Friday, December 2, 2022

Hepatitis B Cure Clinical Trials

How Can I Prevent Spreading Hepatitis B To Others

Clinical trial investigates possibility of stopping medication as cure for Hepatitis B

If you have hepatitis B, follow the steps above to avoid spreading the infection. Your sex partners should get a hepatitis B test and, if they arent infected, get the hepatitis B vaccine. You can protect others from getting infected by telling your doctor, dentist, and other health care professionals that you have hepatitis B. Dont donate blood or blood products, semen, organs, or tissue.

Who Is More Likely To Get Hepatitis B

People are more likely to get hepatitis B if they are born to a mother who has hepatitis B. The virus can spread from mother to child during birth. For this reason, people are more likely to have hepatitis B if they

  • were born in a part of the world where 2 percent or more of the population has hepatitis B infection
  • were born in the United States, didnt receive the hepatitis B vaccine as an infant, and have parents who were born in an area where 8 percent or more of the population had hepatitis B infection

People are also more likely to have hepatitis B if they

  • are infected with HIV, because hepatitis B and HIV spread in similar ways
  • have lived with or had sex with someone who has hepatitis B
  • have had more than one sex partner in the last 6 months or have a history of sexually transmitted disease
  • are men who have sex with men
  • are injection drug users
  • work in a profession, such as health care, in which they have contact with blood, needles, or body fluids at work
  • live or work in a care facility for people with developmental disabilities
  • have been on kidney dialysis
  • live or work in a prison
  • had a blood transfusion or organ transplant before the mid-1980s

In the United States, hepatitis B spreads among adults mainly through contact with infected blood through the skin, such as during injection drug use, and through sexual contact.12

Why Are Further Hepatitis B Clinical Trials Important

Hepatitis B clinical trials have the potential to virtually eradicate Hepatitis B within the next 30 years. For Hep B clinical trials to be successful, however, current and past Hepatitis B patients of all ages and backgrounds should be included. The more people participate in Hepatitis B clinical trials, the easier it will be to develop and deploy new Hepatitis B clinical resources.

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What Causes Hepatitis B

The hepatitis B virus causes hepatitis B. The hepatitis B virus spreads through contact with an infected persons blood, semen, or other body fluids. Contact can occur by

  • being born to a mother with hepatitis B
  • having unprotected sex with an infected person
  • sharing drug needles or other drug materials with an infected person
  • getting an accidental stick with a needle that was used on an infected person
  • being tattooed or pierced with tools that were used on an infected person and werent properly sterilized, or cleaned in a way that destroys all viruses and other microbes
  • having contact with the blood or open sores of an infected person
  • using an infected persons razor, toothbrush, or nail clippers

You cant get hepatitis B from

  • being coughed on or sneezed on by an infected person
  • drinking unclean water or untreated water that has not been boiled
  • eating food that is unclean or has not been properly cooked
  • hugging an infected person
  • shaking hands or holding hands with an infected person
  • sharing spoons, forks, and other eating utensils
  • sitting next to an infected person

Mothers who have hepatitis B can safely breastfeed their babies. If a baby receives hepatitis B immune globulin and starts receiving the hepatitis B vaccine to prevent hepatitis B infection shortly after birth, hepatitis B is unlikely to spread from mother to child through breastfeeding.15

European Commission And Thervacb Join Forces

Hepatitis B Reactivation with Hepatitis C Treatment

The role of viral hepatitis as a public health threat has long been underestimated. Only very recently, the United Nations in their 2030 Agenda for Sustainable Development called for international action to combat viral hepatitis and reduce the disease burden. The major killer is the hepatitis B virus causing liver cirrhosis and liver cancer. Worldwide 880,000 humans die each year from the consequences of an HBV infection.

A prophylactic vaccine is available to prevent HBV infection, but more than 3% of the worlds population are chronically infected and do not profit from that vaccine anymore. For those suffering from chronic hepatitis B, until today no curative treatment option exists.

The European Commission therefore selected the project TherVacB led by Helmholtz Zentrum München for a five-year funding within the Horizon 2020 program. A consortium of leading virologists, immunologists and physicians specialized in treating viral hepatitis, will use a newly designed therapeutic vaccine, TherVacB, as an immunotherapy to cure HBV. TherVacB will be evaluated in a three-year clinical trial starting in 2022 conducted in Europe and in Africa. Integration of a partner site in Tanzania shall help building local capacities for diagnosing and treating hepatitis B and support an important goal of the consortium to raise awareness for hepatitis B.

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Benefits Of A Clinical Trial

Enrolling in clinical trial programs can be very beneficial. Expensive blood work, treatment medications, and clinical monitoring are usually provided free of charge for those accepted into a study. Clinical trials also provide the opportunity to potentially benefit from the latest advances in medical science.

How Can I Locate A Clinical Trial Near Me

The clinical trials website is a global database of privately and publicly funded clinical studies. The website is managed by the National Institutes of Health U.S. National Library of Medicine. This is an excellent resource for finding studies in all 50 U.S. states and in 201 countries around the world. Before participating in a clinical trial, it is important to get information about the potential risks and benefits.

You can search for hepatitis B clinical trials anywhere in the world with the button below. You can also search for hepatitis Delta and liver cancer clinical trials by visiting their pages on the website.

You can also search for clinical trials using the National Institutes of Health’s website. Steps to navigating the website are listed below.

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Hbsag Clearance After Na Treatment

There are few large or conclusive studies on the clearance of HBsAg after NA treatment, and some of these studies are single-centre retrospective studies. Kim et al. reported a clearance rate of 1% or less in 110 CHB patients who were treated with ETV/LAM for approximately 1 year. A retrospective study by Yip et al. reported an HBsAg clearance rate of 2.1% after an average follow-up of 4.8 years in 20,263 CHB patients treated with ETV/TDF for longer than 6 months. Wong et al. retrospectively evaluated 1072 CHB patients on antiviral therapy for approximately 6 years and found an HBsAg clearance rate of 4.58%. This study found no significant difference in the clearance rate between HBeAg-positive and HBeAg-negative patients, but the rate in patients with cirrhosis was significantly lower than patients without cirrhosis . These results suggested that the clearance rate of non-cirrhosis patients was higher after NA treatment, which is not consistent with the results of patients who experienced spontaneous clearance. Compared to patients with normal baseline ALT, patients with higher ALT levels had significantly higher rates of achieving HBsAg clearance. In general, the clearance rate may increase with the extension of treatment in CHB patients, but the overall rate with currently available NA treatment is low. The HBsAg clearance rates were 1.45.1% after an average follow-up of 27 years after NA treatment .

Hbrn: Immune Regulation And Costimulation In Natural History And Therapeutic Outcome Of Chronic Hepatitis B

HEP-COVID Clinical Trial Results on the Prevention of Blood Clots

Sorry, in progress, not accepting new patients

This is an ancillary to the NIDDK-sponsored treatment trials titled: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B and Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B . This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN’s clinical trials to define natural history and treatment outcome.

San Francisco, California

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Lack Of Impact Of Na On Covalently Closed Circular Dna

A major hurdle to HBV cure is the presence of cccDNA in the hepatocyte nucleus in a non-integrated form or episome. cccDNA serves as the template for transcription of all viral RNAs including pregenomic RNA and thus plays a key role in the viral lifecycle. There are two sources of cccDNA: incoming virions and re-cycling of encapsidated DNA from the hepatocyte cytoplasm. The half-life of cccDNA is long thus explaining why it is difficult to cure HBV infection and why HBV can reactivate either spontaneously or following immune suppression, many years after clearance of HBsAg. Chain terminating NAs block the reverse transcription of pregenomic RNA to HBV DNA but they have marginal effect on cccDNA production, stability or transcription. Continued transcription from cccDNA and integrated viral genomes may explain the relatively minor decrease in serum HBsAg levels during NA therapy despite undetectable serum HBV DNA levels.33 Unfortunately, current assays for circulating HBsAg cannot distinguish the transcription of HBsAg from cccDNA versus integrated HBV DNA.

Natural History Of Chronic Hbv Infection

Phases of chronic HBV infection.

1) Immune tolerant. HBeAg positive, high serum HBV DNA but normal ALT levels.

2) Immune clearance/HBeAg-positive chronic hepatitis. HBeAg positive, high serum HBV DNA and elevated ALT levels. HBeAg seroconversion to anti-HBe occurs after varying duration.

3) Inactive carrier. HBeAg-negative, serum HBV DNA low or undetectable.

4) Reactivation/HBeAg-negative chronic hepatitis. HBeAg-negative, elevated levels of HBV DNA and ALT in serum, HBV precore and/or basal core promoter variant often present.

Traditionally phases of chronic HBV infection are defined by HBeAg status, serum HBV DNA and ALT levels. Quantitative HBsAg levels are different in each phase and are generally highest in immune tolerant phase and lowest in inactive carrier phase. While most patients progress from one phase to the next, not all patients go through each phase, and reversion to an earlier phase can occur.

Abbreviations: ALT, alanine aminotransferase anti-HBe, hepatitis B e antibody HBeAg, hepatitis B e antigen HBsAg, hepatitis B surface antigen

Identifying individuals at greatest risk for development of cirrhosis and HCC is an important goal in the management of chronic HBV infection. Recent studies have highlighted the importance of viral load in predicting risk of cirrhosis and HCC.12,13 However, many other host , viral , and environmental factors contribute to liver disease progression.

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Study Participants And Dosing

The ISIS 505358-CS3 study was a phase 2, double-blinded, placebo-controlled, dose-escalation trial of bepirovirsen in 31 patients with CHB who were either treatment-naïve or receiving stable NA therapy , n=7) . The study protocol can be accessed at . Treatment-naïve patients were randomized to placebo , bepirovirsen 150mg or 300mg and on-NA patients to placebo or bepirovirsen 300mg . Six doses of bepirovirsen or placebo were administered via subcutaneous injection during the 4-week treatment period: twice weekly during weeks 1 and 2 and once weekly during weeks 3 and 4 . Patients were then followed for 26 weeks.

One on-NA patient withdrew from the study on day 8, after two doses of bepirovirsen 300mg, due to transient mild fevers after each dose that were considered treatment-related all other patients completed the treatment and follow-up periods. Demographics and baseline characteristics were similar between treatment arms .

Table 1 Demographics and baseline characteristics in patients with CHB

Hepatitis B Treatment 100% Effective In Preclinical Trials

Hepatitis C Treatment/Research Opportunity from the NIH

the Clinical Advisor take:

A newly-developed treatment for the hepatitis B virus was 100% effective in curing the virus in preclinical trials, according to two papers published in the Proceedings of the National Academy of Sciences.

The treatment is a combination of the antiviral drug entecavir and the anti-cancer drug birinapant.

Researchers at Melbournes Walter and Eliza Hall Institute developed the treatment based on their previous research on the behavior of HBV in infected cells. The treatment targets cell signaling pathways that HBV uses to keep host liver cells alive.

Birinapant enabled the destruction of hepatitis B-infected liver cells while leaving normal cells unharmed. Excitingly, when birinapant was administered in combination with current antiviral drug entecavir, the infection was cleared twice as fast compared with birinapant alone, said Marc Pellegrini, BSc, MBBS, PhD. We are hopeful these promising results will be as successful in human clinical trials, which are currently underway in Melbourne, Perth and Adelaide.

The treatment lets the host cells rid themselves of the virus as opposed to targeting the virus itself. The researchers hope that this will help prevent drug-resistant strains of HBV from emerging. Additionally, this type of treatment may represent new research avenues for other chronic infectious diseases.

Phase 1/2a clinical trials of the drug have been underway since December 2014.

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Hepatitis B Lifestyle Changes And Recovery

Hepatitis B often clears up on its own and may not require medical intervention. In the most serious cases, patients can benefit from antiviral medication. Hepatitis B is responsible for about 887,000 deaths worldwide each year, only a fraction of them taking place in the United States.

With appropriate treatment and medical supervision, many Hepatitis B suffers do not experience loss of quality of life from Hepatitis B. However, they must be careful not to transmit the disease through infected fluids, including blood, urine, and respiratory fluids.

When undergoing treatment for Hepatitis B, it is important to minimize strain on the liver. This means eliminating alcohol intake for the duration of treatment. Ideally, a Hepatitis B infection runs its course with minimal organ damage, allowing the patient to resume all normal activities.

Prevent Infection After Contact With The Virus

If you think you have been in contact with the hepatitis B virus, see your doctor right away. Doctors typically recommend a dose of the hepatitis B vaccine to prevent infection. In some cases, doctors may also recommend a medicine called hepatitis B immune globulin to help prevent infection. You must get the vaccine dose and, if needed, HBIG shortly after coming into contact with the virus, preferably within 24 hours.

Also Check: How Is Hepatitis C And B Transmitted

Vir Biotechnology Initiates Phase 2 Clinical Trial Evaluating The Combination Of Vir

SAN FRANCISCO, July 15, 2021 — Vir Biotechnology, Inc. today announced that the first patient has been dosed in the Phase 2 MARCH trial evaluating VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus infection a combination designed to achieve a functional cure.

VIR-2218 is an investigational small interfering ribonucleic acid designed to inhibit the production of all HBV proteins , which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 vaccinal mutation, allowing it to potentially function as a therapeutic T cell vaccine against HBV.

About VIR-2218

VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the companys collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About VIR-3434

About Vir Biotechnology

Forward-Looking Statements


Eating Diet And Nutrition For Hepatitis B

Free Treatment at Ohio Stateâs Hepatitis B Clinic

If you have hepatitis B, you should eat a balanced, healthy diet. Obesity can increase the chance of nonalcoholic fatty liver disease , and NAFLD can increase liver damage in people who have hepatitis B. Talk with your doctor about healthy eating and maintaining a healthy weight.

You should also avoid alcohol because it can cause more liver damage.

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The Clinical Cure Project Of Chronic Hepatitis B In China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
First Posted : July 29, 2019Last Update Posted : December 22, 2021
  • Study Details
Condition or disease

Potential Cure For Hepatitis B Enters Phase 1/2a Clinical Trial

A new treatment developed by Walter and Eliza Hall Institute researchers to promote the cure of chronic hepatitis B virus infection is now recruiting patients for a phase I/2a clinical trial.

Dr Marc Pellegrini, Dr Greg Ebert and colleagues developed the new treatment in collaboration with TetraLogic Pharmaceuticals, a biotech company based in Malvern, Pennsylvania, US. The clinical trial will be held at sites across Australia and New Zealand, with planned sites in Melbourne, Adelaide, Perth and Auckland.

Hepatitis B is a viral disease that infects liver cells. Although a vaccine has been available since 1982, more than two billion people worldwide are infected with the virus. Most patients will recover from the disease, but 5-10 per cent of patients will develop a chronic infection, with children most at risk. More than 780,000 people die every year from complications associated with chronic hepatitis B infection, including cirrhosis and liver cancer.

The new treatment uses TetraLogic Pharmaceuticals drug birinapant, which triggers the breakdown of proteins that prevent infected cells from self-destructing. Dr Pellegrini said these proteins, known as inhibitors of apoptosis proteins , can be targeted to allow infected cells to die.

Our new therapy combines an existing anti-viral drug, which reduces the viral load, with birinapant that promotes efficient killing of hepatitis B infected cells and clearance of the virus from the system.

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