TheraSphere® Recommended by the National Institute for Health and Care Excellence (NICE) for the Treatment of Primary and Secondary Liver Cancer

LONDON, July 30, 2013 /PRNewswire/ --

BTG plc (LSE: BTG), the specialist healthcare company, today announces that the National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of Selective Internal Radiation Therapy (SIRT)⁽¹⁾, which includes TheraSphere^®, for patients with liver cancer across the NHS. The guidance supports the use of this innovative treatment for patients with primary hepatocellular carcinoma as well as for those with intrahepatic cholangiocarcinoma⁽²⁾ and follows the previous recommendation for its use in patients with colorectal cancer liver metastases⁽³⁾.

The NHS in England is currently preparing guidelines on how SIRT should be used as a treatment option for patients with liver cancer, including those with colorectal cancer liver metastases and cholangiocarcinoma, after recently issuing an interim policy on how this therapy should be funded⁽⁴⁾. It is anticipated that this latest NICE guidance will result in a similar evaluation for patients with primary liver cancer. "NICE's guidance further highlights the growing acceptance and understanding of radioembolization in the treatment of liver cancer," said Peter Pattison, General Manager TheraSphere^®. "With over 4,000 new liver cancer cases diagnosed annually in the UK⁽⁵⁾, this new guidance will potentially provide patients with access to a broader range of treatment options."

Pattison added: "With many countries looking to the UK for direction on their own reimbursement decisions and processes, this guidance should lead to greater awareness amongst physicians and patients and may also prompt similar guidance in other geographies. In addition to increasing liver cancer treatment options for physicians and patients in the UK, this guidance will assist BTG as we continue to explore other reimbursement opportunities in various regions across the world."

About TheraSphere®

TheraSphere is a form of radioembolization therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the artery of the patient's liver through a catheter, which allows for a high dose of radiation to be delivered directly to the tumour via blood flow thereby limiting the damage to surrounding healthy tissue and side effects to the patients.

TheraSphere is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters. Since its introduction in Europe, more than 1,000 patients have been treated with TheraSphere.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert/instructions for use at http://www.nordion.com/therasphere.

1. National Institute of Care Excellence. IPG460 Selective internal radiation therapy for primary hepatocellular carcinoma: guidance. London. 24 July 2013.
2. National Institute of Care Excellence. IPG459. Selective internal radiation therapy for primary cholangiocarcinoma. London.  24 July 2013.
3. National Institute of Care Excellence. IPG401. Selective internal radiation therapy for non-resectable colorectal metastases of the liver: guidance. London. July 2012 (updates May 2013).
4. NHS England. Interim Clinical Commissioning Policy Statement: Selective Internal Radiotherapy (SIRT). June 2013.
5. http://www.cancerresearchuk.org/cancer-info/cancerstats/types/liver/

About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and varicose veins. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at http://www.btgplc.com.

For further information please contact:

BTG
Andy Burrows, Director of Investor Relations
+44(0)20-7575-1741; Mobile: +44(0)7990-530605

FTI Consulting
Ben Atwell/Simon Conway
+44(0)20-7831-3113

SOURCE BTG plc

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Getting hepatitis on the policy agenda in Asia

For Vietnam, where 15-17% of the population have hepatitis B or C, the global health burden has been heavy. Photograph: Hemis/Alamy

For health ministries trying to tackle hepatitis, the advice is: know your epidemic, get government on board to find a solution, educate the population and have the right policy in place

Guardian Professional, Sunday 28 July 2013 03.00 EDT

Viral hepatitis causes 1 million deaths a year in the Asia Pacific region, the equivalent of one death every 30 seconds and more than three times as many as HIV. Of the 350 million people in the world living with hepatitis B, 74% of them live in Asia, but getting the disease on the health policy agenda of some of the worst affected countries has not been easy.

"We have a vaccine for hepatitis B and new treatments for chronic hepatitis C that could save millions of lives, but none of these matter if governments fail to tackle viral hepatitis," says professor Stephen Locarnini, director of the WHO Regional Reference Laboratory for Hepatitis B at the Victorian Infectious Diseases Reference Laboratory in Melbourne and joint secretary of the Coalition to Eradicate Viral Hepatitis in Asia Pacific (Cevhap).

"What we need is for governments across the region to approach viral hepatitis in the same way that most have HIV/Aids, TB and malaria. This starts with the development of a national action plan and our expert members are ready and willing to help governments in the development of these, following the framework for global action blueprint provided by WHO."

Dr Robert Gish, Cvevhap's co-founder has been doing just that with the government in Vietnam, where an estimated 15-17% of the country's 100 million people have hepatitis B or C. "It's clear that the country needs a policy for liver health," he said.

Gish, together with colleagues in Vietnam and from UN and other international agencies has been working to get hepatitis and liver health on the Vietnamese government's health agenda.

A white paper published in 2011 in the Journal of Gastroenterology and Hepatology spelt out the rationale for a dedicated policy for liver health in Vietnam: 12% estimated prevalence of chronic hepatitis B, at least 2% prevalence of chronic hepatitis C and heavy alcohol use by men, adding up to liver cancer as the most common cause of cancer death in the country. Despite the sizeable liver cancer wards in all of Vietnam's major hospitals, a general lack of understanding of liver disease both among the public and health professionals and no systematic screening for those at risk has left the epidemic unchecked.

The white paper advocated liver disease education for the public and healthcare workers and an expansion of countrywide screening, hepatitis B vaccination and treatment of chronic hepatitis. These measures coupled with long-term surveillance for liver cancer, enhanced infection control to prevent transmission in health care settings and ongoing prevalence data analysis can help bring the epidemic of liver disease under control.

The message fell on fertile ground: in December 2012 the ministry of health set up a technical action group and by the end of this year is likely to have a draft policy in place.

Vietnam currently vaccinates approximately 60% of babies within 24 hours of birth and, says Gish, has the rural healthcare system in place to reach the WHO's revised target of 90% coverage (up from 80%).

Vaccination for adults is far less widespread but Gish and his colleagues are currently running pilot projects to test and vaccinate 20,000 adults, recruited from medical, dental pharmacology and nursing schools. "They are easy to reach and can carry the message forward to their patients, but they can only do so effectively if they themselves have been tested and vaccinated," says Gish.

But progress is stunted in parts of Asia, such as the Philippines, where hepatitis is accompanied by discrimination. Prevalence estimates range from 8% to 20% across different segments of the 96 million population and the stigma attached to hepatitis B is severe. Pre-employment tests for the disease screen out those who test positive. Overseas workers from the Philippines face similar discrimination notably in Middle Eastern countries. People with hepatitis are blatantly discriminated against," says Gish. "Workplace discrimination is a huge problem that deters people from getting voluntarily tested."

Gish has also been working with the Hepatology Society of the Philippines, which is leading the effort in the country, and also with hepatitis activist group Yellow Warriors Society Philippines to get hepatitis on the health policy agenda but, he says the contrast with Vietnam at government level has been "like night and day. The department of health has sat on a draft hepatitis policy for three years, so we're trying to revitalise a lot of activity. In Vietnam we were starting from scratch, but now the Vietnamese ministry of health is moving forward quite aggressively on its own."

Having become interested in hepatitis in Asia when treating Asian patients in his practice in San Francisco, Gish decided he could make a bigger impact on the disease by supporting colleagues to get it more widely recognised in Asia. His interest has spread to central Asia, another hepatitis hotspot, with a regional project underway in Armenia.

"Every country I've worked with has different customs and problems, but what they have in common is a need to know their hepatitis epidemic, get government on board to find a solution, educate the population and have the right policy in place."

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CHMP OKs Eltrombopag for HCV Patients With Thrombocytopenia

International Approvals > Medscape Medical News

Troy Brown

Jul 30, 2013

The indications for eltrombopag (Revolade, GlaxoSmithKline Trading Services) should be extended to include adults with chronic hepatitis C virus (HCV) infection who have thrombocytopenia severe enough to prevent the initiation of interferon-based therapy or limit the maintenance of optimal therapy, according to a July 25 recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

"Treatment with pegylated interferon and ribavirin is the current standard of care for patients with HCV, however both the European Association for the Study of the Liver guidelines and the American Association for the Study of Liver Diseases report the presence of thrombocytopenia among the relative contraindications to antiviral therapy," according to a GlaxoSmithKline statement.

"A sustained virologic response is the goal for treatment of hepatitis C infection and our clinical study, the largest ever in cirrhotic patients with low platelet counts and chronic hepatitis C infection, demonstrated that eltrombopag in combination with interferon-based therapy, allowed more cirrhotic patients with low platelet counts to reach this goal," Rafael Amado, MD, head of oncology research and development at GlaxoSmithKline said in the statement.

The committee's opinion was based on data from 2 randomized, double-blind, placebo controlled, multicenter phase 3 studies with a total of 1521 patients with platelet counts below 75000 µl, the ENABLE 1 and 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE) trials. Patients in ENABLE 1 received peginterferon alfa-2a (Pegasys, Genentech) plus ribavirin for antiviral treatment and patients in ENABLE 2 received peginterferon alfa-2b (Pegintron, Merck) plus ribavirin.

Eltrombopag was previously approved in the European Union to treat thrombocytopenia in adult splenectomized patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who haven't responded to other treatments including corticosteroids and immunoglobulins. It can be considered as a second-line treatment for adult nonsplenectomized patients in whom surgery is contraindicated.

Eltromopag is marketed in the US under the trade name Promacta (GlaxoSmithKline) and is approved for both indications there.

Limitations to the use of eltrombopag include:

• Eltrombopag should not be used to normalize platelet counts;
• Eltrombopag should only be used in patients with chronic HCV whose thrombocytopenia is severe enough to prevent initiation of interferon therapy or maintenance of optimal interferon therapy; and
• The safety and efficacy of eltrombopag have not been established in combination with direct-acting antiviral agents that are approved to treat chronic hepatitis C genotype 1 infection.

Eltrombopag can cause hepatotoxicity, and hepatic enzymes should be measured before beginning therapy. When used in combination with interferon-based antiviral therapy, eltrombopag can increase the risk for hepatic decompensation, so patients should be monitored closely.

Venous and arterial thrombotic and thromboembolic events have occurred in patients receiving eltrombopag, with portal vein thrombosis reported most frequently. Patients with poor baseline liver function are at increased risk and should be monitored closely.

At least 10% of patients in both trials experienced headache, anemia, decreased appetite, insomnia, cough, nausea, diarrhea, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, muscle weakness, chills, and peripheral edema.

The European public assessment report (EPAR) will be revised to include the updated summary of product characteristics (SmPC) after the European Commission grants marketing authorization for this indication.

The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within 3 months of the CHMP recommendation.

European Medicines Agency statement, July 25, 2013. Overview

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HBV vaccine birth dose practices in Laos need more improvement

Provided by Healio

CDC. MMWR. 2013;62:587-590.

July 31, 2013

The median hepatitis B vaccine birth dose coverage at facility-based births was 74% in Laos, where hepatitis B virus is highly endemic, according to data published in Morbidity and Mortality Weekly Report.

From December 2011 to February 2012, the Laos Ministry of Health and WHO staff members evaluated coverage at 37 health facilities. At 18 of the facilities (49%), the HBV vaccine was not in stock. Among the 17 facilities that assisted with home births, seven included the vaccination in the services. Twenty-three facilities conducted postnatal visits, and only 15 of these provided the vaccine in the visit.

“Administration of the hepatitis B vaccine birth dose followed by timely completion of the hepatitis B vaccine series is 70% to 95% effective in preventing mother-to-child HBV transmission,” the researchers wrote. “During 2006 to 2011, the reported coverage in Laos increased from 3% to 34%. Despite this increase, the country continues to have the lowest coverage in the region, largely because only 37% of women in Laos give birth with the assistance of a skilled birth attendant.”

The study was conducted in five of the 24 provinces of Laos and included provincial or central hospitals, as well as two district hospitals and four health centers. Staff members at each facility participated in an in-person interview, answering questions about the HBV vaccine birth dose procedures.

Among the 31 facilities that provided birthing services onsite, all reported proving the vaccine to newborns. There were 5,072 onsite births recorded during the 3-month study period, of which 70% received the vaccine. Four additional facilities that did not provide onsite birthing services also reported providing newborns with the vaccine.

“Laos has shown a strong commitment toward the Western Pacific Region goal of reducing chronic HBV infection prevalence in children aged 5 years and younger to less than 1%,” the researchers wrote. “Such a reduction in HBV prevalence will require prevention of both perinatal and early childhood infections.”

Disclosure: The researchers report no relevant financial disclosures.

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Labeling for HBV medication updated following new safety, efficacy data

Provided by Healio

July 31, 2013

The FDA has approved changes to the labeling for Viread, a treatment for chronic hepatitis B, following the results of a 96-week study.

Updated labeling for tenofovir disoproxil fumarate (Viread, Gilead Sciences) reflects that the indication was the product of trials of treatment-experienced, lamivudine-resistant adult patients with chronic HBV and chronic liver disease who were naive to nucleoside-based therapy. Adverse events observed among these patients during treatment were similar to those observed in other HBV-related clinical trials.

In a randomized, double blind, active-controlled study, 141 patients with chronic HBV, HBV DNA of 1,000 IU/mL (mean 6.4 log₁₀ copies/mL) or more and resistance to lamivudine received Viread for 96 weeks. Forty-six percent of the cohort were HBeAg-positive, and 56% had abnormal serum ALT levels at baseline (mean 71 U/L).

Upon completion of treatment, 89% had HBV DNA below 400 copies/mL, and 62% of those with abnormal ALT had normalized. HBeAg loss occurred in 15% of the HBeAg-positive patients, and 11% experienced anti-HBe seroconversion through the final treatment week.

The labeling also indicates a potentially significant drug-drug interaction between Viread and didanosine. A didanosine dose reduction is recommended upon coadministration with Viread: to 250 mg once daily among patients weighing more than 60 kg and 200 mg among those weighing less than 60 kg. The drugs should be taken under fasting conditions or with a light meal containing fewer than 400 kcal and 20% fat.

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Turmoil for AIDS Conference Organizers

FLICKR, NIAID

Conflict between former conference organizers has shuttered a website that has come to serve as a resource for the HIV/AIDS community.

By Kate Yandell | July 30, 2013

The website for the annual Conference on Retroviruses and Opportunistic Infections (CROI), a major US HIV/AIDS meeting, is currently offline following a conflict between the two groups that formerly organized the event, ScienceInsider reported.

CROI, which has taken place annually for the past 20 years, has been the site of many important announcements in the history of HIV/AIDS research. The conference website was host to years’ worth of conference abstracts and other resources for AIDS researchers and the public.

The nonprofit CROI Foundation and the for-profit CROI LLC have previously been responsible for organizing the conference each year. But the two groups appear to have had a falling out. “I’m not allowed by our confidentially agreement to divulge anything,” Constance Benson, CROI Foundation board president and a professor at the University of California, San Diego, told ScienceInsider. “We reached an impasse this past couple of years over several issues and decided we needed to go in a different direction.”

Melissa Sordyl, head of CROI LLC, told ScienceInsider, “CROI LLC is no longer the conference secretariat and that is why the site is no longer active.”

Benson told The Scientist in an email that anyone seeking information on the 2014 conference, which will take place in Boston in March, should go to a new website: www.CROI2014.org. “We have no further update on the old website at this time,” Benson said. She added that Sordyl owned and maintained the old website and that it does not belong to the CROI Foundation.

The CROI Foundation is partnering with the International Antiviral Society-USA to put on the 2014 conference, according to the new website.

Simon Collins, head of HIV i-Base, a website for HIV treatment activism and information, wrote on his site that the loss of the CROI website was a frustrating one: “CROI is established as the most important HIV scientific meeting,” he wrote, adding that  “the website is a vital resource not only as a record of previous meetings but as a free open-access research tool.”

Benson told The Scientist that the conference organizers are “working on a solution for the old content from past meetings.”

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Engineered mice act as hepatitis C model

Hepatitis C particles (yellow) infect liver cells, causing disease and cancer.

THOMAS DEERINCK, NCMIR/SPL

Nature | News

Rodents may eventually replace chimpanzees in vaccine research.

Beth Mole

31 July 2013

Researchers have created the first strain of mouse that is completely vulnerable to hepatitis C. The advance, reported today in Nature¹, promises to aid efforts to develop a vaccine against the virus, which causes liver disease and cancer.

Chimpanzees have been the primary animal model for studying hepatitis C infection over the last several decades. But in the past few years scientists have begun phasing out chimp experiments, a process accelerated by the US government’s decision to retire most of its research chimps. That has created a need for alternative models to test potential drugs and vaccines.

Enter the mouse, which is naturally immune to hepatitis C. To transform the rodent into a model organism for studying infections with the virus, researchers genetically altered the animals to hamper their natural immune response. The team also engineered the animals to produce proteins found on the outside of human liver cells.

“It has been very difficult to get to this point,” says Alexander Ploss, a virologist at Princeton University in New Jersey and lead author of the study.

In 2011, Ploss — then at Rockefeller University in New York — and his colleagues showed that hepatitis C could infect mice engineered to produce the two human proteins². But the virus did not replicate well in those animals, making them a poor model for human infections. So the team created another strain by breeding the human-protein-containing mice with animals that carried a broken version of a gene involved in antiviral responses. The result, they report, is mice in which hepatitis C can take root and flourish, creating new viral particles to spread the disease.

“For the first time you can study the whole spectrum of hepatitis C replication” in a mouse model, says Lishan Su, an immunologist at the University of North Carolina at Chapel Hill, who was not involved with the study.

Strong immune system

Researchers have previously tested candidate hepatitis C drugs using a mouse containing human liver cells, developed in 2010 by Karl-Dimiter Bissig, a virologist at Baylor College of Medicine in Houston, Texas, and his colleagues³. But that mouse model had no immune system. Su says that Ploss and colleagues' strain may be more useful for testing vaccines, because most of the mouse's immune system is intact.

Michael Houghton, a hepatitis C researcher at the University of Alberta in Edmonton, Canada, says that scientists should still be careful when interpreting results from tests with the latest mouse model. The mouse's immune system is still partially damaged, so the response to vaccines may be altered — which could cause falsely negative results when testing vaccines that are actually effective.

“This model still cannot replace chimpanzees,” says Ploss, who is working with his colleagues to improve the mouse strain. “It gives us a first glimpse of what may be possible with mice in coming years.”

Nature doi:10.1038/nature.2013.13477

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‘HCC-4 risk score’ IDs hepatitis C patients likely to develop HCC

^{Courtesy US. Dept of Veterans Affairs}

A new risk score may help identify the patients with chronic hepatitis C who are most at risk for developing hepatocellular carcinoma.

By: MARY ANN MOON, Family Practice News Digital Network

07/31/13

Vitals

Major finding: The annual incidence of HCC was 0.06% in the group designated as low risk, 0.5% in the group designated as medium risk, and 2.6% in the group designated as high risk, indicating that the HCC-4 risk score was highly predictive of actual outcomes.

Data source: A retrospective study of data collected in a 17-year longitudinal cohort study involving 829 adults with chronic hepatitis C, of whom 58 developed HCC.

Disclosures: There was no external funding source for this study, and no financial conflicts of interest were reported.

A risk score derived from four simple test results readily obtained during routine care may help identify the patients with chronic hepatitis C who are most at risk for developing hepatocellular carcinoma, according to a retrospective study published online July 12 in the European Journal of Internal Medicine.

The score could enable physicians to target only the highest-risk patients for annual surveillance for malignant hepatic nodules, which is crucial because current screening methods are too invasive, too expensive, and too low-yield to be applied broadly across all risk groups.

The new risk score also may help identify patients with chronic hepatitis C who are at lowest risk for developing HCC, who can then be reassured that they can safely forgo invasive and expensive surveillance, reported Dr. Juan Carlos Gavilan and his associates at University Hospital Virgin de la Victoria, Malaga (Spain).

The investigators reviewed data from a 17-year longitudinal cohort study involving 829 patients with chronic hepatitis C. These subjects were assessed every 6 months for the development of HCC using serum alpha-fetoprotein (AFP) levels and ultrasound imaging to detect new focal hepatic lesions.

A total of 58 subjects (7%) developed HCC during follow-up.

An initial univariate analysis identified numerous clinical and epidemiologic factors associated with elevated risk for HCC. The researchers constructed a formula for predicting risk using the four independent factors that were most predictive of HCC in this cohort: patient age, platelet count, gamma-globulin level, and AFP level at baseline.

By dividing the study population into tertiles, Dr. Gavilan and his colleagues established cutoff ranges for low, medium, and high risk. They then classified each study participant as belonging to one of these three categories, to see how well this risk score correlated with the actual rates of HCC.

The annual incidence of HCC was 0.06% in the group designated as low risk, 0.5% in the group designated as medium risk, and 2.6% in the group designated as high risk, indicating that this "HCC-4 risk score" was indeed highly predictive, Dr. Gavilan and his associates said (Eur. J. Intern. Med. 2013 July 12 [doi: 10.1016/j.ejim.2013.06.010]).

In fact, the score was more accurate at predicting HCC than was the commonly used fibrosis index, they noted.

According to recently published recommendations, surveillance is only justified in populations with an HCC incidence of 1.5% or more per year. Thus, patients found to be high risk using this HCC-4 risk score would be appropriate for such surveillance, while those at medium or low risk would not be.

"These results must be confirmed in other studies," the investigators said.

There was no external funding source for this study, and no financial conflicts of interest were reported.

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