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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?
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!
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