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Promacta
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Promacta

My husband is three months shy of completing triple treatment for his hep C.  Last three blood draws his viral load is undectable.  His liver function test shows he is still not eligible for transplant listing.  He has been on procrit for 2 months now but recently has been bleeding from his nose and gums.  Lab work this week shows he is still very low on platelets even with procrit.  So they have started him on promacta.  Has anyone tried this drug and if so what were the results/side effects.  Getting worried now.  We are so close to him completing his 46 weeks of triple treatment would hate to have to stop now.  You all have been a great wealth of information so I am asking for help again.  Thanks so much.  

Also, what are the chances of returning hep after stopping the triple treatment?
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446474_tn?1404424777
"GSK seeks to expand low platelet drug Promacta to hepatitis C patients"
May 30, 2012

GlaxoSmithKline (NYSE:GSK) now wants approval to use its low platelet drug Promacta to treat hepatitis C patients.

"GSK has filed regulatory applications in Europe and the United States to add the new indication to the drug. The drug eltrombopag, which is marketed under the brand name Promacta in the United States and Revolade globally, is approved in 88 countries to treat immune thrombocytopenia, a condition in which a patient has low blood counts because the platelets are destroyed by his own immune system. The condition puts patients at the risk of bleeding. Promacta was codiscovered by GSK predecessor SmithKline Beecham and partner Ligand Pharmaceuticals.

The British pharmaceutical giant, which has its U.S. headquarters in Research Triangle Park, North Carolina, is now seeking to expand approval of the drug to increase platelet counts in patients who have chronic hepatitis C virus infection. The drug would allow them to start interferon-based therapy and could also be used to optimize interferon-based therapy, according to GSK’s supplemental new drug application.

GSK last year completed a phase 3 study of Promacta in hepatitis C patients whose low platelet levels make them unable to start interferon therapy to treat the virus. The trial met the primary endpoint of improving the sustained virological response.

Promacta does come with some safety risks. Until late last year, the U.S. Food and Drug Administration required doctors and patients to follow a strict regimen in order to watch for adverse effects that include liver damage, blood clots and bleeding risks after discontinued use of the drug. But the FDA eased those requirements and concluded that it was unlikely the safety data collected could determine whether adverse effects were caused by the drug or by thrombocytopenia. While mandatory collection of safety data is no longer required, the agency continues to ask that any adverse events be reported."


Hector
5 Comments Post a Comment
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446474_tn?1404424777
"Last three blood draws his viral load is undectable."
Which weeks were this blood draws?

"He has been on procrit for 2 months now but recently has been bleeding from his nose and gums."
"very low on platelets even with procrit"

There seems to be a misunderstand here. Procrit is used to treat ANEMIA. Anemia is a low Red Blood Cell Count. Having anemia makes a person feel tired as oxygen it carried in the red blood cells to other body cells that need oxygen to operate properly.

Promacta is a drug used to treat low platelet counts. It is use to temporarily raise Platelet count. Platelets are used to clot blood. Patients with advanced cirrhosis commonly have low platelet counts as a complication of their liver disease. Not having enough platelets will cause a patient to be prone to bleeding and it will take longer than usual for the clotting to occur.

Promacta or Platelet Transfusions are the ONLY temporary means to raise a person with cirrhotic's platelet count. In your husband's cause this makes sense as the goal is to allow him to complete treatment so he can rid the virus that has and is continuing to damage his liver. This is especially important because he doesn't have the option of a liver transplant. Getting through treatment is the most important thing he can due at this point in his disease to improve his prognosis.

Whatever it takes to get him through the 48 weeks is critical.
Bleeding from his nose and gums is very common. I have experienced this myself. It is nothing to be overly concerned about. As soon as he finishes treatment his platelet count will start to rise again and his bleeding will stop.


He will be on Promacta for a short time this minimizes the risk. There have been a few people here who have used Promacta. It raised their platelet counts and helped them get through their treatment.
As long as your husband is being closely monitored by a transplant center the risk is well worth the reward. OKU does use Promacta. Send a PM to crossroadsec. She was on Promacta for some time I believe as she was treated at OKU.

What is his platelet count?

"Also, what are the chances of returning hep after stopping the triple treatment?"
Only his doctor knows all the factors of his illness. Ask his doctor if you are interested in the chances.
Personally I would try as hard as possible to be positive about his success. Having a hopeful and positive attitude is critical when dealing with serious illness. Without hope we are lost. No matter how dire our circumstance there is always room for hope. Even it is just to live another hour or minute. We may not be able to change of circumstances but we always have control over how we think about things and behave. I am not saying it is easy. We are all fearful and have doubts but we can still bounce back from the dark thoughts and find a silver lining no matter how bad things are. There are no guarantees. I would suggest focusing on his finishing treatment and then recovering from treatment. The rest is beyond yours or his control.  Try not to add to the challenges you are already facing. Focus on the here and now and all you two have together and not on what you don't have.

I wish you both the best!
Keep us aware of how your husband is progressing.

Hector
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Sorry, ignore my psychobabble. But the info above platelet count is accurate.



Hector
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446474_tn?1404424777
"GSK seeks to expand low platelet drug Promacta to hepatitis C patients"
May 30, 2012

GlaxoSmithKline (NYSE:GSK) now wants approval to use its low platelet drug Promacta to treat hepatitis C patients.

"GSK has filed regulatory applications in Europe and the United States to add the new indication to the drug. The drug eltrombopag, which is marketed under the brand name Promacta in the United States and Revolade globally, is approved in 88 countries to treat immune thrombocytopenia, a condition in which a patient has low blood counts because the platelets are destroyed by his own immune system. The condition puts patients at the risk of bleeding. Promacta was codiscovered by GSK predecessor SmithKline Beecham and partner Ligand Pharmaceuticals.

The British pharmaceutical giant, which has its U.S. headquarters in Research Triangle Park, North Carolina, is now seeking to expand approval of the drug to increase platelet counts in patients who have chronic hepatitis C virus infection. The drug would allow them to start interferon-based therapy and could also be used to optimize interferon-based therapy, according to GSK’s supplemental new drug application.

GSK last year completed a phase 3 study of Promacta in hepatitis C patients whose low platelet levels make them unable to start interferon therapy to treat the virus. The trial met the primary endpoint of improving the sustained virological response.

Promacta does come with some safety risks. Until late last year, the U.S. Food and Drug Administration required doctors and patients to follow a strict regimen in order to watch for adverse effects that include liver damage, blood clots and bleeding risks after discontinued use of the drug. But the FDA eased those requirements and concluded that it was unlikely the safety data collected could determine whether adverse effects were caused by the drug or by thrombocytopenia. While mandatory collection of safety data is no longer required, the agency continues to ask that any adverse events be reported."


Hector
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His last three blood draws were the middle of each of the last few months.  He goes to the doctor around the 18th of the month.  But now with the Promacta that said lab work will be weekly.  Thanks for helping we figure all this out.  With the anemia and low platelets I get confused.  Thanks for the information on the medication.  I had never heard of it.  I will find out more exact on his numbers.  His aunt flew in from California to go to the doctor with him yesterday.  I have several other family members who are very ill.  So she helped me out for the day. I am trying to stay postive.  Sometimes I just let myself get down.  I will snap out of it.  I know he needs me to be strong.  Thanks again for the great information.  
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446474_tn?1404424777
I am happy they are looking at his numbers carefully. Some individuals have a bad response to Promacta. as the warning label states. I am also taking a possible liver toxic drug. For both of us the risk is worth the benefit when we are very ill.

I know it is difficult. We all have or ups and downs. I am having a rough time now but I know it is temporarily and I will pick myself up when I can and carrying on. I am sorry your have ourselves that are ill also. I understand. I am going to a memorial service today. So that is one reason I have been down all week. We are all human and it is normal to be fearful and be upset.

Here is a link to the latest info on Promacta.
http://www.rxlist.com/promacta-drug.htm

http://www.drugs.com/promacta.html

Don't let the label scare you. The label for hepatitis C treatment drugs are scary too.

I wish you both all my best.

Hector
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