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
Drugs in Development / Clinical Trials—Updated March 17, 2015
Monday, July 6, 2015
Hepatitis C, a treatable but sometimes deadly viral disease that attacks the liver, was diagnosed in 719 people in Franklin County five years ago. The number had nearly doubled by last year, to 1,369, according to data from Columbus Public Health. So far this year, the county is on pace to record more than 1,400 cases. In just one year, the number of hepatitis C cases statewide grew from 10,020 in 2013 to 15,887 in 2014.
Some of that most certainly is due to a push for testing at-risk baby boomers that has been fueled by better treatments. But there’s little question among doctors and public-health leaders that needle-sharing by people using heroin and other drugs is playing a role. Last year, 603 of the cases in Franklin County were in people 34 or younger.
The heroin epidemic is causing many undesirable ripple effects in Maine, public health advocates say, including the spread of infectious diseases such as hepatitis C.
Acute cases – a six-month infection where symptoms manifest themselves – more than tripled from 2013 to 2014, from nine to 31, according to the Maine Center for Disease Control and Prevention. At the same time, chronic hepatitis C – long-term infections that can sometimes last a lifetime – increased 25 percent, from 1,142 cases in 2010 to 1,425 in 2014.
Canada: Leading Canadian researcher calls for inclusion of co-infected people in large HCV clinical trials
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:
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.
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
FOSTER CITY, Calif.--(BUSINESS WIRE)--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
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
- 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
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 firstname.lastname@example.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).