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GlaxoSmithKline Recruiting for B-Together Hep B Clinical Trials

The company GlaxoSmithKline (GSK) is launching a new clinical trial, called B-Together, that will investigate how two study drugs might work together to treat chronic hepatitis B (CHB). Researchers are hoping to find new potential treatments that could be more effective than those that are currently available and could lead to positive results that last long after the treatment ends. Participants in this trial could play a role in shaping science and changing the landscape of CHB treatment around the world, and will have an opportunity to learn more about the disease itself.

The two drugs that will be investigated in this trial are GSK3228836 and pegylated interferon, also known as Pegasys. In a previous Phase 2 trial, people living with CHB received GSK3228836 for 4 weeks. The Phase 2b B-Together trial will test longer treatment with GSK3228836, followed by Pegasys, to see what effects this may have on viral antigens (such as HBsAg) in the body. 

About the Study Drugs

GSK3228836 is an investigational drug being tested as a potential treatment for CHB, meaning it is not yet approved for this purpose. Current medicines available to treat CHB only stop the virus from multiplying – they do not enable the body to fully clear the infection, so people have to keep taking these medicines. GSK3228836 is designed to stop the virus from producing proteins that may prevent the immune system from fighting the virus. Thus, the study drug may potentially allow the body to gain control over the infection.

The other drug used in this study, Pegasys, is a medicine that is already used on its own by doctors to treat CHB. Pegasys works by enhancing the body’s immune response to viral infections such as hepatitis B.

What Will Happen During This Trial?

During this trial, all participants will receive GSK3228836 followed by Pegasys. After you have finished treatment with GSK3228836, your doctor will check if it is appropriate for you to start treatment with Pegasys. If it is not appropriate, you may not receive Pegasys at all. At the beginning of the trial, you will be assigned by chance to one of two groups. Each group will receive the study drugs for different lengths of time. You will know which group you are in. The B-Together trial lasts about 79 weeks for each participant. This includes a screening period, a study treatment period, and a follow-up period.

Screening Period

At a screening visit, the study doctor will give you a physical examination, ask about your medical history, and conduct medical tests. The screening period may last up to about 6.5 weeks while the study doctor reviews the results of your screening visit to determine if you meet all requirements for participation.

Trial Treatment period

While receiving GSK3228836, you will visit the clinic for either 12 or 24 weeks. For the first two weeks of your treatment with GSK3228836, you will visit twice per week and for the remaining weeks you will visit the clinic once per week.

When you have finished treatment with GSK3228836, your doctor will assess if it is appropriate for you to start treatment with Pegasys. If it is appropriate, then you will then receive treatment  with Pegasys once a week for up to 24 weeks.

In some countries, it will be possible for you to self-inject Pegasys at home after discussion and training from your study doctor. This could reduce the number of times you have to visit the clinic.

Other study activities will vary from visit to visit and may include:

  •         Discussions about your health and medications you may take outside the trial
  •         Measurement of vital signs (i.e. blood pressure, pulse, weight)
  •         Collection of blood or urine samples
  •         Physical examination
  •         Questionnaires about your health and well-being

Follow-Up Period

During the 24-week follow-up period, you will not receive injections of study treatment, but you will complete other study visit activities as scheduled. There are eight visits scheduled in the follow up period. Your study participation will end about 72 weeks after your first dose of the trial drug.

Who Can Participate?

You may be eligible to participate in this trial if you are at least 18 years old, have been living with documented CHB for at least six months, and have also been receiving stable nucleos(t)ide treatment (not telbivudine) with no changes for at least six months prior to screening and no planned changes for the duration of the study. There are other eligibility requirements that the study doctor will review with you. Individuals who have a current co-infection with or past history of hepatitis C virus, HIV or hepatitis D virus are not eligible to participate in this trial. 

Where Is This Trial Taking Place?

This trial is ongoing in the UK, Spain, Russia, Poland, Italy, Korea, Japan, China, the US, Canada, and South Africa.

You can play a role in shaping your own health and the science of tomorrow! To learn more about this trial and check your eligibility to participate, visit https://clinicaltrials.gov/ct2/show/NCT04676724

Announcing New Liver Cancer Clinical Trials

Over the past few decades, there have been several advancements in liver cancer research and treatment. These have included improvements in chemotherapy treatments that can now successfully shrink tumors to a size at which they can be more easily surgically removed, and the development of therapies that block blood flow to tumors. Liver ablation (tissue removal) and transplantation techniques have also been greatly improved in recent years (Johns Hopkins Medicine, 2020). Many of these advancements would not have been possible without the help of clinical trial volunteers with liver cancer. Your contribution is important and valuable and may help research for the future. Learn more about these opportunities today.

The pharmaceutical company Bristol Myers Squibb (BMS) is now enrolling for two clinical studies in liver cancer (also called hepatocellular carcinoma or HCC). These trials have the reference numbers CA209-9DW and CA209-74W. If eligible and you are willing and able to take part, you will be helping to advance research.

One of these trials is researching a study drug called nivolumab. Researchers want to find out how well the study drug works, both with and without ipilimumab in combination with trans-arterial ChemoEmbolization (TACE), when compared to TACE alone in participants with intermediate-stage HCC. Eligible trial participants must be at least age 18 years old and must not have had a liver transplant, or be on the waiting list for a liver transplant. This is not a full list of trial requirements.

Another trial is researching nivolumab in combination with another study drug called ipilimumab (also called Yervoy) in participants with advanced HCC. Researchers in this trial want to find out how well this study drug combination works when compared to other drugs called sorafenib or lenvatinib. Eligible trial participants must be at least 18 years old and must not have had any type of prior chemotherapy. This is not a full list of trial requirements.

For more details about each trial, including full trial requirements, lists of tests and procedures used to determine trial eligibility, and more details about Bristol Myers Squibb, please visit the BMSStudyConnect website.

Before you decide to enroll in a clinical trial, you can download the Study Participant’s Guide. This guide is available in many languages on this site, and includes information about trial participation, why clinical studies are important, questions to ask your doctor before participating, guidance on transportation and lodging during a clinical trial, helpful tips on how to prepare to take part in a trial, and links to helpful resources.

References

Johns Hopkins Medicine. (2020). 4 Liver Cancer Treatment Advances. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/4-liver-cancer-treatment-advances.

Eiger Presents Clinical Trial Results at The Liver Meeting Digital Experience™ 2020

By Beatrice Zovich

The 2020 meeting of the American Association for the Study of Liver Diseases (AASLD) in November offered the opportunity for scientists from industry and academia to present their findings from clinical trials, studying new medications for hepatitis B and D. Two such presentations were given by Eiger BioPharmaceuticals, Inc. who presented their findings about how well their medications peginterferon lambda and lonafarnib work, both independently and in combination, to treat hepatitis delta virus (HDV) and halt liver fibrosis. The results are promising and offer hope for those affected by HDV.

The two medicines under investigation in these studies work in different ways. Lonafarnib works by blocking farnesyl transferase, an enzyme involved in prenylation, the modification of proteins that is necessary for the life cycle of HDV. Peginterferon lambda, on the other hand, triggers immune responses that are crucial for host protection during viral infections. Lambda can also target liver cells accurately, thus reducing the effects of inadvertently targeting central nervous system cells and making it more tolerable to those taking it (Eiger, 2020).

Eiger’s first study examined how well peginterferon lambda and lonafarnib (known as LIFT – Lambda InterFeron combo Therapy) work together to lower levels of HDV RNA, 24 weeks post-treatment (Eiger, 2020). This was a Phase 2 study. Lambda was administered at a dosage of 180 mcg once weekly, in combination with 50 mg of Lonafarnib and 100 mg of ritonavir given twice daily, for 24 weeks. The results of this study found that 77% of the 26 participants saw their HDV RNA levels decline and reach a level that was either undetectable or below the level of quantification. 23% of these participants were able to maintain these levels for 24 weeks after treatment had ended. Both tenofovir and entecavir were started prior to treatment for management of HBV. The observed side effects of this regimen were mild to moderate and included mostly gastrointestinal issues or were related to blood chemistry (Eiger, 2020).

The second study found that peginterferon lambda caused the regression of liver fibrosis after 48 weeks of treatment in people living with hepatitis delta. Two case studies emerged from the completed Phase 2 LIMT (Lambda Interferon MonoTherapy) study (Eiger, 2020). In these studies, a total of 33 participants received either 180 µg or 120 µg of lambda subcutaneous injections weekly for 48 weeks. Results indicated that degrees of liver fibrosis and levels of HDV RNA declined below the level of quantification in some participants, even after 72 weeks in a handful of cases. In some instances, ALT levels decreased as well. Side effects were found to be mild to moderate and fewer than those experienced by participants who had taken peginterferon alpha in the past. Side effects were primarily flu-like in nature (Eiger, 2020). 

Therapies for hepatitis B and D will only continue to improve and become more precise and targeted as time goes by. Check out the Hepatitis Delta Connect website for detailed information on HDV, as well as current clinical trials and a drug watch page, both of which are updated regularly. (A brand-new clinical trial has just been added!) For more information about Eiger BioPharmaceuticals, click here

References

Eiger BioPharmaceuticals, Inc. (2020, November 17). Eiger Announces Positive Peginterferon Lambda – Lonafarnib Combination End of Study Results from Phase 2 LIFT HDV Study in Late-Breaker Session at The Liver Meeting Digital Experience™ 2020. Retrieved December 30, 2020, from https://www.biospace.com/article/releases/eiger-announces-positive-peginterferon-lambda-lonafarnib-combination-end-of-study-results-from-phase-2-lift-hdv-study-in-late-breaker-session-at-the-liver-meeting-digital-experience-2020/

Eiger BioPharmaceuticals, I. (2020, November 16). Eiger Announces Case Studies Demonstrating Regression of Liver Fibrosis Following 48 Weeks of Therapy with Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection Presented at The Liver Meeting Digital Experience™ 2020. Retrieved December 30, 2020, from https://www.prnewswire.com/news-releases/eiger-announces-case-studies-demonstrating-regression-of-liver-fibrosis-following-48-weeks-of-therapy-with-peginterferon-lambda-in-patients-with-chronic-hepatitis-delta-virus-hdv-infection-presented-at-the-liver-meeting-digital–301173992.html 

Clinical Trials Finder – Find A Clinical Trial Near You!

 

The Hepatitis B Foundation is thrilled to announce the addition of a new clinical trials search tool to our website! People around the world can now easily search for clinical trial opportunities on the Hepatitis B Foundation website. Created by Antidote – a company that designs technologies to link patients with scientific opportunities – the new tool filters through all of the trials listed in the U.S. National Library of Medicine’s database of private and publicly funded studies. Searching for clinical trials can be time-consuming and confusing to navigate, but this resource eases the process by finding the best trials for you based upon a series of questions.

You can now search for hepatitis B, hepatitis D and liver cancer clinical trials with a few simple clicks! Clinical trials are a series of research phases that a new drug must go through in order to be approved for widespread use. They are an essential to proving that a treatment is safe and effective for the larger population. Generally, these trials take 10-15 years to go from the laboratory to the public, but delays in finding or retaining enough volunteers can extend the process. 

Diverse participation in clinical trials is needed to make sure that a treatment is effective for all groups. Research diversity matters greatly for several reasons. Studies have shown that different races and ethnicities may respond differently to a certain medication. In addition, researchers need to examine the impact of the medication on the populations that will eventually use them. According to data from the U.S. Food and Drug Administration (US FDA), individuals from Africa and Asia or of African and Asian descent consistently remain underrepresented in clinical trials; these populations are also disproportionately impacted by hepatitis B.  If these groups are underrepresented in trials for hepatitis B treatments, new drugs may not be as effective in these communities, or there may be side effects that researchers were not aware of. 

How Our Clinical Trials Finder Works 

 Using our Clinical Trial Finder takes just a few minutes. After clicking the ‘search’ button, the user will answer a series of questions of general demographic and health questions to determine what trials are near you and you fit the criteria for. You will be able to view the available trials at any point while answering questions, but answering all of the questions will give you the best results. You will also have the option to leave your email to receive personalized trial alerts for new trials that you are eligible for in your area! The new tool is designed to match those who wish to join a clinical trial to the best option for them; it is not designed to benefit any company.

 Benefits of Participating in Clinical Trials

While participating in clinical trials helps drug developers, it can also provide major benefits to the participant as well! Blood work, treatments, and monitoring – which can be expensive –  are often provided for free to those who are eligible for the duration of their participation in the study. Volunteers can also potentially benefit from the latest medical advancements and developments! 

Help Improve the Future of Clinical Trials 

5You can also help improve the future of drug development and clinical trials by taking our patient engagement survey! The survey, which takes approximately 20-25 minutes to complete, will be made available for use by the US FDA and drug development researchers to help clinical trial development for future hepatitis B therapies. All survey responses are anonymous.  

 

Hep B Patient Engagement Survey: Help Guide The Future of Hepatitis B Therapies

If you’ve ever wanted to help guide the future of hepatitis B treatments, now is your chance! The Hepatitis B Foundation has created a short survey that is designed to capture a comprehensive view of the patient experience. The survey, which takes approximately 20-25 minutes to complete, will be made available for use by the US Food and Drug Administration (FDA) and drug development researchers to help clinical trial development for future hepatitis B therapies. All survey responses are anonymous.  

All individuals living with chronic hepatitis B are welcome to take this survey! After answering a few standard questions, participants will be asked whether or not they are currently on treatment for hepatitis B. If they are on treatment, the survey will prompt the participant to answer a few questions about their experience with the medication, such as how it makes you feel to take it, 

and what challenges you may face while taking your medication. All participants, regardless of their current treatment status, will have an opportunity to provide feedback on what they hope future medications will look like! 

The patient perspective is essential to creating a treatment that is not only effective but something that those living with hepatitis B would be willing to take. Oftentimes, researchers do not have the opportunity to gather insight into what patients are looking for or how a therapy would impact their lives. This can result in missed dosages of a medication, or avoiding a therapy altogether, rendering the treatment ineffective. This survey is also unique because it seeks to capture the diverse experiences of global patients living with hepatitis B. As we want to ensure that new treatments are as universal as possible, gathering the thoughts of both international and national individuals will ensure that different voices and opinions are captured! 

The survey is the first part of a multistep process to collect information on the patient experience. In the upcoming months, we will carry out focus groups and interviews to have a better understanding of what it is like to live with hepatitis B, its impact on a person’s daily life, and more. The information collected will help to direct our patient-focused drug development meeting – a chance for stakeholders and those living with hepatitis B to meet and discuss the patient perspective –  in June 2020.

The work being done will result in a broader understanding of how individuals are affected by the disease and more informed decisions regarding future hepatitis B therapies. Help guide the future of hepatitis B clinical trials and drug development by taking the survey today! 

Spotlight on Hepatitis Delta: Renewed Scientific Interest Paves the Way for New Data and Treatments

 

For decades, hepatitis delta, the dangerous coinfection of hepatitis B, was thought to only affect about 5-10% of the estimated 292 million people worldwide with chronic hepatitis B infections. With limited data and funding for research related to this complicated virus, true prevalence data, diagnostic tools and skilled physicians to manage hepatitis B and delta coinfection have remained limited until recent years. Publications in 2019 by Miao, et al., Chen, et al., Shen, et al., are helping to reveal a possibly more accurate picture of the burden of coinfection, conducting meta-analyses comprising data from hundreds of thousands of hepatitis B patients and the general population. While it was previously thought that 15-20 million coinfections existed globally, this new research has suggested there may be between 48-74 million1,2,3. Although these studies analyzed data that classified the presence of hepatitis delta antibodies, which can be present in cases of both past or current infection, there is a strong correlation between their presence and likelihood of an ongoing infection. These new studies may place coinfection at upwards of 10-15% of those with hepatitis B, with some of the hardest hit areas facing coinfection rates greater than 30%, in regions like Central Asia, Eastern Europe, Central Latin America and West and Central Africa1,2,3.

 

Understanding hepatitis delta is vital to helping to identify coinfected patients, who require altered treatment and management plans, and who may progress to cirrhosis and/or liver cancer in periods as little as 5-10 years. Diagnosis and management for hepatitis delta is still a challenge in much of the world, but in the US, it is becoming easier than ever before, with Quest Diagnostics, a commercial U.S. lab, rolling out a new HDV RNA test, a game-changer for physicians to easily order the test and manage patients. HDV RNA testing was previously available only through the Utah-based lab, ARUP, and Boston’s Cambridge Biomedical, but had to be specialty ordered. As testing continues to become more widely available and affordable, hepatitis B patients can more easily access testing. The more patients who are diagnosed, the more evidence for the urgent need for improved treatments to combat the virus, which is currently poorly controlled by the only available treatment; pegylated interferon.

Luckily, the virus has attracted the attention of nine pharmaceutical companies from around the world, with each working on a different approach to better controlling, or even curing hepatitis delta. Two of these companies, Eiger Biopharmaceuticals (US) and Myr Pharma (Germany) are now in Phase 3 clinical trials, where patients are flocking to enroll in these trials, which present new opportunities to receive treatments that may be more effective in controlling their coinfection. Eiger’s clinical trials will test their new drug, Lonafarnib, in clinical trial arms with and without pegylated interferon and/or ritonavir, with sites open in many countries throughout the world. Myr’s clinical trial will test their new drug, Myrcludex B, in similar triple-treatment combinations. Their clinical trial sites are now open in Russia, and the drug is already being prescribed for “compassionate use” in France. The United States Food and Drug Administration (FDA) has even taken notice; issuing guidance for industry on the development of hepatitis delta drugs for treatment in October 2019. This provides a valuable set of standards and expectations for clinical trials in regard to ethics, trial design, and patient needs.

Hepatitis delta coinfection has also received more attention this year at international hepatology conferences such as at the European Association for the Study of the Liver (EASL)’s International Liver Congress in Vienna, Austria, the International Liver Congress in American Association for the Study of the Liver (AASLD) meeting in Boston, and HEP DART in Hawaii. This year has brought many milestones for hepatitis delta data, diagnostics, and clinical trials. With continued scientific research and interest, Hepatitis Delta Connect hopes to continue to support these milestones and drive awareness efforts.

References:

1. Zhijiang Miao, Shaoshi Zhang, Xumin Ou, Shan Li, Zhongren Ma, Wenshi Wang, Maikel P Peppelenbosch, Jiaye Liu, Qiuwei Pan, Estimating the global prevalence, disease progression and clinical outcome of hepatitis delta virus infection, The Journal of Infectious Diseases, jiz633.

2. Chen H, Shen D, Ji D, et al. Prevalence and burden of hepatitis D virus infection in the global population: a systematic review and meta-analysis. Gut 2019;68:512-521.

3. Shen D, Ji D, Chen H, et al. Hepatitis D: not a rare disease anymore: global update for 2017–2018. Gut Published Online First: 09 April 2019.

Ten Things People with Hepatitis B Need to Know in 2016

Image courtesy of Serge Bertasius Photography at FreeDigitalPhotos.net
Image courtesy of Serge Bertasius Photography at FreeDigitalPhotos.net

In 2015, doctors continued to unlock the mysteries of hepatitis B and uncovered promising new treatments. Armed with new information, here are 10 things we can do in 2016 to safeguard our health and help prevent the spread of hepatitis B.

  1. Get monitored regularly. No one likes a blood draw or to be reminded they have hepatitis B, but it’s important that you’re tested annually or more often if you have a high viral load and/or signs of liver damage. There’s no cure yet, but there are effective treatment options with more in the pipeline. So be brave, protect your health, and go to the lab for a blood test.
  2. If you’ve been prescribed an antiviral, don’t forget to take it. Taking a pill every day is tedious and it’s tempting to skip it, but failing to take your daily antiviral reduces its effectiveness and can lead to drug resistance. The hepatitis B virus is a master at mutating to escape whatever is attacking it. Forgetting to take your daily pill can lead to an uptick in your viral load and liver damage. Stay strong, take your daily pill, and keep that virus undetectable.
  3. Face it, antivirals are a long-term commitment. Until a cure is developed, antivirals—either tenofovir (Viread) or entecavir (Baraclude)—are the best treatment to quickly reduce both viral load (HBV DNA) and liver damage. But they work for only as long as we take them, and once we start, we are usually committed to years of treatment. Quitting antivirals before we’ve achieved undetectable viral load and lost the hepatitis B surface antigen (HBsAg) often results in a resurgence of both viral load and liver damage. Antivirals are a long-term treatment that help prolong our lives.
  4. Demand to be screened for liver cancer. Some experts say current medical guidelines that recommend when we should be screened for liver cancer  don’t go far enough to protect us. So take charge of your health and ask for a liver cancer screen, which includes a semi-annual blood test and an ultrasound.  Hepatitis B-infected Asian men (or of Asian descent) over age 40 years and Asian women over age 50 years, patients with a family history of liver cancer, patients with cirrhosis, and Africans over the age of 20 should all be screened. Think you’re not at risk for cancer because you take antivirals? Think again. Antivirals help reduce liver damage, but if you’ve had cirrhosis or are older, the risk of liver cancer remains.
  5. If someone promises a new cure or treatment that sounds too good to be true….it probably is. In our search to be rid of hepatitis B, we may be tempted to yield to clever marketing and try a supplement that promises to cure us. But first, do your homework and practice precaution. To check out an herbal supplement, visit the National Center for Complementary and Integrative Health’s website to see what scientific evidence exists for a supplement and talk to your doctor. There is no magic bullet that will cure hepatitis B. Experts hope to find one soon, but for now be patient and stay skeptical. If you want to safeguard your health, eat healthy foods and avoid alcohol and cigarettes.
  6. Experts say a cure is coming … so stay informed about new drug developments and clinical trials. There is lots happening on the research front. To find out what drugs are in the development pipeline, visit the Hepatitis B Foundation’s Drug Watch page for the latest news. You can also find out if you qualify for a clinical trial. Expensive blood work, treatment medications, and doctor’s visits are usually free-of-charge for those accepted into a study. The foundation features a list of hepatitis B-related clinical trials that are recruiting patients in the U.S. and around the world at its Clinical Trials page. You could become part of the cure.
  7. Pregnant with hepatitis B? Get your viral load tested and ask your doctor about antivirals. In November, the American Association for the Study of Liver Disease (AASLD) for the first time recommended that pregnant women with viral loads (HBV DNA) higher than 200,000 IU/mL (or 1 million copies/mL) receive an antiviral (either tenofovir or telbivudine) starting at their 28th week of pregnancy. The antivirals won’t hurt you or your baby and will reduce the risk that your baby will be infected with hepatitis B to nearly zero, as long as your baby gets the first dose of the hepatitis B vaccine and a dose of HBIG (hepatitis B antibodies) within 12 hours of birth.
  8. Fight discrimination against hepatitis B and know your rights. Hepatitis B should never be a barrier to the education or job you want. Sadly, ignorance and stigma remains in the U.S. and abroad. It depends on us, our friends, and our family, to stand up and fight for our civil rights. We can’t back down. If we don’t fight, who will?
  9. Practice safe sex and never re-use needles. Today, in some areas of the U.S., hepatitis B is increasing—even though a safe and effective vaccine exists. Unfortunately, not everyone is immunized and the infection is still getting transmitted sexually. In the midst of America’s heroin epidemic, it’s also spreading when syringes are re-used and shared. Do you want to end hepatitis B? Make sure your friends and family members know how to prevent sexually-transmitted infections (even if those conversations are challenging, their lives may depend on it) and support needle exchange programs in your region and state. Countless studies show that when needle exchange programs are available, HIV, hepatitis B and C rates decline! It saves lives and healthcare dollars!
  10. Be brave, disclose, and get your friends, family, and lovers screened for hepatitis B and vaccinated. Yes, it will be one of the hardest conversations you will ever have, but if you are infected with hepatitis B, you need to disclose your infection to people who may be at risk. If you just discovered you have chronic hepatitis B, which you may have contracted at birth, you need to tell your siblings and your mother and get them screened and immunized if needed. Dating someone, and about to take the next step? You need to disclose ahead of time and give them information and choices. It builds trust and it’s the right thing to do. You would want the same for yourself.

Continue reading "Ten Things People with Hepatitis B Need to Know in 2016"

Clinical Trials Webinar -What YOU need to know!

Why do we have clinical trials? What is involved with clinical trial participation? How do I find a trial that’s right for me? Find out by listening to this webinar from Liver Cancer Connect, a dedicated program of the Hepatitis B Foundation. Presenters Jill McNair of the Center for Information & Study on Clinical Research Participation, and Katelyn Levy, BS, clinical research coordinator at Johns Hopkins Suburban Hospital, explain what clinical trials are and answer frequently asked questions about participating in a trial.

Continue reading "Clinical Trials Webinar -What YOU need to know!"

Clinical Trials in Liver Cancer: What You Need to Know

diversegroupMyth: Clinical trials are only for people with advanced stages of cancer.

Fact: No! Trials are available for all stages of cancer, not just for people who have advanced cancer that is not responding to treatment.

If you or a loved one needs treatment for liver cancer, clinical trials are an option to think about. Continue reading "Clinical Trials in Liver Cancer: What You Need to Know"

The Drug Discovery Process

It takes talent, dedication, lots of  time, and a sizable investment to bring a safe and effective drug to market. The Drug Discovery Process YouTube video, compliments of PhRMAPress, introduces the long and arduous drug process from the identification of a compound in the lab, though clinical trials and the FDA approval process. It may sound simple, but this process may take up to 1,000 people, 12-15 years and up to 1.3 to 1.6 billion dollars to put a new drug in the hands of the patient.

Consider this process when following the progress of  hepatitis B drugs on the Hepatitis B Foundation Drug Watch page.  Compounds could remain in various stages for years. Note that the “preclinical” phase represents the drugs that are still in the lab and not yet ready for human clinical trials.

The Hepatitis B Foundation also maintains a webpage with the latest hepatitis B related clinical trials. Contact information is provided for each trial for those wishing to volunteer to participate.  Volunteers must meet the criteria for participation in a trial.

The future looks bright for a functional cure for hepatitis B. It may take a few more years to get the drug into the hands of the patient, but each step of the process is crucial in order to produce a drug that is both effective and safe.