Off RO study drug and Peg for 12 wks - still Und

[livininminn]

Hi all

I have posted about this before but here is the update.

I was on the Roche RO study for 12 weeks (RO,Peg,Riba) and the study stopped the RO and Peg due to low
lymphocytes, I stayed on Riba. They said I can get back on Peg when my lymphocytes are above .5

Well it has been 12 weeks since I stopped RO/Peg and I am still Und, that is all good and better than I expected. I was told that indications are from other studies and data from the field that I will most likely attain SVR from the
treatment that I got. But they were careful not to commit to that and I feel like I am being given a line from the Roche
handbook. They suggested that I continue SOC with the study. The other option is to stop everything and hope tx worked. I have came this far and going to do what I can to stay rid of this virus. I am going to continue tx with the study.

By the way my lymphocytes are at .52 so I took my first dose of Peg in 12 weeks today.

Trish and Willie hope things are good and hope this helps, keep it up and I will see you SVR

MikeH

[Willy50]

Here's some of the latest on r1626.

http://www.hivandhepatitis.com/hep_c/news/2008/071508_a.html

It looks like a very effective compound.  They are reporting no resistance issues with it (at 14 days, anyway).  It seems to have efficacy in the range of Vertex.  It seems to have sides that can be treated with current rescue drugs.  One would think that it could be used in tandem with Telaprevir.

I would hope that a new stronger treatment could also trump the issue that a few members have that have been exposed to telaprevir without ribaviren.  Vertex has reported that they may initiate (even this year) a trial in which Telaprevir is added to a polymerase inhibitor (such as r1626) and interferon.  At the last report I heard they were not planning on adding ribaviren to the mix (why does this sound familiar?)

Enjoy and hope you both are faring well.

Willy

[livininminn]

Trish
Come to think of it at week 6 or so they put me on 75% dose of Peg till week twelve.
I was still feeling it though when I took my dose and I suspected I was on one of the 180 Peg Arms. So I might have been getting 135IU Peg for the second 6 weeks of the twelve that I took Peg. Our Trial Centers may be closer in policy than we think. I am on the Roche RO4588161 study is that the same one you are? My Trial Center has one DR. and one NP and they have lost/letgo two coordinators since I started. The whole overall experience there has been very frustrating. The DR is one of those Dr. See Ya for a Second types. The NP is not tuned to people just his own thinking. The coordinator that handles my case is a really great person but she is new in her career and that makes it a little difficult to navigate. I am so skeptical of what anybody at my trial center says. I was told that growth factors were allowed when I pressed for them was told wasnt sure. Then I asked to see the Dr. myself and they set up an appointment. On the appointment day I was told the Dr. had to leave and the NP would have to see me and he gave me such a line. During the same appointment he said it would not be long for me to get back on Peg, then I started to ask about Nupogen and he said almost in the same breath as before, why use nupogen because you may not even need to take Peg anymore if my VL test is still UND. So what is it Nurse yes Peg or no Peg? When that came back UND three days later my TC said they suggest I continue SOC and Procrit and Nupogen are NOT allowed. There is only 4 people in my study at this center. I am just going to continue and get free Peg and hope everything works out.

Willy
I hear ya and agree with your line of thought. I will continue SOC because I want to do everything I can. If they can use the data great. I am realistic about this and a bit skepticle about if I will achieve SVR but am encouraged and have hope. We will see.

Thanks

[Trish77]

Well, Mike and I are in the same trial so I was really referring to inconsistencies across trial centres in the same trial.  Wondering if there are some parameters where the trial centres are given leeway to use their own discretion, although choosing when to do a dosage reduction and on what criteria doesn't seem like it should be at the discretion of the individual trial centre to have consistent data but that's just my own thought process.  

I think there are a number of variables.  At my trial centre, there is more than one doc that we can end up seeing.  I have never even SEEN the doctor sponsoring this trial, no idea what she looks like, never seen her or talked to her.  I have seen two other hep doctors instead.  One takes a different approach from the other, such as my TC putting me with the more aggressive doc on purpose.  I assume from that I'd have had more of a fight on my hands with the other doc with my approach.  Then there is the approach of the specific NP in charge of the trial.  If you can get past him/her, you can get to the doctor.  So...I dunno, Willy.  Just starting to wonder how trials are impacted per trial centre, more of a thinking out loud thing perhaps but I'd like to understand this variable better just the same.

Trish

[Willy50]

Mike I was very encouraged to see this news for a number of reasons;
1)  It would appear that you have cleared and are going to stay that way.  It's kinda premature to call you cured but you might ask the doctor before starting in again about your odds of maintaining your status.

2)  Not only are your personal results good but it may prove the concept that the compound is relatively safe and effective.  Once again..... the "proof" does not exist since it will take hundreds of similar results before one can see that this isn't an isolated situation.  Still..... IF there are also many others like you we have another potent compound (a polymerase inhibitor) which can be used in conjunction with protease inhibitors such as Telaprevir or Boceprevir.  Combining the compounds could provide a synergistic effect and possibly provide shorter treatment times with higher efficacy rates than what Telaprevir may bring. (I'm hoping that could be 75% SVR or better for geno 1's)

To your question Mike......it is one that truely no one can answer but I can provide a few things to consider.  I would think that they could or would hold true in this case;

1)  The argument to NOT treat further...... You've already cleared and maintained for 12 weeks.  I think there are some studies which suggest that an RVR held thru TX (that's a wild card here; apparently 12 weeks is the extent of your TX) if the person has a SVR 12 that nearly 100% of the time the results will be the same at 6 months as at 12 weeks; the only caveat to that is that it doesn't hold true of cirrhotics.  You can research this general principle out but I think you at this point may have in excess of a 95% chance  of a SVR without further TX.  (it's unproven since this is a new compound added to other existing, but my presumption is that the same rules will apply as with SOC)

2)  Once again...theory...... but IF you were to relapse.....lets say if you chose not to treat you could be saddled with a more tougher to treat/ resistant virus.  As mentioned.... I think the odds of a relapse at this point are slim.  You could ask about what would happen in this scenario; what would be the retreatment options....and the odds of success?  What type of continued treatment would they want of you?  How much would that raise their appraisal of a success?  You basically have to see how much more TX you are expected to do to raise your chances__________ %.   I'd be interested in hearing their answers.

I hate to sound like a cynic but you may have already cleared and succeeded.  Since you stopped treatment you may look like a treatment failure (since you had to stop)  
You may merely be listed as a withdrawn from treatment since you didn't "finish" it.  Therfore they may not be able to use your stats, even if you cleared and SVR'ed

On the other hand....IF you were to start treatment again and hit a certain milestone and clear....then they get to use your stats as part of the success of the compound.  For that reason....is it possible that additional treatment may not be that needed for you but would be more useful for the trial?   This is just rumination on my part but I would wonder why they would want you to continue if indeed in effect you have cleared and maintained that status through week 12.  I'm just a layman and so don't take anything I have to say with any great weight.


Trish......I don't claim to know the answers but generally speaking I believe that the drug manufacturers set up the trials.  They all have different parameters and may or may not be the same.  They all have to submit the info to the FDA who gets to decide if they have clear evidence of safety and efficacy.  Bottom line, I wouldn't expect the same rules to apply across the board from trial to trial.
It could be that some companies soften from their hard line approach when in the face of tanking blood tests....... that they have to allow a the use of rescue drugs.  I think that they may have that flexibility but on the other hand I have not heard of the use of rescue drugs allowed in the Prove 1, 2 or 3 trials.  (And so my final answer is.... I have no clue but it never hurts to ask them.  ; )  I think that once you are "in" and have more leverage  than they'll agree to at the trial start.

best,
Willy

[Trish77]

What is frustrating is that different strokes for different trial centres seems to be the way it goes.  There is someone else in this trial who got both rescue drugs very early on, procrit AND neupogen.  I know when I first asked about rescue drugs, I don't recall the exact answer but I was left with the impression that none were to be used until Laurie posted that she'd gotten them so I went back to the trial co-ordinator and she said they were allowed but used reluctantly.  I am on the eprex/procrit now because I advocated for alternatives with the doctor, he decided to put me on eprex now and the trial co-ordinator told him it was allowed.  So I'm on it to keep my hgb up.

As for ANC....it was always a standard on this trial, from what I understand, that they don't want it going below 1.5 or they would take measures, such as reduce dosage. Now that's a fair bit higher than what would be tolerated on regular SOC, however the issue with R1626 is what it can do to white blood cell levels, so perhaps that was as low as they were willing to let it go.

Have they been reviewing your ANC with you all along?  As it stands, you ARE below the 1.5 on your ANC and your lymphocytes are below .5, so you happen to fit both of those criteria anyway.  Actually looking back at your posts above, your ANC dropped below 1.5 at Week 8 .. surprised they didn't drop your Peg at that time.

My lymphocytes have been below .5 since Week 12 for all but one week and they have not dropped my Peg because the ANC has been above 1.5.  They came very close the one week and the doc was discussing it back and forth with the trial co-ordinator while I waited anxiously on the phone listening to them...doc in favour, trial co-ordinator pushing for one more week and because I was tolerating that level of hgb well, then the doc agreed to go one more week.  So...it gets confusing and I will ask once again where it stands.  I begin to wonder how clear the direction was from Roche on the parameters of the trial and whether this IS simply leeway given to various trial centres.  However, one would think these things should be consistent.

Sometimes I wonder just how much direction the docs at my trial centre are giving to my own trial co-ordinator and how much she's flying on her own.

[livininminn]

Ha... my computer got stuck and posted as I was writing
Anyway as I was saying

ANC: Wk 8 = 1.15   Wk 12 = 1.10   Wk 18 = .62   Wk 24 = .69

Hemoglobin is at 12.1

They have never mentioned ANC as a factor. They always look at my Lymphocytes.
I asked and am being told that Nupogen is NOT allowed in this study. They did not say anything about Procrit.

I was also told that if my Lymphocytes go below .5 I have to stop Peg. Well they are at .52 now and after my shot most likely will go down so I will be ping poning around the rest of my tx

This is crazy

[livininminn]

My ANC was at 3.83 day one then steadily went down until:
Week 81.15
Week 12 1.10 week

[Trish77]

Mike, I would like to know what your ANC has been...your Absolute Neutrophil Count.  The reason I ask is because my lymphocytes have only hit .5 once since the trial drug stopped 7 weeks ago.  I haven't had to dose reduce on the Peg because my ANC has hovered just above 1.5 or on occasion lifted well above 1.5.   Have they reduced your Peg ONLY on your lymphocyte count or is your ANC below 1.5 also?

Same question to you, Willie.  Meant to ask you before.

Here's a point of interest for both of you.  I got a ribavirin reduction two weeks ago because my hemoglobin dropped below 10.0 to 9.6.   That was at Week 17.  Does reduced to 1000mg of riba from 1200mg for 7 days.  In the meantime, I decided I didn't want any more dosage redcutions and when I talked to my doctor about it on my Week 18 appointment, he put me on Eprex/Procrit to bring my hemoglobin up high enough that it wouldn't be in danger of dropping to dosage reduction amounts any longer.  My hgb raised by the Week 18 appt to 10.8, enough to resume riba and this week it's 10.6 on the Wednesday and I started Procrit that evening.    

So my doc's strategy is to give me the rescue drug to keep me up out of dosage reduction territory.  I did ask him about neupogen and he doesn't like using it ... I'm in MORE danger of dosage reduction with the white blood cell count, seems to me...but anyway, for the time being, it's the hemoglobin we're focusing on and using the Procrit to be proactive about keeping the numbers from dropping.

Just wanted to share that situation with both of you.

Mike, glad you get to resume your Peg.  I think I would continue myself rather than stop.  I know if I got the 24 week arm, I would have stopped but we didn't so I'm good with going ahead and giving this as much of a knockout punch as I can, particularly being UND by six weeks.  

Good luck Mike and Willy.

Trish