Aa
SF Biz Times "Gilead has the Cure"
http://www.bizjournals.com/sanfrancisco/print-edition/2013/03/01/gilead-reaches-for-a-cure.html
Fourteen months after buying a small biotech company with a promising hepatitis C treatment for $11 billion, Gilead Sciences Inc. is on the cusp of seeking approval for a potential cure.
But even with the drug’s accelerated pace, some say, Foster City-based Gilead is leaving behind an important player: patients with the debilitating and potentially deadly virus. Bristol-Myers Squibb Co. and a handful of vocal patients say the cure could arrive more quickly if Gilead cooperated with its competitor.
“I get that it’s all about their profit,” said Margaret Dudley, a San Antonio woman with hepatitis C who has launched ...
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This is all I can see of the Article or I have to pay 59.00 for subscription but this just was published in weekly "San Francisco Business Times"
Would like to see whole article but can afford the 59 bucks.
Anyone subscribe to SFBIZ?
Fourteen months after buying a small biotech company with a promising hepatitis C treatment for $11 billion, Gilead Sciences Inc. is on the cusp of seeking approval for a potential cure.
But even with the drug’s accelerated pace, some say, Foster City-based Gilead is leaving behind an important player: patients with the debilitating and potentially deadly virus. Bristol-Myers Squibb Co. and a handful of vocal patients say the cure could arrive more quickly if Gilead cooperated with its competitor.
“I get that it’s all about their profit,” said Margaret Dudley, a San Antonio woman with hepatitis C who has launched ...
-------------------------------------------------------------
This is all I can see of the Article or I have to pay 59.00 for subscription but this just was published in weekly "San Francisco Business Times"
Would like to see whole article but can afford the 59 bucks.
Anyone subscribe to SFBIZ?
http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/AASLD%202012/AASLD_2012_Slides.aspx
The arm in which sofosbuvir & daclatasvir were administered from day one achieved 100% cure rate (SVR24) in genotpyes 1, 2, and 3, without toxic ribavirin or interferon.
This information was presented at the AASLD Liver Meeting in Boston.
The arm in which sofosbuvir & daclatasvir were administered from day one achieved 100% cure rate (SVR24) in genotpyes 1, 2, and 3, without toxic ribavirin or interferon.
This information was presented at the AASLD Liver Meeting in Boston.
"We are only here to tell the truth, Really???
--------------------------------
Misleading facts...
"Did you know there is a cure for Hepatitis C but we may never see it?"
I find this misleading, we are not stupid here, many of us are already CURED.
-------------------------------------------------
From Mududley.... "Now a safe 100% cure exists, without toxic ribavirin or interferon, but is being held back by 'big pharma'."......... Again NOT true!
A total of 44 patients with the relatively easy-to-treat viral genotypes 2 and 3 were enrolled in three arms – one with a seven-day sofosbuvir run-in followed by 23 weeks of the two together, one with the combination for 24 weeks, and one with the combination plus ribavirin for 24 weeks.
Sulkowski said 88% of patients in the first group reached an SVR12, compared with 100% in the second group, and 86% in the third group.
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Ribavirin is toxic???... Mududley says, "Now a safe 100% cure exists"
Yet we don't mention in Mdudleys own thread is this, what amounted to about 4% had serious adverse effects using this combo
--------------------------------------------------
Ready for primetime, yet we don't mention that the experts has said this many times,
"These very promising findings require confirmation in a larger study"...
--------------------------------------------------
" Your doctor will not be able to pick sofosbuvir to use with daclatasvir"
Again not true, from the Doctor himself,
"In addition, he said, both daclatasvir and sofosbuvir are likely to be approved soon, with an indication for therapy in combination with the standard HCV drugs, pegylated interferon and ribavirin.
There would then be nothing to stop doctors from using them together off-label, while avoiding the other two, which are associated with a host of adverse effects."
--------------------------------
Misleading facts...
"Did you know there is a cure for Hepatitis C but we may never see it?"
I find this misleading, we are not stupid here, many of us are already CURED.
-------------------------------------------------
From Mududley.... "Now a safe 100% cure exists, without toxic ribavirin or interferon, but is being held back by 'big pharma'."......... Again NOT true!
A total of 44 patients with the relatively easy-to-treat viral genotypes 2 and 3 were enrolled in three arms – one with a seven-day sofosbuvir run-in followed by 23 weeks of the two together, one with the combination for 24 weeks, and one with the combination plus ribavirin for 24 weeks.
Sulkowski said 88% of patients in the first group reached an SVR12, compared with 100% in the second group, and 86% in the third group.
--------------------------------------------------
Ribavirin is toxic???... Mududley says, "Now a safe 100% cure exists"
Yet we don't mention in Mdudleys own thread is this, what amounted to about 4% had serious adverse effects using this combo
--------------------------------------------------
Ready for primetime, yet we don't mention that the experts has said this many times,
"These very promising findings require confirmation in a larger study"...
--------------------------------------------------
" Your doctor will not be able to pick sofosbuvir to use with daclatasvir"
Again not true, from the Doctor himself,
"In addition, he said, both daclatasvir and sofosbuvir are likely to be approved soon, with an indication for therapy in combination with the standard HCV drugs, pegylated interferon and ribavirin.
There would then be nothing to stop doctors from using them together off-label, while avoiding the other two, which are associated with a host of adverse effects."
"We are only here to tell the truth and it is up to each of you to decide what to do with it."
REALLY? Not sure who "we" is unless your speaking of this new person Quest who just happened to join....... If you really mean what you said then why all the misleading statements? Just give the facts as they are and let everyone decide... Drop the spin...OK?
REALLY? Not sure who "we" is unless your speaking of this new person Quest who just happened to join....... If you really mean what you said then why all the misleading statements? Just give the facts as they are and let everyone decide... Drop the spin...OK?
"Your doctor no longer can pick and choose what he wants to use off lablel. Your doctor will not be able to pick sofosbuvir to use with daclatasvir"
Why not ? The compound will be available in stand alone form for use in genotype 2/3's and once it is FDA approved the doc can do whatever he wants with the drug.
Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration.[1] In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication.[2] If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.
The FDA approves a drug for prescription use, and continues to regulate the pharmaceutical industry's promotional practices for that drug through the work of the Office of Prescription Drug Promotion (OPDP, formerly the Division for Drug Marketing, Advertisement and Communication (DDMAC).[3] The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates. Actiq, for example, is commonly prescribed off-label even though it is a Schedule II controlled substance. While it would be legal for a physician to independently decide to prescribe a drug such as Actiq off-label, it is illegal for the company to promote off-label uses to prescribers. In fact, Cephalon, the maker of Actiq, was fined for illegal promotion of the drug in September 2008.[4] Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing a drug for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with publications on off-label uses of a drug, in response to an unsolicited request.[5] In 2004, the federal government and whistleblower David Franklin reached a $430 million settlement in Franklin v. Parke-Davis to resolve claims that Warner-Lambert engaged in off-label promotion of Neurontin in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the False Claims Act. At the time, the settlement was one of the largest recoveries against a pharmaceutical company in U.S. history, and the first off-label promotion settlement in U.S. history.[6]
http://en.wikipedia.org/wiki/Off-label_use
Why not ? The compound will be available in stand alone form for use in genotype 2/3's and once it is FDA approved the doc can do whatever he wants with the drug.
Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration.[1] In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication.[2] If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.
The FDA approves a drug for prescription use, and continues to regulate the pharmaceutical industry's promotional practices for that drug through the work of the Office of Prescription Drug Promotion (OPDP, formerly the Division for Drug Marketing, Advertisement and Communication (DDMAC).[3] The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates. Actiq, for example, is commonly prescribed off-label even though it is a Schedule II controlled substance. While it would be legal for a physician to independently decide to prescribe a drug such as Actiq off-label, it is illegal for the company to promote off-label uses to prescribers. In fact, Cephalon, the maker of Actiq, was fined for illegal promotion of the drug in September 2008.[4] Under the Food, Drug, and Cosmetic Act (FDAC) at U.S.C. 21 §§301-97, manufacturers are prohibited from directly marketing a drug for a use other than the FDA approved indication. The Food and Drug Administration Modernization Act of 1997 created an exception to the prohibition of off-label marketing. Manufacturers are now able to provide medical practitioners with publications on off-label uses of a drug, in response to an unsolicited request.[5] In 2004, the federal government and whistleblower David Franklin reached a $430 million settlement in Franklin v. Parke-Davis to resolve claims that Warner-Lambert engaged in off-label promotion of Neurontin in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the False Claims Act. At the time, the settlement was one of the largest recoveries against a pharmaceutical company in U.S. history, and the first off-label promotion settlement in U.S. history.[6]
http://en.wikipedia.org/wiki/Off-label_use
"We have people who are post treatment with these two drugs and have no toxcity."
Once again your misleading, why are you disconting the 4% that had serious adverse effects with this combo?
Once again your misleading, why are you disconting the 4% that had serious adverse effects with this combo?
Please do your research on the compounds you speak of.
Sofosbuvir will be approved in stand alone form for use with riba in genotype 2 patients before anything else, look it up.
Sofosbuvir will be approved in stand alone form for use with riba in genotype 2 patients before anything else, look it up.
Wake up...once Gilead combines its sofosbuvir with its 5885 and they file it that way with the FDA, that is it! Your doctor no longer can pick and choose what he wants to use off lablel. Your doctor will not be able to pick sofosbuvir to use with daclatasvir.
We have people who are post treatment with these two drugs and have no toxcity. They have their life back.
The Government can make anybody do anything they want.
We have people who are post treatment with these two drugs and have no toxcity. They have their life back.
The Government can make anybody do anything they want.
Maybe you wasn't around then but a few years back there was several here that was able to go off label and add Alinia (Nitazoxanide) to the mix, it seemed more common in genotype 4 people... So Doctors can and will do it........ Just ask Bali05, he is now SVR thanks to that combo.
You seem to want to forget the 4% serious adverse effects there was in the last trial... Nobody has a clue just how toxic these two drugs will become.... Please speak the facts and stop the misleading.
http://www.aafp.org/afp/2005/0815/p655.html
Ribavirin causes birth defects, fetal demise, serious hemolytic anemias, and worsening of cardiac disease. It also may be carcinogenic. Patients should be carefully counseled about the risks of these medications and monitored closely during treatment.
Ribavirin can cause a hemolytic anemia. The traditional approach to hematologic toxicity has been reducing the dose of the offending antiviral; however, lower doses also may reduce treatment efficacy.
Elevations of bilirubin usually are an indication of hemolysis caused by the ribavirin and usually are concomitant with drops in the hematocrit. Between 1 and 2 percent of patients will develop thyroid abnormalities severe enough to require clinical interventions, so thyroid-stimulating hormone levels should be checked periodically while the patient is on treatment. Triglycerides can be elevated and can cause pancreatitis.
Posttreatment Issues
Side effects of the medications may linger for some weeks after they are discontinued, and in some cases may be permanent, so monitoring is important even after successful completion of a course of treatment. It is important to reinforce to patients that contraception must be maintained for a full six months after cessation of ribavirin.
===================================
http://www.news-medical.net/health/Hepatitis-C-treatment-no-benefits-and-possible-harm.aspx
Concluding comment (from the article above)
Given the natural history of chronic hepatitis C, as well as what we know therapy accomplishes, it is very difficult to justify a policy for routinely treating such patients to prevent decompensated liver disease. The surrogate outcomes were not valid in the one occasion when validation information was available. The treatment has not been proven to be efficacious with regard to preventing clinically important disease, it is expensive, and it causes substantial morbidity (including death). It is an inappropriate clinical decision to prescribe a toxic therapy (especially an expensive one) that has never been shown to provide clinical benefit in properly-done randomized trials.
=================================
We have met with leading physicians and even if both of these drugs are eventually approved, most doctors will not prescribe them for 'off-label' use because of the liability issues. And even if some do prescribe 'off-label', payers (i.e., insurance, Medicaid, Medicare, VA, etc.) will only cover the cost of one of the drugs.
We are only here to tell the truth and it is up to each of you to decide what to do with it. It is after all your life or the lives of your loved ones, so do what you think is in your own best interests.
And while two drug companies cannot be 'forced' to work together, they can certainly be 'forced' to reconsider their stance on this in a variety of ways. We are not only The People, we are the voters, the consumers (of these drugs), the stockholders, the patients, the doctors, the nurses, etc.
Bristol-Myers still wants this collaboration because it is the biggest development in the history of hepatitis C, a cure for the most prevalent types of hepatitis C (1, 2 and 3) without toxic ribavirin or interferon. Many leading and well-respected doctors are doing their best to 'encourage' this as well. These doctors have willingly stepped forward (on OUR behalf) and now we need to show that we are willing to do the same. Without the support of the people who are actually infected or affected by hepatitis C, we may fail.
Physicians for The HCV Cure with Sofosbuvir and
Daclatasvir (without toxic ribavirin or interferon)
Quote from Dr. Mark Murphy – Savannah Morning News – February 26 2012:
Hepatitis C patients have been waiting for a treatment regimen like daclatasvir and sofosbuvir for decades. It’s a true rarity in medicine — an honest-to-goodness game-changer, a phenomenally effective regimen for a serious, life-threatening disease that is also safe and well-tolerated.
For reasons that are almost certainly financial in nature, Gilead has refused to do further work on this drug combination with Bristol-Myers Squibb, so there will be no further study of the regimen. With no Phase III trials, that means that the daclatasvir/sofosbuvir combination regimen will likely not be approved for use by the FDA.
Quote from Dr. Paul Thuluvath - Wall Street Journal – November 2012:
"We had never, ever imagined—even in our wildest dreams—we could treat" hepatitis C so quickly, effectively and without serious side effects, said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests."
Quote from Dr. Scott Friedman – New York Times – April 2012:
“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders,” said Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, who was not involved in the trial.”
Quote from EASL Secretary General Mark Thursz – New York Times – April 2012:
EASL Secretary General Mark Thursz wants to see the two companies work together. "The combination of daclatasvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatasvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.
HCV Coalition for The Cure
www.HepC-Cured.org
Ribavirin causes birth defects, fetal demise, serious hemolytic anemias, and worsening of cardiac disease. It also may be carcinogenic. Patients should be carefully counseled about the risks of these medications and monitored closely during treatment.
Ribavirin can cause a hemolytic anemia. The traditional approach to hematologic toxicity has been reducing the dose of the offending antiviral; however, lower doses also may reduce treatment efficacy.
Elevations of bilirubin usually are an indication of hemolysis caused by the ribavirin and usually are concomitant with drops in the hematocrit. Between 1 and 2 percent of patients will develop thyroid abnormalities severe enough to require clinical interventions, so thyroid-stimulating hormone levels should be checked periodically while the patient is on treatment. Triglycerides can be elevated and can cause pancreatitis.
Posttreatment Issues
Side effects of the medications may linger for some weeks after they are discontinued, and in some cases may be permanent, so monitoring is important even after successful completion of a course of treatment. It is important to reinforce to patients that contraception must be maintained for a full six months after cessation of ribavirin.
===================================
http://www.news-medical.net/health/Hepatitis-C-treatment-no-benefits-and-possible-harm.aspx
Concluding comment (from the article above)
Given the natural history of chronic hepatitis C, as well as what we know therapy accomplishes, it is very difficult to justify a policy for routinely treating such patients to prevent decompensated liver disease. The surrogate outcomes were not valid in the one occasion when validation information was available. The treatment has not been proven to be efficacious with regard to preventing clinically important disease, it is expensive, and it causes substantial morbidity (including death). It is an inappropriate clinical decision to prescribe a toxic therapy (especially an expensive one) that has never been shown to provide clinical benefit in properly-done randomized trials.
=================================
We have met with leading physicians and even if both of these drugs are eventually approved, most doctors will not prescribe them for 'off-label' use because of the liability issues. And even if some do prescribe 'off-label', payers (i.e., insurance, Medicaid, Medicare, VA, etc.) will only cover the cost of one of the drugs.
We are only here to tell the truth and it is up to each of you to decide what to do with it. It is after all your life or the lives of your loved ones, so do what you think is in your own best interests.
And while two drug companies cannot be 'forced' to work together, they can certainly be 'forced' to reconsider their stance on this in a variety of ways. We are not only The People, we are the voters, the consumers (of these drugs), the stockholders, the patients, the doctors, the nurses, etc.
Bristol-Myers still wants this collaboration because it is the biggest development in the history of hepatitis C, a cure for the most prevalent types of hepatitis C (1, 2 and 3) without toxic ribavirin or interferon. Many leading and well-respected doctors are doing their best to 'encourage' this as well. These doctors have willingly stepped forward (on OUR behalf) and now we need to show that we are willing to do the same. Without the support of the people who are actually infected or affected by hepatitis C, we may fail.
Physicians for The HCV Cure with Sofosbuvir and
Daclatasvir (without toxic ribavirin or interferon)
Quote from Dr. Mark Murphy – Savannah Morning News – February 26 2012:
Hepatitis C patients have been waiting for a treatment regimen like daclatasvir and sofosbuvir for decades. It’s a true rarity in medicine — an honest-to-goodness game-changer, a phenomenally effective regimen for a serious, life-threatening disease that is also safe and well-tolerated.
For reasons that are almost certainly financial in nature, Gilead has refused to do further work on this drug combination with Bristol-Myers Squibb, so there will be no further study of the regimen. With no Phase III trials, that means that the daclatasvir/sofosbuvir combination regimen will likely not be approved for use by the FDA.
Quote from Dr. Paul Thuluvath - Wall Street Journal – November 2012:
"We had never, ever imagined—even in our wildest dreams—we could treat" hepatitis C so quickly, effectively and without serious side effects, said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests."
Quote from Dr. Scott Friedman – New York Times – April 2012:
“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders,” said Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, who was not involved in the trial.”
Quote from EASL Secretary General Mark Thursz – New York Times – April 2012:
EASL Secretary General Mark Thursz wants to see the two companies work together. "The combination of daclatasvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatasvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.
HCV Coalition for The Cure
www.HepC-Cured.org
Hey you guys, I haven't looked too hard at the new drugs because I'm hopeful I may have achieved SVR, and if it turns out that I haven't, well I will do my studying then. Now, that said, I've learned a lot from reading this thread and I appreciate that a lot, but I find the posts just starting to get a wee bit harsh. Can the more excited ones please take a little calming break, maybe with music, meditation or a quiet nature walk? All of your opinions are wanted and valued, but some of us are uncomfortable with the heat. Thank you!
Looks like all this Hype, misleading info, and Petition is for nothing.
In addition, he said, both daclatasvir and sofosbuvir are likely to be approved soon, with an indication for therapy in combination with the standard HCV drugs, pegylated interferon and ribavirin.
There would then be nothing to stop doctors from using them together off-label, while avoiding the other two, which are associated with a host of adverse effects.
http://hepatitiscnewdrugs.blogspot.ca/2012/11/daclatasvir-and-sofosbuvir-promising.html
----------------------------------------
So Mdudley maybe you ought to be ready to take your fight to the doctors instead of what is a sure losing cause... You cannot force two companys to work together, but you already know that from Senator John Cornyn office right? Since you posted this response..."And they will look into it but can't force two companies to work together..."
In addition, he said, both daclatasvir and sofosbuvir are likely to be approved soon, with an indication for therapy in combination with the standard HCV drugs, pegylated interferon and ribavirin.
There would then be nothing to stop doctors from using them together off-label, while avoiding the other two, which are associated with a host of adverse effects.
http://hepatitiscnewdrugs.blogspot.ca/2012/11/daclatasvir-and-sofosbuvir-promising.html
----------------------------------------
So Mdudley maybe you ought to be ready to take your fight to the doctors instead of what is a sure losing cause... You cannot force two companys to work together, but you already know that from Senator John Cornyn office right? Since you posted this response..."And they will look into it but can't force two companies to work together..."
You are completely out of line with your response to Hector. You might try using whatever processes left to you to read Hector's profile. Then if you do not want to crawl back under your rock, you might try a heartfelt apology.
Really Hector???!!!!! It seems you have forgotten about all of those poor souls that have treated with interferon and ribavirin, and have been told they are cured, that now have to go on living their lives with new health problems caused by their drug toxicity. Heart disease, thyroid disease, visual problems, kidney disease, diabetis, just to name a few. With you the amount of time you spent with your answer, it seems you are the one with nothing better to do, nor does anyone else care to hear your thoughts on capitalism.
Here is a link to the SVR24 results of the Gilead/Bristol trials Reported by Jules Levin | AASLD | Nov 9-13 2012 Boston
http://hepc-cured.com/new-clinical-studies-high-rate-of-sustained-virologic-response-with-the-all-oral-combination-of-daclatasvir-plus-sofosbuvir-with-or-without-ribavirin/
And a link from TAG (Treatment Action Group) with available trial results from all studies including the daclatasvir/sofosbuvir trials:
http://www.pipelinereport.org/toc/HCV/dec-treatment-pipeline-update
We know trial results can be confusing and Jules Levin (NATAP) and Tracy Swan (TAG) have done an excellent job in order to make these results easier to understand.
The AIDS Healthcare Foundation is now lending their support on this petition:.
http://www.aidshealth.org/archives/15802
http://hepc-cured.com/new-clinical-studies-high-rate-of-sustained-virologic-response-with-the-all-oral-combination-of-daclatasvir-plus-sofosbuvir-with-or-without-ribavirin/
And a link from TAG (Treatment Action Group) with available trial results from all studies including the daclatasvir/sofosbuvir trials:
http://www.pipelinereport.org/toc/HCV/dec-treatment-pipeline-update
We know trial results can be confusing and Jules Levin (NATAP) and Tracy Swan (TAG) have done an excellent job in order to make these results easier to understand.
The AIDS Healthcare Foundation is now lending their support on this petition:.
http://www.aidshealth.org/archives/15802
Posted in San Francisco Business Journal & Medhelp March 2, 2013
http://www.aafp.org/afp/2005/0815/p655.html
Ribavirin causes birth defects, fetal demise, serious hemolytic anemias, and worsening of cardiac disease. It also may be carcinogenic. Patients should be carefully counseled about the risks of these medications and monitored closely during treatment.
Ribavirin can cause a hemolytic anemia. The traditional approach to hematologic toxicity has been reducing the dose of the offending antiviral; however, lower doses also may reduce treatment efficacy.
Elevations of bilirubin usually are an indication of hemolysis caused by the ribavirin and usually are concomitant with drops in the hematocrit. Between 1 and 2 percent of patients will develop thyroid abnormalities severe enough to require clinical interventions, so thyroid-stimulating hormone levels should be checked periodically while the patient is on treatment. Triglycerides can be elevated and can cause pancreatitis.
Posttreatment Issues
Side effects of the medications may linger for some weeks after they are discontinued, and in some cases may be permanent, so monitoring is important even after successful completion of a course of treatment. It is important to reinforce to patients that contraception must be maintained for a full six months after cessation of ribavirin.
===============
The combination of Gilead's sofosbuvir and Bristol's daclatasvir when administered together from day one for 24 weeks cured 100% of genotypes 1, 2, and 3... without TOXIC ribavirin or interferon. These SVR24 results were released in November 2012 at the AASLD Liver Meeting in Boston. There were a total of 88 people in the 24 week trial with three arms (we are referring only to the arm mentioned). There were an additional 82 genotype 1 patients in a 12-week treatment clinical trial. They only had SVR4 results on 68 of the 82 patients in this 12-week trial at the AASLD Liver Meeting November 2012 and results were 95 to 98%.
===============
Leading Physicians Statements about this cure combining Sofosbuvir and Daclatasvir (without toxic ribavirin or interferon)
Quote from Dr. Mark Murphy – Savannah Morning News – February 26 2012
Hepatitis C patients have been waiting for a treatment regimen like daclatasvir and sofosbuvir for decades. It’s a true rarity in medicine — an honest-to-goodness game-changer, a phenomenally effective regimen for a serious, life-threatening disease that is also safe and well-tolerated.
Quote from Dr. Paul Thuluvath - Wall Street Journal – November 2012:
"We had never, ever imagined—even in our wildest dreams—we could treat" hepatitis C so quickly, effectively and without serious side effects, said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests."
Quote from Dr. Scott Friedman – New York Times – April 2012:
“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders,” said Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, who was not involved in the trial.”
Quote from EASL Secretary General Mark Thursz – New York Times – April 2012:
EASL Secretary General Mark Thursz wants to see the two companies work together.
"The combination of daclatasvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatasvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.
==============
Petition to the Obama Administration:
https://petitions.whitehouse.gov/petition/expedite-cure-hepatitis-c-drug-companies-hold-cure-without-toxic-ribavirin-or-interferon/tXC9B6S2
We petition the Obama Administration to:
Expedite Cure for Hepatitis C - Drug Companies Hold the Cure (without toxic ribavirin or interferon)
Hepatitis C infects almost 4 million Americans and more than 170 million people worldwide, and it now kills more people than AIDS.
Now a safe 100% cure exists, without toxic ribavirin or interferon, but is being held back by 'big pharma'. Immediate action is required to facilitate collaboration between the drug companies with this cure.
HCV Coalition for The Cure
Representing over 17,000 people who have signed the petition at Change.org and/or the White House Petition.
www.HepC-Cured.org
http://www.aafp.org/afp/2005/0815/p655.html
Ribavirin causes birth defects, fetal demise, serious hemolytic anemias, and worsening of cardiac disease. It also may be carcinogenic. Patients should be carefully counseled about the risks of these medications and monitored closely during treatment.
Ribavirin can cause a hemolytic anemia. The traditional approach to hematologic toxicity has been reducing the dose of the offending antiviral; however, lower doses also may reduce treatment efficacy.
Elevations of bilirubin usually are an indication of hemolysis caused by the ribavirin and usually are concomitant with drops in the hematocrit. Between 1 and 2 percent of patients will develop thyroid abnormalities severe enough to require clinical interventions, so thyroid-stimulating hormone levels should be checked periodically while the patient is on treatment. Triglycerides can be elevated and can cause pancreatitis.
Posttreatment Issues
Side effects of the medications may linger for some weeks after they are discontinued, and in some cases may be permanent, so monitoring is important even after successful completion of a course of treatment. It is important to reinforce to patients that contraception must be maintained for a full six months after cessation of ribavirin.
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The combination of Gilead's sofosbuvir and Bristol's daclatasvir when administered together from day one for 24 weeks cured 100% of genotypes 1, 2, and 3... without TOXIC ribavirin or interferon. These SVR24 results were released in November 2012 at the AASLD Liver Meeting in Boston. There were a total of 88 people in the 24 week trial with three arms (we are referring only to the arm mentioned). There were an additional 82 genotype 1 patients in a 12-week treatment clinical trial. They only had SVR4 results on 68 of the 82 patients in this 12-week trial at the AASLD Liver Meeting November 2012 and results were 95 to 98%.
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Leading Physicians Statements about this cure combining Sofosbuvir and Daclatasvir (without toxic ribavirin or interferon)
Quote from Dr. Mark Murphy – Savannah Morning News – February 26 2012
Hepatitis C patients have been waiting for a treatment regimen like daclatasvir and sofosbuvir for decades. It’s a true rarity in medicine — an honest-to-goodness game-changer, a phenomenally effective regimen for a serious, life-threatening disease that is also safe and well-tolerated.
Quote from Dr. Paul Thuluvath - Wall Street Journal – November 2012:
"We had never, ever imagined—even in our wildest dreams—we could treat" hepatitis C so quickly, effectively and without serious side effects, said Paul Thuluvath, a doctor at Mercy Medical Center in Baltimore who had six patients test the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests."
Quote from Dr. Scott Friedman – New York Times – April 2012:
“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders,” said Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York, who was not involved in the trial.”
Quote from EASL Secretary General Mark Thursz – New York Times – April 2012:
EASL Secretary General Mark Thursz wants to see the two companies work together.
"The combination of daclatasvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatasvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.
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Petition to the Obama Administration:
https://petitions.whitehouse.gov/petition/expedite-cure-hepatitis-c-drug-companies-hold-cure-without-toxic-ribavirin-or-interferon/tXC9B6S2
We petition the Obama Administration to:
Expedite Cure for Hepatitis C - Drug Companies Hold the Cure (without toxic ribavirin or interferon)
Hepatitis C infects almost 4 million Americans and more than 170 million people worldwide, and it now kills more people than AIDS.
Now a safe 100% cure exists, without toxic ribavirin or interferon, but is being held back by 'big pharma'. Immediate action is required to facilitate collaboration between the drug companies with this cure.
HCV Coalition for The Cure
Representing over 17,000 people who have signed the petition at Change.org and/or the White House Petition.
www.HepC-Cured.org
I will also say this about Pharma companies and profits. If it was not for a competitive market, and yes with profits being the bottom line...I doubt we would see the aggressive research to reach the closest type of cure we can hope for....and at an astounding pace.
I did sign the petition and know Margaret (great dedicated Lady), but I will say this about Gilead and the study I am on. For the first time in 3 years...and currently on my 4th Tx attempt...I have reached UND at week 4 on the combination sofosbuvir/gs-5885 and riba. I never reached UND on the 3 prior attempts with interferon, riba and the last one including Victrelis. I am having virtually no side effects. In the 3 porior attempts with interferon...I had horrible side effects including rashes, swollen prostate, the "cough", weight loss, numbness from elbow to fingertips, mental fog, insomnia, blurred vision, horrible anger issues etc etc. This leads me to believe most of the nasty side effects in my 3 prior attempts were due to the interferon. I am on week 11 still und with 1 more week to go (12 week arm). I know I am not "out of the woods" yet...but this combination has brought me closer than I have ever been before. Hopefully I (and the rest of us) will attain SVR this time. I know Sofosbuvir will be approved before gs-5885...but probably not long after it.
Thank you.
I think sometimes we might forget that all these drug companies are in it for the profit and we all are in the middle of the fight.
Hector, your way of condensing the fog into a digestible read is priceless...
" It is a beautiful thing to see when we see the post of someone we have known for a long time on here say they have achieved SVR."
I think sometimes we might forget that all these drug companies are in it for the profit and we all are in the middle of the fight.
Hector, your way of condensing the fog into a digestible read is priceless...
" It is a beautiful thing to see when we see the post of someone we have known for a long time on here say they have achieved SVR."
Excellent points Hector, totally agree with you.
Gilead is filing for FDA approval in a couple of months.
Hopefully Sofosbuvir will be available by the end of the year.
I need to treat soon, and weigh the option of doing it right away with teleprevir/IFN/Riba or wait a year and treat with Sofosbuvir/IFN/Riba (genotype 1). The big unknown to me is if this combination will indeed be approved by the end of the year?
Previous experience shows that things get delayed, but the current statements from Gilead sound so optimistic...
Jeff
Gilead is filing for FDA approval in a couple of months.
Hopefully Sofosbuvir will be available by the end of the year.
I need to treat soon, and weigh the option of doing it right away with teleprevir/IFN/Riba or wait a year and treat with Sofosbuvir/IFN/Riba (genotype 1). The big unknown to me is if this combination will indeed be approved by the end of the year?
Previous experience shows that things get delayed, but the current statements from Gilead sound so optimistic...
Jeff
Lots to learn. I hate to jump on bandwagons and look gullible. My brain is so small these days. Baby steps......
Let's be serious, that petition will never gain the desired support and nothing will ever happen. Even if through a miracle 100,000 signatures will materialize, so what. Ultimately it means nothing and a private company cannot be forced to do anytthing.
So let's just move on and hope for the best with the new combinations, whatever they are
So let's just move on and hope for the best with the new combinations, whatever they are
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