DENVER (CBS4) – Local artists spent Sunday creating a mural to raise awareness about Hepatitis C. It’s a disease that patients call a silent killer.
Patients and survivors came out to the event to support World Hepatitis Day, including Rhonda Robineau. Today she is happy and healthy, but it wasn’t always that way.
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Sunday, July 26, 2015
Ireland: Faithfull promotes Hepatitis C awareness week
Singer songwriter Marianne Faithfull is set to front Ireland’s
first campaign to promote awareness of hepatitis C.
first campaign to promote awareness of hepatitis C.
The 68-year-old will front The National Hepatitis C Awareness Week. The campaign takes place from July 27 to 31, and Faithfull will be the guest speaker at the launch of the campaign tomorrow at 6pm in the Smock Alley Theatre in Dublin.
Hepatitis C is a viral infection that affects the liver, causing it to become inflamed and not work as effectively in the body. It can be contracted via blood-to-blood contact with an infected person’s blood.
Speaking to The Sunday Times, Faithfull said she was diagnosed with the virus 23 years ago.
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Saturday, July 25, 2015
Canada: Quebec to start reimbursing for 'revolutionary' Hepatitis C treatment
Quebec has decided to reimburse “revolutionary” drugs that can cure Hepatitis C, but only for the sickest patients at first.
According to the rules adopted by the Régie de l’assurance maladie du Québec, some Quebecers with the disease will have to wait three years before getting access to new treatments.
The measures concern two drugs called Harvoni and Holkira Pak that are supposed to cure the condition in 8-12 weeks.
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According to the rules adopted by the Régie de l’assurance maladie du Québec, some Quebecers with the disease will have to wait three years before getting access to new treatments.
The measures concern two drugs called Harvoni and Holkira Pak that are supposed to cure the condition in 8-12 weeks.
Read more...
Tuskegee launches hepatitis C virus testing initiative
In honor of the third annual National African American Hepatitis C Action Day today, the City of Tuskegee is taking steps to eradicate the hepatitis C virus (HCV) infection in its community, beginning with testing.
Mayor Johnny Ford of Tuskegee joined with national and local health leaders to discuss starting an initiative to diagnose and treat those infected with HCV in his area Friday morning.
C. Virginia Fields, president and CEO of the National Black Leadership Commission on AIDS, joined Ford in announcing that something must be done to counteract the spread of hepatitis C in the African American community.
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Mayor Johnny Ford of Tuskegee joined with national and local health leaders to discuss starting an initiative to diagnose and treat those infected with HCV in his area Friday morning.
C. Virginia Fields, president and CEO of the National Black Leadership Commission on AIDS, joined Ford in announcing that something must be done to counteract the spread of hepatitis C in the African American community.
Read more...
Friday, July 24, 2015
Bristol-Myers wins approval for 1st hepatitis C type 3 drug
TRENTON, N.J. (AP) - An experimental drug for one of the hardest-to-treat types of hepatitis C has been approved by the Food and Drug Administration, adding to the surge of new options - all much more effective but extremely costly - for patients with the liver-destroying virus.
Daklinza, developed by New York-based Bristol-Myers Squibb Co., is the first drug approved to treat genotype 3, the second-most-common form. About 10 percent of Americans with hepatitis C have genotype 3.
Because genotype 3 is so hard to cure and damages the liver more quickly than other types, Daklinza is to be taken with Sovaldi, one of two blockbuster hepatitis C drugs sold by market leader Gilead Sciences Inc., along with Harvoni.
Meanwhile, the FDA on Friday also approved Technivie, a combination drug made by AbbVie Inc. for one of the least common forms of hepatitis C, genotype 4. Technivie also must be taken with a second drug, a much-older, generic pill called ribavirin.
Read more..
Daklinza, developed by New York-based Bristol-Myers Squibb Co., is the first drug approved to treat genotype 3, the second-most-common form. About 10 percent of Americans with hepatitis C have genotype 3.
Because genotype 3 is so hard to cure and damages the liver more quickly than other types, Daklinza is to be taken with Sovaldi, one of two blockbuster hepatitis C drugs sold by market leader Gilead Sciences Inc., along with Harvoni.
Meanwhile, the FDA on Friday also approved Technivie, a combination drug made by AbbVie Inc. for one of the least common forms of hepatitis C, genotype 4. Technivie also must be taken with a second drug, a much-older, generic pill called ribavirin.
Read more..
FDA approves new treatment for chronic hepatitis C genotype 3 infections
The Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which, approximately 10 percent are genotype 3.
“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The safety and efficacy of Daklinza in combination with sofosbuvir were evaluated in a clinical trial of 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection. Participants received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks post treatment. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.
Results showed that 98 percent of the treatment-naive participants with no cirrhosis of the liver and 58 percent of the treatment-naive participants with cirrhosis achieved sustained virologic response. Of the participants who were treatment-experienced, 92 percent with no cirrhosis of the liver and 69 percent with cirrhosis achieved sustained virologic response. Daklinza labeling carries a Limitations of Use statement to inform prescribers that sustained virologic response rates are reduced in HCV genotype 3 infected patients with cirrhosis.
Safety information was available for approximately 1,900 patients with HCV treated with the recommended dose of Daklinza in combination with other anti-HCV drugs in clinical trials. The most common side effects of Daklinza with sofosbuvir were fatigue and headache.
Daklinza carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza. Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended.
Daklinza was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Press Release Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which, approximately 10 percent are genotype 3.
“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The safety and efficacy of Daklinza in combination with sofosbuvir were evaluated in a clinical trial of 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection. Participants received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks post treatment. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.
Results showed that 98 percent of the treatment-naive participants with no cirrhosis of the liver and 58 percent of the treatment-naive participants with cirrhosis achieved sustained virologic response. Of the participants who were treatment-experienced, 92 percent with no cirrhosis of the liver and 69 percent with cirrhosis achieved sustained virologic response. Daklinza labeling carries a Limitations of Use statement to inform prescribers that sustained virologic response rates are reduced in HCV genotype 3 infected patients with cirrhosis.
Safety information was available for approximately 1,900 patients with HCV treated with the recommended dose of Daklinza in combination with other anti-HCV drugs in clinical trials. The most common side effects of Daklinza with sofosbuvir were fatigue and headache.
Daklinza carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza. Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended.
Daklinza was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Press Release Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm
FDA approves Technivie for treatment of chronic hepatitis C genotype 4
For Immediate Release
July 24, 2015
The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).
Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection.
“Today’s approval provides the first treatment option for patients with genotype 4 HCV infections without requiring use of interferon,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop cirrhosis over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV, of which genotype 4 is one of the least common.
The safety and efficacy of Technivie with ribavirin were evaluated in a clinical trial of 135 participants with chronic HCV genotype 4 infections without cirrhosis. Ninety-one participants received Technivie with ribavirin once daily for 12 weeks. Forty-four participants received Technivie once daily without ribavirin for 12 weeks. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.
Results showed that 100 percent of the participants who received Technivie with ribavirin achieved a sustained virologic response. Of those who received Technivie without ribavirin, 91 percent achieved sustained virologic response.
Safety information was available for 316 participants with HCV treated with the recommended dose of Technivie in combination with other anti-HCV drugs in clinical trials. The three drugs included in Technivie are also included in Viekira Pak, previously approved for the treatment of HCV genotype 1 infection. Additional safety information for those drugs was available from the Viekira Pak trials. The most common side effects of Technivie with ribavirin were fatigue, weakness (asthenia), nausea, insomnia, itching (pruritus) and other skin reactions.
Technivie carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants. The elevations occurred more frequently in females taking contraceptives containing ethinyl estradiol. Contraceptives containing ethinyl estradiol must be discontinued prior to starting Technivie. Hepatic laboratory testing should be performed during the first four weeks of starting treatment, and as clinically indicated thereafter.
Technivie and Viekira Park are marketed by AbbVie Inc. based in North Chicago, Illinois.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Press Release Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455857.htm
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