Hepatitis C Support Group
Hepatitis C is a blood-borne viral disease which can cause liver inflammation, fibrosis, cirrhosis and liver cancer. The hepatitis C virus (HCV) is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment. Hepatitis C infects an estimated 150-200 million people worldwide.
Bristol-Myers Squibb said Thursday that it was discontinuing development of a hepatitis C drug that it had acquired in a $2.5 billion deal, after nine patients in a clinical trial had to be hospitalized and one of them died.
The company suspended testing of the drug on Aug. 1, after one patient in a midstage clinical trial experienced heart failure. At that time, however, there was still some question of whether the drug, known as BMS-986094, had caused the problem.
But Thursday evening, the company said that initial patient had died and that eight other patients also had to be hospitalized. Two of them remained hospitalized.
While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the company has determined that it is in the best interest of patients to halt development of BMS-986094, the company said in a statement.
The scrapping of the drug is a big setback for Bristol-Myers in the heated race to develop a combination of pills to treat hepatitis C, a viral infection that can cause liver scarring and liver cancer.
Current treatment now involves up to a year of weekly injections with alpha interferon, which causes severe side effects. The hope is that combinations of pills that work by different mechanisms could eradicate hepatitis C without the need for interferon. So companies are scrambling to assemble the components of such an all-oral regimen.
Bristol-Myers paid $2.5 billion in January to acquire Inhibitex, which was developing the drug that became known as BMS-986094. Bristol-Myers hoped to combine that drug with daclatasvir, another hepatitis C drug that it is continuing to test in clinical trials.
One question is whether the troubles with BMS-986094 will extend to other drugs in its class, known as nucleotide polymerase inhibitors.
Last week, Idenix Pharmaceuticals said the Food and Drug Administration placed a hold on a trial of its nucleotide polymerase inhibitor, IDX184, because of the heart failure case in the Bristol-Myers trial. Idenix said it had not seen any cardiac toxicity with its drug.
Gilead Sciences also has a drug in that class that it obtained by acquiring Pharmasset for $11 billion, though that drug, GS-7977, is somewhat different chemically.
http://www.nytimes.com/2012/08/24/business/bristol-myers-ends-work-on-hepatitis-c-drug.html?partner=MYWAY&ei=5065
The company suspended testing of the drug on Aug. 1, after one patient in a midstage clinical trial experienced heart failure. At that time, however, there was still some question of whether the drug, known as BMS-986094, had caused the problem.
But Thursday evening, the company said that initial patient had died and that eight other patients also had to be hospitalized. Two of them remained hospitalized.
While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the company has determined that it is in the best interest of patients to halt development of BMS-986094, the company said in a statement.
The scrapping of the drug is a big setback for Bristol-Myers in the heated race to develop a combination of pills to treat hepatitis C, a viral infection that can cause liver scarring and liver cancer.
Current treatment now involves up to a year of weekly injections with alpha interferon, which causes severe side effects. The hope is that combinations of pills that work by different mechanisms could eradicate hepatitis C without the need for interferon. So companies are scrambling to assemble the components of such an all-oral regimen.
Bristol-Myers paid $2.5 billion in January to acquire Inhibitex, which was developing the drug that became known as BMS-986094. Bristol-Myers hoped to combine that drug with daclatasvir, another hepatitis C drug that it is continuing to test in clinical trials.
One question is whether the troubles with BMS-986094 will extend to other drugs in its class, known as nucleotide polymerase inhibitors.
Last week, Idenix Pharmaceuticals said the Food and Drug Administration placed a hold on a trial of its nucleotide polymerase inhibitor, IDX184, because of the heart failure case in the Bristol-Myers trial. Idenix said it had not seen any cardiac toxicity with its drug.
Gilead Sciences also has a drug in that class that it obtained by acquiring Pharmasset for $11 billion, though that drug, GS-7977, is somewhat different chemically.
http://www.nytimes.com/2012/08/24/business/bristol-myers-ends-work-on-hepatitis-c-drug.html?partner=MYWAY&ei=5065
This is probably going to get me in a hot water, but I'm going for it anyway, mainly because I don't see why.....maybe I'm ignorant. okay here goes....
I don't know why all the fuss about excluding the interferon.... For me it has been the least side effect med in the tx. I do my shot now on Friday and it doesn't have any effect anymore. No flu like symptoms at all!
I of course DO NOT LIKE to give myself the shot, but it doesn't hurt, and now that I don't suffer any sx, it's just a thing I do on Fridays.
Here's what the side effects are listed for Interferon alpha 2a which is the one that I take (pegasys).
SIDE EFFECTS:
The most common side effect of interferon alfa-2a or alfa-2b therapy is a flu-like reaction with fever, fatigue, irritability, chills, headaches, and muscle aches. These effects should become less severe and less frequent as you continue your therapy. Tell your healthcare provider if any of these problems continue or worsen.
Tell your healthcare provider if any of these symptoms are severe or do not go away:
nausea
loss of appetite
stomach pain
diarrhea
skin rash
dry skin
itching
If you experience either of the following symptoms, call your healthcare provider immediately:
dizziness
numbness or tingling in the arms, hands, legs, or feet
Compared to what the Incevik and the Ribavarin cause, these seem pretty tame to me. Granted when I first started and probably thru week 8, I got the sx from it, (basically flu symptoms that lasted a few days a week) but they started lasting for a shorter, and shorter period each week I did it, until I don't have any now at all and today was my shot # 18.
They have used, and still do use Interferon for many diseases, and they are working on putting it in the yearly flu vaccine! Wonder what people will think then. Probably won't care because it's just one shot a year.....but what about these "serious side effects" that the phama's developing the new "easier tx for us" talks about?
Here's alink that tells about Interferon.
http://en.wikipedia.org/wiki/Interferon
Okay, so here's my question...If the trials are all still including Riba (which in my mind is the worst of the meds as far as SX goes), and they are still planning on using some type of protease inhibator (simular to Incevik and Vic, but have to be different some way because of patents).....
WHAT is going to make this tx more tolerable? Excluding the Interferon because people don't want to have to give themsleves shots, and they don't want to suffer flu symptoms?
I am kind of inclined to believe that BIG Pharma is jumping on the band wagon, promising that it will be easier, when in fact, I don't see that, and since 2011 when Incevik and Vic were approved, we have a tx that works 85% of the time (for GT 1 anyway). So I see these companies seeing the $'s that the 2 new PI's are making and saying " Well, let's one up them and tell everyone we'll remove the Interferon from the mix. Everyone hates giving themselves shots! The patients will definately go for it! It will be great and we'll definately make more money than the other 2 companies with their already approved PI's!"
My HCV doc said that he could maybe get me into a trial, but at the changed his mind while he stood there. I don't know why, but he said " No, I think we better go with the Incevik/Riba/Interferon. My Hemo doc also said that there were some wonderful drugs available to me right now (meaning the above combo) and that it was time to treat my HCV.
So off I went to the HCV doc and that is my cocktail. I have 6 weeks left to go and have been undie since week 4.
Comments anyone? I certainly don't mean to dash anyone's hope, but this whole news release has me upset especially when the BAD sx happened to one of our own.... Bago! Sure hope you're feeling better.
Love to all!
Kelly
What's going on w/ Bristol-Myers Squibb anyway?
I'm on a Gilead long-term study.... Trials are scary.... what phase was this trial?
I'm waiting on Gilead........................................................
Abbott has some good results....
Sandy is that w/ SOC?
I have decided to stay on tx. The trial coordinator is sending me to a cardiologist sept. 3rd. I want to see what he says.
Love ya,
kelly
And yeah...trials are risky and potentially lethal. I've heard people here encourage others to jump on trials. I would urge approaching them with extreme caution and armed with as much knowledge as possible.