Wednesday, December 17, 2014

NICE plans to support device for diagnosing liver damage without surgery

NICE is consulting on draft guidance on a device that aims to diagnose and monitor liver damage, without the need for surgery. The provisional recommendations support using the device, Virtual Touch Quantification (VTq), in adults and children with chronic hepatitis B or C who need assessment of liver fibrosis.

Liver fibrosis occurs when there is a lot of scar tissue in the liver. The scar tissue can result from damage to liver cells caused by infections such as chronic hepatitis B or C, inflammation and injury.  Other causes of liver fibrosis (not considered in this guidance) can include heavy alcohol consumption, toxins and some rare inherited diseases.

The standard methods [1] of assessing whether there is damage in the liver are ultrasound scans, transient elastography, and biopsy. The draft guidance advises that VTq is as accurate as transient elastography in diagnosing and staging liver fibrosis, and may offer additional benefits in terms of allowing liver imaging as well as sampling selected areas.  Using VTq may also create greater savings for hospitals where liver biopsy is the primary method for diagnosing and monitoring liver fibrosis.

VTq is a software application which assesses the stiffness of the liver based on readings of a high intensity ultrasound wave which is transmitted through the liver. The wave travels at different speeds through liver tissue depending on whether the liver is flexible and healthy, or whether it is stiff due to fibrous scar tissue caused by damage. The device measures the speed of the sound waves to determine the condition of the liver tissue and allows the liver to be imaged at the same time.

The company which manufactures the system claims that the benefits of VTq include the procedure being painless and possibly safer than liver biopsy, and reduced costs.

The cost modelling suggests that using VTq could save around £434 per patient compared with liver biopsy and around £53 per patient compared with transient elastography.

Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “Liver fibrosis can result from infections such as chronic hepatitis B and C – conditions which affect hundreds of thousands of people in the UK. Diagnosing and monitoring any liver damage caused by these infections is important for ensuring that an affected person receives appropriate care and treatment.

“This draft guidance, developed by the independent Medical Technologies Advisory Committee (MTAC), proposes supporting VTq for diagnosing and monitoring liver fibrosis in adults and children with hepatitis B or C. The evidence examined by MTAC indicates that VTq may avoid the need for surgical biopsy – which could mean no pain for the patient, and potentially save the health service over £400 compared to performing a biopsy.  It could also be used for patients where obesity or other factors mean that the standard form of non-invasive fibrosis testing – transient elastography – isn’t suitable.

“MTAC also considered that VTq is likely to be used in an outpatient setting as part of the initial referral from primary care for people who test positive for chronic hepatitis B or C. Clinical experts advised that there is also potential for VTq to be done in future in primary care settings, if performed by staff with specialist training in ultrasound imaging and its interpretation. We welcome comments on the draft guidance during this consultation.”

More information on the medical technology draft guidance consultation for VTq  is available at: https://www.nice.org.uk/guidance/indevelopment/gid-mt210. The consultation closes on 19 January 2015. 

ENDS
For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142.

Notes to Editors

Explanation of terms
[1] The standard methods of assessing whether there is damage in the liver include ultrasound scans, transient elastography, and biopsy. Transient elastography is a procedure which measures the stiffness of the liver tissue based on patterns of distortion created in the tissue when nearby skin is vibrated. Biopsy is an invasive procedure where a small sample of liver tissue is removed using a fine needle and then assessed for changes.

About the NICE draft guidance
1. The draft medical technologies guidance, “Virtual Touch Quantification to diagnose and monitor liver fibrosis”, is available at https://www.nice.org.uk/guidance/indevelopment/gid-mt210 from 17 December 2014.

2. Virtual Touch Quantification (VTq) is manufactured by Siemens. The VTq software application uses acoustic radiation force impulse (ARFI) imaging technology to measure the elasticity of liver tissue. VTq is used in combination with a Siemens Acuson S2000 or S3000 ultrasound platform. Liver tissue can be damaged by inflammation, causing high levels of collagen to be deposited in the liver cells (fibrosis), which become stiff. ARFI imaging involves generating a shear wave by applying an acoustic ‘push pulse’ lateral to the area of interest identified during a conventional ultrasound scan. The speed of the shear wave is proportional to the stiffness of the tissue.

3. Cost modelling suggests that using VTq is cost saving compared with transient elastography and liver biopsy, whether or not a compatible Siemens ultrasound machine needs to be purchased. The estimated overall cost saving per patient compared with transient elastography, including the purchase of an ultrasound machine for which VTq assessment of liver fibrosis accounts for 10% of the patient throughput, is around £53. Compared with liver biopsy, the corresponding saving is around £434.

4. The cost of the VTq software stated in the company’s submission is £4415. A compatible Siemens Acuson S2000 ultrasound system costs £59,700, with yearly maintenance costs, starting from year 2, of £2246. All costs are excluding VAT.

5. In the UK, chronic hepatitis B affects an estimated 170,000 people (British Liver Trust), and around 214,000 individuals have long-term (chronic) infection with hepatitis C (Public Health England).

About the Medical Technologies Evaluation Programme

6. The focus of Medical Technologies Evaluation Programme is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available at http://www.nice.org.uk/MT.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.

Entecavir Cuts Hep B Reactivation in Diffuse Large B-Cell Lymphoma

TUESDAY, Dec. 16, 2014 (HealthDay News) -- Entecavir is more efficacious than lamivudine for preventing hepatitis B virus (HBV) reactivation among patients who are seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma receiving rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy treatment. These findings have been published in the Dec. 17 issue of the Journal of the American Medical Association.

The researchers found that the incidence of HBV-related hepatitis was significantly lower in the entecavir group than in the lamivudine group (0 versus 13.3 percent; P = 0.003). The incidence of HBV reactivation was also significantly lower in the entecavir group (6.6 versus 30.0 percent; P = 0.001), as was chemotherapy disruption (1.6 versus 18.3 percent; P = 0.002).


"If replicated, these findings support the use of entecavir in these patients," the authors write.

Read more...

Monday, December 15, 2014

Arrowhead Files IND for RNAi Therapeutic ARC-520 to Begin Phase 2b Multiple-Dose Studies in Chronic Hepatitis B Patients

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for ARC-520, it's drug candidate for the treatment of chronic hepatitis B virus (HBV) infection. Arrowhead plans to submit additional clinical trial authorization applications with regulatory authorities in various jurisdictions in Europe and Asia.

Pending national regulatory review and approval, Arrowhead intends to initiate two Phase 2b, multicenter, randomized, double-blind, placebo-controlled, multi-dose studies to determine the depth of hepatitis B surface antigen (HBsAg) reduction following ARC-520 injection in combination with entecavir or tenofovir in patients with chronic immune active HBV infection. The Heparc-2002 study is planned to include patients who are negative for hepatitis B e-antigen (HBeAg) at screening and the Heparc-2003 study is planned to include patients who are positive for HBeAg at screening. The primary objective is to evaluate the depth of HBsAg decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic HBV infection as a measure of drug activity. Secondary objectives are to assess measures of safety and tolerability and to evaluate multi-dose pharmacokinetics of ARC-520 in patients with chronic HBV infection when co-administered with a fixed dose of entecavir or tenofovir, in addition to other exploratory safety and pharmacodynamic objectives.

"As with our recent application to begin a Phase 1 study with ARC-AAT, this IND represents achievement of a key 2014 goal," said Arrowhead President and CEO, Dr. Christopher Anzalone. "We look forward to beginning multi-dose studies with ARC-520."

About ARC-520
Arrowhead's RNAi-based candidate ARC-520 is being investigated in the treatment of chronic HBV infection. The small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC-520 specifically, to determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. Arrowhead has completed a Phase 1 single ascending dose study in normal volunteers and the company is conducting a single dose Phase 2a study in chronic HBV patients. Approximately 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.

About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate™ delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead's pipeline includes ARC-520 for chronic hepatitis B virus, ARC-AAT for liver disease associated with Alpha-1 antitrypsin deficiency, and partner-based programs in obesity and oncology.

For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadresearch.com/alerts.cfm.

Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, actions of the U.S. Food and Drug Administration (FDA) and similar global regulatory bodies, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Research Corporation


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Vince Anzalone, CFA, 626-304-3400
ir@arrowres.com
or
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Sunday, December 14, 2014

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 (HBV) 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 Pharmaceutical’s 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’ (IAPs), can be targeted to allow infected cells to die.

“Our preclinical models have shown that birinapant kills infected liver cells, while not harming uninfected cells,” he said. “Used in conjunction with an existing treatment for hepatitis B, this drug has the potential, for the first time, to functionally cure chronic hepatitis B infections.”

Dr Pellegrini said the new treatment had the potential to revolutionise the way chronic HBV infections were treated. “Patients who develop chronic infections can be treated with drugs that prevent the virus from replicating, reducing the amount of virus in the liver, but do not completely eliminate the virus,” he said. “These patients are dependent on anti-viral drugs that need to be taken for a very long period of time to reduce the risk of virus-induced liver damage and the complications that come with it.

“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.”

“We are really excited that this treatment has entered phase 1/2a clinical trials as it is a culmination of many years work in developing new strategies to tackle chronic infections.”

Based on his crucial research, Dr Pellegrini is the key scientific and clinical advisor for the clinical study that is now underway. The study is sponsored by TetraLogic Pharmaceuticals Corporation in collaboration with Nucleus Network in Melbourne and hospitals across Australia and New Zealand.
The phase 1/2a clinical trial will involve approximately 50 patients and is currently recruiting eligible participants. For more information about the trial and eligibility, contact Nucleus Network on 1800 243 733 or contactus@centreforclinicalstudies.com.au.

Download the media release (PDF).

Further information:


Alan Gill
Science Communications Officer
P: +61 3 9345 2719
M: +61 419 591 102
E: gill.a@wehi.edu.au

Press Release Source: http://www.wehi.edu.au/site/latest_news/potential_cure_for_hepatitis_b_enters_phase_1_2a_clinical_trial


Thursday, December 11, 2014

Some patients with hepatitis B should be screened for HCC

NEW YORK (Reuters Health) - Screening some patients who have been cured of chronic hepatitis B (HBV) for hepatocellular carcinoma (HCC) is worthwhile, new research from Korea suggests.

Doctors should consider screening cirrhotic patients and noncirrhotic males over age 50, even after hepatitis B surface antigen (HBsAg) seroclearance, if they have HBV genotype C, the authors reported online November 28 in the Journal of Hepatology.


"Though serum HBsAg loss is generally considered as a cure of HBV, the risk of future HCC development is still high. The incidence of HCC in cirrhotic patients is also high," wrote co-author Dr. Han Chu Lee of the University of Ulsan in Seoul, in email to Reuters Health.

Read more....

Friday, December 5, 2014

Nucleoside analogues reduced HCC incidence among patients with HBV

Patients with hepatitis B virus infection treated with long-term nucleoside analogue therapy had a decreased risk for developing hepatitis B virus infection-related hepatocellular carcinoma, according to study data.

“The incidence of HCC varies significantly by geographical origin and ethnic group due to differences in the age at infection, genetic background, HBV genotype and exposers to HCC risk factors,” the researchers wrote. “We hypothesized that the observed risk of HCC would be lower than that expected in the absence of treatment, supporting a chemopreventative effect of [nucleoside analogues] on HCC development.”


In a retrospective study, researchers analyzed data from 322 patients (median age, 46 years) with chronic HBV who underwent treatment with nucleoside analogues between 1999 and 2012 at the Calgary Liver Unit in Canada. The data, collected using the REACH-B model before the initiation of treatment, were used to predict annual risk for HCC. Patients were treated with either lamivudine, telbivudine (Tyzeka, Novartis), adefovir, entecavir or tenofovir (Viread, Gilead Sciences). Median follow-up was 3.2 years.


Study Confirms HBV Patients Have Higher Kidney Disease Rates

— Christine M. Kukka, Project Manager, HBV Advocate

It has been suggested that HBV infection may increase the risk of kidney disease. Taiwanese researchers conducted a nationwide study comparing end stage renal (kidney) disease rates in HBV patients and an uninfected control group and found hepatitis B did increase the risk of kidney disease.

Researchers examined insurance claims data from the Taiwan National Health Insurance Research Database over a 12-year period and identified 17,758 HBV-infected adults who had never taken antivirals and compared them to a healthy control group of 71,032. (Antivirals may affect kidney function, so this study looked only at the impact of HBV infection alone.)

The risk of end stage kidney disease was significantly higher in the HBV group (with a cumulative rate of 1.9%) than in the uninfected group (with a 0.49% occurrence). The risk of kidney disease among adults with HBV was highest in men and women under the age of 60.

"Thus, a large national cohort study indicates that untreated chronic HBV infection is associated with increased risk of [end stage kidney disease]," they wrote. "Hence, high-risk HBV-infected patients should have targeted monitoring for the development of [kidney disease]," they wrote in the November issue of the journal Kidney International.