Aa
No RVR on SOC
Drum roll............HCV RNA iu/mL: 226
Nurse called with week 4 labs and I didn't clear. Kinda bummed, but I will be really bummed if I don't clear at 6 weeks as that will mean I got placebo. It is an official 4 log drop by week 4 though, so I am thankful for that.
And my platelets are a freak show. The are almost normal in the 120s and have been over 100 since I screened!! It is so confusing. My spleen is enlarged, HR had my Fibroscan at 21, I have varicies and my platelets are hanging in on tx. I know they fluctuate, but I am clearly interferon sensitive and yet it is not making my platelets tank. Go figure.
This does make for a weird situation as far as figuring out the placebo thing, though. Stormrider, did you ever get your 4 week labs? Were you clear at 4? If I am clear at 6, I will not know if it was just SOC or I got the Boceprevir.
If I am NOT clear, I feel that it means placebo, right? NYGirl hung at 400 forever on SOC. Even though it would be only two weeks of trial drug, there is only 226 of those suckers to kill. Also, if in placebo arm and you are clear at treatment week 24, I think (I have to look the week up again) you aren't offered the rollover to the real drug.
Another thing is my blood has been drawn about 44 hours after injection on 2 and 4. My week 6 will be next Wednesday, 96 hours post injection. Does that screw things up? Here are my labs to date:
TREATMENT WEEK 0 (Day 1)
HCV RNA iu/mL: 9,920,000
Bilirubin: 0.7
ALT: 44 AST: 41
Creatinine: 0.8
Hemoglobin: 15.75
WBC: 5.36
ANC: 3.7
Neutrophils: 69
Platelets: 137
TREATMENT WEEK 2
HCV RNA iu/mL: 2420
Bilirubin: 1.1
ALT: 21 AST: 30
Creatinine: 0.6
Hemoglobin: 12.2
WBC: 2.95
ANC: 1.67
Neutrophils: 56.7
Platelets: 127
TREATMENT WEEK 4
HCV RNA iu/mL:
Bilirubin: 0.7
ALT: 18 AST: 27
Creatinine: 0.6
Hemoglobin: 10.9
WBC: 1.78
ANC: 1.0
Neutrophils: 56.9
Platelets: 124
Nurse made no comment about anything and didn't ask how I was feeling (which, I realize now, doesn't matter to them after no help through the horror of the first three weeks). I have nurse appointments but do not see the doc until February. I thought a few things seemed a little low but I guess not enough to concern them. Just can't walk for more than 20 paces without having to sit down, but oh well (unless I am having chest pains or am ready to kill myself, there is no reaction). I guess the upside is my body is absorbing the hell out of the riba.
Super smiley sweet and nice nurses though! Plenty of nodding of the heads, "Oh gosh darn it, that's unfortunate, yes, those darn sides, cripes that's too bad, are you drinking enough water, oh, don't drink too much water, hmmm you should be feeling fine by now, because most people don't have many side effects at this center, you know a positive attitude really takes care of many of our patients side effects..." ARRRGGGHHH.
One thing that I don't get is the helper for whites getting pooh-poohed by two doctors I am dealing with. My main doc (big shot transplant guy, hcv expert) said they don't believe it works and don't prescribe it, and the trial doc says it isn't part of the trial. I know that shouldn't be a concern unless ANC would drop quite a bit lower, but I would like to know what the deal is. Wonder if I will have to be near heart attack to get Procrit.
I am due for my 6 month AFP and ultrasound for HCC that is through my main guy, maybe he will go ahead and prescribe whatever I need. I have the damn insurance.
Can you tell I am crabby? Anyone? Anyone? I guess that is enough venting/rambling for now. I will return before the New Year in a better mood.
Foo
Nurse called with week 4 labs and I didn't clear. Kinda bummed, but I will be really bummed if I don't clear at 6 weeks as that will mean I got placebo. It is an official 4 log drop by week 4 though, so I am thankful for that.
And my platelets are a freak show. The are almost normal in the 120s and have been over 100 since I screened!! It is so confusing. My spleen is enlarged, HR had my Fibroscan at 21, I have varicies and my platelets are hanging in on tx. I know they fluctuate, but I am clearly interferon sensitive and yet it is not making my platelets tank. Go figure.
This does make for a weird situation as far as figuring out the placebo thing, though. Stormrider, did you ever get your 4 week labs? Were you clear at 4? If I am clear at 6, I will not know if it was just SOC or I got the Boceprevir.
If I am NOT clear, I feel that it means placebo, right? NYGirl hung at 400 forever on SOC. Even though it would be only two weeks of trial drug, there is only 226 of those suckers to kill. Also, if in placebo arm and you are clear at treatment week 24, I think (I have to look the week up again) you aren't offered the rollover to the real drug.
Another thing is my blood has been drawn about 44 hours after injection on 2 and 4. My week 6 will be next Wednesday, 96 hours post injection. Does that screw things up? Here are my labs to date:
TREATMENT WEEK 0 (Day 1)
HCV RNA iu/mL: 9,920,000
Bilirubin: 0.7
ALT: 44 AST: 41
Creatinine: 0.8
Hemoglobin: 15.75
WBC: 5.36
ANC: 3.7
Neutrophils: 69
Platelets: 137
TREATMENT WEEK 2
HCV RNA iu/mL: 2420
Bilirubin: 1.1
ALT: 21 AST: 30
Creatinine: 0.6
Hemoglobin: 12.2
WBC: 2.95
ANC: 1.67
Neutrophils: 56.7
Platelets: 127
TREATMENT WEEK 4
HCV RNA iu/mL:
Bilirubin: 0.7
ALT: 18 AST: 27
Creatinine: 0.6
Hemoglobin: 10.9
WBC: 1.78
ANC: 1.0
Neutrophils: 56.9
Platelets: 124
Nurse made no comment about anything and didn't ask how I was feeling (which, I realize now, doesn't matter to them after no help through the horror of the first three weeks). I have nurse appointments but do not see the doc until February. I thought a few things seemed a little low but I guess not enough to concern them. Just can't walk for more than 20 paces without having to sit down, but oh well (unless I am having chest pains or am ready to kill myself, there is no reaction). I guess the upside is my body is absorbing the hell out of the riba.
Super smiley sweet and nice nurses though! Plenty of nodding of the heads, "Oh gosh darn it, that's unfortunate, yes, those darn sides, cripes that's too bad, are you drinking enough water, oh, don't drink too much water, hmmm you should be feeling fine by now, because most people don't have many side effects at this center, you know a positive attitude really takes care of many of our patients side effects..." ARRRGGGHHH.
One thing that I don't get is the helper for whites getting pooh-poohed by two doctors I am dealing with. My main doc (big shot transplant guy, hcv expert) said they don't believe it works and don't prescribe it, and the trial doc says it isn't part of the trial. I know that shouldn't be a concern unless ANC would drop quite a bit lower, but I would like to know what the deal is. Wonder if I will have to be near heart attack to get Procrit.
I am due for my 6 month AFP and ultrasound for HCC that is through my main guy, maybe he will go ahead and prescribe whatever I need. I have the damn insurance.
Can you tell I am crabby? Anyone? Anyone? I guess that is enough venting/rambling for now. I will return before the New Year in a better mood.
Foo
Good luck calling schering, when i first saw this trial posted i noticed the cut off limit on platelets was 100,000. I just had a CBC done and my level was at 80,000. I though oh s h i t that excludes me. I send an email right then to my hepo. He gave me a quick response...... Don't worry about it I'll get you in.
Still worried i called and talked with a rep at schering, he finally told me there was a 10% lead way which would allow one in at 90,000. He also told me that the final call would be my doctors so if my doctor said 80,000 was not a problem then it would not be a problem.
He also said while there is certain rules that must be followed even by the doctor there is also alot of things the doctor can do.
My Hepo is very comfortable in his skin and has no problem letting patients state their case, and yes there are times he's very busy and is in and out fast but for the most part he will set and gab and shoot the c r a p. Plus he has a hell of a sense of humor.
Still worried i called and talked with a rep at schering, he finally told me there was a 10% lead way which would allow one in at 90,000. He also told me that the final call would be my doctors so if my doctor said 80,000 was not a problem then it would not be a problem.
He also said while there is certain rules that must be followed even by the doctor there is also alot of things the doctor can do.
My Hepo is very comfortable in his skin and has no problem letting patients state their case, and yes there are times he's very busy and is in and out fast but for the most part he will set and gab and shoot the c r a p. Plus he has a hell of a sense of humor.
Good luck...i try to get answers to these questions and it seems they are so busy..its like an assemly line....i cant really blame them because it seems they dont even know all the details..like i said...i shall call Schring and Plough on monday from work...i even have a ext ph number ...you gotta admit...it does seems a wee bit complicated...Arm 1 is the thorn in our sides...no pun intended
Yes from what i understand your right. My thinking is and i can't say for sure because my doctor never came right out and said this is because we are geno 1 relapsers/nonresponders that had to extend because we didn't clear by week 12 the first time the odds are we will be slow responders this tx.
One other thing is this is a double blinded trial but at week 12 does it become just blinded??? To where the doctor then is aware of what drug your getting and switch you over to the boceprevir in a blinded fashison.
Between brain fog and the time between my screening and long talk with the doctor i do remember him saying at some time i would get the real drug.
You have brought up alot of good questions and sense my hepo has been very involved in these trials my next visit i will have a list and i'll be checking it twice. And as i get the answers i will be writing them down.
One other thing is this is a double blinded trial but at week 12 does it become just blinded??? To where the doctor then is aware of what drug your getting and switch you over to the boceprevir in a blinded fashison.
Between brain fog and the time between my screening and long talk with the doctor i do remember him saying at some time i would get the real drug.
You have brought up alot of good questions and sense my hepo has been very involved in these trials my next visit i will have a list and i'll be checking it twice. And as i get the answers i will be writing them down.
am i right in saying we wont know what arm we are in until the trial is completely over....?
i wonder when unblind us ?
o well...just eat and shoot the freakn stuff
i wonder when unblind us ?
o well...just eat and shoot the freakn stuff
this means you can end up doing 48 weeks of tx with SOC...just like the last tx in 2006....what are the odds of SVR for that senario?....i am not liking this at all
Arm 1 is bogus....in order to have any chance in this arm...you need the virus in your blood at wK 12,in order to get the BOC...if you clear at wk 12...you dont get the BOC...just 48 weeks of SOC....that really ***** for non responders...and the sad thing is....i dont think they will unblind you at wk 12....SCARY STUFF?
but if you clear by week 12 ,dont you just continue on with the SOC drugs if you are in arm 1?
Foo, yes my platelets tank on tx. Last time they got down into the 30 to 40,000 range. Also have problems with my hgb. Its already went down from over 15 to 11.
Rock, yes that is the navie trial study storm posted.... My Hepo told me my week 12 pcr should be back in a week, at which time if i'm on the placebo he will start me right then on the real thing. So your still looking at 35 weeks of boceprevir.
Rock, yes that is the navie trial study storm posted.... My Hepo told me my week 12 pcr should be back in a week, at which time if i'm on the placebo he will start me right then on the real thing. So your still looking at 35 weeks of boceprevir.
I THINK THIS INFO is for the naive trial...because my papers say i have a 4 out of 5 chance of getting the real drugs...not 2/3...
I do have all this info already...but for the life of me...i still dont fully understand it all..i need a "nut shell" version...LOL
It looks like no matter waht arm we are in....we have the option to get the real drugs at certain times in all 3 arms....not too bad
Hi foo... Happy New Year!
Looks like you are getting some good results so far. Hang in there and keep the prize in your sights. I have not yet received my 4 week PCR, I do have all the other labs for week 4. You brought up some good questions about the different arms and duration, I scanned the trial docs in and did a copy/paste, thought we could use this for a quick reference if needed. If there are some grammer errors it's from the OCR. This is for the naive study only.
---------------------------------------------------------------------------------------------
How Long Will This Study Last?
The screening phase to determine whether you qualify for the study should take approximately 1 to 8 weeks. The study will include 28 or 48 weeks of therapy. The length of the study phase will be based on the study arm to which you will be assigned. The follow-up phase will, also depend on the study arm to which you are assigned, and will range from 24 weeks to 44 weeks. In total, you will be participating in the study for 72 weeks once you are randomly assigned to the study.
Study Procedures
All arms initially will start with “Lead-in”. The lead-in period will be therapy with only Peglntron and ribavirin for 4 weeks. Peglntron (1.5 mcg/kg) will be injected subcutaneously (under the skin) weekly and ribavirin (600 to 1400 mg/day, based on your weight) will be taken by mouth 2 times a day.
After the “lead in” period, the drugs you receive will depend on which arm of this study you are randomly assigned to and how the virus in your blood responds to the drugs.
How will the assignment be done?
Assignment to a study arm will be determined by chance like a toss of a coin. You will have a 2 out of 3 chance to receive the experimental drug boceprevir plus standard treatment with Peglntron and ribavirin, and a 1 out of 3 chance to receive standard treatment with Peglntron and ribavirin alone. The study subjects who receive Peglntron and ribavirin alone, will also receive a placebo, which by appearance looks like boceprevir, but doesn’t have any active medical ingredient. The study assignment will be done by a computerized system, called the Interactive Voice Response System (IVRS), in a “double blind” fashion. This means that neither you nor your study doctor will know which arm you are in and what drug regimen you will receive. The dose of your Peglntron and ribavirin will be based on your weight when you enter the study. The study procedures for each of the arms is described below:
Arm 1: Subjects in this arm will receive Peglntron 1.5 mcg/kg and ribavirin, along with placebo. The arm is called the “control” arm.
• Lead-in phase: Peglntron + ribavirin for 4 weeks (see above)
• After week 4 (TW4), you will be given a placebo pill. This will be taken by mouth 3 times a day, in addition to your Peglntron and ribavirin therapy.
• You may continue with placebo, Peglntron and ribavirin for up to 44 weeks.
• At TW 24, the amount of virus in your blood will be measured to determine whether or not you will be able to continue the study after week 28:
- If the hepatitis C virus is not detectable (no hepatitis C virus measured in your blood), you will continue with placebo + Peglntron and ribavirin therapy for a total of 48 weeks.
- If the hepatitis C virus is detectable after 24 weeks, you will be discontinued from the study at TW 28. If you are discontinued from this control arm, you will have two options. You can either proceed to follow-up, where you will no longer be receiving the study drug but will be monitored for side effects, or since you were in the control arm, you can choose to participate in another boceprevir study called “PROVIDE” (where you will be given boceprevir as well as your Peglntron and ribavirin treatment). While you are receiving the study drug, the study doctor and staff will not know you are in the control arm. If your virus is detected after week 24 and the study drug is stopped, the study doctor and staff will be informed by SPRI whether or not you are might qualify for the PROVIDE study. Your study doctor will discuss these options with you in detail during your discontinuation visit.
Arm 2: Subjects in this arm will receive a short period (24 weeks) of boceprevir plus Peglntron 1.5 mcg/kg and ribavirin and possibly an additional 20-week with Peglntron and ribavirin, along with boceprevir placebo, depending on how fast they respond to therapy.
• Lead-in phase: Peglntron + ribavirin for 4 weeks.
• After TW 4, boceprevir (800 mg by mouth, 3 times a day), will be added to the Peglntron + ribavirin.
• At TW 8, the amount of hepatitis C virus in your blood will be measured to determine whether or not, you will be continuing the study after week 28:
-If the hepatitis C virus is not detectable in your blood at TW 8 and at all subsequent visits, then at TW 28 you will discontinue active study therapy, and proceed to 44 weeks of follow-up.
-If the hepatitis C virus is detectable in your blood at TW 8 or at any subsequent visit, t hen at TW 28 the boceprevir will be switched to a placebo pill (neither you nor your study doctor will know this has occurred), and you will continue, to take placebo + Peglntron + ribavirin for an additional 20 weeks (for a total duration of 48 weeks) followed by 24 week follow-up.
• At TW 24 the amount of virus, in your blood will be measured to determine whether or not you will be continuing the study therapy:
-If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned therapy.
-If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study. For that reason you might be asked to come to the clinic for an unscheduled visit for a test of the amount of hepatitis C virus in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.
Arm 3: Subjects in this arm will receive 44 weeks of boceprevir, along with Peglntron 1.5 mcg/kg and ribavirin.
• Lead-in phase: Peglntron +ribavirin for 4 weeks
• After week 4, boceprevir (800 mg by mouth 3 times a day), will be added to the Peglntron + ribavirin.
• You will continue with boceprevir, Peglntron and ribavirin for up to 44 weeks (for a total duration of 48 weeks).
• At TW 24 the amount of virus in your blood will be measured to determine whether or not you will be continuing the study:
-If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned study therapy.
-If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study at TW 28. For that reason you might be asked to come to clinic for an unscheduled visit for a test of the amount of hepatitis C in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.
Unblinding of the study
During the study neither you nor your study doctor or study staff will know whether you are receiving boceprevir, or placebo. After the study is completed at all centers worldwide, and the study report is issued, SPRI will provide the unblinded information to your study doctor. In case of emergency for which it is necessary to know whether you received boceprevir or placebo, your study doctor will call the IVRS (lab) which can provide this information 7days a week 24 hours per day.
Looks like you are getting some good results so far. Hang in there and keep the prize in your sights. I have not yet received my 4 week PCR, I do have all the other labs for week 4. You brought up some good questions about the different arms and duration, I scanned the trial docs in and did a copy/paste, thought we could use this for a quick reference if needed. If there are some grammer errors it's from the OCR. This is for the naive study only.
---------------------------------------------------------------------------------------------
How Long Will This Study Last?
The screening phase to determine whether you qualify for the study should take approximately 1 to 8 weeks. The study will include 28 or 48 weeks of therapy. The length of the study phase will be based on the study arm to which you will be assigned. The follow-up phase will, also depend on the study arm to which you are assigned, and will range from 24 weeks to 44 weeks. In total, you will be participating in the study for 72 weeks once you are randomly assigned to the study.
Study Procedures
All arms initially will start with “Lead-in”. The lead-in period will be therapy with only Peglntron and ribavirin for 4 weeks. Peglntron (1.5 mcg/kg) will be injected subcutaneously (under the skin) weekly and ribavirin (600 to 1400 mg/day, based on your weight) will be taken by mouth 2 times a day.
After the “lead in” period, the drugs you receive will depend on which arm of this study you are randomly assigned to and how the virus in your blood responds to the drugs.
How will the assignment be done?
Assignment to a study arm will be determined by chance like a toss of a coin. You will have a 2 out of 3 chance to receive the experimental drug boceprevir plus standard treatment with Peglntron and ribavirin, and a 1 out of 3 chance to receive standard treatment with Peglntron and ribavirin alone. The study subjects who receive Peglntron and ribavirin alone, will also receive a placebo, which by appearance looks like boceprevir, but doesn’t have any active medical ingredient. The study assignment will be done by a computerized system, called the Interactive Voice Response System (IVRS), in a “double blind” fashion. This means that neither you nor your study doctor will know which arm you are in and what drug regimen you will receive. The dose of your Peglntron and ribavirin will be based on your weight when you enter the study. The study procedures for each of the arms is described below:
Arm 1: Subjects in this arm will receive Peglntron 1.5 mcg/kg and ribavirin, along with placebo. The arm is called the “control” arm.
• Lead-in phase: Peglntron + ribavirin for 4 weeks (see above)
• After week 4 (TW4), you will be given a placebo pill. This will be taken by mouth 3 times a day, in addition to your Peglntron and ribavirin therapy.
• You may continue with placebo, Peglntron and ribavirin for up to 44 weeks.
• At TW 24, the amount of virus in your blood will be measured to determine whether or not you will be able to continue the study after week 28:
- If the hepatitis C virus is not detectable (no hepatitis C virus measured in your blood), you will continue with placebo + Peglntron and ribavirin therapy for a total of 48 weeks.
- If the hepatitis C virus is detectable after 24 weeks, you will be discontinued from the study at TW 28. If you are discontinued from this control arm, you will have two options. You can either proceed to follow-up, where you will no longer be receiving the study drug but will be monitored for side effects, or since you were in the control arm, you can choose to participate in another boceprevir study called “PROVIDE” (where you will be given boceprevir as well as your Peglntron and ribavirin treatment). While you are receiving the study drug, the study doctor and staff will not know you are in the control arm. If your virus is detected after week 24 and the study drug is stopped, the study doctor and staff will be informed by SPRI whether or not you are might qualify for the PROVIDE study. Your study doctor will discuss these options with you in detail during your discontinuation visit.
Arm 2: Subjects in this arm will receive a short period (24 weeks) of boceprevir plus Peglntron 1.5 mcg/kg and ribavirin and possibly an additional 20-week with Peglntron and ribavirin, along with boceprevir placebo, depending on how fast they respond to therapy.
• Lead-in phase: Peglntron + ribavirin for 4 weeks.
• After TW 4, boceprevir (800 mg by mouth, 3 times a day), will be added to the Peglntron + ribavirin.
• At TW 8, the amount of hepatitis C virus in your blood will be measured to determine whether or not, you will be continuing the study after week 28:
-If the hepatitis C virus is not detectable in your blood at TW 8 and at all subsequent visits, then at TW 28 you will discontinue active study therapy, and proceed to 44 weeks of follow-up.
-If the hepatitis C virus is detectable in your blood at TW 8 or at any subsequent visit, t hen at TW 28 the boceprevir will be switched to a placebo pill (neither you nor your study doctor will know this has occurred), and you will continue, to take placebo + Peglntron + ribavirin for an additional 20 weeks (for a total duration of 48 weeks) followed by 24 week follow-up.
• At TW 24 the amount of virus, in your blood will be measured to determine whether or not you will be continuing the study therapy:
-If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned therapy.
-If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study. For that reason you might be asked to come to the clinic for an unscheduled visit for a test of the amount of hepatitis C virus in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.
Arm 3: Subjects in this arm will receive 44 weeks of boceprevir, along with Peglntron 1.5 mcg/kg and ribavirin.
• Lead-in phase: Peglntron +ribavirin for 4 weeks
• After week 4, boceprevir (800 mg by mouth 3 times a day), will be added to the Peglntron + ribavirin.
• You will continue with boceprevir, Peglntron and ribavirin for up to 44 weeks (for a total duration of 48 weeks).
• At TW 24 the amount of virus in your blood will be measured to determine whether or not you will be continuing the study:
-If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned study therapy.
-If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study at TW 28. For that reason you might be asked to come to clinic for an unscheduled visit for a test of the amount of hepatitis C in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.
Unblinding of the study
During the study neither you nor your study doctor or study staff will know whether you are receiving boceprevir, or placebo. After the study is completed at all centers worldwide, and the study report is issued, SPRI will provide the unblinded information to your study doctor. In case of emergency for which it is necessary to know whether you received boceprevir or placebo, your study doctor will call the IVRS (lab) which can provide this information 7days a week 24 hours per day.
BTW...i am calling the big guns on monday and find out once and for all what this study is all about....they didi call me back last week and they gave me an ext number...no offece to my dotors and stuff...but it seems like im in the dark still on details...I WILL FIND OUT
i just re read my papeers from my doc...it says if i am in arm 1 and i dont clear by wk 12....i have 2 options...i can decide to stop,which seems stupid too me...or i can continue with "open label' BOC will be given...it does not mention how long after the 12 weeks tho...but again...it looks good but it dont...its like a trade off...any way i look at these arms...its always better to RVR...seems like thats the most determing factor here...if you get chosen to be in arm 3 you have the best chance to SVR.....BUT...more drug toll on the body....it seems to me its all a trade off....i guess we cant have the cake and it it too again
sorry....im getting the two trail times (navie and nonresponder) mixed up here....but i think you know what im talkn about....
...if you are clear at week 28
i meant to say if yu stop tx at week 28 and clear by wek 8
i meant to say if yu stop tx at week 28 and clear by wek 8
YOU SAID:
In our Arm 2, if und at TW8, you are DONE. Kinda scary.
it is,but at the same time its not...if you are clear at week 28...your odds are 82% to SVR.thats based on the lastest naive trial results...BUT...if are still detectable at week 28,you do another 12 weeks...now im not sure if those extra 12 weeks will be SOC,or with BOC/PLECBO..you know about that/?
....me thinks i want to clear at wk 28
AS FOR THE the arm 1 ,i think if your not clear by week 12...you get the real stuff
In our Arm 2, if und at TW8, you are DONE. Kinda scary.
it is,but at the same time its not...if you are clear at week 28...your odds are 82% to SVR.thats based on the lastest naive trial results...BUT...if are still detectable at week 28,you do another 12 weeks...now im not sure if those extra 12 weeks will be SOC,or with BOC/PLECBO..you know about that/?
....me thinks i want to clear at wk 28
AS FOR THE the arm 1 ,i think if your not clear by week 12...you get the real stuff
So, if in Arm 2, you guys will be rolled into the 36 or 48 weeks soon? After TW8 labs come back?
Nothing happens for naives until TW28 (but what happens is still based on those week 8 VL results). In our Arm 2, if und at TW8, you are DONE. Kinda scary.
BTW, has anyone pinned their doc down on how the rollover works for Arm 1's?
Can-do, are your platelets hanging in? Do you have a problem with them on tx?
Nothing happens for naives until TW28 (but what happens is still based on those week 8 VL results). In our Arm 2, if und at TW8, you are DONE. Kinda scary.
BTW, has anyone pinned their doc down on how the rollover works for Arm 1's?
Can-do, are your platelets hanging in? Do you have a problem with them on tx?
Hell...id go 5 years of tx if they would let me...as long as i can still get redipen to my belly and the blue pills to my lips....aint this crazy?....wanting to do drugs just to save my a@ss
Yep i see your point...... Here were hoping to do tx longer, something about that does make us sound crazy. But after doing 86 weeks the first time, 48 weeks this time seems like i only have to do tx half the time........ Heck that makes me feel like a geno 2
BTW...the trial study number i am asigned has the same number as my birth date...0158... and get this.....the name of the new BOC drugs that are 10 times more effective that the current BOC drugs...the code name is...you guessed it..."158"...i was born on the DEC1/58
I may be crazy,but not stupid,easy but not sleazy...LOL....my nurse said the same thing when i mentionED this to her...its better to be detecable just a few days before the 'cut off"date...this way you get to go longer ...so you do see my point...?...EITHER WAY...we do 36 weeks of BOC and SOC....anyway....i want arm 3....48 weeks with the pedal flat to the floor..both SOC and BOC ....the SVR odds are only 10% difference between going 32 weeks and 48 weeks...but thats in the navie trials...the non responder trial will be lower of course...we still have a chance to kill the monster
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