Wednesday, April 16, 2014

Dynavax Starts Phase III Study on Heplisav-B

Dynavax Technologies Corp. (DVAX - Snapshot Report) commenced a new phase III study (HBV-23) on its hepatitis B vaccine candidate, Heplisav-B. Dynavax is seeking to get Heplisav-B approved in the U.S. and EU.

The randomized, active-controlled, HBV-23 (n=8,000) study will randomize (2:1) patients to receive a 2-dose series of Heplisav-B and 3-dose series of GlaxoSmithKline’s  Engerix-B.

The primary endpoints of the study are for evaluation of the overall safety of the candidate and demonstrate the non-inferiority of the seroprotection rate induced by Heplisav-B compared with Engerix-B at week 28 in type II diabetes patients.

Secondary endpoints include safety profile of Heplisav-B with respect to specific outcomes and assessment of immunogenicity in subpopulations.

Saturday, April 12, 2014

Assembly Pharma, BioCrossroads to advance potentially curative therapy for chronic hepatitis B virus

Assembly Pharmaceuticals, a virology-focused biopharmaceutical company, and BioCrossroads announced that the BioCrossroads Indiana Seed Fund II has made an investment in Assembly Pharmaceuticals. Assembly is developing novel drugs for the treatment and potential cure of chronic hepatitis B virus (HBV) infection. Johnson & Johnson Development Corporation, Twilight Ventures, Luson Bioventures and private investors also participated in the financing round.

Assembly Pharmaceuticals is applying its novel science to develop agents with the potential to cure chronic HBV. HBV is an under-appreciated global epidemic with more than 350 million people worldwide chronically infected, including two million in the US Chronic HBV causes cirrhosis and liver failure, and it is a leading cause of liver cancer. Over 600,000 deaths each year are attributable to HBV. Current treatments can suppress the infection but require lifelong therapy since they are not curative.

Assembly Pharmaceuticals was formed in 2012 to develop drugs based on the breakthrough science of co-founder and Indiana University professor Adam Zlotnick,  Dr. Zlotnick is a pioneer in the biophysics of viral capsid assembly. His research has led to the discovery of multiple families of small molecules known as Core Protein Allosteric Modulators (CpAMs), which target the HBV core protein, a unique viral protein with no human analogue that is involved in multiple stages of the HBV life cycle.

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EASL 2014: Three new studies help clarify optimal use of combination therapy in chronic hepatitis B patients

Three new studies presented today at the International Liver Congress 2014 have helped clarify the optimal use of combination therapy with peginterferon and nucleoside analogues (NUCs) to achieve the best treatment outcomes in patients with chronic hepatitis B (CHB).

"Together these ground-breaking data will go a long way to influencing future CHB treatment guidelines," said EASL's Educational Councillor Professor Cihan Yurdaydin from the Department of Gastroenterology, University of Ankara, Turkey.

In the first study , CHB patients who had failed on prior long-term exposure to one of the nucleoside analogue (NUC) antivirals demonstrated high rates of complete response and HBsAg loss when prescribed a sequential combination of peginterferon and NUC.

In the second study , adding peginterferon to the nucleoside analogue entecavir was shown to enhance response rates and viral decline in HBeAg-positive CHB patients with compensated liver-disease, was generally safe and well tolerated, and may facilitate the discontinuation of entecavir.

Finally, data from a third study suggested that adding on a NUC for six weeks to PegIFNalfa-2a does not enhance treatment response, with no increase in HBeAg seroconversion rates beyond that achieved by PegIFNα-2a alone after 24 weeks follow-up.

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EASL 2014: Pegylated Interferon Improves Entecavir Response in Patients With Hepatitis B e Antigen-Positive Chronic Hepatitis B

LONDON -- April 11, 2014 -- Patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B show improved response in eliminating viral load after pegylated interferon (peg interferon) is added to entecavir therapy, according to trial data reported at the International Liver Congress, the 49th Annual Meeting of the European Association for the Study of the Liver (EASL).

Willem Pieter Brouwer, MD, PhD, Erasmus Medical Center, Rotterdam, The Netherlands headed an international team in conducting this multicentre, controlled trial. He reported results here on April 10 that included data up to 96 weeks after randomisation to either add-on peg interferon alpha 2a (180µg/week) from weeks 24 to 48 (n = 85), or continued entecavir monotherapy (0.5mg/day) (n = 90).

The trial’s primary endpoint was met when a data analysis at week 48 showed the response rate was nearly doubled in the add-on group; the response rate was 19% in the peginterferon group and 10% in those receiving monotherapy (P = .005).

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Friday, April 11, 2014

High preop hep B surface antigen levels predict HCC recurrence

NEW YORK (Reuters Health) - High preoperative levels of hepatitis B surface antigen (HBsAg) in patients with a low viral load predict an increased likelihood of hepatocellular carcinoma (HCC) recurrence after resection, Chinese researchers report.

"We are somewhat surprised by our results," Dr. Wei-ping Zhou from Eastern Hepatobiliary Surgery Hospital in Shanghai told Reuters Health by email. "It is difficult to find a good marker that actually reflects the status of HBV infection and predicts postoperative prognosis in HCC patients with a low HBV-DNA load."

Patients with HBV DNA levels below 2,000 IU/mL are designated as being inactive or low-risk carriers, but even these patients have a high postoperative tumor recurrence rate.

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Thursday, April 10, 2014

Small financial incentives can improve people’s completion of HBV vaccination, study finds

Small financial incentives, totalling as little as £30, can dramatically increase the likelihood of people who inject drugs completing a course of hepatitis B virus (HBV) vaccination, according to new research published in The Lancet.

 Researchers in the UK found that people undergoing treatment for heroin addiction who received a maximum total of £30 supermarket vouchers in equal or graduated instalments in return for full compliance with a regimen of three HBV vaccine injections were at least 12 times as likely to complete the course within 28 days compared to those not receiving a financial incentive (45% for equal payment instalments and 49% for graduated payment instalments vs 9% for no payment incentive).

The study was led by Professor John Strang from the National Addiction Centre at King’s College London, UK, working in close collaboration with senior colleagues at Imperial College London and University College London (UCL), in the UK.

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Tuesday, April 8, 2014

CDC Resources for May & Hepatitis Awareness Month

CDC Letterhead
April 8, 2014

Dear Partners,
Hepatitis Awareness Month and the third annual national Hepatitis Testing Day are almost here! In continuation from last year, CDC’s Division of Viral Hepatitis (DVH) is providing numerous free resources and materials designed to support your efforts for the month of May and testing day on May 19th. Throughout the month of May, we will continue to send additional updates, so stay tuned!

Hepatitis Awareness Month & Hepatitis Testing Day Resources:
We hope the resources on our Hepatitis Awareness Month and Testing Day Resource Center page will help you spread the word about the month and support your activities. In the Resource Center you’ll find a variety of digital tools including a quiz widget, buttons, and banners that we encourage you to use on your websites and in emails. Several different Live Script Radio PSAs are available should you want to adopt or customize for your events and pitch to local radio stations. Information on how to request a Hepatitis Awareness Month and/or national Hepatitis Testing Day proclamation be issued in your community is also available.

Hepatitis Testing Day Event Page:
The NPIN-sponsored Hepatitis Testing Day Event page is back and is being updated! If you are hosting an event, please register your event now. Once events are registered people can search for testing events in their area by entering their zip code. You can promote the event page by featuring one of two different buttons on your site, so that others can register their events and your constituents can find testing events near them.

Hepatitis Risk Assessment:
Support Hepatitis Testing Day by continuing to promote the Hepatitis Risk Assessment by using free resources, including downloadable buttons, badges, or banner ads to feature on your website and sending out the risk assessment e-card to your constituents.

Know More Hepatitis Campaign:
The Know More Hepatitis campaign continues to raise awareness about Hepatitis C and encourage people born 1945-1965, or baby boomers, to talk to their doctor about getting tested. Campaign resources are available free for your use, including a fact sheet, posters, digital tools, live radio scripts, an infographic, and supporting images and templates. Also, a video PSA encouraging baby boomers to get tested for Hepatitis C is available – check it out and share!

Know Hepatitis B Campaign:
Last year, DVH, in coordination with community partners, released Know Hepatitis B, a national education campaign designed to educate Asian Americans and Pacific Islanders (AAPIs) about the importance of getting tested for Hepatitis B. Free, culturally appropriate materials and resources are available in English and multiple Asian languages, including TV and radio PSAs, fact sheets, posters, paper risk assessments, and digital tools. The website also contains resources for health professionals outlining the rationale and importance of testing their AAPI patients.

Hepatitis Poster Ordering Page:
Free posters are available through our online ordering page. Posters provide information on hepatitis in general, but posters for the Know More Hepatitis and Know Hepatitis B campaigns are also available to order. Feel free to visit the site and order posters for your organization and activities you have planned throughout the month of May!

Twitter:
If you are on Twitter, we hope you will follow DVH’s Twitter account @cdchep. Please join the conversation by using the following hashtags:
  • #Hepatitis
  • #HepAware for Hepatitis Awareness Month
  • #HTD for Hepatitis Testing Day
  • #HepRisk for the Hepatitis Risk Assessment
  • #KnowHepB for the Know Hepatitis B campaign
Please let us know if you have any questions or suggestions by emailing us at dvhwi@cdc.gov. We look forward to working with you!

DVH Education and Training Team
 Hepatitis Awareness Month

 Know More Hepatitis
 Know Hepatitis B