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 –

 

July 03, 2015 02:00 AM Eastern Daylight Time

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

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 3^rd 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 (1^st – 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).

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.

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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."

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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.

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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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