Travis Manint - Advocate and Consultant Travis Manint - Advocate and Consultant

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:

  1. 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.

  2. 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.

  3. 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.

  4. 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.

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Jen Laws, President & CEO Jen Laws, President & CEO

Return of the Flu: Flurona, a Co-occurring Infection that is NOT

The beginning of 2022 brought about an ominous rise in COVID-19 cases as the Omicron variant began to ravage the United States in earnest, with the Centers of Disease Control and Prevention reporting about 1.3 million new cases on January 10th. While this report is inclusive of a weekend backlog, representing the majority of states’ reporting for 2 days, rather than 1, this kind of report for any respiratory transmission is truly startling. In the background, another virus with a respiratory transmission mode, influenza, had been crushed to near non-existence during the 2020-2021 season, according to the CDC’s FluView surveillance report. Indeed, on the surface, what appears to stop COVID transmission, stops flu transmission even better. But with the relaxing of mitigation measures, “pandemic fatigue”, and society eagerly looking to move on, the flu has begun to mount its seasonal return.

In comes the frightening shadow of “flurona”! Social media sites buzzed with the dire warning experts had given in 2020: a ghastly winter with two very dangerous, highly communicable diseases ripping through the nation. The difference in late 2021 and early 2022, compared to the year before, is obvious: wide access to COVID-19 vaccinations (in the United States, at least) and a continuation of annual influenza vaccination availability. This co-occurring infection, however, isn’t new. Indeed, the United States likely experienced some combined infections during the early days of the COVID pandemic in 2020, prior to the wide availability of diagnostic COVID tests, and again in the 2020-2021 flu season. While the instances may have been relatively rare due to the decrease in influenza transmission, the situation was not entirely unknown. It was, after all, the CDC’s FluView surveillance that shaped our initial tracking of community transmission of SARS-CoV-2 (the virus that causes COVID-19); the surveillance program tracks weekly reports from health care providers and local and state health departments of influenza like illness (ILI) incidence and the results of flu screenings in order to ascertain key metrics of public health response.

Let’s pause for a moment to acknowledge just how remarkable the 2020-2021 flu season was. A key measure in tracking influenza is pediatric mortality. In both the 2018-2019 and 2019-2020 flu seasons, the CDC reported 144 and 199, respectively, pediatric deaths attributed to the flu. In the 2020-2021 season, the CDC reported only 1 pediatric flu death (CDC data application). The total national percent positivity (or number of reactive tests relative to total tests administered) for influenza during the 2020-2021 flu season never crested the national baseline for the season of 2.6% positivity compared to only being about half way through the season this year and already having crested the national baseline (2.5%) for the last 5 weeks. In the 2019-2020 flu season, percent positivity for the flu crested the national baseline (2.4%) for 22 weeks.

We shouldn’t be dismissive of influenza. It is still a serious illness that hospitalizes many, especially vulnerable populations. National vaccination programs have done a great deal to help curb the potentially deadly impacts of influenza, though, schools have been known to be shut down due to flu outbreaks, including in early 2019. The idea of selective mitigation efforts coming and going in order to address outbreaks, isn’t new.

So here we are with Flurona – an incidence which may well have been happening this whole time, but because we don’t specifically track this particular co-occurring infection, we can’t say for sure. While there’s limited data on what to expect with a co-occurring flu and COVID infection, that data is a tad concerning; mortality did not necessarily increase but the symptomology of this type of situation did require frequent use of mechanical ventilation.

The catchy combined name of these viruses went…well…viral, even if only for a short period of time. As the project director for CANN’s HIV-HCV Coinfection Watch, the idea of a co-occurring viral infection didn’t surprise me. And it probably doesn’t surprise many of our readers here. The fact that it did surprise many members of the public, even after Dr. Anthony Fauci and other officials had previously mentioned the possibility, is indicative, inditing even, of how information is delivered and disseminated in today’s world. Numerous studies have been done on the amount of stress and anxiety people are experiencing in light of the COVID-19 pandemic. The CDC has also dedicated a page to “Coping with [pandemic-related] Stress” and many states have adopted mental health helplines for residents to dial into. The relationship between the public, experts, and news media is deeply damaged by practices of all parties – a busy public less interested in reading longer, more detail articles, a news media competing for clicks and attention in order to fund their outlets, and experts competing for space and importance because of outlet bias and lack of vetting have all harmed our ability to cohesively respond to the COVID-19 pandemic.

I’m not usually one to say “can’t we all just get along”, my job, in fact, is often about digging deep into spaces of disagreement or interest conflict and hammering out mutually beneficial concessions. This place we’ve found ourselves in as a society, where we’re all operating out of scarcity and competition at all costs is ultimately how we all “lose”; be it this pandemic, the next, or even in combatting long standing ills already needing address. Patient advocates and public health officials having to divert time and resources to educate patients and the public when a panic-inducing headline aimed at derailing the reader’s tasks is, in fact, derailing to multitudes of efforts to better the world around us if by sheer inability to focus on our tasks at hand.

If you’re struggling with coping with stress of the pandemic, flurona headlines, COVID variant headlines, any headlines, please, take a moment to review the National Alliance on Mental Illness (NAMI) COVID Resource and Information guide, or give them a shout on their hotline to be directed to area specific resources by calling 800-950-6264 or by clicking “chat with us” at the bottom of this page.

There’s little in this world that can’t be made a tiny bit more manageable with a snack, a nap, or a hug. Check those boxes, take a deep breath, and know you’re not alone.

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