Thursday, September 29, 2022

Hepatitis B Foundation Drug Watch

Up To Six New Hbv Drugs Set To Launch By 2027

Externally Led Patient-Focused Drug Development Meeting On Chronic Hepatitis B Infection

Within the next 10 years, up to six new drugs are projected to be approved for the treatment of chronic

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Clinical Course Of Hbv Infection

The outcome of HBV infection largely depends on the hostvirus interaction, mediated by the adaptive immune response. The virus-specific T cell response is one of the key factors in the pathogenesis of HBV infection. Viral variants may influence the course and outcome of the disease. The effect of host factors on the progression of disease is poorly understood. Only very rarely does the hepatitis B virus probably become directly cytopathic.

2.1 Natural history

The clinical course of HBV infection is variable and includes acute infection, fulminant hepatic failure, inactive carrier state, and chronic hepatitis with chances of progression to cirrhosis and HCC .

2.2 Chronic HBV infection

The risk of chronicity in acute HBV infection is related to age at primary infection. Adults who become chronically infected during childhood have a 1525% lifetime risk of dying from HBV-related cirrhosis or liver cancer, with a significantly increased risk in men in comparison with women .

Table 2 Risk of chronicity and age at primary infection

Fig. 2 Sequence of serologic markers in acute hepatitis B infection .A, resolution of active infection B, progression to chronic infection.

2.3 CHB disease phases

CHB is a dynamic disease that fluctuates over time, likely relating to interactions between the virus and the host immune system. The following fivenot necessarily sequentialphases can be identified in chronic HBV infection.

2.4 Progression of CHB

Preventing The Spread Of Hbv

The hepatitis virus has been affecting various parts of the world, with the worst of it being in Africa and areas of Southeast Asia, as well as China, Japan and India. The United States has felt the effects of liver disease as well, especially with the rise of the opioid crisis. Sharing needles is one of the most common ways that liver disease is spread, and with opioid abuse on the rise in states from California to Pennsylvania, hepatitis B and liver cancer cases are becoming more and more frequent.

The goal of the Baruch S. Blumberg Institute is to prevent hepatitis B from spreading as a result of the opioid crisis and other common causes. We also aim to find ways to help those who are living with liver disease anywhere from California to Japan to India with better methods of treatment. Our non-profit research center extends our solutions to anyone battling Hep B through living science.

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In Search Of A Cure: First Steps Toward The Conquest Of Hepatitis B

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Hepatitis B is a quiet virus that can take decades before its damaging effects on the liver are realized. However, with approximately 257 million people globally living with hepatitis B and an accounted 887,000 hepatitis B-related deaths in 2015 from complications such as cirrhosis and hepatocellular carcinoma, it requires as much attention as has been recently given to the elimination of hepatitis C.

The current state for HBV care includes vaccination for uninfected individuals or long-term treatment. While treatment is effective at suppressing the virus, the potential for a cure is years away and will most likely require a combination therapy approach, as the structure of the virus is even more complicated than that of HCV. This leaves those who are infected at a continued risk for liver-related complications.

For hepatitis C, everything is now about access, elimination strategies, and risk reduction, as the therapies work exceptionally well,Paul Y. Kwo, MD, director of hepatology at Stanford University, told Healio Gastroenterology and Liver Disease. In hepatitis B, which is a far more complicated virus to treat than hepatitis C, we are just beginning to see the earliest efforts to probe the various strategies that are going to lead to a therapy with a finite duration that allows clearance of hepatitis B surface antigen.

The Character of HBV

Improving Hepatitis B Awareness Screening Vaccination And Linkage To Care Among Lgbtq Communities

Hepatitis B Foundation: Crystal Ball Gala

Panelists discuss efforts to improve hepatitis B awareness, screening, vaccination, and linkage to care among LGBTQ communities. Speakers share efforts to raise hepatitis B awareness, testing, and vaccination among the MSM Latinx community in King County, Washington and the CDCs Division of Viral Hepatitis share resources to promote hepatitis A and B vaccination among MSM communities.

Presentation Slides:Communication Materials for Gay and Bisexual Men Amanda Carnes

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What Happened With Vbiv Stock

December is off to a good start for VBI Vaccines, as it announced today that PreHevbrio, a new vaccine for the prevention of Hepatitis B, had received full FDA approval for administration to adult patients. It has been reported that the vaccine is effective against all previously identified subtypes of hepatitis B virus .

This news sent VBIV stock shooting up this morning. Although its come down a bit within the first hour of trading, it is still up almost 4% as of this writing. The past week has seen the stock remain mostly stagnant, hovering just below the $3 mark. With todays gains, though, it is currently up by more than 14% for the past five days. Despite hitting a period of decline in late November, VBIV stock is still up by more than 3% for the month.

International Workshop On Hbv Cure 2021 Taking Place 9

Organized by Virology Education in close collaboration with the Toronto Centre for Liver Disease and chaired by Drs. Harry Janssen and Adam Gehring, the International Workshop on HBV Cure has since 2014 been a scientific platform that acts as a catalyst to accelerate the progress for achieving a cure. In order to optimize curative treatment for HBV, outstanding speakers from around the globe will share the newest therapeutic options for viral hepatitis, and experts will discuss the path forward to cure this deadly disease, leading to liver cirrhosis and liver cancer. This workshop also brings together global inter-disciplinary experts to provide a framework for how academia and industry should collaborate to achieve the goal of curing hepatitis B.

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Linkage To Care And Treatment For Persons With Hepatitis B In Tanzania

This session focuses on a project that was conducted to link people living with chronic hepatitis B in Dar es-Salaam and Zanzibar, Tanzania to care and treatment. Panelists share the background and history of the project, the process of data collection, the design and implementation of interventions, and future research and opportunities.

Presentation Slides:Linkage to Care and Treatment for Persons with Hepatitis B in Dar es-Salaam and Zanzibar, Tanzania Brian McMahon and Shuan Shadaker

Inhibition Of Hbsag Secretion

HBV Cure Development with Dr Block Pt 2

The release of HBsAg is independent of virion release and the antigen itself is postulated to be involved in suppressing the host innate immunity allowing the virus to cause persistent infection in human liver. REP 9AC, a nucleic acid polymer compound, is a potent HBsAg secretory inhibitor, which can eliminate HBsAg from the human circulation as early as 7 d of administration in a small study. This was followed by reactivation of the suppressed innate immune system of the host to produce anti-HBs antibody by weeks 15 and achieved sustained virological response after stopping the administration. HBV DNA remained undetectable if add on immunotherapy was given. More work is being carried out to better understand the optimal duration of treatment to sustain its effects, tolerability and the best route of administration.

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Finding The Missing Millions

We endorse the Find the Missing Millions campaign recently initiated by The World Hepatitis Alliance to identify all persons living with chronic viral hepatitis, as well as the goals of the World Health Organisation to ensure that antiviral therapy reaches 50% of CHB patients worldwide by 2030. It is estimated that currently only 10% of the worlds population were diagnosed and 5% of people eligible for treatment were receiving it in 2016 . Treatment rates are extraordinarily low even in western countries, reaching 8% in Australia in 2017 . Of major importance to increasing diagnosis rates will be the development of point-of-care tests that enable the accurate detection of HBsAg and DNA in field applications at a limited cost. To date, two HBsAg POC test have received WHO precertification . Pan-genotypic POC tests that function equally well in Africa, America, Asia, Alaska, Australia and Europe are urgently required. If a future cure is to be restricted to some stages of CHB natural history, a POC test identifying immune correlates of liver disease will also be required.

Vbiv Stock Is Shooting Higher On Big Fda Vaccine Approval News

Since reports of the fast-spreading omicron variant began circulating, coverage has often centered around vaccine producers and their efforts to combat the virus as it manifests in new and unpredictable ways. Many vaccine stocks have been trending this week, but in an interesting turn of events, one company with the word vaccine in its title is making headlines for a different type of innovation. VBI Vaccines recently confirmed that it has received good news from the Food and Drug Administration . Today, VBIV stock is reacting well to the news.

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Hepatitis B Educational Resources For African Communities

Panelists from the CDC and African Services Committee discuss Know Hepatitis B Campaign resources for community health workers working within African communities and community-based hepatitis B prevention initiatives. Additionally, hepatitis B activist and storyteller Bright Ansah shares his personal experiences with hepatitis B and highlight the need for greater awareness, education, and resources about hepatitis B in African communities.

Presentation Slides:

  • Mark K. Weng MD, MSc, FAAP, Medical Epidemiologist, CDC
  • Rita Kuwahara, MD, MIH, Internal Medicine, Connecticut Institute for Communities, Inc.
  • Abby Bownas, Manager, Adult Vaccine Access Coalition
  • Judith Feinberg, MD, Professor of Behavioral Medicine and Psychiatry, Professor of Medicine/Infectious Diseases, Dr. E.B. Flink Vice Chair of Medicine for Research
  • Y-Uyen Le Nguyen, MD, Hepatitis B Program Director, Charles B Wang Community Health Center
  • Patricia Jones, MD, Assistant Professor of Clinical Medicine, Division of Digestive Health and Liver Diseases, Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine
  • Monde Nyambe, CHES, Hepatitis B Coordinator, IPHA Americorps Member

Finding A Cure For Hepatitis B: Asia

Join the Conversation at the Hep B United Summit  Watch ...

On 29 July 2021 for World Hepatitis Day ICE HBV, together with Coalition to Eradicate Viral Hepatitis in Asia Pacific and Yellow Warriors Society Philippines, Inc. , co-hosted the webinar Finding a Cure for Hepatitis B: Asia-Pacific Regional Webinar. An event aimed discussing the latest research in HBV Cure and surrounding topics with people living with HBV and their community.

Speakers were Dee Lee, Inno Community Development Organisation, China, Lien Tran, Doherty Institute Melbourne, Margaret Hellard, Burnet Institute, Melbourne, and Seng Gee Lim, National University Health System, Singapore.

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Welcome To The Definitive Industry Forum For Chronic Hbv Drug Development

While direct acting antiviral therapies have been effective in controlling viral replication, its clear that combination therapy with multiple mechanisms of action may be the key to achieving functional cure in chronic HBV, and the landscape for drug development in antiviral agents and immune modulation has never been more exciting.

Uniting 20+ industry heavyweights, the 2nd Chronic HBV Drug Development Summit is the definitive industry forum focusing exclusively on late translational through to phase II clinical trials for chronic HBV.

Hear from Gilead Sciences, Vir Biotechnology, VBI Vaccines, Drug Farm, Replicor, GSK, Assembly Biosciences and many more accelerating the frontier of novel therapies beyond the current standard of care to move the needle on functional cure.

From dissecting pivotal insight into sequencing multiple mechanisms of action acting on immune and viral targets to attain durable treatment, to leveraging advances in prediction of efficacy with novel serum markers including HBV RNA and core-related antigen, the HBV Summit is dedicated to driving progress in combination therapy paradigms.

Delineate clinically meaningful hepatitis B surface antigen loss to establish a pathway to finite treatment, explore the latest updates on immunotherapies in development to illuminate opportunities to restore antiviral immunity,

Join us in Boston to forge successful industry collaborations in combination therapy for chronic HBV.

Optimizing Drug Delivery In Hbv Vaccination

Optimization of vaccine delivery by using innovative viral vectors encoding HBV antigens was investigated in normal and HBV transgenic mice. Stimulation of HBV-specific T-cell responses in the liver and increased production of HBc- and HBs-specific IgG were observed without significant hepatotoxicity, providing new insights for clinical investigations.

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Inhibiting Viral Replication By Rna Interference

RNA interference is carried out using complementary double stranded RNA to silence the homologous gene in post-transcriptional mRNA level. In mammalian cells, the silencing is induced by the small interfering RNA . In HBV-infected cells, siRNAs had been used to produce sequence-specific and dose-dependent knockdown of HBV surface or polymerase region of viral mRNA. siRNA functions by binding to complementary HBV mRNA and pgRNA, which will be degraded, resulting in no translation/reverse transcription. Animal studies conducted by biotechnology company had demonstrated long-term suppression of HBV RNA, HBsAg, HBeAg and HBV DNA can be achieved by co-injection of ARC-520 with DPC delivery vehicle into chimpanzees. This was followed by a phase 1 study, showing that all studied doses were safe and well-tolerable by normal volunteers and this result had led to an ongoing phase 2a clinical trial of ARC-520 in combination with entecavir in Hong Kong. This study will evaluate not only the safety and pharmacodynamics of the drug but also its efficacy on the levels of HBsAg, HBeAg and HBV DNA quantity, when given in combination with entecavir. Meanwhile, some researchers suggested that the use of combination of siRNAs may achieve a stronger inhibition on HBV replication and antigen expression in HepG2.2.15 cell line and in mice models.

Core Protein Allosteric Modulators

CURE Grant Awarded to HBF/IHVR – ABC Action News Reports

Numerous pharmaceuticals targeting Cp have been tested in clinical trials. RO7049389 is an orally administered compound that belongs to class I of CpAMs and has shown a satisfactory safety and tolerability profile. When administered to patients with CHB over a 28-d period, RO7049389 resulted in a significant reduction in HBV DNA . Remarkably, HBV DNA decreased below the limit of detection in 13/16 HBeAg-negative patients. Currently, RO7049389 is being studied in a Phase II trial as part of a combination therapy that also includes an immunomodulator and an NUC . GLS4 and , which exhibit potent antiviral activity and low cytotoxic effects in experimental models, are among the HAP derivatives that promote defective capsid assembly and have successfully entered clinical development.

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Improving Diversity In Clinical Trials For Hepatitis B Treatments

This session discusses why representation, including of persons living with hepatitis B, is essential to research, and communication and outreach strategies to improve diversity in clinical trials. Christine Lee, PharmD, PhD, from the U.S. Food & Drug Administration provides an overview of clinical trials recruitment and strategies to improve participation and Rhea Racho, MPAff, discusses the Hepatitis B Foundation’s participation in the National Institute of Health’s All of Us Research Program and how the program is working to make medical research more inclusive.

Presentation Slides:

How Close Are We To Clinical Application

Most of the new antiviral agents discussed above remains in the early preclinical phase .1). A few of these, driven by established biotechnology and pharmaceutical companies, had made it to phase-I/IIA clinical trials. Gaining momentum and safety profiles from the HIV trials, the newer nucleoside analogues are likely to be the first group of drugs to obtain formal approval for clinical use. Being in the same class as the existing therapy, they are unlikely to be game changers, but they may add to the arsenal of reverse transcriptase inhibitors to tackle the drug-resistant HBV strains that may emerge with long-term use of current agents.

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Tenofovir Reduces Severity Of Covid

Encouraging data from a new study found that antiretroviral drug, tenofovir, prevented serious COVID-19 illness amongst people living with chronic Hepatitis B.

A study conducted in Spain found that antiretrovira drug tenofovir reduced the severity of COVID-19 in patients with chronic Hepatitis B.Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology at the Hospital Universitario Ramón in Spain, said the study analysed data from 4736 patients from 28 Spanish hospitals.

Of the 117 COVID-19 positive patients who were identified, 67 were taking tenofovir and 50 were on entecavir, an antiviral drug in the treatment of hepatitis B virus infection. Muñoz said the incidence of COVID-19 in patients on tenofovir or entecavir were similar, but that patients on entecavir more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died.

The study found that tenofovir seemed to offer some protection in patients with chronic hepatitis B infected by COVID-19.

In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, tenofovir reduced by 6-fold the risk of severe COVID-19. Patients with chronic hepatitis B on tenofovir have a lower risk of severe COVID-19 infection than those on entecavir.

This is an excerpt from the article Leading Researchers Highlight the Impact of COVID-19 on Global Liver Disease on Health Policy Watch. Read more here.

The Global Impact Of The Covid

New Hepatitis Delta Treatment Approved by European ...

Panelists discuss the short and possible long-term impacts of the global pandemic on hepatitis B initiatives, including disruptions to prevention, diagnosis, and treatment services, that potentially threaten global hepatitis B elimination goals. Speakers also share local experiences and recommendations on strategies to mitigate the impact of the COVID-19 pandemic.

Presentation Slides:Access to Health Care for Vulnerable Groups Arafat Bwambale Introductory Video

Resources:BMJ Global Health Article: The global impact of the COVID-19 pandemic on the prevention, diagnosis and treatment of hepatitis B virus infection

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