Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog
click here, the HCV drug pipeline click here, and for more information on HCV clinical trials click here

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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated March 17, 2015

Thursday, July 2, 2015

National African American Hepatitis C Action Day (NAAHCAD) 2015



The National Black Leadership Commission on AIDS, Inc. and Coalition On Positive Health Empowerment are celebrating the 3rd Annual National African American Hepatitis C Action Day (NAAHCAD). We invite organizations to support the day by signing-on to host activities in your City on or leading up to July 25, 2015.
  • Outreach & Testing events– Testing and linkage to care
  • HCV Health Literacy – Workshops to educate the community
  • Social Marketing Campaign  – Facebook, Twitter, Instagram, other
  • Town Hall/Policy Intervention – Targeting policy-makers and legislators
Signing-on entitles your organization to receive a NAAHCAD promotional package which includes:
  • 2 – NAAHCAD  T-shirts (1st – 75 organizations)
  • 1 – CDC NAAHCAD “Hit The Streets Poster” – 18 x 24
  • 1 – NAACHAD Events Poster – 18 x 24
  • 25 – CDC Hepatitis C Flyer – 8 ½ x 11
  • 200 – NAACHAD Palm Cards – 4 x 6
In addition, your organization will be mentioned as a national partner in our social media campaign and your event will be listed on NBLCA’s web page.

As a national partner, your participation will help to ensure the success and impact of this critically important campaign—namely, increased Hepatitis C awareness, increased Hepatitis C testing, increased access to treatment for individuals infected with the Hepatitis C virus, and, ultimately, a decrease in the number of people infected with Hepatitis C.

Please contact Melissa Baker at mbaker@nblca.org or 212.614.0023 ext. 109 if you have any questions or comments. Together, we can help our communities get educated, get tested, and get the word out about HCV.

For more information on the National African American Hepatitis C Action Day (Click Here).

Wednesday, July 1, 2015

Vietnam era veteran carries battle cry of hepatitis C

ATHENS – Mike Blackburn didn’t serve in Vietnam but he was a veteran of that era. He never served in combat. But his war continues to this day. And according to his doctors, his war will end soon.

Blackburn, 62, has hepatitis C virus with stage 4 liver failure. A few weeks ago he was placed on hospice with 3-6 months life expectancy. His diagnosis of hepatitis C didn’t come until Aug. 10, 2014, just six days before his 62nd birthday, when he went to the hospital with severe stomach pain.

Last year’s birthday of course is a blur for Blackburn and his wife, Pam. But he’s a self-proclaimed old country boy from Kentucky and he’s a fighter and he hasn’t given up hope.

Read more...

Most U.S. Hepatitis C Infections May Be Missed

TUESDAY, June 30, 2015 (HealthDay News) -- New cases of hepatitis C are drastically underreported to federal officials, researchers contend in a new study.

And they suggested that may be hampering public health efforts to cope with the chronic infection that can lead to cirrhosis or liver cancer.

The new study found that only one out of 183 Massachusetts residents diagnosed between 2001 and 2011 with acute hepatitis C infection was reported to the U.S. Centers for Disease Control and Prevention.

The rest went unreported, either because their test results didn't come back quickly enough or because the results didn't meet the strict CDC definition for hepatitis C infection, said senior study author Dr. Arthur Kim, director of the Viral Hepatitis Clinic at Massachusetts General Hospital in Boston.

Tuesday, June 30, 2015

New analysis looks at costly impact of new Hepatitis C treatments in California

A new analysis and infographic released today estimate California's exposure to high-priced Hepatitis C medications could range from hundreds of millions of dollars, even if only 5 percent of Californians infected with Hepatitis C receive treatment through state programs. The analysis, which looks at the costly impact of new Hepatitis C treatments on public programs, comes at a time when state and federal agencies grapple with hefty price tags for drugs like Gilead Sciences' Harvoni and Sovaldi.

California's state agencies have already acknowledged the impact of high-priced Hepatitis C drugs by setting aside hundreds of millions in the state budget and establishing workgroups to address the high-cost drug trend. The analysis released today supports the need for these proactive actions as these highly-effective, but costly, treatments pose a significant threat to the stability of our health care system at a time when health care reform has expanded coverage to millions of Americans.

"With a host of potentially six-figure priced drugs due to hit the market this year, this report shows how just one new treatment can blow a hole in state and federal budgets," said Charles Bacchi, President and CEO of the California Association of Health Plans. "These findings illustrate that this pricing trend is not sustainable for our state, its taxpayers and our public programs."

Read more...

Canada: Ontario approves second costly drug for hepatitis C

With provincial approval of a second costly drug that can cure hepatitis C, Ottawa liver specialist Dr. Curtis Cooper is now expecting to see thousands of his patients cured of the disease that, without treatment, had the potential to destroy their lives.

The Ontario government agreed this week to pay for the drug Holkira Pak which, pharmaceutical company AbbVie says had a 97 per cent cure rate in genotype 1 hepatitis C patients during clinical trials. It is the second hepatitis C drug the province has approved this year under the Ontario Drug Benefit exceptional access program. Earlier,the province agreed to pay for the drug Harvoni, which has a similar high cure rate for hepatitis C.

Both drugs cost in the $50,000 to $60,000 range, or more, which, until the province approved them, meant they were out of reach to most patients. Unlike previous treatments for hepatitis C, the drugs are easy to take in daily pill form, are well tolerated by patients and cure the disease in the vast majority of cases.

Read more...

Monday, June 29, 2015

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

File this under ‘Show me the data.’

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.38%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Here’s what happened:

Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs. They sought the data because the drugs are widely prescribed, thanks to very high cure rates, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated review.

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National study finds life-threatening barriers in access to breakthrough drugs

Most states violate federal Medicaid law because they deny coverage for sofosbuvir, a new and highly effective treatment to cure hepatitis C, according to Lynn E. Taylor, M.D., director of The Miriam Hospital's HIV/Viral Hepatitis Coinfection Program. Taylor's team of researchers examined Medicaid policies for hepatitis C virus treatment using sofosbuvir, more commonly known as Solvadi, and found that most should change policy to improve access to the treatment. The study and its findings were published online in advance of the August issue of the Annals of Internal Medicine.

Hepatitis C virus affects over three million Americans. Worldwide, an estimated 120 to 150 million people have chronic hepatitis C. Left untreated, the infection can lead to cirrhosis, liver failure, and liver cancer. Sofosbuvir is a highly effective pharmaceutical used in combination with other medications to cure the disease.

Taylor's research team, which included the Harvard Law School Center for Health Law and Policy Innovation, Treatment Action Group, Kirby Institute of Australia, and Brown University, found that most Medicaid coverage restrictions for sofosbuvir violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration (FDA) labels.

Read more...