New USPSTF Recommendation on Hepatitis B Screening for People at High-Risk

Posted on May 28, 2014 | Leave a comment

Unknown-1Truly historic news! Those living with chronic hepatitis B will be identified sooner and learn more about their HBV infection. They can live full lives by improving their health through regular monitoring, treatment when necessary, and adopting healthy lifestyles that benefit the liver. Symptoms may not occur for decades so many are completely unaware of their infection. If you believe you are at risk, please talk to your doctor about being screened for hepatitis B.

By Ronald Valdiserri, M.D., M.P.H., Deputy Assistant Secretary for Health, Infectious Diseases, and Director, Office of HIV/AIDS and Infectious Disease Policy, U.S. Department of Health and Human Services

On Monday, May 26th, the U.S. Preventive Services Task Force (Task Force) published its final recommendation statement on screening for hepatitis B virus (HBV) infection in individuals at high risk. This recommendation includes adults and adolescents who are not pregnant and who have not been vaccinated, as well as other individuals at high risk for infection.

Click here to better Understand the details of the Task Force Recommendations.

After reviewing the evidence, the Task Force recommends screening people who have the following risk factors for HBV infection:

  • People born in countries and regions with a high prevalence of HBV infection, such as Africa, Southeast Asia, Pacific Islands, China, Middle East, Eastern Europe, and the northern countries in South America;
  • U.S.-born persons not vaccinated as infants whose parents were born in countries or regions with a high prevalence of HBV infection;
  • HIV-positive people, injection drug users, men who have sex with men, and those living with or having sex with someone with HBV infection; or
  • Patients with weakened immune systems or undergoing treatment for kidney failure (hemodialysis).

There are still as many as 2.2 million people in the United States chronically infected with hepatitis B and 15 to 25 percent of those individuals die from liver disease including liver cancer. “Screening can identify people who have chronic HBV infection, and the good news is that treatment can help prevent liver cancer in these people,” says Task Force member Dr. Douglas K. Owens of Stanford University.

The Task Force’s final recommendation statement has been published online in Annals of Internal Medicine , as well as on the Task Force Web site . A fact sheet  [PDF 151KB] explains the recommendation statement in plain language.

“The Task Force’s new Grade B recommendation in favor of HBV screening for persons at high risk for infection – people who are more likely to get infected or to pass on the infection – provides us with another important tool to use as we pursue the goals of the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis,” observed Ms. Corinna Dan, Viral Hepatitis Policy Advisor at the HHS Office of HIV/AIDS and Infectious Disease Policy. “In the weeks and months ahead, federal and nonfederal stakeholders alike will incorporate this recommendation into efforts detailed in the Action Plan to improve viral hepatitis testing, care and treatment to prevent liver disease and cancer.”

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Operation Storm Philadelphia City Council : The Aftermath

Posted on May 14, 2014 | 1 Comment

Operation SCC 01

Hepatitis B Foundation Intern and Guest Blogger Limi Lo shares her personal reflection of last week’s advocacy event when hepatitis B partners and advocates stormed Philadelphia City Council 

A few months ago, I was sitting in my public policy class learning about advocacy. In simple English, it means, “to fight for a cause that you believe in.” As much as I understood what it meant, I never thought I would take part in a real advocacy event until I attended the City Council resolution presentation on May 8th, 2014. The event was held at the Philadelphia City Council during a city council session, and included supporters from Hep B United Philadelphia (lead by the Hepatitis B Foundation), HepCAP, and Philadelphia County Medical Society. Together, supporters came out and advocated for better viral hepatitis care in the greater Philadelphia area. City Councilman David Oh had introduced a resolution declaring May as Hepatitis Awareness Month and calls for all high-risk Philadelphians to receive appropriate testing and proper care for viral hepatitis.

The event not only provided me with a valuable learning experience, but more importantly, it was a life changing experience. I was able to witness community partners, students, professors, and other advocates coming together to help raise awareness and fight for a substantial cause (to improve hepatitis care). There were dozens of posters held high and being displayed: “Be proactive, get tested today”, “know more hepatitis”, and “Give hope to your family”. These messages were inspirational in addressing the need for city leaders to pay greater attention for the silent epidemic of viral hepatitis. Throughout the event, the atmosphere was filled with positive energy and a sense of hope was tangibly present—a hope that, in Philadelphia, all high-risk individuals can access screening tests, vaccines, and care for viral hepatitis.

Since beginning my practicum with the Hepatitis B Foundation, I’ve gained a variety of hands-on experience to raise community awareness, such as through screening events, providing linkage to care and now, participating in public health advocacy. I am grateful to be working with passionate and motivated individuals that want to make a difference in their community. Although, there is still much work to get done in improving the care for viral hepatitis, I can already feel the positive impact we are making as a community. The City Council event was a major stepping stone in advocating the cause at a local level and it was a huge success. I know in the near future, more and more people will become aware of the hepatitis issue and attention will be brought up to the federal and state level. But until then, let’s all be heroes and help save lives through advocacy.

 

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Alnylam Discloses HBV Program, Shows 2 Log HBSAG Knockdown with Research-Grade SNALP Tech

Posted on May 13, 2014 | Leave a comment

HepatitisBVirus-1

Harnessing the Power of RNAi Gene Silencing in Quest of a Cure for Chronic Hepatitis B, and the HBV KnockDown blog written by Dirk Haussecker, who believes it’s about time everyone got serious about a functional cure for hepatitis B. 

Following cryptic remarks during a conference call earlier this year, Alnylam today officially announced its entry into the cure-HBV race.  In impressive data presented at the ongoing TIDES meeting, the company showed that up to 0.5mg/kg SNALP-siRNA was able to knock down HBsAg by ~2 log (99% knockdown) in infected chimpanzees.  The data had been generated by Merck from which Alnylam acquired the RNAi assets in January.  The goal is now to apply some of the learnings generated with Merck’s research-grade SNALP LNP technology and come up with a new candidate based on Alnylam’s GalNAc delivery platform (IND to be filed end of 2015).
In addition to the impressive HBsAg knockdowns, 3-4log knockdowns of viral DNA in serum were seen in the 4 chimpanzees.  In the most viremic chimp, the 4log lowering of viral load was able to normalize liver enzyme (ALT) levels that had been elevated by ~5x ULN.  Intriguingly, in 2 chimps with normal ALTs at the time of treatment, liver enzymes started to increase after dosing had finished (ruling out SNALP LNP as the culprit) and in 1 case also well after viral DNA had started to recover following cessation of RNAi dosing.
Intriguingly, while viral DNA recovered in this short study involving the administration of 3 doses (for every chimp 0.125mg/kg, then 0.25mg/kg, then 0.5mg/kg) over a span of 40 days, there were indications of a desired immunological response similar to that seen withARC520 in the chimp study, most notably an elevation of interferon gamma accompanied by ~2x increases in ALT in 2 of the chimps.
The competition
 
With Tekmira, ISIS/GSK and now Alnylam (and possibly more to come) following on the heels of Arrowhead Research and ARC520, the competitive landscape is starting to look quite complex.  How it will play out will likely depend on the degree of HBsAg knockdown required (in relative and absolute terms) and who will run the right combination studies with other HBV agents, especially immune boosters such as interferon and possibly RT inhibitors (note: Alnylam speculates that RT inhibitor co-treatment will be beneficial and thereby justified its use of a single RNAi trigger).
If a deep multi-log HBsAg knockdown were required, it would favor Tekmira’s candidate which will be based on a 3rd gen SNALP LNP which can be considered superior to what came out of Merck’s copy-cat efforts subject of today’s presentation.  If lesser knockdowns were able to achieve comparable cure rates, then the power would shift to the subcutaneous versions by Alnylam and ISIS/GSK (esp. the likely GalNAc-based follow-up version).
For ARC520, especially at 2mg/kg and Tekmira probably just 6 months behind, the competition may prove too much, not least because in the 2-dose study in the chimpanzee, the HBsAg knockdown was less than a log (80%).  Granted it was an extremely viremic chimp and one of the RNAi triggers was a mismatch, but still.  If Arrowhead and/or Tekmira demonstrate increased cure rates in 2015, Arrowhead should waste no time and push a single-molecule DPC into development to potentially once again take the lead.
The big question is how far along the way to clinical translation is single-molecule DPC?  Tomorrow may provide an answer.

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Do You Know Your Hepatitis Facts from Fiction?

Posted on May 7, 2014 | 3 Comments
Hepatitis-Awareness-Month(2)

May is Hepatitis Awareness Month!

In recognition of May as Hepatitis Awareness Month, Liver Cancer Connect reviews some important facts and dangerous fiction about chronic hepatitis B and C- the world’s leading causes of liver cancer.  Continue reading →

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Posted in Blood Tests, HBV Awareness, Hep B Prevention, liver cancer prevention

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HBV Journal Review – May 2014

Posted on April 30, 2014 | 2 Comments

ChrisKHBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
 latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

  • Adding Interferon to Ongoing Antiviral Treatment Is Highly Successful
  • Vitamin E Helps HBV-Infected Children Lose HBeAg, Reducing Liver Damage
  • Common Chinese Toad May Hold the Key to Preventing and Treating Liver Cancer
  • Even at Top Hospitals, Doctors Fail to Treat Hepatitis B Patients Properly
  • Study Finds Doctors More Likely to Treat Hepatitis B in Men Than Women
  • Study Confirms Doctors Frequently Fail to Screen and Vaccinate Those at Risk
  • Antiviral Treatment Dramatically Improves Liver Cancer Test Accuracy
  • $50 Cash Incentive Increases HBV Immunization 12-Fold
  • Hepatitis B and C Cause Ten-Times More Deaths Than HIV in Europe

HBV Journal Review
May 1, 2014
Volume 11, Issue 5
by Christine M. Kukka

Adding Interferon to Ongoing Antiviral Treatment Is Highly Successful 

Adding pegylated interferon to ongoing antiviral treatment produced remarkable rates of hepatitis B “e” antigen (HBeAg) loss and even hepatitis B surface antigen (HBsAg) loss, according to a study presented at the International Liver Congress held in London in April.

Eighty-three HBeAg-positive patients in China, who had been on antivirals for more than two years, had 48 weeks of interferon treatment added to their treatment regimen. A control group continued on only antivirals:

  • 60% of the group treated with add-on interferon lost HBeAg and their viral loads dropped below 2,000 IU/mL. In contrast, only 13.8% of patients treated with only antivirals achieved those benchmarks.
  • 27.7% of patients in the combination treatment group lost HBsAg. No one in the antiviral group lost HBsAg.
  • All patients who had low HBsAg levels (less than 1,000 IU/mL) at the start of interferon treatment achieved HBeAg loss and 91% cleared HBsAg.

” Sequential combination therapy of (antivirals) and pegylated interferon effectively resulted in high rates of complete response and HBsAg loss in patients with prior long-term exposure to (antivirals),” researchers wrote. (Abstract 0117)

Another study exploring the benefits of sequential antiviral and interferon treatment found that HBeAg-positive patients who had been on antivirals for three years or longer also experienced high rates of HBeAg loss and development of “e” antibodies (HBeAg seroconversion) when their antivirals were replaced with pegylated interferon.

At week 48, the HBeAg seroconversion rate in the interferon-treated group was 66.67% compared to 2.5% in the antiviral group. (Abstract P1071)

A third study from India also found notable improvements when pegylated interferon was added to ongoing tenofovir treatment. Sixty patients were treated with tenofovir for 12 weeks (300 mg daily), then:

  • One group had pegylated interferon added to the ongoing tenofovir regimen for 24 weeks, and then were followed for another 28 weeks.
  • The other half continued their tenofovir treatment for 52 weeks.

Sixty percent of the interferon-plus-tenofovir group achieved healthy liver health, with normal alanine aminotransferase (ALT) levels, compared to 30% in the tenofovir-only group. The combination-treatment group also experienced greater viral load (HBV DNA) declines and HBeAg seroconversion (53.3% vs. 23.3% in the antiviral-only group).

“Sequential therapy using tenofovir and pegylated interferon may provide rapid and high biochemical and virological response in selected HBeAg-positive patients,” researchers noted. “Long-term clinical trials are needed to assess (the) sustained durable response.” (Abstract P1092)

Source: www.hbvadvocate.org/EASL_2014_
Abstracts.pdf

Vitamin E Helps HBV-Infected Children Lose HBeAg, Reducing Liver Damage

A small study, presented at the 2014 Liver Congress found that HBeAg-positive children who were treated with vitamin E (15 mg/kg/daily) for 12 months achieved higher rates of HBeAg conversion, lower viral loads and normal ALT levels than did untreated children.

Continue reading the HBV Journal Review… 

 

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