HCV NEWS

The Weekly Round-up

Every week or so we update this section with news as it relates to HCV.

Trial for TT-034 in Hepatitis C. TT-034 is being developed as a potential "one-shot-cure" for Hepatitis C (HCV).

SYDNEY and DURHAM, NC —
"We are very excited to be working with Duke, a world renowned research institution with significant experience in this area," said Peter French, Ph.D., Chief Executive Officer of Benitec... MORE>>

Gilead And Its Competitors In The Hepatitis C Race

The race-

One analyst called the race to develop an all-oral drug for hepatitis C a biotech version of the Daytona 500. The medical advances in hep C have been dizzying this year... MORE>>

With Hep C, Alcohol is a No Go

Hepatitis C infections can increase risks of dying from liver disease linked to alcohol consumption

(dailyRx News) For healthy people, a drink or two can be okay. But for people with hepatitis C liver infections, a drink or two a day might be very dangerous... MORE>>

Interferon-Free Hep C Regimen Cures 95% of First-Time Treaters

A pair of studies of the second-generation hepatitis C virus (HCV) direct-acting antiviral ABT-450, combined with ribavirin and ABT-072 or ABT-333, yielded cure rates as high as 95 percent in treatment-naive study participants, but only 47 percent in a group who had failed a previous therapy... MORE>>

HCV Treatment in Special Populations

Single Topic Conference was an examination of treatment types for special populations. The six sessions held covered:

• the current state-of-the-art genotype,
• FDA designated special populations,
• treatment in the face of comorbidities,
• treatment of HCV associated extrahepatic disease,
• "other" special groups,
• the elimination of underserved populations, and
• point/counterpoint regarding controversial groups.

Watch the videos!>>

PIPELINE: Fastest viral decline ever seen with anti-HCV drugs... more>>

Interferon-Free Therapy For Hepatitis C May Become A Reality... more>>

Hepatitis C progress in pipeline

New drugs to treat virus expected be available in 2014-15
By Bonnie Miller Rubin, Chicago Tribune reporter
A diagnosis of hepatitis C — a stubborn virus that is a common cause of chronic liver disease — can be devastating. In 2007, it passed HIV/AIDS in annual deaths, with more than 17,000 annually, according to the Centers for Disease Control and Prevention... MORE>>

February 19, 2013 | By John Carroll
Gilead races to FDA with interferon free hep C blockbuster

This morning Gilead ($GILD) announced that it has successfully wrapped up positive top-line data from its fourth and last Phase III study for sofosbuvir, putting the biotech on a short path to the FDA with what promises to be the first oral drug for hepatitis C... MORE>>

New Evidence Suggests Hepatitis C Transmits Sexually Among HIV-Positive Gay Men

February 20, 2013
Echoing past findings coming largely from Europe, a report from the Fenway Institute in Boston finds a high, 1.6 percent annual incidence of hepatitis C virus (HCV) infection among its large population of HIV-positive gay men; researchers there speculate sexual transmission and non-injection drug use were the most likely causes... MORE>>

US: Hepatitis C in HIV positive gay men at an all-time high

by Scott Roberts 20 February 2013,
The transmission of hepatitis C in the US is at an all-time high for HIV positive gay men, according to a study published in Clinical Infectious Diseases.... MORE>>

Health workers most at risk from Hepatitis C

Staff Reporter / 18 February 2013
Healthcare workers are among thoses most at risk of contracting Hepatitis C, the Abu Dhabi Municipality said at a lecture for employees aimed at spreading awareness about the often incurable virus.... MORE>>

Vertex Swings to Loss on Weak Hep C Drug Sales

From Associated Press
CAMBRIDGE, Mass. -- Specialty drug maker Vertex Pharmaceuticals Inc. swung to a loss in the fourth quarter as doctors turned away from the company’s best-selling drug for treating hepatitis C.
Vertex said revenue for quarter ended Dec. 31 fell 41 percent to $334 million. Most of the decline was due to lower sales of the company’s hepatitis C pill, Incivek... MORE>>

Gilead moves closer to first hepatitis C pill

By Joseph Walker
Gilead Sciences Inc. GILD +0.31% said its experimental liver disease pill was successful in two late-stage trials that will support a regulatory filing to market the first non-injectable treatment for hepatitis C.
The positive results had been expected by investors and analysts after a previous study had been successful... MORE>>

As Hepatitis C Sneaks Up On Baby Boomers, Treatment Options Grow

A smoldering epidemic already affects an estimated 4 million Americans, most of whom don't know it. It's hepatitis C, an insidious virus that can hide in the body for two or three decades without causing symptoms — and then wreak havoc with the liver, scarring it so extensively that it can fail. Half of all people waiting for liver transplants have hepatitis C.... LISTEN TO THE STORY>>

Hepatitis C linked to ink

NEW YORK (Reuters Health) - Researchers are hoping that people will do some research about where to get a tattoo, after a study found a link between body art and hepatitis C. The new study found that people with the virus were almost four times more likely to report having a tattoo, even when other major risk factors were taken into account, co-author Dr. Fritz Francois of New York University Langone Medical Center told Reuters Health. Although the study could not prove a direct cause and effect, "Tattooing in and of itself may pose a risk for this disease that can lay dormant for many, many years," Francois said. About 3.2 million people in the U.S. have hepatitis C, and many don't know because they don't feel ill, according to the Centers for Disease Control and Prevention (CDC)... more>>

As Hepatitis C Sneaks Up On Baby Boomers, Treatment Options Grow

A smoldering epidemic already affects an estimated 4 million Americans, most of whom don't know it. It's hepatitis C, an insidious virus that can hide in the body for two or three decades without causing symptoms — and then wreak havoc with the liver, scarring it so extensively that it can fail. Half of all people waiting for liver transplants have hepatitis C.... LISTEN TO THE STORY>>

Boehringer Ingelheim Launches Hepatitis C Web Portal for Patients, Health Care Providers

Boehringer Ingelheim recently launched a website, HepCRedefined.com, to help improve the lives of people with hepatitis C virus (HCV) infection. Created in collaboration with HCV community advocates and health care providers, the portal offers a range of interactive resources that can be shared via social media channels, embedded on other websites or viewed on various smart devices.... more>>

Hep C shame

Hepatitis C kills 350,000 people a year worldwide and only 1 per cent of 6000 Tasmanian sufferers are currently receiving treatment. It doesn't help that many people live with the disease for years before symptoms arise.... more>>

Boehringer Ingelheim enrols first patients in pivotal Phase III interferon-free hepatitis C trial programme

INGELHEIM, Germany, 17 January 2013 – Today, Boehringer Ingelheim announced that the first patients have been enrolled in the company’s pivotal Phase III interferon (IFN)-free hepatitis C (HCV) clinical trial programme, HCVerso™. Boehringer Ingelheim’s IFN-free investigational polymodal* regimen combines faldaprevir (BI 201335)+, a next wave once-daily protease inhibitor, and BI 207127+, a non-nucleoside polymerase inhibitor, plus ribavirin. more>>

How American Health Care Killed My Father by David Goldhill

(The Atlantic) After the needless death of his father, the author, a business executive, began a personal exploration of a health-care industry that for years has delivered poor service and irregular quality at astonishingly high cost. It is a system, he argues, that is not worth preserving in anything like its current form. And the health-care reform now being contemplated will not fix it. Here’s a radical solution to an agonizing problem... more>>

Interferon-free regimens for the treatment of HCV infection just around the corner?

(NEJM) Nucleotide Polymerase Inhibitor Sofosbuvir plus Ribavirin for Hepatitis C...all 10 (100%) who received sofosbuvir plus ribavirin without interferon and all 30 (100%) who received sofosbuvir plus ribavirin for 12 weeks and interferon for 4, 8, or 12 weeks had a sustained virologic response at 24 weeks. ... more>>

Competition affects who gets a liver transplant: study

(Reuters) - More competition between medical centers that perform liver transplants may mean sicker patients get lower-quality donor organs, according to a U.S. study... more>>

Transplanted Genetically-Modified Adipose Cells Offer Potential Therapy For Liver Diseasest

It adds to the developments in cell transplantation that have the potential to offer an alternative to liver transplantation for patients with liver disease. It also increases the validation of the therapeutic potential for cell transplantation with cells other than hepatic cells,... more>>

HIV and hepatitis C co-infection increases the risk of cognitive impairment

Investigators from the United States Department of Veterans Affairs compared cognitive function between co-infected men, hepatitis C mono-infected men, HIV mono-infected men and a control group. Co-infection was associated with mild cognitive impairment and significantly poorer scores ... more>>

Adherence to hepatitis C treatment: unravelling the complexities

Lauren Rover of George Mason University, Virginia, and Inova Health Systems, a large non-profit healthcare provider in northern Virginia, told a conference session that, for short-term treatment regimens, adherence rates of 70 to 80% are often achieved. For longer-term treatments, adherence rates drop to 40 to 50%, while adherence rates for therapies that also include an element of behaviour change are stuck at around 20 to 30%. more>>

Chronic hepatitis C: new cause for optimism

By: JENNIE SMITH, Family Practice News Digital Network
Chronic hepatitis C virus infection is currently responsible for more U.S. deaths than HIV; is complicated to treat; is not vaccine preventable; and is a major driver of liver transplants, cirrhosis, chronic and end-stage liver disease, and liver cancer. more>>

Aethlon Medical Announces Expansion of Compassionate-Use Program To Treat Hepatitis C Virus (HCV)

SAN DIEGO, Dec. 12, 2012 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that a compassionate-use clinical program that provides HCV-infected individuals with access to the Hemopurifier® therapy, has been expanded to include individuals who experience a viral breakthrough during standard-of-care drug therapy. more>>

Most People with Hepatitis C Go Untreated, Despite Effective Drugs

12/10/2012 Just 20 percent of people infected with the hepatitis C virus (HCV) begin the recommended treatment regimen and less than 5 percent go on to successfully overcome the virus, according to a new review in General Hospital Psychiatry. This is despite the availability of highly effective anti-viral drugs that clear hepatitis C virus in about 80 percent of patients participating in clinical trials. Major barriers to recommended care are substance abuse and depression in HCV patients. more>>

Triple therapy has poor safety in cirrhotic hepatitis C

BOSTON – In patients with chronic hepatitis C virus infections and compensated cirrhosis, a combination of a direct-acting antiviral agent, pegylated interferon, and ribavirin produced high on-treatment virologic response rates, but at the cost of significantly increased toxicities in an interim analysis of a French multicenter trial looking at the safety of the regimen. more>>

Summary from EASL 2012 for Hepatitis C - Will there be an interferon-free HCV therapy for all: upcoming reality or just a vision?

"Interferon free therapy has been shown to work in a whole range of different combinations and treatment schedules clearly making interferon free regimens a very realistic scenario for the upcoming years. Nevertheless the "therapy for all" option has not yet been presented and clearly more challenging patient populations such as cirrhotics and previous interferon null-responders will need at least longer durations of treatment or even more potent combinations."more>>

Inhibition of enzyme NOX4 prevents liver fibrosis

Researchers at the Bellvitge Biomedical Research Institute (IDIBELL) have led a study published in PLoS One showing that the inhibition of a family member of NADPH oxidase enzyme, NOX4, plays an important role in liver fibrosis.more>>

HIV and Viral Hepatitis Summit Fosters National Dialogue Across Sectors

December 6, 2012 • 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

Last week in Washington, DC, researchers, clinical and public health providers, advocates, federal leaders and representatives of health departments, professional societies, academia, and the pharmaceutical sector gathered for important discussions at the 2012 National Summit on HIV and Viral Hepatitis Diagnosis, Prevention and Access to Care...more>>

Aging hepatitis C population escalates demand for liver transplantation

New research reveals that the greatest demand for liver transplantation due to hepatitis C (HCV)-related liver disease occurs among Americans born between 1941 and 1960. Findings in the December issue of Liver Transplantation, a journal published by Wiley on behalf of the American Association for the Study of Liver Diseases (AASLD), suggest that... more>>

Aspirin Tied To Lower Risk For Liver Cancer And Death From Liver Disease

A new study from the US finds that use of aspirin is tied to a reduced risk for hepatocellular carcinoma, the most common type of primary liver cancer, and also to a reduced risk of death from chronic liver disease. more>>

9 & Soon 11 New HCV Drugs in Phase 3

Shortly before AASLD Abbott announced the start of their phase 3 studies which will examine the coformulation of ABT450/r (protease) + ABT267 (NS5A) + their non-nuc + rbv. In addition Gilead is starting a phase 3 study looking at their coformulation of GS7977+ GS5885 (NS5A) + rbv.,, more>>

New Hampshire man accused of spreading hepatitis C denies charges

Jason McLure Reuters 10:33 a.m. CST, December 4, 2012 LITTLETON, New Hampshire (Reuters) - A traveling hospital technician accused of spreading hepatitis C to more than 30 former patients nationwide has pleaded not guilty to federal charges of tampering with a consumer product and obtaining controlled substances by fraud. more>>

Less Support for Hepatitis C Testing for Baby Boomers

An influential advisory committee has given only lukewarm support to a government recommendation that all baby boomers be tested for hepatitis C. In a draft opinion Monday, the United States Preventive Services Task Force said that clinicians may “consider offering” hepatitis C screening to adults born between 1945 and 1965. That falls short of the recommendation made in August by the Centers for Disease Control and Prevention that all ...
more>>

Loyola expands hepatology services to Rockford

ROCKFORD — Loyola University Health System expanded hepatology services to the new Loyola Hepatology Clinic in Rockford. Scott Cotler, MD, a professor of medicine and division director of hepatology, now sees patients at OSF St. Anthony Medical Center, 5666 E. State St., Rockford...
more>>

Abbott Announces Phase 3 Hepatitis C Program Details

ABBOTT PARK, Ill., Nov. 13, 2012 /PRNewswire/ -- Abbott (ABT) today released details on its phase 3 hepatitis C registrational program following promising results from its phase 2b clinical trial, known as Aviator, presented at the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston. The phase 3 clinical trials are designed to evaluate safety and efficacy of a 12-week regimen of three direct acting antivirals (DAA), with and without ribavirin, for the treatment of HCV in genotype 1 (GT1) non-cirrhotic, treatment-naïve and treatment-experienced patients.
more>>

Boomers are getting old. They just won't admit it.

"Most people with hepatitis C don't know they've got it," Hagen said. "The big issue for boomers was they may have been infected in an era when we weren't able to test for hepatitis C... a generation that adopted the Who's mantra "hope I die before I get old" simply doesn't think it has gotten old yet. As Kane put it, "there's going to be a wakeup call for a whole lot of people." more>>

Gilead’s Single Pill Hepatitis C Study Targets 2014 Approval

Gilead Sciences Inc. (GILD) said it plans to start a combination study of two drugs in a single pill to treat hepatitis C by the end of the year, putting it on track to request U.S. regulatory approval for the medicine in 2014. Gilead, which spent $10.8 billion to acquire one of the medicines, GS-7977, plans to combine it with another, GS-5855, in a trial of 800 patients starting in the fourth-quarter, said Norbert Bischofberger, chief medical officer of the Foster City, California-based company, in a conference call yesterday. If the combination is effective, the company could apply for regulatory approval in the middle of 2014, Bischofberger said. more>>

Boy, Oh Boy, By George!

Boy George hosted a star-studded private ‘C Party’ dinner at his opulent house in London, with the help of top chef and hepatitis C ambassador, Gizzi Erskine. more>>

Antiviral therapy may halve the risk of liver cancer after chronic hepatitis C infections

Treating chronic hepatitis C infection with antiviral drugs could halve the risk of developing the most common form of liver cancer in some cases, indicates an analysis of the published research in one of the new BMJ Open editions. The authors reviewed the published evidence on the use of antiviral therapy — interferon or pegylated interferon, or ribavirin, or a combination — in people with chronic Hep C infection, to assess its impact, and to see if the level of viral clearance, prompted by the treatment, made any difference. more>>

Timing and Magnitude of Ribavirin Dose Reduction do not impact SVR with Boceprevir + Peginterferon / Ribavirin

From the 2012 AASLD - 63rd Annual Meeting of the American Association for the Study of Liver Diseases Boston, MA Nov 9-12 2012. more>>

Veterans twice as likely to be infected with chronic hepatitis C

Among those disproportionately affected by chronic hep C is the veteran community, a population twice as likely to be infected with chronic hep C as the general population. Veterans may be at increased risk because they may have additional risk factors, such as having had blood exposure during combat, or immunization by air gun injection.....more>>

Smallpox vaccine kills liver cancer

A global team of scientists led by Bay Area doctors is studying an unusual new technique - involving, in part, injecting a genetically engineered smallpox vaccine directly into tumors - that they hope will prolong the lives of patients with untreatable liver cancer. more>>

Patients with HCV, diabetes at greater risk for liver-related death

CDC to Boomers: "Get a Hepatitis C Test"

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