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Peers and Perspectives

1rem

, where we delve into some of the social factors that create and widen healthcare disparities.

In honor of World Hepatitis Day, we interviewed Carl Schmid, executive director of the 

, about the persistent challenges in the fight against 

Schmid acknowledged there are many diseases and health concerns plaguing the world right now, but World Hepatitis Day is a chance to pause and recognize “we still have hundreds of millions of people with hepatitis right now, and it’s an infectious disease.”

Schmid himself is living with chronic hepatitis B, and thus, “This issue is personally very important to me.”

The different types of hepatitis disproportionately affect different populations. Schmid notes that in the US, homeless people are often most affected by hepatitis A, while Asian Americans make up the majority of hepatitis B cases. In the US, all people are recommended for hepatitis B vaccination at birth; immigrants who may not have been vaccinated have a higher risk for hepatitis B.

Even though we have a vaccine for hepatitis B, and viral hepatitis treatments are better than ever, the opioid epidemic is significantly increasing hepatitis infection by injection drug use. “We’re seeing more and more younger people, and more and more women who are contracting hepatitis C,” Schmid said.

“Every 30 seconds,” Schmid says, “someone is dying of hepatitis, and the sad thing is people don’t even know about it.”

“Like HIV, there’s so much stigma…a lot of people feel shame, and they don’t talk about it,” Schmid said, pointing out that this stigma leads to many unnecessary deaths.

Schmid noted that the hepatitis testing recommendations have been changed, and now every person between 18 and 79 years of age should be tested, which should reduce the stigma.

“It all comes down to testing,” he emphasized.

Proper surveillance for hepatitis is another area that is sorely lacking. “We don’t even have enough money to do proper surveillance of hepatitis,” Schmid said, “We know surveillance is so important for infectious diseases.”

The HIV+Hepatitis Policy Institute is a Washington, DC-based policy and advocacy organization for HIV and viral hepatitis issues. They are currently working with Congress to help pass the Biden Administration’s push for more funding.

Schmid said we have a long way to go in the fight against hepatitis: “This is an infectious disease, remarkably, that can be cured,” but, “We need more resources.”

Missed Episode 5 of Contagion Community? 

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: 

What steps need taken to end viral hepatitis by 2030? “It all comes down to testing,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.

World Hepatitis Day: Where Do We Go From Here?

Social determinants, a legacy of distrust, and inequities have all been challenges for people of color in the delivery of health care. And these factors have translated to the administration of 

The university hosts the biggest vaccination site in its county, San Bernadino. However, there is low representation of Black vaccinees. Abdul-Mutakabbir and faculty at Loma Linda worked with leaders from local Black churches to get the word out and communicate about the availability and benefits of the COVID-19 vaccine.

“From February 1 until April 30, 2021, 24,808 individuals were vaccinated in the LLU mass clinic with a first dose (Pfizer or Moderna) or single dose (Janssen) of a COVID-19 vaccine, however, only 908 (3.7%) were Black vaccinees. Contrastingly, the LLU remote site clinics vaccinated 1542 individuals with a first or single dose of a COVID-19 vaccine. Of those vaccinees, 675 (44%) were Black,” Abdul-Mutakabbir and coauthors wrote in their poster.

Along with protection against COVID-19, Abdul-Mutakabbir makes the point that preventative measures such as vaccines can help avoid hospital stays and subsequent health care associated infections and antimicrobial resistance. She believes vaccination goes hand-in-hand with antimicrobial stewardship.

Hear what vaccine equity means to Abdul-Mutakabbir, and the vaccine drive in which she was involved.

Missed Episode 1 of Contagion Community? 

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: ncosdon@mjhlifesciences.com

In this latest episode of Contagion Community, we interview Dr. Jacinda Abdul-Mutakabbir about vaccine equality vs vaccine equity as well as her experience on a COVID-19 vaccine drive to increase vaccinations in communities of color.

Vaccine Equality vs Equity with Dr. Jacinda Abdul-Mutakabbir

Yael David, PhD, discusses how cccDNA nucleosome positioning drives HBV transcription and how CBL137 disrupts this process to block infection.

Disrupting HBV Chromatin Structure Blocks X Gene Transcription and Infection

Precision BioSciences received the designation for its gene editing therapy, PBGENE-HBV, developed to eliminate the root cause of chronic hepatitis B virus (HBV). 

Gene Editing Therapy Receives FDA Fast Track Status in Aiming For Potential Chronic HBV Cure 

The loss of surveillance capabilities complicates efforts to control hepatitis outbreaks, explore new preventive treatments, and support new research trials.

Impact of CDC Hepatitis Lab Closure on US Public Health

National Youth HIV & AIDS Awareness Day emphasizes the urgent need for culturally responsive initiatives, discoveries in hepatitis B and C, FDA fast tracks H5N1 vaccine development, and more.

Alaska Sees HCV Reduction, But Need For Greater Test-And-Treat Adoption Remains

Andrew  Aronsohn, MD, assistant professor of Medicine University of Chicago Medical Center discusses the hepatitis C (HCV) screen and treat in one visit approach 

AASLD/IDSA Develop a New Hepatitis C Point of Care Test and Treatment Algorithm

For people who are battling HCV, there are a number of challenges to getting this patient population into the continuum of care, explains Andrew Aronsohn, MD, associate professor of Medicine, University of Chicago Medical Center.

“I think what's really important to think about when caring for people with hep C—both on an individual and a population basis—is that oftentimes, we're really focusing on helping very vulnerable populations,” said Aronsohn. “So these are folks that may be struggling with addiction; these are folks that may have difficulty with transportation or navigating huge health systems, or maybe undomiciled. Every time you set up another step for them to have to follow-up, you risking losing them to follow-up. There's a lot of data in HIV and even in hep C, that if you put this all into 1 visit and you can work on some education and actually give them medication in hand before they go out the door it is beneficial."

With these challenges, AASLD/IDSA (American Association for the Study of Liver Diseases/ Infectious Diseases Society of America) have partnered together to create a “screen and treat” algorithm. The algorithm provides guidance for clinicians to show them how to carry out this model and expedite the time needed to get tested and on HCV medication. 

Aronsohn is one of the chairs of the AASLD/IDSA HCV panel. He and others on the panel periodically update the guidelines to include new patient populations and the addition of new treatments and testing.

“This is a brand new algorithm. There was general treatment guidelines, and we did have a simplified treatment guidance that was a little bit easier, but this is not for every patient—that's really important,” Aronsohn said. “These updated treatment algorithms are for a certain subset of patients, which is spelled out in the algorithm itself…With the availability of point of care testing, that was the missing piece to actually do a test and treat pathway,” Aronsohn said.

Within this 1 clinical visit, there are few major aspects of the algorithm the panel wants to see providers perform during patient encounters, including: point-of-care HCV RNA testing, which allows for quick diagnosis; for those who test positive for the disease, give patients medication at that same encounter; test for hepatitis B and follow-up with patients if they test positive; and lastly, give patients an HCV RNA test 4 weeks after completion of therapy to determine if the virus has been cleared.

"This is just another option that providers can have in their armamentarium, if that makes sense for the population that they're taking care of,” Aronsohn said. “And really the big goal is we want to diagnose and treat as many people as possible for this entirely treatable disease that still kills.”

For those interested in downloading the algorithm, readers can go 

Andrew Aronsohn, MD, associate professor of Medicine, University of Chicago Medical Center, discusses the hepatitis C (HCV) screen and treat plan that looks to utilize a one visit approach to get people tested and on medication in the same patient encounter. 

AASLD/IDSA Develop a New Algorithm for Hepatitis C Point of Care Testing and Treatment 

Anchalee Avihingsanon, MD, PhD highlights 95.4% HIV suppression, 86.6% HBV suppression, and 52% ALT normalization after 48 weeks of B/F/TAF treatment in patients who switched from DTG+F/TDF.

At CROI 2025, Anchalee Avihingsanon, MD, PhD, principal investigator of the ALLIANCE study and researcher at the HIV-NAT at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand, discussed findings from the ALLIANCE trial. This Phase 3 study evaluated the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) compared to dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) in adults with HIV-1 and hepatitis B virus (HBV) co-infection.

The study demonstrated that B/F/TAF was noninferior to DTG+F/TDF for HIV-1 RNA suppression and superior for HBV DNA suppression at Week 48. Following 96 weeks of the randomized phase, participants who switched from DTG+F/TDF to B/F/TAF continued treatment for an additional 48 weeks in the open-label extension (OLE), showing continued success in managing both HIV-1 and HBV.

Avihingsanon explained the study design and results, "In this study, we enrolled 243 HIV and hepatitis B (HBV) co-infected participants who received one of two drug regimens: either bictegravir (BIC) plus emtricitabine (FTC) and tenofovir alafenamide (TAF), or dolutegravir (DTG) plus tenofovir disoproxil fumarate (TDF) and FTC. The backbone for hepatitis B treatment was either TDF or TAF, and our main goal was to compare these two drugs in terms of their effectiveness for both HIV and HBV treatment.”

“We had two primary endpoints: 1) HIV viral suppression, and 2) HBV viral suppression and HBV-related outcomes. The first phase of the study was a randomized phase, which lasted 96 weeks, where participants were assigned to one of the two regimens. After 96 weeks, patients who had been receiving the DTG+TDF regimen were given the option to switch to the BIC+FTC+TAF regimen. Of the 122 patients eligible for the switch, 89 chose to continue into the open-label extension phase for an additional 48 weeks.”

Avihingsanon outlined the positive impact of switching to B/F/TAF on HBV suppression and liver health, "At the end of the 96-week randomized phase, we observed that both regimens were equally effective at suppressing HIV viral load. However, the outcomes for hepatitis B were different. Starting from the 48-week mark, the TAF-containing regimen showed better results for HBV suppression and also higher rates of HBeAg (hepatitis B e-antigen) and HBsAg (hepatitis B surface antigen) loss, which are important markers of HBV replication and infection resolution.”

“Before switching to the TAF-based regimen, nearly 85% of patients had abnormal alanine aminotransferase (ALT) levels, indicating liver inflammation. After switching to the TAF-based regimen, almost 50% of patients achieved ALT normalization, which is important because abnormal ALT levels suggest ongoing liver inflammation, which can lead to liver fibrosis, cirrhosis, and liver cancer over time.”

Avihingsanon emphasized the importance of TAF in managing HIV and HBV co-infection, “For patients co-infected with HIV and hepatitis B, it's essential to consider both HIV and hepatitis B outcomes. The TAF-based regimen is very effective for both HIV and hepatitis B. Therefore, any regimen containing TAF should be preferred as the first-line treatment for HIV and HBV co-infected patients.”

She also compared TAF and TDF-based regimens, “Additionally, when comparing TAF-based regimens to TDF-based regimens, TAF has the advantage of being safer for renal and bone health. This is important for HIV co-infected patients because they often have a higher risk of renal toxicity and related kidney problems.”

Avihingsanon discussed the long-term goals of hepatitis B treatment, “In terms of hepatitis B serology, the ultimate goals of treatment are ALT normalization, HBeAg loss, and HBsAg loss. Achieving these goals suggests a functional cure for hepatitis B, especially when there is HBsAg seroconversion. This is the ideal outcome we want to see. If we can normalize liver function, it helps reduce the risk of liver inflammation, liver fibrosis, cirrhosis, and ultimately liver cancer in the long term.”

Avihingsanon concluded by highlighting the importance of addressing both infections and their comorbidities, “For HIV and hepatitis B co-infection, it's not just about managing HIV; we must also consider the hepatitis B co-infection and the long-term comorbidities. Hepatitis B increases the risk not only of liver cancer but also of ALT-associated hepatotoxicity. Therefore, we must focus on how to rapidly reduce hepatitis B DNA, decrease HBeAg and HBsAg, and normalize ALT levels. These are crucial steps to managing the co-infection effectively and preventing future liver complications.”

Avihingsanon A, et al. Virologic and Immunologic Outcomes at OLE W48 in Participants Who Switched to B/F/TAF After 96W of Initial Treatment With DTG+F/TDF. Poster #XXX presented at CROI 2025. March 9-12, 2025, San Francisco, California.

Anchalee Avihingsanon, MD, PhD presents results showing 95.4% HIV RNA suppression and 86.6% HBV DNA suppression after 48 weeks of B/F/TAF in HIV-HBV co-infected patients.

Conferences

ALLIANCE Study: B/F/TAF Achieves Sustained HIV and HBV Suppression

In Part 2 of our interview, Su H Wang discusses combating vaccine misinformation, preventing outbreaks, and highlight global health interconnectedness

Science Is Science: Navigating Clinical Trust Amid Political Shifts

Recent changes in US health policy have raised serious concerns within the global health community. In a recent Lancet correspondence, 

, and fellow clinicians and public health experts highlighted the alarming impact of the US administration’s decisions to withdraw from the World Health Organization (WHO), halt vital CDC communications, and freeze foreign aid. These actions have placed international health partnerships at risk and threaten progress made in disease control, particularly for vulnerable populations worldwide.

Experts agree that swift action is needed to restore these programs and safeguard the progress made in global health. The freezing of foreign aid, particularly programs like PEPFAR, which supports more than 20 million people, is of particular concern. The current situation is a stark reminder of how interconnected the world’s health systems are and how vulnerable these systems are to political shifts.

In Part 2 of our interview with Wang, the discussion shifted to the impact of these policy changes on vaccine strategies

 and public health communication, with a focus on maintaining public trust in vaccines. Wang highlighted the role of clinicians in combating vaccine misinformation and reinforcing the importance of vaccines as life-saving tools. “We’ve seen time and time again that it’s not always the facts that sway people, but the messages they hear from friends and family,” Wang explained. “Clinicians need to be ready to counter misinformation with stories that show how vaccines have saved lives.”

Wang offered examples of how the MMR vaccine has played a key role in preventing devastating diseases like measles encephalitis

, and how the Hepatitis B vaccine has contributed to a significant decline in liver cancer rates.

 "Vaccines prevent more than just immediate diseases—they prevent long-term health complications that can affect entire generations. The Hepatitis B vaccine alone has made incredible strides in reducing liver cancer rates, and reversing that progress would be catastrophic,” Wang said.

The conversation then turned to the average American's potentially nonintentional lack of awareness about global health systems and how they contribute to the consequences of these policy shifts. Wang pointed out that many people in the US fail to recognize the broader systems that support public health—systems that rely on international cooperation and funding. “What we’re seeing is that there’s a sense that if it doesn’t happen in my neighborhood, within my country’s boundaries, it doesn’t affect me,” Wang said. “But the reality is, global health is interconnected. Epidemics in one part of the world can, and do, affect us here in the US in ways we don’t often realize.”

“If you go into a hospital, all the devices you use have been approved, and there are complex systems in place to ensure your safety, from blood donation screenings to medication approvals,” Wang explained. “These systems, though often invisible, are crucial to our well-being. And when we ignore them, we risk undermining the very protections that keep us safe.”

Wang also emphasized the importance of clear communication in maintaining public trust, particularly in times of political uncertainty. “At times like these, good reporting and journalism are more important than ever. It's crucial that we share information from reputable sources and make sure the truth gets out to wider audiences. But it’s not just the media’s job—each of us has a role to play in our own spheres, whether it's within our families, communities, or patient populations.”

Addressing the growing vaccine hesitancy in the US, Wang warned of the potential consequences of reversing vaccination progress. “If we backslide, we’ll see outbreaks of diseases we thought were eradicated. Polio, measles, and Hepatitis B will make a comeback,” she said. "Our children, our future generations, will bear the brunt of this. We've made so much progress, especially with vaccines like Hepatitis B, which has dramatically reduced acute cases and prevented liver cancer. Reversing that progress would be disastrous.”

WHO reported that measles cases increased globally from 8·6 million in 2022 to 10.3 million in 2023.

 Now, concerns about the ongoing measles outbreak in Texas, where children have fallen ill.

 “Measles is incredibly transmissible, and this outbreak is a stark reminder of the consequences of vaccine reluctance,” she said. “These outbreaks could be avoided if we stay vigilant and continue to communicate the importance of vaccines.”

Wang summarized, "Some of what’s happening in politics is politics. But we must keep science, science. We need to reassure people that vaccines are safe, and that science stands firm even in the face of political transitions."

Listen to the first part of our interview here: 

US Health Policy Changes Threaten Global Public Health Cooperation

1. Wang S, Harrington M, Graham CS, Downs LO, Kagwanja N, Etyang AO, Iwuji C, Ndung'u T, Cowie BC, Kabagambe K, Matthews PC. Pathogens don't respect politicians: US federal disruption poses a new threat to global public health. Lancet Gastroenterol Hepatol. 2025 Feb 6:S2468-1253(25)00045-7. doi: 10.1016/S2468-1253(25)00045-7. Epub ahead of print. PMID: 39923777

2. Seitz A. Vaccine skeptic Robert F. Kennedy Jr. is sworn in as Trump’s health chief after a close Senate vote. 

. February 13, 2025. Accessed February 14, 2025. https://apnews.com/article/rfk-trump-health-secretary-vote-5dbefeef0537dc241e6fb33b8f2a748b

3. Di Pietrantonj C, Rivetti A, Marchione P, Debalini MG, Demicheli V. Vaccines for measles, mumps, rubella, and varicella in children. Cochrane Database Syst Rev. 2021;11(11):CD004407. Published 2021 Nov 22. Accessed February 14, 2025. doi:10.1002/14651858.CD004407.pub5

4. Flores JE, Thompson AJ, Ryan M, Howell J. The Global Impact of Hepatitis B Vaccination on Hepatocellular Carcinoma. Vaccines (Basel). 2022;10(5):793. Published 2022 May 17. doi:10.3390/vaccines10050793

5. World Health Organization. Measles cases surge worldwide, infecting 10.3 million people in 2023. WHO. Published November 14, 2024. Accessed February 14, 2025. https://www.who.int/news/item/14-11-2024-measles-cases-surge-worldwide–infecting-10·3-million-people-in-2023

6. Texas Department of State Health Services. Measles Outbreak–Feb. 14, 2025. Texas Department of State Health Services. Published February 14, 2025. Accessed February 14, 2025. https://www.dshs.texas.gov/news-alerts/measles-outbreak-feb-14-2025

Su H Wang, MD, FACP, MPH discusses combating vaccine misinformation, preventing outbreaks, and highlighting global health interconnectedness





Combining over 1,000 human antibodies, GIGA-2339 aims to achieve viral clearance and activate the immune system, offering a potential solution where current therapies fall short of providing a cure.

GigaGen Doses First Patient in Phase 1 Trial of GIGA-2339, a Potential Functional Cure for Chronic Hepatitis B

GigaGen Inc has announced the dosing of its first patient in a Phase 1 clinical trial investigating GIGA-2339, a recombinant polyclonal antibody for the treatment of chronic 

 B virus (HBV) infection. The trial will assess the safety and tolerability of the drug, which holds a potential functional cure for chronic HBV.

Current treatments for chronic HBV can suppress viral replication but do not offer a cure. It remains a global health threat, affecting over 296 million people worldwide and causing more than 800,000 deaths each year. GIGA-2339 is designed to target the Hepatitis B surface antigen (HBsAg), a key protein that facilitates viral replication, potentially allowing for viral clearance and long-term immune system activation.

Developed using GigaGen’s innovative recombinant polyclonal antibody platform, GIGA-2339 combines over 1,000 fully human antibodies targeting HBV, providing a highly potent and diverse treatment option. The drug is over 2,000 times more potent than existing therapies and aims to tackle a broad range of circulating HBV variants, including potential escape mutations.

In an exclusive interview, Carter Keller, senior vice president at Grifols and Head of GigaGen, shared his excitement about the trial's launch and the drug’s potential to address the challenges of chronic HBV.

“We’re really excited. We just announced that we’ve dosed our first patient in our Hepatitis B trial,” Keller said. “The Hepatitis B trial is for a product called GIGA-2339. This is a mixture of thousands of different antibodies made recombinantly. They’re human antibodies, all targeted towards the Hepatitis B surface antigen, and it really represents a new way to treat the disease. We’re really excited to see how it performs in the clinic.”

GIGA-2339 is unique in that it uses a polyclonal approach, meaning it includes multiple antibodies that target different parts of the virus. Keller explained how this could offer advantages over existing therapies.

“We have a unique platform that allows us to take the best human immune systems, extract the genetic components of those immune systems, and recombinantly reproduce them,” he said. “We can then select the antibodies that are directed towards the virus or viral target we’re interested in. This is a very unique way to treat disease, nobody’s ever done it like this before.”

The approach allows for a diverse and multifaceted immune response. “The fact that we have thousands of different antibodies against Hepatitis B antigens means we can target multiple epitopes of the HBV. By coating the surface of the virus and viral particles, we can mount a highly efficient immune response to clear the virus,” Keller added.

Moreover, this diversity of antibodies allows GIGA-2339 to target all HBV genotypes and tackle potential escape mutations that can arise during treatment. “Having thousands of antibodies against different epitopes allows us to target all genotypes of the virus. This means we won't miss patients with different or diverse genotypes. It also helps us address any potential escape mutations that might arise during treatment.”

Focus on Safety and Efficacy in Phase 1 Trial

The Phase 1 clinical trial is primarily focused on determining the safety and tolerability of GIGA-2339 in individuals with chronic HBV who have not responded to previous nucleoside analog therapy. Keller explained that this study differs from typical Phase 1 trials, which are often conducted in healthy volunteers.

“We’re definitely interested in determining what dose is safe and tolerable for different patients. But many safety and tolerability studies are conducted in healthy volunteers. In contrast, this Phase 1 study is being done in individuals with chronic HBV. This gives us an opportunity to find a safe dose that also optimally depletes the Hepatitis B surface antigen in these patients,” Keller noted.

The goal of the trial is to find the optimal dose that can effectively reduce the levels of HBsAg, which could lead to better outcomes in later trials. “Finding the dose that optimally depletes the surface antigen will allow us to move into Phase Two clinical trials, where we can expand the patient population at that dose and better assess the drug’s efficacy in a statistically significant way,” he said.

The Path Toward a Functional Cure for HBV

A key objective for GigaGen is to explore the possibility of a functional cure for HBV. Keller explained that GIGA-2339 could offer something beyond just viral suppression.

“We have a hypothesis that if we can downregulate the Hepatitis B surface antigen, an antigen that’s known to suppress the immune system, we might be able to not only clear the virus but also reactivate the immune system,” Keller explained. “This could potentially lead to what we call a functional cure. We’re very interested to see how this plays out in our clinical trial.”

By reducing HBsAg levels, the drug could help restore the body's natural immune response to the virus, which may lead to a sustained immune-mediated clearance of the infection. Keller referred to this as a “virtuous cycle”: “There’s this kind of 'virtuous cycle' where we efficiently deplete the virus, reactivate the immune system, and then the immune system helps to clear the virus.”

Keller highlighted the importance of this innovation in the context of HBV treatment and beyond. “Our platform allows us to create these incredibly diverse therapies. It’s the only platform that can do this at scale while maintaining manufacturing consistency. This gives us the ability to treat as many patients as needed,” Keller said.

As GigaGen’s clinical trials progress, the company remains hopeful that GIGA-2339 will offer a novel solution to the millions living with chronic HBV. With its unique combination of potent, broad-acting antibodies and a potential to reactivate the immune system, GIGA-2339 could play a key role in advancing the treatment landscape for chronic hepatitis B.

“We’re really excited to see where this takes us. If we’re successful in targeting the surface antigen and reactivating the immune system, we could see significant improvements for people living with chronic HBV,” Keller concluded.

Watch our previous interview with Keller to gain additional background and insights into the developments that led to this milestone: 

HBV Antibody GIGA-2339 Cleared for Clinical Trials to Address Hepatitis B Cure Gap

GigaGen Doses First Patient in Phase 1 Trial of Recombinant Polyclonal Drug Candidate, GIGA-2339, for Hepatitis B Virus. 

HCV / Hepatitis

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