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.
Read more...
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Alan Franciscus
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HCV Advocate
Saturday, July 25, 2015
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.
Read more...
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..
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daklinza + sofosbuvir,
GT3,
GT4,
Technivie
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
Thursday, July 23, 2015
MSD Announces European Medicines Agency Acceptance of Marketing Authorisation Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Infection
KENILWORTH N.J., Jul 23, 2015 (BUSINESS WIRE) -- MSD, known as Merck MRK, -0.10% in the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a marketing authorisation application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy, for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection.1 The EMA will initiate review of the MAA under accelerated assessment timelines.
“Given the diversity of patient populations affected by chronic hepatitis C, including the estimated 15 million people living with the disease in Europe, it is important to provide patients and physicians with treatment options,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories, a U.S.-based division of Merck & Co., Inc., Kenilworth, N.J., U.S.A. “We are pleased to be working with regulatory authorities as we advance grazoprevir/elbasvir for appropriate patients living with chronic hepatitis C around the world.”
The EMA’s accelerated assessment is available for products that respond to unmet medical needs or represent a significant improvement over current treatment options within a major public health interest, such as the treatment of chronic HCV infection. The Committee for Medicinal Products for Human Use (CHMP) will continue to evaluate the accelerated assessment status throughout the MAA evaluation process.
The MAA for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials programme, as well as the C-SURFER, C-SALVAGE and C-SWIFT clinical trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic HCV infection. Collectively, these trials evaluated treatment regimens in multiple genotypes (GT1, 3, 4 and 6), including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (i.e., HIV co-infection, chronic kidney disease stages 4 and 5).
The company submitted a New Drug Application for grazoprevir/elbasvir (100mg/50mg) to the U.S. Food and Drug Administration (FDA) in May 2015 for the treatment of chronic HCV GT 1, 4 or 6 infection, and is submitting additional license applications in other markets by the end of 2015. In April 2015, the U.S. FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is MSD’s investigational, once-daily, single-tablet combination therapy consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of MSD’s broad clinical trials programme, grazoprevir/elbasvir is being evaluated in multiple HCV genotypes including patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and in those on opiate substitution therapy.
About MSD
Today's MSD is a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programmes and partnerships.
Read complete press release here..
“Given the diversity of patient populations affected by chronic hepatitis C, including the estimated 15 million people living with the disease in Europe, it is important to provide patients and physicians with treatment options,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories, a U.S.-based division of Merck & Co., Inc., Kenilworth, N.J., U.S.A. “We are pleased to be working with regulatory authorities as we advance grazoprevir/elbasvir for appropriate patients living with chronic hepatitis C around the world.”
The EMA’s accelerated assessment is available for products that respond to unmet medical needs or represent a significant improvement over current treatment options within a major public health interest, such as the treatment of chronic HCV infection. The Committee for Medicinal Products for Human Use (CHMP) will continue to evaluate the accelerated assessment status throughout the MAA evaluation process.
The MAA for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials programme, as well as the C-SURFER, C-SALVAGE and C-SWIFT clinical trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic HCV infection. Collectively, these trials evaluated treatment regimens in multiple genotypes (GT1, 3, 4 and 6), including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (i.e., HIV co-infection, chronic kidney disease stages 4 and 5).
The company submitted a New Drug Application for grazoprevir/elbasvir (100mg/50mg) to the U.S. Food and Drug Administration (FDA) in May 2015 for the treatment of chronic HCV GT 1, 4 or 6 infection, and is submitting additional license applications in other markets by the end of 2015. In April 2015, the U.S. FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is MSD’s investigational, once-daily, single-tablet combination therapy consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of MSD’s broad clinical trials programme, grazoprevir/elbasvir is being evaluated in multiple HCV genotypes including patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and in those on opiate substitution therapy.
About MSD
Today's MSD is a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programmes and partnerships.
Read complete press release here..
Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir
Filing Supported by Data from the Phase 3 OPTIMIST-1 and -2 Clinical Trials Evaluating OLYSIO® Combination Therapy in Hepatitis C Patients with and without Cirrhosis
TITUSVILLE, N.J., July 23, 2015 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the label for once-daily, all-oral OLYSIO® (simeprevir). OLYSIO® is a hepatitis C virus (HCV) NS3/4A protease inhibitor, currently approved for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection as a 12-week treatment for patients without cirrhosis or a 24-week treatment regimen for patients with cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor marketed by Gilead Sciences, Inc.
OLYSIO® was approved in November 2014 in combination with sofosbuvir based on the Phase 2 COSMOS clinical trial. This sNDA is based on results from the Phase 3 OPTIMIST-1 and OPTIMIST-2 trials, which evaluated 12 and eight weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients with cirrhosis.
"OLYSIO® has contributed significantly to the care of people living with hepatitis C. The availability of multiple treatment options is important to help offer an opportunity for cure, and we believe OLYSIO® will continue to play a meaningful role going forward," said Richard Nettles, M.D., vice president, Medical Affairs, Janssen Therapeutics. "We're pleased to submit the data from the Phase 3 OPTIMIST trials, which adds to the body of clinical information about this combination in patients with and without cirrhosis."
Results from the OPTIMIST trials were presented in April 2015 at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) in Vienna.
About the OPTIMIST TrialsOPTIMIST-1 is a Phase 3, randomized, open-label trial to investigate the efficacy and safety of the all-oral regimen of simeprevir and sofosbuvir (SMV/SOF) among treatment-naive and treatment-experienced genotype 1 CHC patients without cirrhosis. The primary study endpoint is sustained virologic response (SVR) at 12 weeks after treatment (SVR12) with 12 and eight weeks of treatment with SMV/SOF versus a historical control (patients previously treated with approved regimens containing a direct-acting antiviral, pegylated interferon and ribavirin).
- Ninety-seven (97) percent of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87 percent among the historical control.
- SVR12 rates of 100 percent were seen among patients with IL28B CC genotype (n=43/43) and those with baseline NS5A and NS3 Q80K polymorphisms (n=9/9).
- Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of 83 percent (n=128/155), which was not superior to the SVR12 rate of 83 percent in the historical control.
- High SVR12 rates were seen among patients with baseline HCV RNA < 4 million IU/mL (96 percent; n=46/48), IL28B CC genotype (93 percent; n=38/41), patients with genotype 1b CHC (92 percent; n=36/39) and patients without baseline NS5A and Q80K polymorphisms (89 percent; n=78/88).
- The most frequently reported adverse events in the 12- and eight-week treatment arms were headache (14 and 17 percent, respectively), fatigue (12 and 15 percent, respectively) and nausea (15 and 9 percent, respectively).
OPTIMIST-2 is a Phase 3, open-label, single-arm trial to investigate the efficacy and safety of SMV/SOF in treatment-naive and treatment-experienced genotype 1 CHC patients with cirrhosis. The primary endpoint is SVR12 with SMV/SOF versus a historical control.
- Twelve (12) weeks of treatment with SMV/SOF resulted in SVR12 rates of 84 percent (n=86/103), which was superior to the SVR12 rate of 70 percent in the historical control.
- Higher SVR12 rates were seen in patients with baseline NS5A polymorphisms with or without NS3 Q80K polymorphisms (100 percent; n=13/13), patients with albumin ≥4 g/dL (94 percent; n=47/50) and treatment-naïve patients (88 percent; n=44/50).
- The most common adverse events were fatigue (20 percent), headache (20 percent) and nausea (11 percent).
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