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, the HCV drug pipeline, and for more information on HCV clinical trials
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Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.


Alan Franciscus

Editor-in-Chief

HCV Advocate



Monday, July 6, 2015

Canada: Leading Canadian researcher calls for inclusion of co-infected people in large HCV clinical trials

Hepatitis C virus (HCV) infects the liver. Chronic infection with HCV causes inflammation in this vital organ and slowly degrades it as healthy tissue is replaced with scar tissue. This ongoing injury to the liver results in complications, including bacterial infections, internal bleeding and liver, kidney and brain dysfunction. If left untreated, HCV infection can cause severe liver injury, the liver can stop working and death can occur. HCV infection also increases the risk for developing liver cancer.

Impact of HIV co-infection
Co-infection with HCV and HIV is relatively common, as both viruses have shared routes of infection. HIV-HCV co-infection accelerates the pace of HCV-related liver injury.

Historically, co-infected people have had increased rates of illness and death compared to people with HCV infection alone (mono-infection). There are at least two reasons for this, as follows:

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Two Current Fronts of the American Health Care Wars: Hepatitis C and Cancer

The Pharmaceutical Industry, Health Insurance and Recurrent Questions of Extortion, Murder and Evil

Asking patients to delay treatment for hepatitis C is like asking patients to delay treatment for diabetes or cancer.

"Waiting for cirrhosis to happen to treat HCV is like waiting for cancer to metastasize or for diabetes to cause complications before treating it. In reality, all cause mortality and per patient per year health care costs are tripled for patients with hepatitis C, whether they have cirrhosis or not."

-- Dr. Douglas Dieterich, leading hepatitis C and liver diseases researcher and specialist at the Mount Sinai Hospital, New York City

My friend John is a retired college professor who lives on a budget. He has hepatitis C, which he acquired from a blood transfusion before the development of blood testing and screening for hep C. He does have health insurance, but like most of those seeking treatment for this condition, he has been told that he must become demonstrably sicker to qualify for treatment coverage. Meanwhile, he must not drink any alcohol and remain vigilant for symptoms, especially fatigue. Since the progression of hepatitis C to cirrhosis of the liver and cancer of the liver can take decades, and John has already had this disease for decades, he is understandably concerned. In fact, he may die sooner from other causes, his untreated hepatitis C playing an indeterminate role. There is, however, an alternative for John. If he had the $100,000+ in cash to pay for the treatment now, he could be fully and safely cured in 8-12 weeks. John does not identify himself as a socialist, and he is willing to pay what he can for treatment, but the cost in this case is overwhelming.

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Save the Date: Patient Community Forum on Hepatitis C - Fresno, CA, August 20, 2015


Friday, July 3, 2015

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

– Harvoni Achieved Cure Rates (SVR12) of 100 Percent in Japanese Phase 3 Study –
– Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C –

FOSTER CITY, Calif.--()--Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi® in March 2015. Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis, with a treatment duration of 12 weeks.
“Today’s approval significantly advances the standard of care for chronic hepatitis C in Japan, as it eliminates the need for interferon and ribavirin, which can be difficult to take and to tolerate, and offers the majority of people with genotype 1 infection to be cured in as little as 12 weeks with a once-daily pill,” said Professor Masashi Mizokami, MD, PhD, The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Ichikawa, Japan.

Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people in Japan chronically infected with HCV, 70-80 percent are infected with the genotype 1 strain of the virus.

Harvoni’s approval in Japan is supported by data from 318 treatment-naïve and treatment-experienced Japanese patients with genotype 1 HCV infection randomized to ledipasvir/sofosbuvir (n=157) or ledipasvir/sofosbuvir plus ribavirin (n=161) in the Phase 3 clinical trial GS-US-337-0113. Of the 318 patients enrolled in this study, 34 percent were ages 65 years or older and 23 percent had cirrhosis.

Among patients receiving 12 weeks of ledipasvir/sofosbuvir without ribavirin, 100 percent (n=78/78) of treatment-naïve and 100 percent (n=79/79) of treatment-experienced patients achieved sustained virologic response 12 weeks after completing therapy (SVR12). Adverse events observed with ledipasvir/sofosbuvir without ribavirin were generally mild and included nasopharyngitis (29 percent), headache (7 percent) and malaise (6 percent).

The approval is also supported by results from three Phase 3 studies (ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of ledipasvir/sofosbuvir among genotype 1 HCV patients. Trial participants included patients from the United States, Europe and Puerto Rico who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis. Trial participants in the ribavirin-free arms (n=1,080) achieved SVR12 rates of 94 to 99 percent.

“Harvoni is a safe, simple and well-tolerated treatment. With cure rates of up to 100 percent and without the need for interferon or ribavirin, it offers genotype 1-infected patients a high likelihood of cure,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development, and Chief Scientific Officer. “We are pleased to have partnered with the medical community in Japan to demonstrate the safety and efficacy of two significant advances in the treatment of chronic hepatitis C – Harvoni for genotype 1 infection and Sovaldi for genotype 2 infection, which was approved just three months ago. We look forward to making Harvoni available in Japan as quickly as possible.”

Read complete press release here

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.