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New Hep C med appoved with 94-99 percent cure rate
US approves pricey new pill against hepatitis C
October 10, 2014
Washington (AFP) - US regulators on Friday approved Harvoni, a daily pill to treat hepatitis C that is simpler to administer than long-standing treatments but that carries a steep price tag.
The combination pill made by California-based Gilead Sciences was shown in trials to cure up to 99 percent of patients within two to three months.
But Harvoni's price is set at $94,500 for a 12-week course of treatment, or $1,125 per pill.
The pill combines two agents -- ledipasvir and sofosbuvir, a previously approved hepatitis C drug marketed by Gilead under the brand name Sovaldi.
Sovaldi had already stoked criticism for its high price tag of $1,000 per pill, or $84,000 per treatment course.
Gilead CEO John Martin said the company was "working to ensure rapid and broad access."
View gallery
Protesters lay on the floor in front of a Gilead Sciences …
Protesters lay on the floor in front of a Gilead Sciences stand to denounce the high price of Sofosb …
"Unlike other serious chronic diseases, hepatitis C can be cured, and Harvoni offers patients the potential for a cure in as little as eight weeks," added Martin.
Harvoni is the first treatment for hepatitis C that does not require administration with interferon or ribavirin, which can cause side effects like headache, fatigue and nausea.
Edward Cox, director of the Office of Antimicrobial Products at the Food and Drug Administration said the new treatments were "changing the treatment paradigm" for people with hepatitis C.
"Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens," he said.
Harvoni is the third drug approved by the FDA in the past year to treat chronic hepatitis C infection.
Others include Olysio (simeprevir), marketed by Janssen Therapeutics in New Jersey and approved in November 2013 and Gilead's Sovaldi which was approved in December 2013.
Hepatitis C, or HCV, is a viral infection that affects the liver, and may cause no symptoms for years until liver damage becomes apparent in the form of cirrhosis, jaundice or cancer.
Between 130 million and 150 million people worldwide are infected with HCV, which kills as many as 500,000 each year, according to the World Health Organization.
"This is a giant step forward for people with HCV. One pill, once daily, no interferon, no ribavirin and 94-99 percent cure," said Douglas Dieterich, professor of medicine in the Division of Liver Diseases at The Mount Sinai Hospital in New York.
"It moves the risk-benefit ratio needle way over toward benefit."
October 10, 2014
Washington (AFP) - US regulators on Friday approved Harvoni, a daily pill to treat hepatitis C that is simpler to administer than long-standing treatments but that carries a steep price tag.
The combination pill made by California-based Gilead Sciences was shown in trials to cure up to 99 percent of patients within two to three months.
But Harvoni's price is set at $94,500 for a 12-week course of treatment, or $1,125 per pill.
The pill combines two agents -- ledipasvir and sofosbuvir, a previously approved hepatitis C drug marketed by Gilead under the brand name Sovaldi.
Sovaldi had already stoked criticism for its high price tag of $1,000 per pill, or $84,000 per treatment course.
Gilead CEO John Martin said the company was "working to ensure rapid and broad access."
View gallery
Protesters lay on the floor in front of a Gilead Sciences …
Protesters lay on the floor in front of a Gilead Sciences stand to denounce the high price of Sofosb …
"Unlike other serious chronic diseases, hepatitis C can be cured, and Harvoni offers patients the potential for a cure in as little as eight weeks," added Martin.
Harvoni is the first treatment for hepatitis C that does not require administration with interferon or ribavirin, which can cause side effects like headache, fatigue and nausea.
Edward Cox, director of the Office of Antimicrobial Products at the Food and Drug Administration said the new treatments were "changing the treatment paradigm" for people with hepatitis C.
"Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens," he said.
Harvoni is the third drug approved by the FDA in the past year to treat chronic hepatitis C infection.
Others include Olysio (simeprevir), marketed by Janssen Therapeutics in New Jersey and approved in November 2013 and Gilead's Sovaldi which was approved in December 2013.
Hepatitis C, or HCV, is a viral infection that affects the liver, and may cause no symptoms for years until liver damage becomes apparent in the form of cirrhosis, jaundice or cancer.
Between 130 million and 150 million people worldwide are infected with HCV, which kills as many as 500,000 each year, according to the World Health Organization.
"This is a giant step forward for people with HCV. One pill, once daily, no interferon, no ribavirin and 94-99 percent cure," said Douglas Dieterich, professor of medicine in the Division of Liver Diseases at The Mount Sinai Hospital in New York.
"It moves the risk-benefit ratio needle way over toward benefit."
12 March 2014
Sofosbuvir and simeprevir are currently under review in Australia and New Zealand. They received FDA approval in the US in December 2013, European Medicines Agency (EMA) approval in January 2014 and were recognised as the treatments of choice for hepatitis C in new US guidelines for the management of hepatitis C published last month [February].
Professor Gane said the next imminent advance for patients infected with HCV genotype 1 was an all-oral, interferon-free treatment regimen such as the combination of sofosbuvir and ledipasvir, which achieved 90-99% cure rates in phase 3 trials.
______________________________________________________
Gilead filed a New Drug Submission for Harvoni in Canada on March 19, 2014 and was granted Priority Review by Health Canada. Gilead has filed private and public payer reimbursement submissions for Harvoni and was granted a Priority Review under the Common Drug Review process on October 6, 2014. Harvoni was approved in the United States on October 10, 2014 and granted a positive opinion by the Committee for Medicinal Products for Human Use in the European Union on September 25, 2014. Applications are pending in Australia and New Zealand.
____________________________________________________
Sofosbuvir and simeprevir are currently under review in Australia and New Zealand. They received FDA approval in the US in December 2013, European Medicines Agency (EMA) approval in January 2014 and were recognised as the treatments of choice for hepatitis C in new US guidelines for the management of hepatitis C published last month [February].
Professor Gane said the next imminent advance for patients infected with HCV genotype 1 was an all-oral, interferon-free treatment regimen such as the combination of sofosbuvir and ledipasvir, which achieved 90-99% cure rates in phase 3 trials.
______________________________________________________
Gilead filed a New Drug Submission for Harvoni in Canada on March 19, 2014 and was granted Priority Review by Health Canada. Gilead has filed private and public payer reimbursement submissions for Harvoni and was granted a Priority Review under the Common Drug Review process on October 6, 2014. Harvoni was approved in the United States on October 10, 2014 and granted a positive opinion by the Committee for Medicinal Products for Human Use in the European Union on September 25, 2014. Applications are pending in Australia and New Zealand.
____________________________________________________
Hey Amanda,
September 26, 2014
Australia Studies Sofosbuvir/Ledipasvir Treatment as Prevention
Australia has begun recruiting inmates to take part in a first-of-its-kind study that will evaluate the efficacy of a new one-pill-per-day treatment for the hepatitis C virus (HCV), Medical Xpress reports.
The SToP-C study (Surveillance and Treatment of Prisoners with hepatitis C) will investigate whether a “treatment as prevention” policy for hep C will actually help reduce new infections among its inmate population. About 30 percent of all prisoners in Australia have HCV.
Health officials involved with the study are seeking out consenting prisoners to participate by taking Gilead Science’s new once-a day-tablet, which combines Sovaldi (sofosbuvir) with the drug ledipasvir for a 12-week course of treatment.
This new combo pill is not available in the United States, though the Food and Drug Administration is expected to decide whether to approve the treatment by October 10.
The Australian study will likely take five years to complete, will recruit more than 1,000 inmates and will be implemented in steps at both maximum- and medium-security facilities.
September 26, 2014
Australia Studies Sofosbuvir/Ledipasvir Treatment as Prevention
Australia has begun recruiting inmates to take part in a first-of-its-kind study that will evaluate the efficacy of a new one-pill-per-day treatment for the hepatitis C virus (HCV), Medical Xpress reports.
The SToP-C study (Surveillance and Treatment of Prisoners with hepatitis C) will investigate whether a “treatment as prevention” policy for hep C will actually help reduce new infections among its inmate population. About 30 percent of all prisoners in Australia have HCV.
Health officials involved with the study are seeking out consenting prisoners to participate by taking Gilead Science’s new once-a day-tablet, which combines Sovaldi (sofosbuvir) with the drug ledipasvir for a 12-week course of treatment.
This new combo pill is not available in the United States, though the Food and Drug Administration is expected to decide whether to approve the treatment by October 10.
The Australian study will likely take five years to complete, will recruit more than 1,000 inmates and will be implemented in steps at both maximum- and medium-security facilities.
Another site just got updated yesterday and sais the Australian Government refuses to subsidize the new drug because it would have a huge impact on our health system, which is a load of crap, because we have one of the best and strongest health care systems in the world. I guess we'll see what happens, hopefully this is the last time the liberals will win office and we will go back to Labour as the government, because they will certainly approve it.
Just had a quick look on google, Harvoni is still pending approval in Aus.
So im guessing that means once approved, it will be covered by medicare, is that right ?
So im guessing that means once approved, it will be covered by medicare, is that right ?
Hey Evan, no its not approved here. Its $90,000 for the treatment. $1,000 a pill. I will double check, but it was on the news about 2 weeks ago and was yet to be approved. But if the US just approved it, we usually follow. Hopefully, this is the case.
Thanks Evan.
Thanks Evan.
Hey Amanda,
It got approved over here on the 10th. Do you have to wait for a separate approval since your in another country? It cost a lot but on the HCV forum it seems like insurance is covering it.
It got approved over here on the 10th. Do you have to wait for a separate approval since your in another country? It cost a lot but on the HCV forum it seems like insurance is covering it.
Hey Evan, i heard this on the news a couple weeks ago, i think its the biggest breakthrough yet.
Unfortunantly, as you say, the price per pill/treatment is phenominal and just cannot be justified.
As soon as the FDA approves it, i will jump on board and try it, if they ever do !!
Thanks for this.
Unfortunantly, as you say, the price per pill/treatment is phenominal and just cannot be justified.
As soon as the FDA approves it, i will jump on board and try it, if they ever do !!
Thanks for this.
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