Antimicrobial Stewardship

Ebola

HCV / Hepatitis

Blood-Borne Diseases

Climate Change

Coronavirus

Covid Vaccine Race

E. Coli

Food Safety

Listeria

Salmonella

Food Borne Infection / Food Safety

C. Difficile

H. Pylori

Norovirus

Gastrointestinal Infections

Healthcare Associated Infections (HAI)

Antibiotics

Immunizations

Vaccines

Prevention

Community-Acquired Pneumonia 

HAP / VAP

Influenza

Respiratory Infections

HIV / AIDS

PrEP

Sexually Transmitted Diseases

MRSA

Skin & Soft Tissue Diseases

Lyme Disease

ZIKA

Zoonotic & Vector-Borne Diseases

News

Media

Medical World News

Podcasts

Videos

Insights

Peer Exchange

News Network

Roundtables

Conference

Conference Coverage

Conference Listing

Publication

CME/CE

Partners

Resources

Interactive Tools

Special Projects

Contribute

Case Studies

Writers and Mentors

Subscribe

Contagion® is a fully integrated news resource for practitioners and specialists to assist with the identification, diagnosis, treatment, and prevention of infectious diseases.

About Us

Advertise

Editorial

Contact Us

Do Not Sell My Information

Privacy

Terms & Conditions

Contagion Live | Infectious Disease News & Expert Insights

Facebook

Twitter

LinkedIn

Spotlight

Bench to Bedside With SIDP

C. difficile 

Clinical Corner

Gastrointestinal infections

Hepatitis

RSV: A New Era in Prevention

Clinical

COVID-19

Food-Borne Infections

Healthcare-Associated Infections

Respiratory Diseases

Respiratory Syncytial Virus (RSV)

Video Series

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

A recent study showed that an increase in anti-hepatitis E virus seroprevalence in patients with chronic inflammatory demyelinating polyneuropathy was not a consequence of intravenous immunoglobulin therapy.



Connection Between Increased Hepatitis E Virus Seroprevalence and Chronic Inflammatory Demyelinating Polyneuropathy

Overall, findings demonstrated a 78% treatment success rate among patients who prematurely discontinued direct-acting antivirals (DAA), and even seeing a 93% success rate among those who discontinued after week 4.

Discontinuation of Hepatitis C Treatment Early Did Not Preclude Sustained Virologic Response

Protein organization could pave the way for effective vaccine development

Advances in Understanding Hepatitis C Virus Structure

The gene USP26 is identified as a factor in hepatocellular carcinoma development and a potential therapeutic target.

USP26: Key Driver in HBV-Induced Liver Cancer

Atea pharmaceuticals' oral nucleotide RNA-dependent RNA polymerase inhibitor advances in phase 3 trials for COVID-19 and phase 2 trials for hepatitis C, showing potential efficacy.

New Data on Bemnifosbuvir's Progress in COVID-19 and HCV Trials

Danjuma Adda on WHO's efforts against Hepatitis B and his call for global vaccination and treatment efforts.

Hepatitis B in Focus Bridges the Gap Between Policy and Implementation in Vaccine Coverage

Danjuma Adda, MPH, FIMS, Dip-IMS, is the past president of the World Hepatitis Alliance and a fellow with the Aspen Voices Fellowship. He is the founder of Appreciate You Organization in Nigeria, which works to improve access to hepatitis testing and increase awareness about the disease. Ida is also living with HBV.

Chronic HBV infection remains a significant global health challenge, leading to approximately 1.1 million deaths in 2022, primarily from cirrhosis and hepatocellular carcinoma, according to WHO. In 2022, an estimated 254 million people worldwide were living with HBV, with the highest prevalence in the African and Western Pacific regions, where 65% of these cases are found.

“There has not been any significant improvement in the diagnosis and treatment of hepatitis B. The prevalence of hepatitis B is alarming, with the disease claiming over 270,000 lives annually in Africa. The rate of diagnosis is dire; only about 3% of hepatitis cases are diagnosed, and merely 2% of those diagnosed receive treatment.”

The primary transmission routes of HBV are from mother to child at birth and through horizontal household contact. Despite the severity of the disease, there has been notable progress in preventing perinatal HBV transmission through universal infant vaccination programs. The administration of a hepatitis B vaccine within 24 hours of birth has been shown to be 90-95% effective in preventing the infection and has significantly reduced the incidence among children. However, global coverage of this birth-dose vaccination is still low at 45%, and even lower in the WHO African region at 18%.

“The WHO recommends that newborns should receive the HBV vaccine within 24 hours of birth, or as early as possible. This is a critical measure to prevent new infections and it's important to remember that this is a cancer-preventing vaccine. To ensure all babies are vaccinated, we need to strengthen immunization systems so that these vaccines are readily available, especially in delivery rooms, not just outside where access can be limited after business hours or on weekends. It's crucial that the vaccines are accessible exactly where and when the babies are born.”

For those already living with HBV, treatments such as tenofovir or entecavir have been highly effective in slowing the progression of liver disease and reducing the incidence of liver cancer, improving long-term survival rates. A substantial gap in diagnosis and treatment persists only 13% of those with HBV were diagnosed in 2022, and a mere 3% received treatment.

“To ensure all babies are vaccinated, we need to strengthen immunization systems so that these vaccines are readily available, especially in delivery rooms, not just outside where access can be limited after business hours or on weekends. It's crucial that the vaccines are accessible exactly where and when the babies are born.”

Achieving the WHO's elimination goals, which aim for 90% testing coverage and 80% treatment coverage, will require a significant overhaul of the current approaches to diagnosing and treating HBV. This includes simplifying treatment criteria, diagnostic methods, and care pathways to enhance access to vital testing and treatment services.

Easterbrook P, Luhmann N, Bajis, et. al. WHO 2024 Hepatitis B Guidelines: An Opportunity to Transform Care.

. Published April 10, 2024. Accessed April 12, 2024. DOI: 

https://doi.org/10.1016/S2468-1253(24)00089-X

Hepatitis B Virus (HBV) Bridges Gap Between Policy and Implementation in Vaccine Coverage

The first-in-class entry inhibitor delivered therapeutic benefits over a long study period for patients with chronic infection. 

Bulevirtide Demonstrates Efficacy, Safety for Hepatitis D Treatment

For patients who have chronic hepatitis Delta (HDV), which is the most severe form of viral hepatitis, the infection can often come with poor prognosis and high rates of mortality. And combined with the possible coinfections such as hepatitis B (HBV) and HIV, disease management can be extremely difficult.

“What we know is hepatitis delta prevalence in people living with HIV is actually higher than in people who do not have HIV,” Anu Osinusi, MD, vice president, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead, said. “And so because of the common routes of transmissions of these diseases, HIV, hepatitis B, and hepatitis Delta, people who have triple infections, what we also know from the data is that there is a higher rate of liver-related outcomes such as developing cirrhosis, decompensated liver disease, liver cancer...larger rates of the need for liver transplantation and overall death, compared to individuals who just have hepatitis B or hepatitis D.”

With the potential severity of chronic hepatitis D and the coinfections and limited treatment options, there is an unmet need for therapies. Bulevirtide (Hepcludex, Gilead) is a first-in-class entry inhibitor that was approved in the European Union for chronic HDV infection in HDV RNA positive adult patients with compensated liver disease. The therapy is an investigational treatment in the United States. 

“What bulevirtide does is it essentially binds to and then inactivates the NTCP receptor, which then has the goal of preventing new infections in the hepatocytes, and then inhibits the propagation of hepatitis Delta itself,” Osinusi said.

At last week’s Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, CO, data was presented on bulevirtide in regards to those with chronic hepatitis D and also included results on 2 patients who had HIV, hepatitis B, and hepatitis D.




In this study, 150 participants with chronic hepatitis D were randomized (1:1:1) into 3 arms including Arm A, which was no active anti-HDV treatment for 48 weeks, followed by bulevirtide 10mg/d for 96 weeks (n=51), and Arms B or C: immediate treatment with bulevirtide at 2 mg/d (n=49) or 10 mg/d (n=50), respectively, each for 144 weeks, with follow-up of 96 weeks after end of treatment. Efficacy was measured by combined (undetectable HDV RNA or ≥2 log10 IU/mL decline from BL and ALT normalization), virologic and biochemical response rates.

“At week 96, 39% to 56% of patients responded with substantially reduced levels of HDV RNA and with normal levels of the liver enzyme alanine aminotransferase, a key marker of liver health. Through 2 years of treatment, bulevirtide was safe and well tolerated,” the study authors wrote.

Osinusi explained that for some participants it may have taken longer time to see a therapeutic benefit.

“Even in the patient participants who didn't have a virologic response at week 24, over time, many of those participants actually go on to have this improved response at week 96,” she said.

For the 2 individual patients in the subset who had HBV/HDV, they also saw a benefit. “At week 96, both patients achieved a combined response (virologic and ALT normalization) as well as improvements in HBV DNA, platelet levels, and liver stiffness measurements,” the investigators wrote. “Neither patient required changes to their anti-HIV regimen nor did they experience serious [adverse events] AEs related to [bulevirtide] BLV.”

 spoke to Osinusi who offered further insights on the study and the therapy.




Wedemeyer H, Aleman S, Brunetto M, et al. Efficacy and Safety of Bulevirtide 2 mg or 10 mg for 96 Weeks in Chronic Hepatitis Delta, Including in 2 Patients With HIV/Hepatitis B Virus/Hepatitis Delta Virus. Poster #735 presented at CROI 2024. March 3-6, 2023. Denver, CO.



2023 year in review

As we close out 2023, it is a time to reflect on the major developments and approvals of some important therapies and vaccines. For example, the approval this year of 4 RSV immunizations will certainly be beneficial in the years ahead. In fact, we created a series around the topic titled, 

, which is a collaborative project with our partners 

 to discuss these significant approvals and how clinicians are counseling patients and families on these immunizations. 

In addition, 2023 saw the approval of antimicrobials, the continued development of rapid diagnostics, and the ongoing evolution of concepts such as 

Our Editor-in-Chief Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS, offered some insights on a variety of topics including what he felt was the most unique development of the year, the FDA approval of Innoviva’s antibiotic, sulbactam-durlobactam (Xacduro). The antibiotic was 

 back in May and is indicated for treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by 

It is this antibiotic that can serve as a microcosm of the industry and the development of these essential therapies. The scope of the indication is limited, and behind this is the question of whether this can be seen as economically viable in an antimicrobial market that has inherent challenges from development to profitability. Gallagher is intrigued by the approval of this therapy and has 

 about it.

“And among the things that's interesting about that to me is honestly, whether it can be commercially successful,” said Gallagher. “I hope it is. I think it's a wonderful new drug, or a revision of an old drug, to our armamentarium. But, if you asked clinicians for years in infectious diseases what they would like to see as that ideal next drug, I think a lot of people would tell you a targeted agent active against highly resistant gram negatives. Most people would probably say 

 and ideally oral, but would such an [agent] really be commercially successful?”

, Gallagher also weighed in on RSV immunizations, the evolution of COVID-19 monovalent vaccines, and the reemergence of the investigational antibiotic, ceftobiprole, and its possible approval in April 2024.



New and novel antimicrobials remain at a crossroads as the path to development and economic viability continue to be serious challenges. Our Editor-in-Chief weighs in on this topic and some of the other most significant ones from this past year.

2023: The Year in Infectious Disease

The panelists discuss the importance of the role of task shifting in Hepatitis C care.

Task shifting in HCV care

 It sounds like there [are] barriers on 3 levels––the patient, provider, and the system itself can be difficult to navigate, right? And one term that we frequently hear about is 

. And that’s a concept that can help us to overcome some of those barriers. Jordan, can you define that? What exactly does that mean? And how do you see that being important to…clos[ing] some of these gaps?

Absolutely. Well what we know is that APPs [advanced practice providers], our nurse practitioners and our PAs [physician assistants], are valuable members of the health care system. And…now about 75 % of patients that have HCV [hepatitis C virus] are being managed by APPs. So I think it’s very important that we are educating our APP colleagues about this disease state, about these great and easy-to-use medications, so that we can continue to screen and treat these patients with the help of our APP colleagues.

 So really they’re an essential component to achieve elimination. I mean, this is where the bulk of patients [are] being screened, [receiving a diagnosis, and being] actually treated, so we really need that support from the APP colleagues to…get this done. Tipu, do you see a similar role for task shifting within the addiction medicine community?

 Yes. This gets me really excited. I love this topic. The incidence, as we were [discussing] with the data with Mark, is young drug-using patients that are injecting drugs are really pushing the incidence of hep[atitis] C right now. And again, these patients are healthy. They’re not going in for health care elsewhere, but where do they go? They go to a methadone clinic. They go to their MAT [medication-assisted treatment] provider, the primary care doc[tor], to get their medications for opioid use disorder.… So when we see them there for that, that’s a perfect opportunity for us to screen and treat them. In my eyes, I really think that addiction medicine is [at] the forefront of hep[atitis] C treatment. As a fellowship director, I train all…my fellows [to recognize] that when you’re treating your patients for whatever substance use disorder they have, you need to be updated on the guidelines for screening, but you need to be comfortable with management because these patients may not go to the primary care doc[tor]. They may not go to a GI [gastrointestinal] doc[tor] or hepatologist or an infectious disease specialist. They may only come to you to get their buprenorphine prescription or their other MOUD [medications for opioid use disorder].… So when you [have] them, you’ve got to feel comfortable treating [them]. And I do think that colocalization of treatment under the same roof by addiction medicine for hep[atitis] C is going to be important in eradication.

 Tipu, I’ll pose this question to both you and Jordan. Do you see hep[atitis] C as serving as a gateway to deal with some of their other comorbidities, whether it’s addiction medicine or addiction comorbidity, or if they have some of the primary care comorbidity, do both of you see that hep[atitis] C leading to potentially dealing with some of these other issues?

I think it’s a 2-way street, actually.… It goes both ways. In my practice, we’ve had a lot of patients that come in for their MOUD…who are then screened and we find out they have hep[atitis] C, and it opens a gateway for getting their hep[atitis] C treated but also establishing some basic primary care. And it definitely goes the other way around. In our primary care clinic, a lot of patients [are] refer[red] to us that were diagnosed with hep[atitis] C by the [emergency department] or wherever else they came from. And [we ask,] “How’d you get hep[atitis] C? Oh, let’s talk about your opioid use disorder. Do you know that we’ve got meds for opioid use disorder?” And they really kind of…integrate treatment to both.

Yes, absolutely. I think as an APP, we may get a little bit more time to spend with these patients.... So when we’re talking about treating their hep[atitis] C, this can be a time that we can also address other primary care issues with these patient populations.

 I think that’s important in that trust building, right? That time that you…are able to spend with patients that really builds that relationship is critical.

Transcript was AI-generated and edited for clarity and readability. 

Experts discuss where we currently stand on the World Health Organization elimination goals for Hepatitis C virus.

The Hepatitis C Elimination Goal

 Hello and welcome to this HCPLive® Peer Exchange program titled, Curing Your Patients from Hepatitis C: Addressing Complex Needs with Simplified Treatment Approaches. I’m Dr Tony Martinez, associate professor of medicine at the Jacobs School of Medicine [and Biomedical Sciences] at the University of Buffalo and the medical director of hepatology at Erie County Medical Center in Buffalo, New York. Joining me for today’s discussion are 4 of my colleagues. Would you each please introduce yourselves.

 [Hello], Tony, I’m Tipu Khan. I’m an addiction specialist and family physician, chief of addiction medicine [at] Ventura County Medical Center and program director of the Addiction Medicine Fellowship. I lead the primary care hep[atitis] C eradication program for our residents there, and I’m an adjunct clinical professor at USC [University of Southern California] Keck School of Medicine.

Thank you, Tony. It’s so nice to be here. I’m a transplant hepatologist at Rush University Medical Center in Chicago, Illinois, where I’m also chief of hepatology.

Hi, Tony. I’m Mark Sulkowski. I’m at Johns Hopkins [University School of Medicine] in Baltimore, where I serve as the medical director of our Viral Hepatitis Center, and a professor of medicine there.

[Hello], Tony. Thanks for having me. I’m Jordan Mayberry. I’m a physician assistant at UT [University of Texas] Southwestern [Medical Center] in Dallas in the digestive and liver disease clinic.

 Fantastic. Welcome. Our discussion today will focus on screening, diagnosis, and treatment of hepatitis C in various clinical settings, including addiction medicine and primary care. We’ll discuss simple treatment regimens and some strategies on how to incorporate HCV [hepatitis C virus] care into your clinical practice. Welcome, everyone. Let’s get started. The World Health Organization [WHO] has a goal to eliminate hepatitis C by the year 2030. Mark, where do we stand in terms of elimination? Are we on track?

Well that’s a great question and it’s a good time to ask that. We’re about 7 years away from 2030 and where are we? Back in 2015, WHO said we want to reduce hepatitis C as a public health threat. We’ve got these great medications. We can do it. They set 2 targets. One was reduce mortality by 65%. The other was reduce incidence, that is new cases, by 90%. Where do we stand? Well, if we focus just on the United States, there [are] some good things. With the treatment of older individuals with more advanced liver disease, we have reduced mortality, and in many senses, achieved that particular goal. Not in every subgroup. In fact, the most recent [data] out from the CDC suggest that certain groups of Americans, particularly African Americans, are still dying at a rate that’s far above the other groups. The other place we’re getting an F grade is on incidence. We still have too many new individuals getting infected with hepatitis C across the full spectrum of ages; not just young people, all the way into people over 60 are getting hepatitis C and that’s linked, of course, to injection drug use.

 When does it appear that we’re on target to eliminate, if we do get there?

Well it’s sort of an affinity curve at the current rate with new cases…perhaps matching the number of people cured with treatment. We’re probably at best treading water.

 So, Tipu, we’ve just heard that maybe we’re not on track here and we’ve got therapies that are highly effective, safe, relatively easy to use, [and that] really [have become] simple. What do you see [as] some of the barriers prohibiting us from getting to elimination?

 Yes, it’s interesting. I think when we think about barriers, we’re breaking them down to a few categories. The first category is patient. It’s hard to identify these patients. We aren’t doing a great job at screening. Universal screening guidelines are out there. But if we don’t screen them, we’re not going to find them, right? We’re not going to be able to link them to care. So we need to make sure we’re screening people appropriately. Everyone 18 [years] or older should be screened at least once and then more often if they’ve got ongoing risk factors [such as] injection drug abuse. I think what we’ll find when we do that is we’re catching these patients more often.

The other thing I think we run into a barrier with––especially with, as Mark was saying, the incidents being in younger drug-using patients right now––[is] we’re finding that they’re otherwise healthy and they don’t engage in health care, and they don’t come to the doctor because they don’t have a lot of other stuff going on. So I think we need to, as a system, understand that whenever we capture them in the health care system, that could be at a medication-assisted treatment program or screening for incarceration,…we should be able to identify them, screen them, and link them to care. But I think the next step beyond that then, of course, is on our level as prescribing providers. We need to realize that there are simplified algorithms that are out there. Treating hep[atitis] C nowadays isn’t what it was 15 years ago. And it really now has become a primary care disease. And we, as primary care physicians, as addiction specialists, should be the leaders in treating this disease now. I always tell my colleagues that there’s not a lot we do in primary care that’s sexy, right? We are in it for the long haul. But this is one of the few diseases that we can actually cure. We can say, “I’ve got to [get a] cure for you. I’m going to shake your hand and get you cured and we’ll be done with this.” So I think we, as providers, as prescribing providers, need to step up to the plate in screening and then understanding that algorithms are really simple for treatment, which we’ll cover today.

I think the other big barrier is systemic. Over the years, we’ve noticed that there were a lot of barriers for patients to jump through to get treatment. We have to prove sobriety. We have to prove a certain level of liver damage already [and] adherence to treatment. Are there other medical comorbidities that make this patient a higher risk to be treated? And more and more states have [got] rid of those, right?…In a lot of states now, you don’t need a specialist to prescribe. You don’t need comorbidities. If you [have] hep[atitis] C, you should get cured. So as we continue to work on this as a nation, as a health care system, we need to focus…on the patient to eliminate those other barriers.

Transcript was AI-generated and edited for clarity. 

, a subsidiary of a company called Grifols, has been developing a platform in the treatment and cure of HBV. Their investigational therapy, GIGA-2339 is a HBV recombinant polyclonal therapy in development, and consists of more than 1000 anti-HBV antibodies made in the laboratory by reproducing the antibodies generated during a natural immune response. This approach could ensure that the therapy covers the large diversity of circulating HBV variants.

Starting with the blood from donors that have been vaccinated against HBV, GigaGen captures millions of individual antibody-producing B cells. It then extracts their antibody-coding DNA and creates cell lines that express the recombinant (synthetic) human antibodies of interest for that particular disease. 

(See the image below for further explanation of the process.)

The product is the result of a platform that has enabled engineering of the first recombinant human polyclonal antibody therapies. Such therapies are comprised of antibodies that recreate the immune responses of the best human donors against a particular disease of biological threat—in this case thousands of antibodies against HBV surface antigen.

“There's a real benefit to being able to attack a disease from multiple angles,” Carter Keller, senior vice president, Grifols and CEO of the company’s GigaGen subsidiary, said.

“We captured immune systems, from people who've been vaccinated with hepatitis B vaccine, and we took the best immune responses, and ran those through our platform,” Keller said. “And then from the diversity of those immune responses, we filtered out the antibodies that were focused just on hepatitis B surface antigen…we believe it has a real chance to cure [HBV].”

GIGA-2339 is one of the leading candidates in GigaGen’s pipeline, and they are prepared for a pre-IND submission in the second half 2023. 

Grifols acquired GigaGen in 2021, buying the remaining 56% of the company after Grifols had initially bought 44% of GigaGen’s stake in 2017. Grifols is a global healthcare company.

Keller and his team are looking not just for GIGA-2339 to stop HBV replication, but their goal is to have the therapy lead to a functional cure.



 spoke to Keller about GIGA-2339, their expected timeline for getting the investigational antibody into clinical trials, and its potential place in the market, pending FDA approval.

A company is developing a platform to enable engineering of the first recombinant human polyclonal antibody therapies with the goal of creating a functional cure for hepatitis b (HBV).

Harnessing Recombinant Human Polyclonal Antibodies for Potential HBV Treatment, Cure


Antiviral therapies will continue to play a significant role in infectious disease. A new investigational antiviral, bemnifosbuvir (BEM, AT-527), is currently in phase 3 development for COVID-19 and phase 2 development for hepatitis C (HCV) in combination with ruzasvir (an oral NS5A inhibitor).

Bemnifosbuvir was developed by Boston-based Atea Pharmaceuticals and has a novel approach with a dual-targeting mechanism of action designed to be less prone to develop resistance.

At the International Conference on Antiviral Research (ICAR 2023) that took place back in March, the company presented data from its phase 1 human absorption, distribution, metabolism, and excretion (ADME) study for bemnifosbuvir demonstrating a favorable profile supportive of the dosing regimen used in SUNRISE-3, a global, multicenter phase 3 registrational trial for the treatment of COVID-19.



 metabolism and transporter interaction studies showed bemnifosbuvir had a low risk for interactions with medicines commonly prescribed to patients at risk for COVID-19 progression and for those with HCV infection.

In addition,

 studies also demonstrated advantages of bemnifosbuvir’s mechanism of action, which targets conserved regions of the viruses that cause COVID-19 and HCV infection. These advantages include a higher barrier to resistance and maintenance of antiviral activity in the presence of COVID-19 variants.

Looking at HCV treatment, the combination of bemnifosbuvir and ruzasvir demonstrated potent in vitro synergistic antiviral activity and in vivo preclinical safety without adverse interactions.

“The data presented at ICAR demonstrate bemnifosbuvir’s unique metabolic activation pathway and how it inhibits enzymes essential to the viral replication of COVID-19 and HCV and its potential to play an important role in the treatment of these serious viral diseases,” Bruno Canard, PhD, lead investigator, Architecture et Fonction des Macromolécules Biologiques, CNRS and Aix-Marseille University, stated.



spoke to Canard and Jean-Pierre Sommadossi, PhD, founder, chairman and CEO of Atea about the investigational therapy’s novel mechanism of action, findings from its clinical trials, and when it expects to report new data.

Atea Pharmaceutical’s investigational therapy, bemnifosbuvir, is in a phase 3 trial for the former and phase 2 for the latter.

HCV / Hepatitis

Latest News