Contagion's 2024 Top Stories: Hepatitis Infections

There were many news updates in the world of hepatitis C virus (HCV) infections, and as always, the Contagion team was on top of it all, spending our time keeping you in the know and speaking with experts from major institutions, pharmaceutical companies, and federal agencies who are working together to push medical science forward.

Here, we'll be providing a list of stories that resonated with our audience in 2024 in the area of blood-borne infections such as HCV, and across the spectrum of variations of the virus, including hepatitis A and B.

Click the headlines to read more from these stories.

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 hepatitis 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...

TherVacB's Journey Against Hepatitis B (HBV)

The development of a therapeutic vaccine for Hepatitis B (HBV) has been challenging over the past 20 years due to the virus's impact on specific immune cells. Advancement was made with the start of TherVacB's first human clinical trial on January 25, 2024. There are plans to start a phase 1b/2a trial for chronic HBV patients, focusing on the vaccine's safety and efficacy across Germany, Italy, Spain, England, and Tanzania.

“TherVacB is based on a deep understanding of the challenges of the immune system in chronic HBV infection and is the result of years of dedicated research here in Munich,” says Ulrike Protzer, the leading scientist behind the vaccine...

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

Since Contagion's first interview last year with Carter Keller, senior VP at Grifols and head of GigaGen, there has been significant progress in the development of the first recombinant human polyclonal antibody therapies aimed at a functional cure for Hepatitis B virus (HBV).

The new therapy, GIGA-2339, is now set to enter phase 1 clinical trials following a recent FDA approval of the company's investigational new drug (IND) application. Developed by GigaGen, a Grifols company, GIGA-2339 is the first recombinant human polyclonal antibody treatment for HBV and the FDA approved this drug to begin trials in late 2024...

Investigational Hepatitis B Therapy is Granted FDA Fast-Track Status

The FDA has granted a fast-track designation for bepirovirsen, an investigational agent for the treatment of chronic hepatitis B (CHB). Fast track designation is intended to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need.

The therapy’s manufacturer, GSK, had requested designation based on the potential for bepirovirsen to address an unmet medical need for chronic hepatitis B, which can be a serious and life-threatening condition...

What it Will Take to Eliminate Hepatitis B Virus?

The World Health Organization (WHO) has called for the elimination of HBV as a public health threat by 2030, but this progression toward elimination has stalled. Nearly 300 million people globally live with HBV, making it the most common chronic infection. Despite stable mortality rates, 2 people die from HBV every minute. WHO’s goals towards eradication include preventing new infections through vaccination and improving testing, clinical management, and treatment.

The Centers for Disease Control and Prevention (CDC) emphasizes, “Hepatitis B is a vaccine-preventable liver infection caused by the hepatitis B virus (HBV). Hepatitis B is spread when blood, semen, or other body fluids from a person infected with the virus enters the body of someone who is not infected."

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. 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.”

Need for Hepatitis B Clinical Trials in Africa

In a study published by The Lancet, researchers found 1,804 unique HBV clinical trials, yet only 18 (1.0%) of these involved the WHO African region. This highlights an urgent need for increased HBV clinical trials focused on testing the effectiveness of new treatments. Moreover, it is crucial to ensure that these interventions are distributed and implemented as they are developed, to address the significant health disparities that exist.

There is no indication that the quantity of HBV clinical trials in this area has seen any improvement over time. In the WHO African region, both the variety of new interventions and the level of industry sponsorship were minimal, with HBV trials falling short when compared to trials for other endemic infectious diseases...

Investigational Hepatitis B Therapy Reduces HBsAg, Maintains Response After End of Treatment

Data from a pair of phase 2a clinical trials are highlighting imdusiran’s ability to induce and maintain undetectable HBsAg levels in patients with chronic hepatitis B virus (HBV) when administered alongside pegylated interferon alfa-2α (IFN) or VTP-300 and standard-of-care nucleos(t)ide analogue (NA) therapy.

An RNA interference therapeutic specifically designed to reduce all HBV viral proteins and antigens, imdusiran targets hepatocytes using Arbutus Biopharma’s covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data has shown single and multiple doses of imdusiran to be safe and well-tolerated while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. The agent is currently in multiple phase 2a clinical trials, including IM-PROVE I (AB-729-201) and IM-PROVE II (AB-729-202)...

New Insights Into Hepatitis E Virus (HEV) Resistance

This study from JHEP Reports investigates the development of genetic variants in HEV during treatment with sofosbuvir (SOF) and ribavirin (RBV) in patients with chronic infection. By analyzing these variants' emergence and their resistance to the combined drug therapy both in vivo and through cell culture evaluations, the research focuses on the virus's intra-host evolutionary dynamics. These dynamics are important for assessing current treatment efficacy and guiding the development of more effective next-generation antiviral therapies.

Combination treatment successfully lowered viral load towards the quantification limit but did not achieve sustained virological response during treatment. Variants like A1343V and G1634R, associated with SOF or RBV, emerged, with A1343V, alone or with G1634R, showing SOF resistance in concomitant in vitro treatment...

Imdusiran for Chronic Hepatitis B Achieves Functional Cure in 50% of Patients

Arbutus Biopharma Corporation has announced breakthrough data from its IM-PROVE I Phase 2a clinical trial, demonstrating that a combination of imdusiran (AB-729), an RNA interference (RNAi) therapeutic, and a short course of pegylated interferon alfa-2α (IFN) can achieve a functional cure in patients with chronic hepatitis B virus (cHBV) infection. The data, showing up to 50% of patients achieving a functional cure, will be presented at The Liver Meeting® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD) on November 18.

In our interview with Michael J McElhaugh, interim president and CEO and director of Arbutus Biopharma, he discussed the promising results from the IM-PROVE I trial...