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

Considerations for Hepatitis C Vaccine in HIV-HCV Co-Infected Populations

The interplay between groundbreaking research and its real-world application can shape the trajectory of entire communities. Once of the most evident place we see this is in the realm of HIV-HCV co-infection. As we stand on the precipice of breakthroughs in Hepatitis C Virus (HCV) vaccine development, the unique challenges posed by HIV-HCV coinfection come into sharp focus, reminding us of the urgency and significance of our endeavors.

Understanding the Landscape of HIV-HCV Coinfection:

HIV and HCV coinfection represents both a medical challenge and a reflection of broader societal issues searching for policy solutions. These viruses mainly impact marginalized communities, highlighting deeper socio-economic disparities. The combination of HIV, which taxes the immune system, even when well-controlled, and HCV intensifies health risks, such as liver diseases, emphasizes the need for effective interventions like a preventive HCV vaccine. Beyond the medical perspective, societal barriers like stigma, payer barriers, and limited healthcare access further complicate the issue. Recent vaccination studies, including those for COVID-19 and Hepatitis B Virus (HBV) among people living with HIV (PLWH), underscore these challenges and the necessity for tailored strategies. To comprehensively address HIV-HCV co-infection, a holistic approach that considers both medical and societal aspects is essential.

Drawing Parallels: Vaccination Lessons for HIV Patients:

The vaccination experiences of PLWH, especially during the COVID-19 pandemic, highlight the need for tailored strategies. While HIV patients were prioritized due to potential severe COVID-19 risks, vaccine efficacy varied based on individual immune responses, suggesting the potential need for boosters. Similarly, the Hepatitis B vaccination journey revealed that many PLWH had suboptimal responses to the standard vaccine. However, alternative, additional, or re-administration dosing regimens emerged as a promising solution. As we approach HCV vaccine development for people with co-occurring conditions, these experiences and the data-driven developments originating from them provide invaluable insights to anticipate challenges and innovate solutions.

Special Considerations for Vulnerable Populations:

Equitable policy and programmatic design in public health ensures everyone has access to optimal healthcare, yet societal barriers often sideline certain groups. Incarcerated people face challenges like close-quartered living and limited healthcare access, amplifying the transmission of illnesses like HIV and HCV. Tailored strategies, informed by COVID-19 vaccination efforts in prisons, such as on-site clinics, can improve vaccine uptake. People experiencing homelessness, battling issues like unstable housing and societal stigma, benefit from strategies like mobile clinics and community collaborations, as seen with HBV vaccinations. Building community trust, especially for populations with historical mistrust, is vital. Addressing HIV-HCV coinfection requires an inclusive, trust-centric approach, ensuring no one is overlooked.

Parallels with Mpox Vaccine: Addressing Vulnerable Populations

The U.S. Mpox outbreak in 2022 highlighted health disparities, especially among people experiencing homelessness, LGBTQ+ persons, and people of color. Mpox's transmission and significant impact on gay, bi sexual, and same gender loving men (GBSGLM), including those living with HIV, mirrors challenges with HIV-HCV co-infection.

The outbreak revealed health inequity issues, such as stigma and misinformation, exacerbated by the disease's former name "monkeypox." The Centers for Disease Control and Prevention’s (CDC) Mpox Vaccine Equity Pilot Program and Chicago Health Department's community-centric strategies provided insights for HIV-HCV coinfection management. Key takeaways included:

  1. Community Engagement: Engage with affected communities, fostering trust through tailored programs and partnerships. Ready availability and responsiveness were critical to earned trust among affected communities.

  2. Combatting Stigma: Deliver clear messages to dispel myths, ensuring vaccine uptake.

  3. Vaccine Accessibility: Emphasize genuine accessibility, especially for marginalized groups, inspired by the Mpox Vaccine Equity Pilot Program.

Addressing HIV-HCV Co-infection in Vulnerable Groups:

Equity is vital in managing HIV-HCV co-infection, with incarcerated persons and populations experiencing homelessness and housing instability demanding special focus.

  • Incarcerated Populations: Prisons, due to their close confines and shared activities, are hotspots for disease transmission. While confinement offers some healthcare delivery opportunities, many lack comprehensive or personalized care, and most-notably, provide a microcosm of healthcare failures affecting surrounding communities. Identifying cost-effective program designs which address these disparate would prove beneficial for communities writ-large. Similarly, ensuring post-release care continuity is essential.

  • Homeless Populations: The transient nature of homelessness poses healthcare consistency challenges. Drawing from smallpox vaccine strategies, mobile clinics and community partnerships are effective. Building trust through tailored campaigns and community collaborations is crucial.

  • General Considerations: Skilled staff, robust data management, and inter-agency collaborations are essential for effective vaccination campaigns. Sufficient appropriations are required in order to build and maintain the missions of public health departments.

By addressing these populations' unique challenges, we can create an inclusive HIV-HCV coinfection strategy.

Future Medical Considerations:

The evolving nature of medical science presents new challenges and questions. The relationship between HIV and HCV may necessitate a tailored vaccine approach. Given experiences with COVID-19 and HBV vaccinations, how can we optimize the HCV vaccine for PLWH? Are there specific strategies to enhance its efficacy?

Public trust in health institutions remains fragile and highly politcized. How can we effectively communicate an HCV vaccine's importance and safety? How can we rebuild community trust?

Globally, ensuring the HCV vaccine's equitable access, especially in vulnerable populations with significant HIV-HCV co-infection risk, is a challenge. Can we learn from other vaccine distribution programs to strategize for HCV?

Urgent Considerations for HIV-HCV Coinfection's Future:

As we navigate the complexities of HIV-HCV coinfection, several pivotal questions arise, guiding researchers, policymakers, and healthcare professionals:

  • Vaccine Efficacy: Given varied vaccine responses in HIV patients, such as with COVID-19 and HBV, how can we optimize the HCV vaccine's effectiveness?

  • Access and Trust: How can we promote equal access, especially for vulnerable groups, and rebuild public trust?

  • Global Collaboration: How can we ensure global HCV vaccine access and which partnerships are essential?

  • Learning from History: Using insights from the U.S. Mpox outbreak, how can we better anticipate and manage health crises?

  • Policy Evolution: How can we swiftly incorporate evidence-based discoveries into health policies?

Actionable Recommendations for HIV-HCV Management:

To effectively combat HIV-HCV coinfection, we should consider:

  • Vaccination Strategies: Given varied responses among PLWH, explore frequent dosing, boosters, or double-dosing for the HCV vaccine, as seen with HBV and COVID-19.

  • Monitoring: Implement regular health assessments post-vaccination and periodic antibody and viral load tests.

  • Policy and Awareness: Prioritize coinfected individuals in vaccine rollouts, ensure accessibility, and launch awareness campaigns.

  • Collaborative Efforts: Foster interdisciplinary and global collaborations to holistically address HIV-HCV coinfection.

  • Addressing Current Deficiencies in Access: Despite curative therapies for HCV being readily accessible for more than decade, HCV remains a pressing public health concern in the United States. Effective vaccine distribution will hinge on addressing the challenges identified by these findings.

By strategically planning with these considerations in mind, we can create a comprehensive plan, prioritizing the well-being of those impacted by HIV-HCV co-infection.

Streamlining Vaccine Delivery and Building Trust in Healthcare

Efficient Vaccine Delivery: Successfully delivering vaccines for HIV-HCV co-infection requires more than just the vaccine. It's about a blend of skilled staff, efficient processes, and the right infrastructure:

  • Continuous Training: Ensure healthcare professionals are updated on the latest in vaccine administration for coinfections.

  • Resource Allocation: Balance routine healthcare with specialized vaccine campaigns, especially in resource-limited settings.

  • Infrastructure Upgrades: Enhance facilities, considering temperature-controlled storage and patient comfort, especially in remote areas.

  • Addressing Staffing Issues: Bridge the gap in healthcare professional shortages to ensure comprehensive care.

  • Workflow Efficiency: Use technology and process improvements for a seamless patient experience.

  • Community Health Worker Integration: Utilize their insights and community rapport to enhance healthcare delivery.

  • Feedback-Driven Improvements: Create a feedback-rich environment for continuous workflow enhancements. 

Rebuilding Trust in Public Health: Trust is the bedrock of public health success, especially in the context of HIV-HCV coinfection:

  • Recognize Historical Mistrust: Address and make amends for past skepticism, especially among marginalized groups.

  • Combat Misinformation: Proactively counter myths about vaccines and transmission in the digital age.

  • Cultural Outreach: Use tailored messages and collaborate with community leaders for effective health drives.

  • Prioritize Transparency: Regularly update and demystify vaccine processes to foster trust.

  • Empathetic Engagement: Address vaccine hesitancy with understanding and compassion.

  • Collaborative Efforts: Partner with trusted community figures to amplify public health messages.

  • Feedback and Accountability: Implement public feedback mechanisms and act on them to reinforce trust.

In addressing HIV-HCV co-infection, both operational efficiency and trust-building are paramount. Together, they form the pillars of a comprehensive approach to public health challenges.

Conclusion:
Exploring the complexities of HIV-HCV coinfection reveals the depth of challenges and potential of modern healthcare. Each revelation, whether from studies on COVID-19, HBV, or HCV, not only highlight the gaps in our current understanding but also illuminates potential pathways forward. These insights should serve as guiding lights, directing our strategic development and interventions in the context of HIV-HCV co-infection.

However, our journey through this complex landscape is not solely guided by scientific discoveries. Central to our mission is a profound commitment to humanity and equity. It's a pledge to ensure that every individual, regardless of their background or circumstances, receives optimal care. From vulnerable groups, such as people experiencing homelessness or incarcerated persons, informed by lessons from the U.S. Mpox outbreak, to those in remote areas with limited healthcare access, our overarching goal remains steadfast: no one should be left behind.

By fostering collaboration across sectors, continuously updating our knowledge, ensuring investment in public health, and placing community engagement and trust at the forefront of our efforts, we can carve out a promising path. A trajectory that not only addresses the immediate challenges of HIV-HCV coinfection but also sets the stage for a healthier, more inclusive future for all affected individuals.

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

One Shot or Two? Necessity of COVID-19 Vaccination Among People Living with HIV and/or Chronic Liver Disease

At the time of this writing, the United States’ Food and Drug Administration (FDA) has provided Emergency Use Authorizations (EUAs) to 3 COVID-19 vaccines, with Novavax’s product potentially leading the race to become the fourth. While some have fretted over “which vaccine” is “the best”, governors and clinicians have resoundingly adopted a simple answer: “which ever vaccine you can get”. While President Biden has pushed to expand eligibility to all adults in the US by May 1st, as we’re all too familiar with in patient advocacy, eligibility does not necessarily equate to access and, in this respect, demand still vastly outstrips vaccine supply domestically.

The debate on who should get a vaccine and when began well before the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations in December 2020. ACIP’s recommendations focused primarily on constructing an ethical model based on hospitalizations and mortality, with an eye toward those performing duties most necessary to meet the health care demands of the moment. Ultimately, outside of this job-based prioritization, ACIP gave top priority via age-based allocation and then ascertaining those at-risk for these outcomes based on pre-existing conditions. Most states adopted some version of these prioritized populations. The debate on the efficacy of this model continues to rage on – what about those in marginalized communities more impacted by COVID-19 than more affluent communities? What about younger people with comorbidities? Which health conditions should be prioritized?

Regardless of where one’s local government falls on this debate, evidence catalogued by the CDC indicates a very real need for people living with HIV and those with chronic liver diseases to seek a vaccine as readily as possible as these cohorts are at increased risk for complications related to a COVID-19 infection. Studies have found PLWH experiencing an acute COVID-19 infection may see as much as 50% drop in CD4 T-cells compared to their historical levels, a condition known as lymphopenia – of which, is also an indicator for severe COVID-19 and protracted recovery or death. Additionally, the same study found key clinical metrics used to measure inflammation were similarly increased among PLWH. Another study out of Wuhan, examining people with chronic, yet controlled Hepatitis B infections may see a reactivation of viral activity and/or potentially face significant progression of liver cirrhosis during and after a COVID-19 diagnosis. Another study found SARS-CoV-2 may target certain cells in the bile tract and cause focused damage to the systems serving a person’s liver, with another study suggesting the need for health care providers to emphasize liver repair post COVID diagnosis.

While Janssen ensured PLWH were enrolled in phase 3 clinical trials for their product, none of the currently authorized products included solid organ transplant recipients in their trials. While the American Society of Transplantation notes COVID-19 vaccine administration recommendations for solid organ transplant recipients remains the same as other vaccines (either completed at least 2 weeks prior to transplant or initiated at least 1 month after transplant). Which may pose a problem according to a study published in March showing transplant recipients having received the first shot in the series mounted an antibody response just 17% of the time. While antibody responses are not necessary to confer immunity, they are the leading indication of an immune response. The authors of this study will be seeking to answer that question later this year.

Furthermore, additional research is needed in assessing post-acute COVID-19 infections and the implications of “long COVID”. Most research at this moment on long-COVID is tied to assessing symptom presentation and frequency of health care needs. However, there is a minor bit of information regarding organ function post-hospitalization with COVID-19 – none of it is “good news”. In particular, people experiencing chronic liver diseases were almost 2 times as likely to experience “major adverse events” after being released from the hospital due to COVID-19.

All of this information culminates with a sense of urgency some states are heeding in expanding vaccine access “ahead of schedule” to include people living with HIV or specific programming targeted to provide vaccines to these communities.

Brandon Macsata, CEO of ADAP Advocacy Association, recently penned a blog addressing any hesitancy among people living with HIV around getting their vaccines: “Vaccines are an important element of the journey, along with proven public health strategies (i.e., wearing masks, remaining social distant, washing hands). For the HIV-positive community, it is even more important for us to do our collective part to protect ourselves, as well as the people around us. Get your Covid-19 vaccine!

With the CDC’s guidance on prioritizing our communities in vaccination schemes, I couldn’t agree more.

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

What About Us? Reflections on What the Global Covid-19 Vaccine Means to HIV

A year ago, the world turned its eyes to a justifiably disparate race to find any possible treatment, cure, or prophylactic for COVID-19. The collective experience was familiar to veterans of the fight against HIV – though, for some, the feeling was tinged with dulling hope and cynicism. Afterall, the first HIV vaccine trial began in 1987. A near 35 years later and we’ve yet to find an effective and safe protective vaccine.

The COVID-19 effort spurred extraordinary and sometimes bizarre theories, with journalists soaking up non-peer-reviewed pre-prints with the abandon of a starving person. From theories on hormone replacement therapies to reduce blood clotting risks to the now-infamous hydroxychloroquine episodes to convalescent plasma to repurposing our own antiretroviral therapies, many, if not most, of these failed the test of time. Something HIV advocates and researchers are all too familiar with. As a result of the pressure and need, the Trump Administration initiated one of the largest scale federal research funding initiatives in history: Operation Warp Speed, promising to deliver a vaccine for the novel coronavirus in record time.

The resulting skepticism was understandable. Previously, the fastest any modern vaccine had been developed was about 5 years, with the current mumps vaccine. The difference this time, though, was vaccine tools that had failed elsewhere, in the fights against cancer, Ebola, and other diseases, had provided us the opportunity to “practice” for such an incident – expanding the unused tools in the toolbox as it were. Included among these was a near 50 year old theoretical approach, using messenger RNA to teach our bodies how to fight this new pathogen. Moderna and Pfizer did indeed produce such a product in December 2020.

While the world praised these developments, HIV also took an exception to the announcements. We’ve been waiting nearly 40 years for the same technological miracle. With more than 75 million known transmissions, approximately 32 million having died from AIDS related complications, and 38 million people currently living with HIV, since the start of our pandemic, it’s understandable to ask “what about us?” Where was this “warp speed” effort in 1995 when AIDS was the leading cause of death among 25-44 year-olds in the United States?

It’s important to note: coronaviruses and HIV are two very different types of viruses. Coronaviruses maintain a greater integrity in their reproduction processes and HIV’s “copy writers” are known for making “mistakes”, developing mutations and resistance to medications. As such, coronaviruses “mutate” at a much slower rate than HIV. Despite the very warranted concerns on SARS-CoV-2 variants, most vaccine products coming to market are showing promise in beating back these emerging threats. Whereas HIV is also known to “hide” viral reservoirs within a person’s body – merely waiting to be activated, thwarting certain progress.

Still, technology moves forward and hope springs eternal. Moderna has already announced intentions to use mRNA vaccine technology to produce more accurate vaccines for influenza, personalized vaccines for certain cancers, and HIV. Scribbs Research has also recently announced a phase I trial utilizing “germline targeting” technology to stimulate the exact B-cell responses for a body to develop HIV neutralizing anti-bodies.
Additionally, in a remarkable find, Abbott has recently identified an extraordinary occurrence of elite controllers, those with HIV antibodies but no or undetectable viral load without the use of antiretroviral therapies, in the Democratic Republic of Congo (DRC). With a prevalence of 2.7-4.3%, as opposed to 0.1-0.2% elsewhere in the world, researchers believe this population provides us an opportunity to investigate what is essentially a natural occurring immunity to HIV, something medicine doesn’t currently understand well enough to replicate. Abbott was able to identify this population through surveillance activities, as its screening tools are used in about 60% of the world’s blood supply donations, where information gathered is also used to identify emerging diseases – in particular “new” strains of HIV and viral hepatitis. Abbott’s findings state this occurrence of elite controllers is extends as far back as 1987, prior to the advent of antiretroviral therapies, at “similarly elevated levels”.

Regardless of the promise (read: hope) of a protective or therapeutic vaccine for HIV, any effective product is bound to face the same persistent issues of equity COVID vaccines are currently facing. From trial design by and inclusion of the most affected communities to equitable distribution outside of western countries, we absolutely run the risk of perpetuating existing global health disparities. Manufacturers, governments, and researchers will need to better align their actions with our moral and ethical obligations in order to truly end HIV for all, instead of just some.

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