Hello, Anna.
I have followed your progress carefully because you are so honest about how you feel. I hope you start to feel better real soon. It hurts to think there is a long "detox" after tx. I can't help but think relief is close. Hang on if you can.
Alan
Anna Christie said
Mar 27, 2012
Congrats Alan How u feeling Brad? I had my ribivarin reduced from 1000 to 800 a lot, and 600 a bit , and 400 a little. Mostly I figure 60% of the time I wa on a 1000 dose especially for the first 9 weeks always. I am still undetectable. I worried and obsessd about it constantly. Believe it was the meds making me so worried about it. It still felt like I took enough to kill an elephant and thank God for it being reduced a lot of the time or I could not have stood it and would feel worse now. Hope all have few sides.
Still feeling really bad mentally and physically one week and one day post last shot. Stopped riba with last shot. Can't sleep. Ativen moderately helps but I am tapering it down. Just hanging in there. Told boss I can't come back to work this Friday so got put on LT Disability for now. Boss said will creat me a job and hire me back when I am ready to come back. Nice having nice people around. Have lost 22 pounds ad am not really hungry but forcing myself to eat. Lost of brain fog and anxiety. Fun fun. People I know who have treated say it passed for them 3rd week post shot. Glad I did it and glad I am undetectable but still feel like I am on treatment the days in the latter part of the week when the flu stuff is gone but anll the fatigue and all mentioned sides are there. I am 58 and was a thin person so got hit with disabiling side from the start. So just hanging around resting and getting out daily with friends who come to get me and waiting for better days. Will post again. about it. Hang on everyone. It is so worth it I keep telling myself that I feel awful and crazy but that I am Udetecable still and that is the important thing to have done to under go a bit more misery post treatment to have saved my life.
Isiscat2011 said
Mar 26, 2012
Sunrise747 wrote:
It is shocking that this critically important data is not readily available after so many years of trials.
Shocking it is, but it is also standard operating procedure for drug cos to bury unfavorable reports and use creative statistics to generate favorable data. Vertex was sued for securities fraud by its stockholders in 2008 when the corp. failed to disclose adverse clinical findings in connection with the Incivek trials.
My personal opinion is that the most critical time for dosing adherence is the first 12 weeks, but even after that 80% adherence should be the goal. There is no longer any doubt that dosage reductions will effect SVR (based on Incivek's own representations to the FDA); the question is how much.
Like the Incivek rep said at the FDA approval hearings "It is what it is." Pretty cold.
Isiscat2011 said
Mar 26, 2012
It just takes a while, Anna, and you will begin to feel better. You had a pretty rough go of it and that makes a difference. I was on triple tx for only 10 weeks but it took at least 6 weeks before I felt like I was half way normal. My bain fog and confusion started to lift right away, which was a blessing, but the other sx continued. Just yesterday (which is about 9 weeks post tx) my blood values had returned to within a normal range. For several weeks my blood actually got worse! These drugs are just working their way out of your system.
Well done to rest and also to hang out with friends when you can b/c you need both of these things.
-- Edited by Isiscat2011 on Tuesday 27th of March 2012 04:13:28 AM
Sunrise747 said
Mar 26, 2012
I too was dropped from 1200 mg riba to 800 in week 10 and to 600 in week 11. I remain at 600 in week 15. I share the collective concern about conflicting data on the impact on SVR. Of course that is partially offset by no desire to go back to the misery of 8.5 hgb. But I would rather do that than get an apology and offer to start over if I relapse. It is shocking that this critically important data is not readily available after so many years of trials.
innerview said
Mar 26, 2012
Phil G wrote:
My understanding is that riba is reduced for low red blood related counts, and peg is reduced for the white blood stuff.
Yes, that is what I was told by the nurse.
I pushed today to raise the doses and she said she will look at the labs and talk to the dr. and call me with results tomorrow. She said they most likely will not be upping the Riba until perhaps after I'm off Inc.
Isiscat2011 said
Mar 26, 2012
innerview wrote:
I am also on reduced interferon... anyone else?
My interferon was reduced when my platelets dropped into the 50s.
Phil G said
Mar 26, 2012
My understanding is that riba is reduced for low red blood related counts, and peg is reduced for the white blood stuff.
news said
Mar 26, 2012
No, they have always blamed the RIBA for my blood problems, so the interferon stayed at the original dose. I was at 600mg/day of riba for about three weeks I guess, then the labs showed the hgb coming back, so they quit the procrit, and a couple weeks later they raised the RIBA dose up 800. I am thinking 1000 would be better, but I'll take what I can get. The pharmacy wanted to send the procrit again this month, but I told them no, but I think I'll call them back tomorrow and tell them to include it after all. That way I'll have it here if things turn south again.
So, find out why they have you on reduced interferon AND riba. I bet they have a reason.
Alan
innerview said
Mar 25, 2012
I'm going to ask again tomorrow for an increase in my Riba... but I have a sinking feeling that if my labs come back with even a little drop in blood count they may want to reduce me again... from 800/d to 600. God I hope not.
I am also on reduced interferon... anyone else?
Mark
Isiscat2011 said
Mar 22, 2012
Hi Brad: I know what you mean, and there comes a point sometimes where you almost don't want to know more, because when you find one deception you know there are probably more.
To me it looks like Fleischer was doing some heavy back peddling trying to recover from his initial representation that riba reductions do not effect SVR. What I take away from this exchange is that riba reductions clearly do effect SVR and the greater and longer the reduction the greater the decline in SVR rates.
The moral of the story is not to be afraid, but rather to discuss all options with doc when making and continuing riba reductions, and also make sure doc is not simply reading the drug co's marketing information or listening to the drug co's reps. With new drugs flooding the market constantly, and most doc working 12-14 hours a day between the office and hospital rounds, I can't imagine that they have time to read through all the FDA approval committee hearing transcripts before they prescribe each new drug.
krowdog said
Mar 21, 2012
Isiscat,
Thanks for the Fleischer/Knodell dialog. Fascinating.
Am I missing something here?
First Mr Fleischer says:
"Among subjects who underwent a dose modification or interruption of ribavirin, a temporary interruption, the SVR rate went down to about 73 percent in naives..."
Then he says:
But just doing things like reducing the dose of ribavirin, interrupting it or discontinuing, can decrease the SVR rate from about 75 percent to about 40 percent in naives..."
What gives? I am beginning to wonder about the validity of much of the information I thought was true.
Brad
Isiscat2011 said
Mar 20, 2012
Alan: I think you are right on this. I hate to sound like a broken record, and I sure don't want to bum anybody out, but sometimes we have to question things.
Shep: You are the amazing one. I am pulling for you all the way.
Shep said
Mar 20, 2012
Alan--glad you have reached the halfway point--hopefully it will be smooth sailing until the end. Also glad you insisted/compromised on the riba--helps to ease one's concerns. Isiscat--you are completely amazing--thanks so much for your research and info. I am starting Procrit for anemia --today--anxiously awaiting the UPS truck on a rainy spring break day. There was some talk of reducing my riba--but as yet that has not happened. I will talk with my doc and get his feelings on the subject. He likes to put a positive spin on things which I do appreciate his" we can do this" attitude but sometimes I wonder if he down plays things to much. They did increase my thryroid--again--between the out-of-control thryoid and anemia I am a bundle of let's hang out on the couch. Shep
news said
Mar 20, 2012
Thanks for the comments. I always tend to oversimplify, but if the ribavirin dose can be reduced without affecting results then why isn't that a part of the protocol from the get go. I am going to campaign for the highest dose I can tolerate up to 1200mg/day for the remaining 18 weeks. I know what low hematocrit feels like now, plus I am doing regular draws, so I don't mind teetering on a fence. I just want to get well.
Alan
Isiscat2011 said
Mar 20, 2012
news wrote:
She gets to remain comfortable with the new medical data showing that reduced riba does not affect success rates, and I get to stop worrying about too little riba. And if my hematocrit stays up, maybe they'll go all the way back up to 1200.
"Just when you think you are out..... they pull you back in." Michael Coreleone.
I know this sounds sadistic but I am glad you are increasing your riba, Alan. The view that dose reduction does not effect SVR has always sounded suspect to me as well.
It seems to me that the only reliable answer to this question would have to come from the people who performed the clinical trials b/c they are the only ones with the beginning to end SVR data. And, guess what? This was a big issue at the Incivek FDA approval hearings, and here is what Incivek (Dr. Fleischer) had to say when questioned:
DR. KNODELL: I have two questions. The first one relates to this ribavirin. I think this is really an important clinical point. When we make dose reductions with ribavirin, we try and do it later in the treatment. If you can carry these people out 16 or 17 weeks and then cut your dose, they seem to do better. There's no question that ribavirin reductions decrease SVR. Now, you made a statement, Dr. Fleischer, that there was no decrease in SVR with ribavirin decreases or reductions, but we didn't see any data to support that. And when I look at their anemia timeline, the timeline of anemia is fairly quick. It's during the first 4 to 12 weeks of treatment than both groups. And the majority of the anemia is due to ribavirin. There is an incremental increase with the telaprevir, but certainly ribavirin would probably be the drug that we'd want to start reducing rather than stopping the telaprevir, if I'm a clinician out in the real world taking care of these patients. So I wondered if you could expand, what is your basis for saying that ribavirin reductions did not decrease SVRs? And what was the timing of those ribavirin reductions when they were made?
MR. FLEISCHER: I'd have to go back and look at the timing. But we found -- let's see. It says, "Among subjects who underwent a dose modification or interruption of ribavirin, a temporary interruption, the SVR rate went down to about 73 percent in naives and about 77 percent in experienced subjects overall." So there was a little bit of a -- I forget what the --
DR. KNODELL: We didn't see that data.
MR. FLEISCHER: I know. I have it in case you want it.
DR. KNODELL: All right.
MR. FLEISCHER: But just doing things like reducing the dose of ribavirin, interrupting it or discontinuing, can decrease the SVR rate from about 75 percent to about 40 percent in naives, and from about 65 percent to about 20 percent in treatment-experienced subjects. So taking the ribavirin away had a much bigger impact than trying to keep some ribavirin on board. And we saw from the Phase 2 trials, where there were ribavirin-sparing arms, that they didn't really actually respond better than control, peg/ribavirin arms. So I think there was an attempt to try to keep patients on ribavirin as best as possible. But it is what it is.
news said
Mar 20, 2012
I went to the doctor this morning to visit with the nurse practioner. She said my labs from last Monday look real good, and specifically my hematocrit was up to 40. This is almost normal for a regular guy. So before I knew what was going on I blurted out "So when do we up the ribavirin dose?" She went to the doctor and when she returned she said "OK, take it up to 800mg/day." So, I have 14 of the old 600mg tabs, and a bunch of the 200's, so she told me to take a 600 in tne morning and a 200 at night, then gave me two weeks worth of ribapacks that have 2 400mg tabs in day packs just like when I started.
Comprimise is a wonderful thing. She gets to remain comfortable with the new medical data showing that reduced riba does not affect success rates, and I get to stop worrying about too little riba. And if my hematocrit stays up, maybe they'll go all the way back up to 1200.
Oh, and most importantly Sunday was my 18th shot and this is my 18th week, marking half way through treatment. That has a good sound to it.
Congrats Alan How u feeling Brad? I had my ribivarin reduced from 1000 to 800 a lot, and 600 a bit , and 400 a little. Mostly I figure 60% of the time I wa on a 1000 dose especially for the first 9 weeks always. I am still undetectable. I worried and obsessd about it constantly. Believe it was the meds making me so worried about it. It still felt like I took enough to kill an elephant and thank God for it being reduced a lot of the time or I could not have stood it and would feel worse now. Hope all have few sides.
Still feeling really bad mentally and physically one week and one day post last shot. Stopped riba with last shot. Can't sleep. Ativen moderately helps but I am tapering it down. Just hanging in there. Told boss I can't come back to work this Friday so got put on LT Disability for now. Boss said will creat me a job and hire me back when I am ready to come back. Nice having nice people around. Have lost 22 pounds ad am not really hungry but forcing myself to eat. Lost of brain fog and anxiety. Fun fun. People I know who have treated say it passed for them 3rd week post shot. Glad I did it and glad I am undetectable but still feel like I am on treatment the days in the latter part of the week when the flu stuff is gone but anll the fatigue and all mentioned sides are there. I am 58 and was a thin person so got hit with disabiling side from the start. So just hanging around resting and getting out daily with friends who come to get me and waiting for better days. Will post again. about it. Hang on everyone. It is so worth it I keep telling myself that I feel awful and crazy but that I am Udetecable still and that is the important thing to have done to under go a bit more misery post treatment to have saved my life.
Shocking it is, but it is also standard operating procedure for drug cos to bury unfavorable reports and use creative statistics to generate favorable data. Vertex was sued for securities fraud by its stockholders in 2008 when the corp. failed to disclose adverse clinical findings in connection with the Incivek trials.
My personal opinion is that the most critical time for dosing adherence is the first 12 weeks, but even after that 80% adherence should be the goal. There is no longer any doubt that dosage reductions will effect SVR (based on Incivek's own representations to the FDA); the question is how much.
Like the Incivek rep said at the FDA approval hearings "It is what it is." Pretty cold.
It just takes a while, Anna, and you will begin to feel better. You had a pretty rough go of it and that makes a difference. I was on triple tx for only 10 weeks but it took at least 6 weeks before I felt like I was half way normal. My bain fog and confusion started to lift right away, which was a blessing, but the other sx continued. Just yesterday (which is about 9 weeks post tx) my blood values had returned to within a normal range. For several weeks my blood actually got worse! These drugs are just working their way out of your system.
Well done to rest and also to hang out with friends when you can b/c you need both of these things.
-- Edited by Isiscat2011 on Tuesday 27th of March 2012 04:13:28 AM
I too was dropped from 1200 mg riba to 800 in week 10 and to 600 in week 11. I remain at 600 in week 15. I share the collective concern about conflicting data on the impact on SVR. Of course that is partially offset by no desire to go back to the misery of 8.5 hgb. But I would rather do that than get an apology and offer to start over if I relapse. It is shocking that this critically important data is not readily available after so many years of trials.
Yes, that is what I was told by the nurse.
I pushed today to raise the doses and she said she will look at the labs and talk to the dr. and call me with results tomorrow. She said they most likely will not be upping the Riba until perhaps after I'm off Inc.
My interferon was reduced when my platelets dropped into the 50s.
My understanding is that riba is reduced for low red blood related counts, and peg is reduced for the white blood stuff.
I am also on reduced interferon... anyone else?
Mark
Hi Brad: I know what you mean, and there comes a point sometimes where you almost don't want to know more, because when you find one deception you know there are probably more.
To me it looks like Fleischer was doing some heavy back peddling trying to recover from his initial representation that riba reductions do not effect SVR. What I take away from this exchange is that riba reductions clearly do effect SVR and the greater and longer the reduction the greater the decline in SVR rates.
The moral of the story is not to be afraid, but rather to discuss all options with doc when making and continuing riba reductions, and also make sure doc is not simply reading the drug co's marketing information or listening to the drug co's reps. With new drugs flooding the market constantly, and most doc working 12-14 hours a day between the office and hospital rounds, I can't imagine that they have time to read through all the FDA approval committee hearing transcripts before they prescribe each new drug.
Isiscat,
Thanks for the Fleischer/Knodell dialog. Fascinating.
Am I missing something here?
First Mr Fleischer says:
"Among subjects who underwent a dose modification or interruption of ribavirin, a temporary interruption, the SVR rate went down to about 73 percent in naives..."
Then he says:
But just doing things like reducing the dose of ribavirin, interrupting it or discontinuing, can decrease the SVR rate from about 75 percent to about 40 percent in naives..."
What gives? I am beginning to wonder about the validity of much of the information I thought was true.
Brad
Alan: I think you are right on this. I hate to sound like a broken record, and I sure don't want to bum anybody out, but sometimes we have to question things.
Shep: You are the amazing one. I am pulling for you all the way.
Isiscat--you are completely amazing--thanks so much for your research and info. I am starting Procrit for anemia --today--anxiously awaiting the UPS truck on a rainy spring break day. There was some talk of reducing my riba--but as yet that has not happened. I will talk with my doc and get his feelings on the subject. He likes to put a positive spin on things which I do appreciate his" we can do this" attitude but sometimes I wonder if he down plays things to much. They did increase my thryroid--again--between the out-of-control thryoid and anemia I am a bundle of let's hang out on the couch.
Shep
Thanks for the comments. I always tend to oversimplify, but if the ribavirin dose can be reduced without affecting results then why isn't that a part of the protocol from the get go. I am going to campaign for the highest dose I can tolerate up to 1200mg/day for the remaining 18 weeks. I know what low hematocrit feels like now, plus I am doing regular draws, so I don't mind teetering on a fence. I just want to get well.
Alan
I went to the doctor this morning to visit with the nurse practioner. She said my labs from last Monday look real good, and specifically my hematocrit was up to 40. This is almost normal for a regular guy. So before I knew what was going on I blurted out "So when do we up the ribavirin dose?" She went to the doctor and when she returned she said "OK, take it up to 800mg/day." So, I have 14 of the old 600mg tabs, and a bunch of the 200's, so she told me to take a 600 in tne morning and a 200 at night, then gave me two weeks worth of ribapacks that have 2 400mg tabs in day packs just like when I started.
Comprimise is a wonderful thing. She gets to remain comfortable with the new medical data showing that reduced riba does not affect success rates, and I get to stop worrying about too little riba. And if my hematocrit stays up, maybe they'll go all the way back up to 1200.
Oh, and most importantly Sunday was my 18th shot and this is my 18th week, marking half way through treatment. That has a good sound to it.
Alan