Still <25 but not UND

[GreatBird]

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 . . .

[Rockerforlife]

OPPS....,<25 IU is the same as <62.5 copies...i had it backwards..i think ive go t it right now....

[GreatBird]

copies are more.

My first VL test back in 2002 was 478,800 copies and 266,000 IU. Quest Diagnostics

[Rockerforlife]

<25 i/u  is the same as saying <10 copies...correct me if im not right

[willing]

approval really is really pretty close, and you know you're going to go into the next round with all guns  blazing. One of the pluses of having such a strong SOC response is the possibility of reducing the dosage (and harsh sides) when getting the real PI. If current soc dosage was too much to handle, getting the placebo was probably a good thing! All the best.

[GreatBird]

When do you find out if you were getting a placebo?

[nygirl7]

FOO

I'm sorry that things didn't work out but maybe since you were in that ultra sx group it's just as well for now that you dropped out. Doesn't sound like much of a silver lining right now but maybe when you're feeling better you will feel better about all of it while you wait for the tele to come out.

Again, I'm just so sorry.

[Bill1028]

Foo, sorry to here about your situation.  Did they give you a date as to when the rollover will start or whether it will start?  I would like to compare notes.  It there a safe way to communicate privately?

[foofighter]

Very interesting stuff on how VL is determined. Bill1954 tried to enlighten me a while ago but my brain is fried. I am gonna recuperate for a while and then will probably be drawn back to research mode in the fall.

I withdrew from trial (final dose of meds last Friday) before getting week 12 results. Didn't matter, I could not tolerate drugs. Doc agreed. Offered a couple of scenarios that didn't make sense to me. Taking a brief break from all drugs, dose reducing some of the drugs, removing the blue pills (which I am sure are placebo anyway), nothing I was interested in.

I was almost completely incapacitated for 4-5 days and unable to function at the level I need to at work on the two days that I could get there. I can't lose my job and I had no one to help at home. I fell into that "nightmare sx" small percentage. It is a terrible decision to make being stage 4. But also factored into that decision was the portal hypertension further reducing odds of response to SOC.

Also Bill1028 is right, doc told me they are outraged about what is happening for the rollover. I can't say too much either, but it was the deal breaker for me, not having any guarantees with what will happen.

I will continue follow-up with trial and then get back with my hepatologist to figure out what is next. I hope he can keep me from croaking till Telaprevir is approved. Then I will try Pegasys and know to plan on not being able to work and get a paid "helper" in place for around the house.

If he feels I have to start before then, I will try in the fall and lead in with Alinia. Hopefully get tons more medical support to deal with sx as well.

As you said, the best news is knowing I had a huge response to interferon (6 log drop) and who knows, I may have cleared at 12 weeks. I will get results today or tomorrow.

Thank goodness it seems most here on the boards on this trial are managing sides AND have gotten the real deal so the rollover won't affect them. Good luck to all!

[willing]

GB: some of this may actually be true ( and if not hopefully someone will correct). Small quantities of RNA need to be amplified to be detected, PCR is a technique for making many copies of a starting sequence, real-time PCR, rt-pcr,  is a way of making copies so you count as you go rather than at the end and taqman is a particular way of doing the rt-pcr counting (so pcr, rt-pcr, and  taqman are all generic terms). On the other hand, Roche  which like at&t in the old Lilly Tomlin sketch, is so big they don't have to care, has a diagnostics unit that sells an hcv rt-pcr taqman kit under the name "cobas taqman" (not to be confused with their pcr but not rt-pcr tests like 'cobas amplicor') This seems to come in a  variety of packages including big honking thermocyclers and automated sample prep machinery so your blood vial never need come near human hands. Testing labs license this stuff. As a patient all you care about is  test performance characteristics, which are spelled out in gory detail in papers (free access) like
http://www.ncbi.nlm.nih.gov/pubmed/17898157
Notice there's quite a gap between the limit of detection (LOD) stats and the bottom of the linear range. The linear range, which starts around 25, is the IU count at which the test starts following a good, predictable, linear dilution pattern. Below that, it's a bit of a judgment call like measuring a length of a 5/8inch  with a ruler only marked in inches. Also, notice that the LOD is a bit squirrely and varies by genotype from 7 to 19.  Bottom line is that detectable <25 makes perfect sense ( and hopefully the next one will be UND).

foo: sorry things are hard, but on the plus side you really did have a great response to soc and it would be great to build on that rather than lose it. I strongly doubt there's anyone on this earth who can reliably tell you whether adding bc late in the game is/is-not worth doing but I can tell you I'd jump at the chance if available. If in fact you've been taking  placebo and have the opportunity to add bc at any point it seems as likely to slice through any remaining virus as effectively as at wk4.

[copyman]

at this point i would put aside all this confusion and run to my GP and ask for a lab order for my own privite PCR test! Ask for the  Labcorp quantasure NGI (<2 to 2 million) or a Quest Heptamax (<5)

Best of luck

[Bill1028]

I wish that I could say more but for selfish reasons I need the real drug more than they need me.  

[Bill1028]

Bill1028--is there any question they wouldn't roll you over? I don't have the info on the non-responder/relapser trial, but it seemed rather guaranteed from what I could read in my consent (and a selling point when they asked me to be in the trial). Glad you are feeling better. :)

------------------------------------------------------------------------------------------------------------------------

Oh yeah, that is the reason that I need to keep my mouth shut.  The consent form, just roll it up and throw it away.  

[miracle05]

I DONT KNOW LOL ! ---I HAVE READ THAT THING 500 TIMES AND STILL DONT GET IT LOL --FOR ME THIS WAS MY ONLY HOPE OF GETTING TREATMENT --I HAVE TO MANY ASSETS FOR STATE HELP AND NOT ENOUGH MONEY FOR INS. --GO FIGURE

MY VOTE IS WE KEEP TAKING WHAT THEY GIVE US AND PRAY FOR THE BEST RESULTS !  SHE DID TELL ME I WAS SAFE TO WEEK 24 OR 28 IF YOU COUNT THE LEAD IN FOR THE SAME MEDS -- I REALLY DONT HAVE A CHOICE SO IM JUST GOING WITH THE FLOW LOL AMY

[can-do-man]

Und or not und, when it comes to the really important stuff i talk to my Hepo, i have found out sometimes the trial nurse is more confused then we are.

I also agree with jim, get copies. Their free and they must give them to you

[GreatBird]

miracle05--I think she was giving you information from the other trial (for non-responders/relapsers). If you have your consent you can read what's on pages 6 to 8 (which is what I posted above). Don't stop posting! :)

For one thing, it doesn't make sense to pull someone off treatment at week 28 because of a result at week 12. Why put them through 16 more weeks of tx? Bill1024 got pulled off of the non-responder/relapser trial because he wasn't clear at 12 weeks and they did it right then.

Bill1028--is there any question they wouldn't roll you over? I don't have the info on the non-responder/relapser trial, but it seemed rather guaranteed from what I could read in my consent (and a selling point when they asked me to be in the trial). Glad you are feeling better. :)

foo--are you really going to quit? you are sooooo close! you must have had a better viral decrease during the first four weeks than I did, because with my results it's so obvious that I'm on the PI. Plus, it's really messing with my digestion. I'm thinking if someone took a look at my stomach it would be all red (inflamed) and blue (boceprevir). And there's an awful taste that I burp up from it (sorry if that's TMI). Maybe they can help you better with the sides??

[jmjm530]

GB: You* may be confused by my nurse's report, but I'm not.
-------------------------------------------------------------------------------------------------

Never said I was "confused", just unclear, and if anyone after reading this entire thread can point to any clarity, they're a better man or woman than I :)

This isn't directed to any one person -- but do your own research folks, and look over your med teams shoulders, regardless of who you're treating with. Get your copies of all tests and make it a point to learn how to read them. Anyone who has been here for any length of time can tell you that this forum is full of anecdotes of people getting misinformation (and/or misinterpreting that information) from the medical teams, and this includes the trials.

-- Jim

[miracle05]

I AM IN THE NAIVE TRIAL --IM ONLY POSTING WHAT I HAVE BEEN TOLD BY MY TX TEAM AS I WAS CONCERNED BECAUSE I REALLY DONT UNDERSTAND IT ALL !

FROM WHAT I WAS TOLD TODAY THEY LOOK AT WEEK 12 BECAUSE THAT IS WEEK 8 ON BOC. ---

MAYBE I SHOULDNT POST BECAUSE I REALLY DONT KNOW-- I ONLY POSTED WHAT MY NP TOLD ME TODAY --I AM SAFE FOR 24WEEKS OF BOC. 28 WEEKS IF YOU COUNT THE LEAD IN

MY HOPE AND PRAYERS GO OUT FOR ALL OF US  

[GreatBird]

She told me she was in the naive trial.

[Bill1028]

That is the difference in the 2 trials, miracle must in the relapser/nonreponder trial.

[GreatBird]

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.

[Bill1028]

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.  

[miracle05]

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

[nygirl7]

<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!)

[GreatBird]

Here's the thing. *You* may be confused by my nurse's report, but I'm not. I don't know *why* you persist on being confused by my nurse's report. I think it's a valid suggestion that I have hard copies, but it won't change the results or her interpretation.