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 . . .

[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. :)

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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.