Senate Health Committee Advances Legislation to Require Hospitals and Health Care Providers to Offer Testing to Certain High-Risk Patients
TRENTON – A bill sponsored by Senators Joseph F. Vitale and Richard J. Codey that would put New Jersey in line with CDC recommendations to test baby boomers for Hepatitis C was advanced today by the Senate Health, Human Services and Senior Citizens Committee.
“I have seen firsthand the effects that Hepatitis C can have on an individual and their family,” said Senator Vitale, D-Middlesex, Chairman of the Senate Health Committee. “If a patient is screened and made aware of the disease earlier, they can have a real shot at treatment, often so successful as to remove any trace of the disease. Real lives can be saved with this legislation.”
The issue is close to Senator Vitale’s heart as his father passed away from complications due to Hepatitis C, a disease that he contracted through a tainted blood transfusion. The Senator notes that through this legislation, individuals will be diagnosed earlier, allowing for effective treatment to avoid liver damage, cirrhosis and even cancer.
Monday, January 26, 2015
EnvisionRx and Gilead Sciences Sign Exclusive Agreement to Help in the Fight Against Hepatitis C
TWINSBURG, Ohio, Jan 26, 2015 (BUSINESS WIRE) -- EnvisionRx®, a national, full-service pharmacy benefit management (PBM) company, today announced a partnership with Gilead Sciences Inc., a pioneer in the treatment of the Hepatitis C virus (HCV), to provide availability to HCV infection treatments Sovaldi® and Harvoni™ for EnvisionRx patients on an exclusive basis.
“EnvisionRx is committed to helping patients attain the most effective drugs at affordable prices, and we are proud to be able to offer our patients Sovaldi® and Harvoni™, the market leaders in the treatment of HCV, ” said Dawn Sherman, President of EnvisionRx. “The safety and efficacy profile of Gilead’s HCV products, coupled with the most competitive pricing in the drug class, have solidified EnvisionRx’s choice to place Gilead’s HCV products in an exclusive and preferred formulary position. We believe our comprehensive HCV approach will enable our patients to receive the best available care.”
Consistent with PBM industry practice, exceptions for other hepatitis C drugs will be allowed in some cases. Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), is the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Sovaldi™ (sofosbuvir) 400 mg tablets, is a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
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“EnvisionRx is committed to helping patients attain the most effective drugs at affordable prices, and we are proud to be able to offer our patients Sovaldi® and Harvoni™, the market leaders in the treatment of HCV, ” said Dawn Sherman, President of EnvisionRx. “The safety and efficacy profile of Gilead’s HCV products, coupled with the most competitive pricing in the drug class, have solidified EnvisionRx’s choice to place Gilead’s HCV products in an exclusive and preferred formulary position. We believe our comprehensive HCV approach will enable our patients to receive the best available care.”
Consistent with PBM industry practice, exceptions for other hepatitis C drugs will be allowed in some cases. Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), is the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Sovaldi™ (sofosbuvir) 400 mg tablets, is a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
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Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent
–Sofosbuvir/GS-5816 Single Tablet Regimen May Provide Important New Option for Patients in Developing Countries –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 26, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS-5816, once approved, for distribution in 91 developing countries, which together account for 54 percent of the total worldwide population of individuals infected with the hepatitis C virus (HCV).
If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.
“Today’s announcement marks an important milestone in Gilead’s effort to make effective hepatitis C treatment accessible to as many patients, in as many places, as quickly as possible,” said Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences. “Developing countries are home to a diverse mix of hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment.”
Professor Abhijit Chowdhury, Head of Hepatology, Institute of Post Graduate Medical Education and Research, Kolkata, commented: “Pan-genotypic hepatitis C treatments have the potential to radically change the treatment landscape in developing countries, removing the need for patients to undergo burdensome laboratory tests. Even if testing facilities are available, their cost is a barrier to treatment access, so a regimen that can be used for any genotype is going to be a real attribute in tackling this disease on a global level.”
The amended agreements expand on Gilead’s existing generic licensing partnerships for hepatitis C, announced in September 2014, under which partners may produce sofosbuvir and the single tablet regimen of ledipasvir/sofosbuvir. Eight Indian-based generic manufacturers now hold licenses to manufacture Gilead’s HCV medicines – Biocon Ltd., Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd.
Sofosbuvir recently received regulatory approval in India (January 2015), and regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.
About GS-5816
The single tablet regimen of sofosbuvir/GS-5816 is an investigational agent and its safety and efficacy have not been established. Phase 3 studies evaluating the combination of GS-5816 and sofosbuvir are currently underway, with data anticipated in the second half of 2015.
Gilead’s Approach to Treatment Access in Developing Countries
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. In developing countries, Gilead’s treatment access strategies include tiered pricing, voluntary generic licensing (often in advance of U.S./EU regulatory approval), negotiation with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations. This approach has been successfully applied to Gilead’s humanitarian program in HIV over the past 10 years, where seven million patients are now receiving Gilead-based HIV medicines in developing countries.
For more information on Gilead Sciences, please visit the company’s website at www.Gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
- See more at: http://gilead.com/news/press-releases/2015/1/gilead-expands-hepatitis-c-generic-licensing-agreements-to-include-investigational-pangenotypic-agent#sthash.XNY7QWgP.dpuf
Saturday, January 24, 2015
Hepatitis C: What Therapy this Week?
“We really have entered this new era of direct acting antivirals, and as of this fall, we’ve finally laid to rest Interferon in the grave that we’ve all been wanting to put it in, for more than 2 decades,” opened Jacqueline G. O’Leary, MD, MPH, AGAF during her presentation at the 2015 AGA Clinical Congress of Gastroenterology & Hepatology.
According to O’Leary, sofosbuvir certainly changed everything – a truly pangenotypic polymerase inhibitor (NSSB) prescribed as 400 mg daily, never modified with no significant food effect reported. It had recently been co-formulated with ledipasvir, the first in class NSSA inhibitor, once daily dose, and also with no existing food effect.
Switching gears, O’Leary discussed the other FDA approved all oral regiment of paritapevir with ombitasvir and dasabuvir, for their genotype 1 patients. “This is a trick from HIV that allows lower dosing in medication, a dramatic increase in half-life, which adds an additional protection. This is binding against the thumb blood site, which definitely gets two thumbs up, because it allows you to give the finger to hepatitis C.”
- See more at: http://www.hcplive.com/conferences/aga-2015/Hepatitis-C-What-Therapy-this-Week#sthash.XnTiU8TC.dpuf
According to O’Leary, sofosbuvir certainly changed everything – a truly pangenotypic polymerase inhibitor (NSSB) prescribed as 400 mg daily, never modified with no significant food effect reported. It had recently been co-formulated with ledipasvir, the first in class NSSA inhibitor, once daily dose, and also with no existing food effect.
Switching gears, O’Leary discussed the other FDA approved all oral regiment of paritapevir with ombitasvir and dasabuvir, for their genotype 1 patients. “This is a trick from HIV that allows lower dosing in medication, a dramatic increase in half-life, which adds an additional protection. This is binding against the thumb blood site, which definitely gets two thumbs up, because it allows you to give the finger to hepatitis C.”
- See more at: http://www.hcplive.com/conferences/aga-2015/Hepatitis-C-What-Therapy-this-Week#sthash.XnTiU8TC.dpuf
Genotype 1: VIEKIRA PAK Therapy
Be sure to check out our new HCSP fact sheet on Genotype 1: VIEKIRA PAK Therapy
Germany: German insurers win discounts on Gilead's Sovaldi
Jan 24 (Reuters) - U.S. biotechnology company Gilead has conceded its first discounts in Germany on its key hepatitis C drugs Sovaldi and Harvoni, German business weekly WirtschaftsWoche reported.
The head of Gilead's German operations told the magazine that discounts from the list price of 60,000 euros ($67,242) per treatment had been negotiated with four of Germany's statutory health insurers but declined to give the size of the discounts.
"Thirty-five percent of people with statutory health insurance are already profiting from the discount agreements," Carsten Nowotsch said in an interview to be published on Monday, adding that more such contracts could follow.
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The head of Gilead's German operations told the magazine that discounts from the list price of 60,000 euros ($67,242) per treatment had been negotiated with four of Germany's statutory health insurers but declined to give the size of the discounts.
"Thirty-five percent of people with statutory health insurance are already profiting from the discount agreements," Carsten Nowotsch said in an interview to be published on Monday, adding that more such contracts could follow.
Read more...
India: Docs get training in liver transplant in Delhi
JAIPUR: There is a ray of hope for the patients who need liver transplant. A team of 14 doctors and 15 nurses from SMS Medical College has returned from Delhi after being trained in liver transplant operation at a private hospital.
According to sources, till now there is no facility for liver transplant in the state. The patients have to go to other states like Delhi and Tamil Nadu for such operations. The Sawai Man Singh Hospital is taking it on a priority basis to introduce the facility as soon as possible in the hospital.
Dr Ashok Jhajharia, who was one of the members of team, said, "It was fruitful 15-day training of liver transplant in Delhi. It will help in introducing the facility of liver transplant in the state."
Read more...
According to sources, till now there is no facility for liver transplant in the state. The patients have to go to other states like Delhi and Tamil Nadu for such operations. The Sawai Man Singh Hospital is taking it on a priority basis to introduce the facility as soon as possible in the hospital.
Dr Ashok Jhajharia, who was one of the members of team, said, "It was fruitful 15-day training of liver transplant in Delhi. It will help in introducing the facility of liver transplant in the state."
Read more...
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