails” (or multi-tablet regimens), complicating daily care for people living with HIV and accessing Medicaid, often subjecting clients to greater experiences of toxicity, and ultimately interjects an unnecessary interruption in both patient choice and provider care.
In aiming to impress the need of Arizona’s Medicaid formulary to expand in both supporting the sustainability of the state’s ADAP and meeting national initiatives Mr. Spencer stated, “It is critically important that Arizona’s Medicaid program include all single-tablet regimens on its formulary to offer patients the right medication for them, and to provide medical providers with the flexibility they need to prescribe the right medication for each patient.”
To this end, Aunt Rita’s advocacy efforts are also expanding with proposed legislation addressing the failure of Arizona’s Health Care Cost Containment System (AHCCCS) to take up the issue. According to Mr. Spencer, the bill is not likely to make it out of committee this year and lacks any great deal of interest for legislators battling over other budgetary and policy concerns and does not currently have a companion bill in the state Senate. On the other hand, the bill is sponsored in the Arizona House by a bipartisan coalition of 9 legislators.
“In order to end the HIV epidemic, both the patient and provider community will need all therapies available to them to support persons living with HIV, save lives, and get patients to an undetectable viral load.” Mr. Spencer added, “This policy not only promotes patients’ ability to lead a robust life, but also prevents new infections given the science behind U=U.”
The state’s ADAP and Medicaid formularies also present a similar situation for medications used to treat Hepatitis C, leaving a critical gap in available health care services and treatment for those at risk of contracting Hepatitis C. While the state’s ADAP coverage includes most direct acting agents, Arizona’s Medicaid formulary only covers Epclusa, Mavyret, Ribovirin, and Peginterferon.
Arizona’s situation offers a critical reminder that even with the value of Medicaid expansion, in order to achieve the greatest reach of ADAPs, tackle the absolutely critical inclusion of treatment and retention in prevention efforts, and to eliminate viral hepatitis, the details matter and advocates will need to adapt old fights to new environments.