Aa
Boceprevir - doctor's choice
Some may remember I'm a 4-time non-responder, type 1a, early Cirrhosis and failed in getting a “compassionate use” for Teleprevir through the FDA because they said that it was the decision of the drug manufacturer as to wether or not to release the drug for this purpose.
Naturally, the manufacturer is concerned with “liability” should the drug be an eventual mortal vehicle. That’s why the clinical trials. However, the doctor feels that after the exhaustive testing that has been done so far and no deaths reported, he now wants to really push for the drug before the clinical trials are over. Especially since I’m progressing and he feels that it’s urgent at this point.
I saw him today and he wants to try once more for a "compassionate use" of Boceprevir, not through the FDA, but through Scherring. He does NOT want me on Teleprevir because he has done an in-depth study along with others and is convinced beyond a doubt that it is more effective than Teleprevir according to test results.
This is news to me because I've been trying to get into a Teleprevir clinical study. He is adamant about getting me on Boceprevir ASAP. He will be in contact with Scherring's rep who comes to his office to deliver samples, and will make a big effort and severely bend his ear about getting me the drug as a "compassionate use".
It’s rare that a doctor not only volunteers his efforts along this path, but his parting words today were “I’ll do all I can to help you”. This should be the motto for all doctors. At any rate, I will report as to what the next chapter will be.
By the way, he also mentioned that there are less side effects with Boceprevir than Teleprevir. So there it is...
Magnum
Naturally, the manufacturer is concerned with “liability” should the drug be an eventual mortal vehicle. That’s why the clinical trials. However, the doctor feels that after the exhaustive testing that has been done so far and no deaths reported, he now wants to really push for the drug before the clinical trials are over. Especially since I’m progressing and he feels that it’s urgent at this point.
I saw him today and he wants to try once more for a "compassionate use" of Boceprevir, not through the FDA, but through Scherring. He does NOT want me on Teleprevir because he has done an in-depth study along with others and is convinced beyond a doubt that it is more effective than Teleprevir according to test results.
This is news to me because I've been trying to get into a Teleprevir clinical study. He is adamant about getting me on Boceprevir ASAP. He will be in contact with Scherring's rep who comes to his office to deliver samples, and will make a big effort and severely bend his ear about getting me the drug as a "compassionate use".
It’s rare that a doctor not only volunteers his efforts along this path, but his parting words today were “I’ll do all I can to help you”. This should be the motto for all doctors. At any rate, I will report as to what the next chapter will be.
By the way, he also mentioned that there are less side effects with Boceprevir than Teleprevir. So there it is...
Magnum
I really hope you will get it this time!!! From what I've heard, it looks like BOC is just as good as Tela or even better.
You're in my thoughts friend,
Marcia
You're in my thoughts friend,
Marcia
Wishing you all the luck to get going on the PI's. I do believe persistence is a key factor in treatment. Both getting in and staying in.
Any idea when the new trials for Boceprevir maybe coming to fruition?
Any idea when the new trials for Boceprevir maybe coming to fruition?
My husband was in the telprivar phase 3 trials. He has early stage liver disease stage 2/3. boarder for cirrosis. He copleted the teleprivar treatment and has been clear of the hep C 3 for 42 weeks. I know that the treatment for hep-c 3 with the teleprivar is for 24 weeks with 12 weeks of the teleprivar and the last 12 weeks with standard treatment. I know what he went throught with the treatment and I am glad that he only had 24 weeks total of treatment. I wish you only the best for whatever you decide and whatever is the best for you.There is hope so don't give up.
Sorry to hear about your plight. I'm not here to preach, but you should stop drinking IMMEDIATELY!!!
It's like throwing fuel on a fire. You're really out on the edge by drinking with Cirrhosis. When the doctor told me 10 years ago to stop drinking, I cold turkeyd right then. I'm no angel and I did have a couple of glasses of champagne for my birthday, but in your situation, drinking daily is just compounding your problems.
Once you stop, you won't really miss it. I don't. I can watch my friends laugh in a drunken stupor and fall all over the place, but I won't join them (although I used to). Sorry if you think I'm preaching, but there isn't and shouldn't be one person here that disagrees with me.
Best of luck in gaining some happiness, and if you stop your drinking, you will most likely be able to wait until the protease inhibitors will be released in a year or so...
Magnum
It's like throwing fuel on a fire. You're really out on the edge by drinking with Cirrhosis. When the doctor told me 10 years ago to stop drinking, I cold turkeyd right then. I'm no angel and I did have a couple of glasses of champagne for my birthday, but in your situation, drinking daily is just compounding your problems.
Once you stop, you won't really miss it. I don't. I can watch my friends laugh in a drunken stupor and fall all over the place, but I won't join them (although I used to). Sorry if you think I'm preaching, but there isn't and shouldn't be one person here that disagrees with me.
Best of luck in gaining some happiness, and if you stop your drinking, you will most likely be able to wait until the protease inhibitors will be released in a year or so...
Magnum
Hi I do appreciate you taking the time to write to me,I try NOT to think about how close I am to leaving this world, but somtimes life just seems to "turn on you' and deal you all bad cards. A little more about me, I was happily married (I thought)for 17 years,) but he walked out on me causing me to have to move to a low income apt. building losing a new car (payments and ins.) I couldn't do on a part time job, and totally not having ANY contact with me for months at a time, he even went so far to tell me that he "didn't know what was wrong with himself' but NEVER has uttered the words "I am sorry" now it's 2 yr's and he is still with the "younger woman" living in a motel room on un-employment, she doesn't do anything, they both get high on pills and herion and coke. he also has HIV and never told her, so it's possible she has it too by now too, I (THANK GOD) didn't get it, we found out 1 year after we got married. when I ask him WHY he doesn't tell her, he saids I never will she is Dominican and he feels her family (who hates him, cause they know he is a married man) would put him in jail for 'attempted murder" !! Which is a real charge, so after all of this I find out my Hep C is now Chirrosis and I am a wreck I don't do drugs i don't smoke and I haven't had sex in years, so I drink a glass of Chinti at night and it sooths me out so I can at least TRY not to have dreams...I have NO living realatives, No family at all, no best friends he was ignorant to my friends when we were together and chased all of them away. I am totally alone with my dog and cat, I am so afraid of just dying here on my floor all by myself, I may sound morbid, but I am afraid. The doctors here won't give depression meds without a fight, I tried over and over, He gave me EFFERFEX which does nothing for me, I developed high blood pressure have a pill for that I have COPD take a pill for that, I take Ultra Milk Thistle (Liv 52) and Vit.B. I try to eat but really have no appitte, my car has been down for 2 months my mechanic can't fix it, saids it's a faulty "wire" I already paid for a Ignition Modular and a Catylic Converter, over 200 bucks plus labor. I have a "scooter" I ride on to go anywhere, It gets me to work the 3 nights a week. It is getting cold out too!!So see I am a mess. I use to be so happy and had a great personality, I cry all the time, I am always "down" I don't care how I look or dress, I gained 15lbs. all my gray roots are over a inch showing, I just have no "stanmia" left. This **** makes you so Tired!!! all the time too. No energy..Well thanks for letting me dump on you!!!!
It's a struggle to be sure, but you must persist. As my dad told me when I was a kid "Knock on a door. If it doesn’t open, knock on another one. Eventually one will open".
My guess is that you just have to keep trying, as I’ve been doing. No one hands you anything in life except your parents and loved ones. You must reach out and grab what you need when you can. And so it is with treatment.
Ask your doctor about the “compassionate use” for Boceprevir. You never know...
My uncle had a sense of humor. He told me when I was a kid. “Never criticize someone until you walk a mile in their shoes”. Some years ago I took his advice, and after I was a mile away, I turned around and criticized the guy, but by then I had his shoes. I got a lot of shoes that way...
There’s your daily laugh. Goes to show that no matter how bad things seem, a sense of humor can get you over the next hurdle.... Smile....
Magnum
My guess is that you just have to keep trying, as I’ve been doing. No one hands you anything in life except your parents and loved ones. You must reach out and grab what you need when you can. And so it is with treatment.
Ask your doctor about the “compassionate use” for Boceprevir. You never know...
My uncle had a sense of humor. He told me when I was a kid. “Never criticize someone until you walk a mile in their shoes”. Some years ago I took his advice, and after I was a mile away, I turned around and criticized the guy, but by then I had his shoes. I got a lot of shoes that way...
There’s your daily laugh. Goes to show that no matter how bad things seem, a sense of humor can get you over the next hurdle.... Smile....
Magnum
Hi i have been looking for a person close to my age with the same medical condition I have. I am a non responder 2 times and have not been able to get on any trials because they don't exist in South Jersey I live in Atlantic City plenty of Casino's NO good doctors or hope or trails. The standard procesure here is give the Interferon and Riberviron for the 38 to 40 weeks and it you don't respond ,then you are told "Well better drugs are being tested so keep up the hope and good luck" the "good doctor" puts his hand out to shake, a big smile and leaves you there sitting on that table with your heart racing, your eyes welling up, and panic setting in as all you can think is I AM GOING TO DIE!!!!!! It is a terrible experience and I have been through it 3 times so far. I now am going to Camden NJ to Our Lady Of Loudes hospital (appt Feb 2010) where this Hepotoligist DOES do trails and does do transplants, I also have early Chirossis and was told I could go into liver failure a year from now or 10-15 yr's, no one knows? Gee...how "soothing" huh? Please write to me and tell me your adventure with this awful disease......
BTW,i asked my nurse about the other 10 people in my study who were on BOCEPREVIR, if they were like me with very minum sides and she said most were like me.very mild sides
Spinoza
Be not astonished at new ideas; for it is well known to you that a thing does not therefore cease to be true because it is not accepted by many.
Spinoza
Be not astonished at new ideas; for it is well known to you that a thing does not therefore cease to be true because it is not accepted by many.
Thanks to all for your well wishes. I forgot to mention that over a year ago, while I was strongly contemplating driving from Las Vegas to Cedar-Sinai Medical Center in L.A. to enter a blind clinical trial, the woman I was in touch with, who put me on the list for the Telaprivir clinical trial, did point out to me that the trials were filled, but she did mention that there are new trials coming up with Boceprevir and that she felt it had better results.
Wether or not it was a slip of the tongue or she volunteered that other possibility, it remained in my mind that there was yet a better opportunity than Telaprivir. At any rate. Either drug is better than waiting in vain. I will now ask Dr. Robert Gish, the renowned Hepatologist for his opinion on the two drugs. I will post future developments...
Magnum
Wether or not it was a slip of the tongue or she volunteered that other possibility, it remained in my mind that there was yet a better opportunity than Telaprivir. At any rate. Either drug is better than waiting in vain. I will now ask Dr. Robert Gish, the renowned Hepatologist for his opinion on the two drugs. I will post future developments...
Magnum
it is great to know that there are some good doc's out there... i wish you all the best of luck, keep us posted
Nice to see you post. I tend to think of the two drugs as equivalent more or less..... but not exactly. The trials were never set up so as to allow easy or wise comparison.
Your doctor could be right.
The initial response rates showed Vertex as superior.... but I think SGP upped their dosing and they may indeed be comparable in response.
I don't think that SGP ever was able to show comparable response rates for null-responders that Vertex did. As a matter of fact..... they did not even try to treat that group in one of their Phase 3 trials. Agreed; that is not proof but it is highly suggestive of it.
On the other hand Vertex has created data showing that (IF memory serves) that they could clear the virus, at least temporarily in half the past null responders. That was something thought to be very unlikely/impossible by many. I don't think we have great data yet but Vertex DID create a trial which would address the ability to treat the null responder and non-responder group. Once again, it ain't proof but it is highly suggestive that there may be a difference between the 2 drugs, at least for null and non responders.
There seems to be a difference in the rash area..... TVR may produce a rash; boceprevir, not.
The drop out rates between the 2 drugs is similar I believe, though. I also believe that Vertex may have been able to treat the rash, or reduce the rash drop out rates. They may have improved their drop out rate.
Boceprevir caused anemia....and I believe that many people were allowed epogen. Compare this to TVR where people were not. I think that makes comparison a little difficult. We will see some time in the future if and when the playing field is level.
Lastly, Boceprevir utilized a 4 week lead in and Vertex did not (except in one trial Phase 3) I have felt that Vertex might have gotten improved response rates with a lead in. Later on I also surmised that it was a double edged sword; improved response rates but possibly greater anemia or earlier rash kick in. I don't know the answer. Vertex probably does at this point.
I have no clue as to whether you should push or not. Many people are able to survive for quite a spell as cirrhotics. I believe that both drugs will be effective on cirrhotics. You need the ability to maintain platelets though so your doctor may be the best authority on that.
My past reasons to you to go slow were that the future will provide quite a bit of data about the best way to treat you;
1) which drug would be best for you
2) which method(s) of treatment would be best for you
a) predose vrs standard
b) whether extending TX is useful given certain responses
3) Utilizing an approved drug may allow greater latitude with your treatment.
4) Given that a treatment failure with a PI causes resistance issues, it will be
important to get it right the first time.
I know..... that may not have made it easier for you. ; )
It could be a mute point anyway. They may not allow the use.
As the drugs get closer and closer to approval I think the argument and benefits of waiting could overtake the temptations of wanting to treat.
It's a tough one though..... you must feel as though there is a small window of opportunity. It happens with this disease. I don't know the answer but my thoughts are with you.
best,
Willy
Your doctor could be right.
The initial response rates showed Vertex as superior.... but I think SGP upped their dosing and they may indeed be comparable in response.
I don't think that SGP ever was able to show comparable response rates for null-responders that Vertex did. As a matter of fact..... they did not even try to treat that group in one of their Phase 3 trials. Agreed; that is not proof but it is highly suggestive of it.
On the other hand Vertex has created data showing that (IF memory serves) that they could clear the virus, at least temporarily in half the past null responders. That was something thought to be very unlikely/impossible by many. I don't think we have great data yet but Vertex DID create a trial which would address the ability to treat the null responder and non-responder group. Once again, it ain't proof but it is highly suggestive that there may be a difference between the 2 drugs, at least for null and non responders.
There seems to be a difference in the rash area..... TVR may produce a rash; boceprevir, not.
The drop out rates between the 2 drugs is similar I believe, though. I also believe that Vertex may have been able to treat the rash, or reduce the rash drop out rates. They may have improved their drop out rate.
Boceprevir caused anemia....and I believe that many people were allowed epogen. Compare this to TVR where people were not. I think that makes comparison a little difficult. We will see some time in the future if and when the playing field is level.
Lastly, Boceprevir utilized a 4 week lead in and Vertex did not (except in one trial Phase 3) I have felt that Vertex might have gotten improved response rates with a lead in. Later on I also surmised that it was a double edged sword; improved response rates but possibly greater anemia or earlier rash kick in. I don't know the answer. Vertex probably does at this point.
I have no clue as to whether you should push or not. Many people are able to survive for quite a spell as cirrhotics. I believe that both drugs will be effective on cirrhotics. You need the ability to maintain platelets though so your doctor may be the best authority on that.
My past reasons to you to go slow were that the future will provide quite a bit of data about the best way to treat you;
1) which drug would be best for you
2) which method(s) of treatment would be best for you
a) predose vrs standard
b) whether extending TX is useful given certain responses
3) Utilizing an approved drug may allow greater latitude with your treatment.
4) Given that a treatment failure with a PI causes resistance issues, it will be
important to get it right the first time.
I know..... that may not have made it easier for you. ; )
It could be a mute point anyway. They may not allow the use.
As the drugs get closer and closer to approval I think the argument and benefits of waiting could overtake the temptations of wanting to treat.
It's a tough one though..... you must feel as though there is a small window of opportunity. It happens with this disease. I don't know the answer but my thoughts are with you.
best,
Willy
Interesting that the doctor is so enthralled with the boce over the tele. Tele has gotten so much press for so long that I'd imagine it must be true and he must have really read the information otherwise anyone would think the opposite.
God I hope he gets it for you - what a difference between this doctor and those that haven't even heard of the two drugs let alone be so helpful and caring. i can't wait for you to come back and say he got it.
It's your turn Magnum it surely is!
God I hope he gets it for you - what a difference between this doctor and those that haven't even heard of the two drugs let alone be so helpful and caring. i can't wait for you to come back and say he got it.
It's your turn Magnum it surely is!
Doctor sounds great. Hope he has some luck with Schering Plough. I'm not so sure about one drug being better than another or one having less side effects than another. I think they are just different side effects. Have been sharing notes with friend in the teleprevir trial while I am in the boceprevir trial. Teleprevir gets more attention because the developer keeps themselves in the press more but they look about the same to me. I hope we'll hear some early results from the Phase 3's for both at the AASLD meeting at the end of the month. Good luck and keep us posted.
I admire yuor determination i think it will pay off in the end best of luck steve
good luck,hope u get into the trial...thats gr8 u have a wonderful doc...hold onto to him...not all docs as u know r as caring.
Great to hear you have a doctor who is really on your side, Magnum. I'm rooting for you, let us know what happens.
This is good news indeed. I've been looking forward to some 'movement' towards the new drugs for you and it's fantastic that he's really doing his best for you (dare I say, "keep on pushing though" - (the HVC mantra).
Best wishes for some good news coming from Scherring!!!! I'll be waiting in the wings for your updates.
Best wishes for some good news coming from Scherring!!!! I'll be waiting in the wings for your updates.
It's wonderful when a Doctor gets on baord with you to fight the good fight. I had exactly the same thing happen to me. Your Doc sounds like a really great guy and I am very happy for you that he is doing everything he can. I look forward to hearing your next update.
All the best to you,
Epi.
All the best to you,
Epi.
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
