Aa
Still <25 but not UND
My eight-week results came in (although they were actually 7 weeks and 2 days because they had me come in early to test Hgb) and I'm not UND yet. To recap:
Day 1 1320K
2 wk 940K
4 wk 629K
6 wk <25 (Boceprevir/placebo added at 4 wk)
7.2 wk <25
I'm somewhat bummed that it isn't UND because this takes me off the possibility of the 6 month arm of the trial (at least I think so), and also those are some lovely statistics for those who go UND at 8 wks on the Boceprevir. But, I am still close and at least I'm not going back up!
Still on Procrit. I wish I liked it as much as everybody seems to. It actually makes me feel not so good for a day or two afterwards. Nothing specific, just generally uncomfortable.
Does anyone else find that they are cold all the time and have a hard time getting warm? I'm wondering if it isn't the interferon effect . . .
Day 1 1320K
2 wk 940K
4 wk 629K
6 wk <25 (Boceprevir/placebo added at 4 wk)
7.2 wk <25
I'm somewhat bummed that it isn't UND because this takes me off the possibility of the 6 month arm of the trial (at least I think so), and also those are some lovely statistics for those who go UND at 8 wks on the Boceprevir. But, I am still close and at least I'm not going back up!
Still on Procrit. I wish I liked it as much as everybody seems to. It actually makes me feel not so good for a day or two afterwards. Nothing specific, just generally uncomfortable.
Does anyone else find that they are cold all the time and have a hard time getting warm? I'm wondering if it isn't the interferon effect . . .
That is the difference in the 2 trials, miracle must in the relapser/nonreponder trial.
According to the consent, that's not quite how it works. I don't see anything that applies to week 12. There is one arm that stops early if a person is undetectable at TW 8 (4 wks boceprevir) and thereafter. Anyone with measurable virus at week 24 gets pulled off. Otherwise, you keep going.
Arm 1: Subjects in this arm will receive Peginterferon 1.5 mcg/kg and ribavirin, along with placebo. The arm is called the “control” arm.
• Lead-in phase: Peginterferon + ribavirin for 4 weeks (see above)
• After treatment week 4 (TW4), you will be given a placebo pill. This will be taken by mouth 3 times a day, in addition to your Peginterferon and ribavirin treatment.
• You will continue treatment with placebo, Peginterferon 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 continuing the treatment after week 28:
o If the hepatitis C virus is not detectable (no hepatitis C virus measured in your blood), you will continue with placebo + Peginterferon and ribavirin treatment for a total treatment of 48 weeks.
o If the hepatitis C virus is detectable after 24 weeks of treatment, you will be discontinued from treatment at TW 28. If you are discontinued from this control arm, you will have two options. You can either proceed to follow-up, or since you were in the control arm, you can choose to participate in another boceprevir study “PROVIDE” (where “open label” boceprevir will be added to your Peginterferon and ribavirin treatment). 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 Peginterferon 1.5 mcg/kg and ribavirin with or without an additional 20-week treatment with Peginterferon and ribavirin, along with boceprevir or placebo, depending on response to therapy.
• Lead-in phase: Peginterferon + ribavirin for 4 weeks.
• After TW 4, boceprevir (800 mg by mouth, 3 times a day), will be added to the Peginterferon + ribavirin.
• At TW 24 the amount of virus in your blood will be measured to determine whether or not you will be continuing the study treatment:
o If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned treatment.
o If the hepatitis C virus is detected in your blood after 24 weeks of treatment, you will be discontinued from the treatment and continue with follow-up. For that reason you might be asked to come to the clinic for an unscheduled visit.
• At TW 28, the amount of hepatitis C virus in your blood since TW 8 will be reviewed to determine whether or not you will be continuing the study treatment after week 28:
ß If the hepatitis C virus is not detectable in your blood at TW8 and at all subsequent visits, then at TW 28 you will discontinue the treatment, and proceed to 44 weeks of follow-up.
• If the hepatitis C virus is detectable in your blood at TW8 or at any subsequent visit, then at TW 28 you will continue on therapy for an additional 20 weeks, but your therapy will be adjusted and may include placebo in place of boceprevir. In this case, you will receive treatment for a total duration of 48 weeks followed by 24 week follow-up.
Arm 3: Subjects in this arm will receive 44 weeks of boceprevir, along with Peginterferon 1.5 mcg/kg and ribavirin.
• Lead-in phase: Peginterferon + ribavirin phase for 4 weeks
• After week 4, boceprevir (800 mg by mouth 3 times a day), will be added to the Peginterferon + ribavirin.
• You will continue treatment with boceprevir, Peginterferon 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 treatment:
o If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned treatment.
If the hepatitis C virus is detected in your blood after 24 weeks of treatment, you will be discontinued from the treatment at TW28 and continue with follow-up. For that reason you might be asked to come to clinic for an unscheduled visit.
Arm 1: Subjects in this arm will receive Peginterferon 1.5 mcg/kg and ribavirin, along with placebo. The arm is called the “control” arm.
• Lead-in phase: Peginterferon + ribavirin for 4 weeks (see above)
• After treatment week 4 (TW4), you will be given a placebo pill. This will be taken by mouth 3 times a day, in addition to your Peginterferon and ribavirin treatment.
• You will continue treatment with placebo, Peginterferon 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 continuing the treatment after week 28:
o If the hepatitis C virus is not detectable (no hepatitis C virus measured in your blood), you will continue with placebo + Peginterferon and ribavirin treatment for a total treatment of 48 weeks.
o If the hepatitis C virus is detectable after 24 weeks of treatment, you will be discontinued from treatment at TW 28. If you are discontinued from this control arm, you will have two options. You can either proceed to follow-up, or since you were in the control arm, you can choose to participate in another boceprevir study “PROVIDE” (where “open label” boceprevir will be added to your Peginterferon and ribavirin treatment). 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 Peginterferon 1.5 mcg/kg and ribavirin with or without an additional 20-week treatment with Peginterferon and ribavirin, along with boceprevir or placebo, depending on response to therapy.
• Lead-in phase: Peginterferon + ribavirin for 4 weeks.
• After TW 4, boceprevir (800 mg by mouth, 3 times a day), will be added to the Peginterferon + ribavirin.
• At TW 24 the amount of virus in your blood will be measured to determine whether or not you will be continuing the study treatment:
o If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned treatment.
o If the hepatitis C virus is detected in your blood after 24 weeks of treatment, you will be discontinued from the treatment and continue with follow-up. For that reason you might be asked to come to the clinic for an unscheduled visit.
• At TW 28, the amount of hepatitis C virus in your blood since TW 8 will be reviewed to determine whether or not you will be continuing the study treatment after week 28:
ß If the hepatitis C virus is not detectable in your blood at TW8 and at all subsequent visits, then at TW 28 you will discontinue the treatment, and proceed to 44 weeks of follow-up.
• If the hepatitis C virus is detectable in your blood at TW8 or at any subsequent visit, then at TW 28 you will continue on therapy for an additional 20 weeks, but your therapy will be adjusted and may include placebo in place of boceprevir. In this case, you will receive treatment for a total duration of 48 weeks followed by 24 week follow-up.
Arm 3: Subjects in this arm will receive 44 weeks of boceprevir, along with Peginterferon 1.5 mcg/kg and ribavirin.
• Lead-in phase: Peginterferon + ribavirin phase for 4 weeks
• After week 4, boceprevir (800 mg by mouth 3 times a day), will be added to the Peginterferon + ribavirin.
• You will continue treatment with boceprevir, Peginterferon 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 treatment:
o If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned treatment.
If the hepatitis C virus is detected in your blood after 24 weeks of treatment, you will be discontinued from the treatment at TW28 and continue with follow-up. For that reason you might be asked to come to clinic for an unscheduled visit.
Greatbird, it would be nice if they would use a more sensitive test when you get that low.
Foo, I’m still in a holding pattern. For now, I want to keep my mouth shut and hopefully get in the rollover study in April.
The good news is that it has been 2 weeks since I stopped taking the meds and I’m 98% back to normal.
Foo, I’m still in a holding pattern. For now, I want to keep my mouth shut and hopefully get in the rollover study in April.
The good news is that it has been 2 weeks since I stopped taking the meds and I’m 98% back to normal.
I CALLED MY NURSE TODAY AND THIS IS WHAT I WAS TOLD ---
THE TRIAL IM IN THEY LOOK AT WEEK 12 WHICH WOULD BE 8 WEEKS OF BOC. --IF AT WEEK 12 YOU ARE DETECTABLE AT WEEK 28 YOU WOULD BE DISCOUNTINUED ON THE TRIAL
SHE TOLD ME THE TRIAL IM IN NO ONES MEDS HAVE THE POSSIBILITY OF CHANGING UNTIL WEEK 28 SO IM SAFE FOR A FULL 24 WEEKS OF BOC. AND 28 WEEKS IF YOU COUNT THE LEAD IN
I THINK WE ALL NEED TO LISTEN TO OUR TX TEAM --HOPE THIS HELPS GB --I VOTE WE BOTH KEEP TAKING WHAT THEY GIVE US AND HOPE FOR THE BEST ! WHAT CHOICE DO WE REALLY HAVE ? AMY
THE TRIAL IM IN THEY LOOK AT WEEK 12 WHICH WOULD BE 8 WEEKS OF BOC. --IF AT WEEK 12 YOU ARE DETECTABLE AT WEEK 28 YOU WOULD BE DISCOUNTINUED ON THE TRIAL
SHE TOLD ME THE TRIAL IM IN NO ONES MEDS HAVE THE POSSIBILITY OF CHANGING UNTIL WEEK 28 SO IM SAFE FOR A FULL 24 WEEKS OF BOC. AND 28 WEEKS IF YOU COUNT THE LEAD IN
I THINK WE ALL NEED TO LISTEN TO OUR TX TEAM --HOPE THIS HELPS GB --I VOTE WE BOTH KEEP TAKING WHAT THEY GIVE US AND HOPE FOR THE BEST ! WHAT CHOICE DO WE REALLY HAVE ? AMY
<25 IU/ml detected
<25 IU/ml undetected
What's so difficult to understand about this? ...
GreatBird is detected, and miracle05 is undetected.
------------------------
Pretty easy to read these results.
Sorry you didn't make it this time GreatBird but you are just SO CLOSE it has to come soon - you just got a couple of those b*tchy stragglers left to kill and then that's that. You will do it, hang in there.
Believe me take it from someone who knows first hand - once you do finally get to post that I'M UND!!! post - it will be ALL the more SWEET! :)
it's coming you just have to have a little more patience (the one lesson we REALLY do learn doing treatment!)
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