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Drugs in Development / Clinical Trials—Updated January 12, 2015

Wednesday, January 28, 2015

Quest Diagnostics and CDC Expand Public Health Collaboration to Improve Hepatitis Diagnosis and Treatment

Multi-year fee-based contract for Quest's test data and analytics expertise aims to reveal insights from national testing trends to promote guideline-based care and better outcomes for 4.4 million Americans with viral hepatitis


MADISON, N.J. and ATLANTA, Jan. 28, 2015 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced that it will collaborate with the Centers for Disease Control and Prevention (CDC) to identify trends in screening, diagnosis and treatment for four strains of viral hepatitis in the United States, based on insights revealed by analysis of Quest's national testing database. Under terms of the multi-year contract, Quest Diagnostics will provide CDC researchers with analytics expertise and access to the company's national Quest Diagnostics Health Trends™ database of de-identified clinical testing hepatitis data. The agreement is the first fee-based contract for hepatitis-related research awarded by CDC to a diagnostic information services provider.

The goal of the collaboration is to generate diagnostic-based insights that will improve the ability of public health authorities to develop and monitor medical guidelines designed to reduce disease prevalence and enhance outcomes through earlier diagnosis and treatment of hepatitis.

"The innovative collaboration with Quest Diagnostics will allow us to use data analytics to better monitor the implementation of CDC's testing guidelines and progress toward reducing deaths from hepatitis," said John W. Ward, MD, director of CDC's Division of Viral Hepatitis. "Increased testing is critical to ensure that those who are infected with hepatitis receive life-saving care and treatment."

"Our partnership with CDC reflects the growing value of data analytics in health care to improve decision making, both for population health and in a clinical setting," said Rick L. Pesano, MD, PhD, vice president, research and development, and medical director, infectious diseases, for Quest Diagnostics. "Transforming data into insights to measure and predict behaviors and outcomes will be increasingly important as the nation's healthcare system moves to fill gaps in guideline-based care."

Quest Diagnostics is a leader in hepatitis diagnostic information services with services that include genotyping, risk stratifying and viral load testing to aid diagnosis, treatment and monitoring. Medical and bioinformatics experts from Quest Diagnostics and CDC's Division of Viral Hepatitis will analyze de-identified test results from the Quest Diagnostics Health Trends™ national database for hepatitis A, B, C and E viral infection in American adults age 18 years and over. Analysis will include results of screening and confirmatory diagnostic tests as well as treatment-guiding genotyping and viral load tests by gender, age group, geography and type of physician. The teams will jointly develop study designs and protocols based on Quest's proprietary data-mining techniques to identify patterns in prevalence and clinical management of patients.

The new agreement supplants a non-fee-based agreement formed by CDC and Quest Diagnostics in July 2013.  Under that prior agreement, the organizations jointly analyzed de-identified hepatitis C testing data in the Quest Diagnostics Health Trends database for individuals born between 1945 and 1965. In 2012, CDC issued recommendations for one-time lab screening for hepatitis C for these "Baby Boomers," who are five times more likely than other adults to be infected with hepatitis C. Untreated, chronic hepatitis can cause liver cancer and death.

A primary objective of the expanded agreement is to identify and monitor trends in hepatitis B and C viral infection in pregnant women and to characterize these patients by demographics and type of physician. About 40% of untreated newborns infected with hepatitis B in utero will develop chronic hepatitis, and one in four of these will die from liver disease. CDC guidelines call for pregnant women to be screened with a lab test for hepatitis B, but only recommend hepatitis C screening when other risks are present. In recent years, CDC's Division of Viral Hepatitis has partnered with Quest Diagnostics and others to add pregnancy status to hepatitis B lab test orders to improve surveillance of infected mothers.

"The right screening and medical interventions can prevent the tragedy of lifelong hepatitis-related liver disease in children born to infected mothers," said Dr. Pesano. "We're proud to work with CDC to assess trends in hepatitis B screening in pregnant women in order to identify gaps in screening and treatment, because it will yield insights that will help health professionals take actions to save people's lives."

Quest Diagnostics maintains the largest private clinical database of diagnostic testing information in the United States, Quest Diagnostics Health Trends, based on more than 20 billion de-identified test results. The company's scientists, in collaboration with top health institutions, analyze and publish studies based on this data in peer reviewed publications and as a public service in order to identify trends in disease and wellness.

In a 2010 report, the Institute of Medicine underscored a lack of awareness among the public and medical providers about the health dangers of hepatitis. The IOM also called upon public and private organizations to partner to increase data collection on infection, treatment and outcomes of hepatitis B and C, and to educate at-risk populations, healthcare providers and the general public about hepatitis to promote vaccination and prevention strategies and encourage screening and testing.

About Quest Diagnostics Quest Diagnostics is the world's leading provider of diagnostic information services needed to make better healthcare decisions. The company offers the broadest access to diagnostic information services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff.  Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.  Additional information is available at QuestDiagnostics.com.  Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

Quest, Quest Diagnostics, the associated logo, and all associated Quest Diagnostics marks are the registered trademarks of Quest Diagnostics. All third party marks — ®' and ™' — are the property of their respective owners.

Quest Diagnostics Contacts:Wendy Bost, Quest Diagnostics (Media): 973-520-2800
Dan Haemmerle, Quest Diagnostics (Investors): 973-520-2900

CDC Contact: CDC Media Line: 404-639-8895

Logo - http://photos.prnewswire.com/prnh/20130717/NY48934LOGO

SOURCE Quest Diagnostics: http://newsroom.questdiagnostics.com/2015-01-28-Quest-Diagnostics-and-CDC-Expand-Public-Health-Collaboration-to-Improve-Hepatitis-Diagnosis-and-Treatment

Can Regulus Therapeutics Double Again on Next Hep-C Drug Trial Update?

BOSTON (TheStreet) -- Let's interrupt the non-stop (and frankly, repetitive) chatter about hepatitis C drug price wars and turn our attention again to Regulus Therapeutics and its experimental, injectable microRNA therapy RG-101.

New trial data from a group of hepatitis C patients treated with a higher dose of RG-101 are expected in early February, according to Regulus. The company's stock price doubled last October when the first slug of RG-101 data were announced, so it's a good time to review what we know about the drug and attempt to determine what the updated results might reveal.

RG-101 uses small (micro) snippets of RNA to disrupt the replication of the hepatitis C virus and lead to its elimination from the liver. Regulus views RG-101 as a potentially new way to treat hepatitis C with a single or even a few simple and easily tolerated injections. It's a controversial idea because the best hepatitis C therapy today are already considered to be incredibly convenient. Gilead Sciences'  Harvoni requires patients to take a single, daily pill for eight or 12 weeks. No injections are needed. Abbvie's   Viekira Pak is just as effective but with a few more pills. [RA Capital portfolio manager Peter Kolchinsky owns Regulus and wrote about the bull thesis for RG-101 earlier this month].

Read more...

UK: Risk of blood-borne viruses from sharps injuries continues, report claims

Healthcare workers continue to be at risk of exposure to blood-borne viruses through occupational sharps injuries, with reported cases increasing, Public Health England (PHE) has warned in a damning report.

This is despite awareness of the risk of sharps injuries, safe practices being much more widespread, and the fact safety-engineered devices to prevent such injuries are now widely available, it has added.

In its latest report on exposures to a blood-borne virus (BBV), PHE said cases reported had increased among healthcare workers from 373 in 2004 to 496 in 2013.

The updated Eye of the Needle report, which was first published in 2012, found that, over this 10-year period, approximately 30% of exposures involved a source patient infected with HIV; 54% involved hepatitis C (HCV) and 9% hepatitis B (HBV).

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UK: St Neots man calls for justice from contaminated blood inquiry after losing three family members

Tony Farrugia, 43, of Howitt’s Gardens, Eynesbury, is pushing for the scope of the Penrose Inquiry – a public inquiry into HIV and Hepatitis C infections acquired from NHS treatment with blood and blood products in Scotland – to bring justice to patients and their families. He said that it would still be relevant to his cause in England, as the blood was given to patients prior to the Scottish NHS being separated from England.

Mr Farrugia lost his father Barry and uncles Victor and David – who were all haemophiliacs – as a result of the treatment they were given with contaminated blood. The hereditary condition, which prevents blood from clotting, meant that they required the protein Factor VIII to be administered during medical treatment.

Unbeknown to the public, the NHS had sourced paid-for blood donations which were distributed by American suppliers and taken from communities with an increased risk of having potentially deadly infections, such as prison inmates.

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Médecins slams Gilead for licencing new hepatitis drug in India

The well-known international humanitarian organisation Médecins Sans Frontières has strongly criticised the decision by US-based Gilead Sciences to expand its existing voluntary licence agreement with eight Indian generic drug-makers for sofosbuvir and ledipasvir to include its investigational compound GS-5816, saying it will restrict access to the drugs for people across the developing world.

''Gilead's anti-diversion programme not only potentially jeopardises patient confidentiality and privacy, but could also exclude many patients that may lack the citizenship and identification papers that Gilead requires them to have in order to get access to treatment.

''Gilead's programme introduces coercion and policing upon medical providers and may result in treatment interruptions for patients, leading to treatment resistance and failure.  As far as is known to MSF, such a programme, motivated solely by commercial interests, is unprecedented,'' MSF said.

- See more at: http://www.domain-b.com/industry/pharma/20150128_hepatitis.html#sthash.REnGdQcH.dpuf

New treatments available in Alaska for Hepatitis C

ANCHORAGE –Hepatitis C is a disease that health officials say kills more Alaskans than HIV and AIDS, but according to state health officials, most of the people who have the virus don’t know it.

State Hepatitis prevention coordinator Ginger Provo says more than 16,000 Alaskans have been infected with the Hepatitis C virus since the state started keeping records in the mid 1990s. But Provo believes the real numbers are much higher. She said up to 75 percent of people who have the disease have not been diagnosed because many of them aren’t experiencing symptoms.

The one bright spot for the disease lies in its treatment. New drugs have been released recently that work better, faster and with fewer side effects than previous treatments, Provo says.

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Tuesday, January 27, 2015

Missouri to save $4.2 million by switching hepatitis C drug

JEFFERSON CITY, Mo. (AP) — State officials say Missouri’s Medicaid program will save an estimated $4.2 million in fiscal year 2016 by using a newer, cheaper drug to treat hepatitis C.

The state joined a group of 25 other states to receive rebates on Viekira from drug maker AbbVie. The state in most cases will provide that drug instead of Gilead Science’s Sovaldi in an agreement announced Monday.

The expensive treatment with Sovaldi, about $84,000 for a normal course, was cited as one driver of increased Medicaid costs for the state in 2015 by the state budget director.

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