CTON ....POSTED BELOW BUT WANTED TO MAKE SURE YOU FOUND ME.

I am so glad to see you posting back on this board again. I understand you have time constraints and it sounds like it's better for you sometimes not to be so actively involved but for whatever it's worth, I'm delighted to see you back.

So, while I have you, (if you're still here) can I ask you a quick question? I just recently found out I'm in group B, the 48 week group, but won't find out my viral loads until next week. I am struggling with making the decision as to whether to stay on treatment as a 1A for the whole 48 weeks or stop at 24.

I've read all the studies that I can find that say achieving rvr at 4 weeks may be an indicator that it's ok to stop treating at 24 weeks even for 1a and 1b. I should qualify that. I'm not actually reading the studies, just the abstracts. I'm not sure how to go about getting my hands on the actual studies and don't know that I would fully understand them anyway. I'm referring to Jensen, et al, Abstract ID 65969, Jules Levin's conference report at the AASLD Oct. 06 conference in Boston, and a retrospective study of the Hadzyiannis data done by Jensen and colleagues, the results of which are "almost identical to those obtained by Zeuzem et al".

Across the board, they all seem to say "A lower baseline HCV RNA level was the only significant and independent factor associated with SVR." and "An RVR at week 4 of treatment is the single best predictive factor for an SVR".

So, my question to you is can you explain to me at all why having a low baseline hcv rna level matters if you clear the virus very quickly, as Pam did. continued

[bobbyullc]

good news on rvr. it shows a quantum leap in sucess.

if you drop out early you will skew the results of the study that mean life and death to so many heppers and maybe many more months before the study can be concluded. i know how hard it is to continue but maybe you should do it for the rest of the heppers. your call.  
bobbyu cured.

[jmjm530]

I somewhat agree with Bobby, especially repeated posts in a public forum about shortening/lengthening treatment on you own and to a lesser degree posts about how to figure out what group you're in by the taste of the pills, etc.

Privately, I imagine many including myself might struggle with these issues, but these matter of fact discussions almost gives the impressions to some that this is the normal way things are approached in a trial.

I do undertand that what you signed, and no doubt partly for legal reasons,  may allow you to make whatever choices you want, but as Bobby suggeted, the future results of these trials may be life and death to some and make no doubt that dropping out will affect the final results and that mass drop outs could theoretically render the results useless. Of course, shortening treatment for medical reasons is an altogether other matter as may be lenghtening treatment if in the view of your treatment doctor response was less than desired.

I have absolutely no desire to start the New Year off with a debate on this issue so this will be my only comment -- but I have to admit I was troubled by PDSs post(s) on this issue and felt I had to say something.

I wish everyone a happy and healthy New Year.

-- Jim

[couldn't think of a nickname]

Pds,

Happy new year, and hope you are well.

As far as the prior studies go, I am not too well-versed to guide on them, as I am pretty much more familiar with the basics. But, being in a trial, there are reasons why they different arms, so that is really an issue for those running the trial. So, it might not be that fair for me to give an opinion (if I had a strong one) as this is a different situation. In fact, when others have asked whether it was better to treat longer, etc, I always kind of stayed away from that, because I just feel I'm not in good position to give an opinion. Different people have different needs.

Sorry I can't offer more than that, but best of luck, and I hope you slayed the dragon.

[prettydamscared]

She was UD at day 4. I'll know next week which day I was UD. But, if I was UD early on, even though I had a high starting baseline HCV RNA of 10M and 27M one month earlier, how does that factor into it if you clear early on. I don't know if I'm making sense. What I'm trying to say is I don't see what significance the one has to do with the other. If you clear early, you're clear. Right? Why would having a lower baseline hcv rna be the only significant and independent factor associated with SVR if it's cleared out early on?

I don't know if you're familiar with these sorts of issues having to do with vertex, but I thought I'd give it a shot?

Any help would be much appreciated. Really glad to see you back.

CHar

[Kalio1]

Although RVR is a positive predictor of success, it certainly does not guarantee success. How many of the negative predictors do you have? Even adding up ALL predictors, you can still have the tx fail. Overall odds are still about the same even with RVR if you stop half way it seems to me your odds are reduced regarless of RVR. We have seen people on the board with RVR who did 48 and still relapsed. Im not trying to be a downer, but the truth remains if you reduce tx by half by only going to 24, you are reducing your chances of success even with RVR.

I dont know what you guys agreed to when you enrolled in the  trial, do you commit to stay in no matter which arm you are randomized to? Obviously if you deviate from the plan, that harms the overall data from the trial and results are compromised. Some end up having to deviate for medical reasons but if there is no medical reason, it seems to go against what was expected. I have not read the agreement but I would imagine they hope all participants stick with the plan so the results will be optimum. I know many would give their eye teeth to be able to have a shot at the trial and 48 weeks of SOC. I bet some of those in the 24 week arm wish they were able to be in the 48 week arm too.

To me, it seems like the best possible arm to be in, you got VX plus you have SOC for the standard amount of time so it seems to me your arm has the best possible chance of success.

[prettydamscared]

Hello and a Happy New Year to you all,

Thanks for your comments.  Jim, I must point out that I don't remember getting into any sort of repeated posts or comments about the taste of the pills.  Early on, I was asked once and answered and have never pursued that particular line of questioning.  Perhaps you have me mixed up with another study paricipant.

Sorry if You disagree with my comments.  I don't happen to believe that dropping out of the 48 week arm is going to significantly skew study results.  There's no reason why my data can't continue to be used to the point that I would drop out, if I would choose to do so. Let's be clear here. Everyone isn't going to drop out of the study as is fairly obvious by the # of posters that visit this site.  Out of 262 study participants in this trial, there are 4 that post here regularly and perhaps 10 that post at all.  I feel that the vast majority of participants do their treatment without questioning it.  Some of us have read studies, become informed and are asking questions, as is our right. Drug companies doing a study know that there will be some drop outs.  It's a part of any study.  I'm not advocating it, I'm simply researching and asking questions.  I find it hard to believe that the few people, over all, that particiapte in this forum are going to be swayed one way or another by my questions regarding my own treatment.  It's an individual choice and I have a perfect right to ask questions.  Please try and remember that we're all thinking, rational adults, no one of whom should be so easily swayed by another's questions or ideas.  Don't we all have minds of our own and if not, perhaps, an iq test should have been a prerequisite in the screening?

This was a study for treatment naive participants which is exactly the point.  In spite of my best research, I didn't think of every question or anticipate every outcome. I didn't have a clue of everything we would go through on this study. I think it's difficult for you or anyone to know exactly what you would do in my place and until you're in that position, you have no right to judge me.  I've been an excellent study participant, compliant and fair minded beyond what I probably should have been. You have no idea what all has transpired since the beginning of this study.  Perhaps I'm not quite as noble as you but we'll never really know what choices you would have made given my circumstances.  I do realize, however, that you are entitled to your opinion as I am mine.

[mremeet]

What PDS said is absolutely correct. No one outside of the study can really understand just what has been going on in its totality, especially in regard to specifically what happened to pds and me. For the record, pds came down with the same nasty rash I had, and suffered greatly as a consequence of it. In fact, she still is dealing with the very real and significant after effects of it (as am I). There's also a possibility that we may be saddled with long term problems from these drug (one of which is experimental). We might even contract some new ailment never seen before as a result of taking the VX and having a very bad long lasting allergic reaction to it. Especially because our immune reactions were/are continually exacerbated by the ongoing IFN and riba. It's also possible that by continuing to take the SOC drugs after having the awful PI allergic reaction, that it may continually increase the odds of that participant having long lasting AI issues.

Of course I don't know if any of these scenarios are realistic, as I'm not a doctor. And I have put my faith in my doctor to look after me, and to look out for the signs of onset for these types of problems. Although at the same time, it is worrisome, more than those of you who are not participating might imagine.

With all of that said though, pds I would continue down the path of 48 weeks. Especially because of the steroid usage and slightly truncated course of VX. Although it is true you have a nice pink healthy F0 liver, and therefore can afford to wait. Odds are IFN and perhaps riba will still be a part of the likely "cure" for many years to come. Relapsing due to too short a course could put you back in this miserable saddle again. I'd keep going, just my opinion of course. There are risks by continuing, but there could be a greater long term risk by stopping at 24 too.

Either way, whatever you decide, I think it's safe to say we're all backing you. Let's all hope for the best: for us trial participants, and for those who will hopefully benefit from what comes out of this trial.

[chcnme]

You don't know HOW much I appreciate yours and APKs and mrmeets and PLN (and anyone else here in a trial whose name I can't remember) giving the side of a trial that only you know. I admire the HECK out of all of you and thank you from the bottom of my heart for giving me a taste of what this might be like (trials - albeit not the VX I had hoped for but possibly the HCV 796).  I haven't read everyone's input here on this thread to the extent I just read the note you just wrote, but what you said is... well - it's just tops.  I'll never forget the first people I met on VX (here), and how much your input has meant to me and will always mean to me.  I will always think of you as pioneers.  I know that none of you in the VX wants to be hailed as something "extra special" or as "heroes" but to me, you are.  I can tell each of you has done extensive research.  I've been around forums for close to 4 years now reading and taking it all in, and no where at any time, not with ANY HCV drug in research have I been able to learn about trials as much as I have from you all.  Huge thanks.  You have well-earned your stars :) Best of luck!

[Imagine]

chcnme said it all for me. I am in the process of working towards the goal of getting in the Prove3 trial for non-responders and relaspers, due to begin this summer or therabouts. Your insights shed some light on this risky but oh so promising attempt to improve upon the current treatment. Thank You!

[bobbyullc]

no one is judging just bring up the point that subjects agree to follow rules IF ALLOWED to enter study. if we all went back on our word the studies would be meaningless. sorry, but i feel if there is no unanticipated danger it becomes a moral question.

i thought the vx950 was stopped after about 12 weeks and just the peg/riba was continued?????

[chcnme]

Hey Imagine.  I sure hope you get in.  Can you (or anyone) help me understand when PROVE3 is starting up?   Not that I'm anticipating possibly having a chance to get in IF I DON'T respond  (but it's in the back of my head).  And so I want to go ahead and treat .. like yesterday -lol.  I am wondering when PROVE3 is anticipated to begin  (is it going to be this summer, do you know,  and another question - is PROVE3 part of the PhaseII trials  (or it is PhaseIII).  

The reason I'm asking is - way down the list is a VX thread I just read some more on this evening, and I asked some questions, but it's so far down the list I don't know that anyone will see it.  

Thanks, if you have time.  Happy New Year!  

http://www.medhelp.org/perl6/hepatitis/messages/44388.html

[Kalio1]

There is only limited data suggesting stopping tx for geno 1's at 24 weeks is a good plan, it's risky even if you weren't in the VX trial. The decision carries a lot more weight then the average person on SOC deciding to give 24 weeks a try vs 38 because you are in this very important trial. It seems even if you discount that fact, it is still in your own best interest to stick with the tx for 48 weeks to improve your chances of success.
Every single participant's data is extremely valuable in a trial. Deviating in any way from what the trial plan will have a negative effect on the data. ALL results have an effect. The fact that one arm would go 48 weeks must have been disclosed to everyone beforehand. Maybe they will be able to salvage some data from your participant slot ( or maybe not) but they won't have all the info they needed from that participant slot in that arm. Im not sure how it could not impact the end results. Some will undoubtedly be forced to stop for medical reasons and that too will affect the results.

Im not saying this to be judgemental, you have every right to your decision obviously, but the info. IS extremely important to many many people in the world. Shortening tx for geno 1's is a brand new untried idea. It seems very iffy to hang your chances on such a small study particulary since you landed this spot in this very important trial. So many people would like to have the opportunity to be in your shoes and get a shot at VX950 no matter which arm they ended up in.

I respect your decision either way. It seems going the 48 weeks is the best option you have for success personally and of course all heppers are looking forward to that data, the more complete it is, the better is it for everyone.

[Imagine]

Hey Happy New Year to you :)

I got the time table for Prove3/non responders/relasper group from the vppharm (vertex) site. The area was product pipeline. It gave timeline/progress graphs for their various products. I followed the vertex timeline/status info. At the time (I went back and checked when I saw your question and noticed it had been revised 12/18 so it doesn't show the same detail???, wonder what that is about?) At the time it showed the trial I was most interested started around July 07. I can't be sure of my answer regarding Prove3 being Phase3. I am trying to find out right now by reading the site again. I am not sure if each Prove segment is spilt into three phases or not. What a tangled web we weave!!!

[prettydamscared]

I forgot to thank you too.  I don't mean to be corny but I do really appreciate all of your thoughful and meaningful replies.

Good night.

[APKhaos]

I think all of the currently announced Prove trials [1,2,3 as described in the release chcnme quoted] are Phase 2 trials. Don't think I've seen any Phase 3 trials discussed so far.

I'm still trying to understand what FDA Fast Track actually means in practice. Have read that it allows some of the Phase 2 results to be treated as Phase 3, and also that it means Phase 3 tests can be run in parallel with Phase 2. Not sure what the facts are. Maybe someone here can shed some light on this.

[prettydamscared]

Ch, mremeet, bobby, kalio, everyone who responded, I appreciate all of your input.  Without intending to, I think I've answered my own questions.  Bobby I think you said it best.  I've been kind of despondent all day concerning some of your replies.  At first I felt a bit indignant and then I think my feelings were a little bruised but after thinking about it all day and reading the last responses, I think you guys hit the nail on the head.  It is a moral issue, I did agree to be in the study and the results are extremely signigicant.  It's a little hard to admit, but I don't actually have any right to deviate unless there is a medically significant reason, as Bobby said. I do appreciate the way you guys answered my posts, matter of factly and without a lot of judgement.  It's actually sort of a weight off my mind and mremeet and Kalio, I know you guys are right.  Chances of svr are obviously better treating for 48 as opposed to 24.  

Ch, thank you for your kind words.  They were as influential to me as any.  This study does mean a lot to a lot of people and I don't have any right to screw that up.  Ok, sorry for all the drama and again thank you for your insightful and really helpful answers.  Best to all of you and I am going to keep on going.  If you guys can do it, so can I.

Charlotte

[chcnme]

Hey.  I had the wrong press release pulled up down there. It was from OCtober, AASLD.  This one  (below, the most recent press release in Dec)  says they expect to initiate PROVE3 in the next few weeks,  and so pardon my error on that other thread. I'm still trying to figure out PhaseII vs. PhaseIII and if PhaseII and PhaseIII are going to be going on at the same time or... one beginning while data from PhaseII is still... "out there" :)  

They have info on the "forward looking statement", too, that's interesting to read (generic but still interesting.)

Yeah good pun - "what a tangled web we weave."  

Excerpt:  

About Telaprevir (VX-950)
Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational agents in development that specifically targets HCV. Vertex is conducting a global Phase 2b clinical development program for telaprevir consisting of three large clinical trials that are expected to enroll approximately 1000 patients with HCV at clinical centers in the United States and Europe. The U.S.-based PROVE 1 trial is fully enrolled and ongoing. The PROVE 2 study is underway in Europe and is expected to complete enrollment with approximately 320 patients within the next few weeks. Also in the next few weeks, Vertex expects to initiate PROVE 3, a clinical trial of telaprevir that will enroll more than 400 treatment-experienced patients. In clinical trials, telaprevir is being dosed as 750 mg every eight hours in combination with pegylated interferon alfa-2a (Pegasys

[bobbyullc]

many of us on the board envy your being chosen to be in this promising trial. it may be the magic bullet so many pray for.
lead the way. thanks for your courage in taking this trial.
bobby

ps. i just cleared last week. cured, so am not involved but for my prayers for the heppers who still are infected. have a wonderful 2007. also i am sorry my " CURED" post messed up the board.
bobby

[Kalio1]

I'm glad you were able to make your decision. I know some of you guys in the trial have had a rough go of your tx. I really do want VX to work out and become a positive addition to SOC but first and foremost I want all of you "lab rats" on our board to succeed in your fight with this virus! I think your decision will give you the best shot. Just remember we are all here and will be here while you plug away at the last 24 weeks!
Happy New Year to you dear.

[prettydamscared]

You're kind words meant a lot to me.  I know you're CURED, CURED, CURED, CURED and I'm so GLAD, GLAD, GLAD,  you are.  Are you kidding?  I was happy to see the board messed up because of that.  May it always be messed up because someone is CURED.  I loved it.

All of my best to you going forward, Charlotte

[prettydamscared]

Me too.  Even this morning I feel good about making the decsion and I'm not going to keep revisiting it.  It's a done thing now.  

Last night is when I think I appreciated this board and you guys the most.  I really can't tell you what it means to be able to come here & be so conflicted and torn as I was and get some straight hard hitting answers.  It was exactly what I needed to hear and I am grateful to you and all the others. It's comforting to know that you all are here day in and day out to help me and others while we all plug away at this.  Happy New Year to you too!

Your grateful friend, Charlotte

[lab-rat]

Hi Char.  I just wanted to add my 2 cents.  I completely agree with bobby, jim, kalio...and most others that have posted regarding this issue.  I'm glad that you chose to stick with the study protocol.  It's easy for me to say this, since I haven't had any of the horrible side effects that you or mremeet have endured.  But many other people on standard SOC have had truly terrible sx as well...and they've gone on and on and on.  Good luck and hang in there!

[prettydamscared]

Thanks for explaining that to everyone.  As always, you are way more articulate than I.  It's basically what I was trying to convey in my first post.  I do agree with you wholeheartedly.  However, as I mentioned earlier, I couldn't shake the feeling of despondency yesterday and it had nothing to do with the normal feelings of depression, for lack of a better word, that I've experienced during my treatment thus far.  As much as I've been tryying to duck the issue, I know continuing on is the right thing to do, both for myself and for the sake of the study.  I totally agree with you though that our data thus far would not be lost.

Something else I'd like to point out, speaking for myself anyway.  All of the "cloak and dagger" stuff took a huge toll on me as well.  At times, it was like riding a roller coaster, remember?  It was physically and mentally exhausting. I guess in some ways I contributed to it just because of who I am and my somewhat anal nature.  I'm too brain dead right now to effectively evaluate alternate ways for the study to be conducted to avoid/minimize all that stuff going forward but I would think that's got to be a priority for future studies.  I'm just grateful our doctor is who he is and didn't try to have me bounced or thrown into some kind of luney bin.  Just kidding about that last part....I don't think I was quite that bad.

[mremeet]

bobbyquote: "no one is judging just bring up the point that subjects agree to follow rules IF ALLOWED to enter study. if we all went back on our word the studies would be meaningless. sorry, but i feel if there is no unanticipated danger it becomes a moral question."

For the record, we didn't sign up or agree to continue with the study under any and all circumstances come hell or high water. There are no "rules" dictating those criteria, I can assure you of that. The agreement expressly states (as it legally must) that we as participants can drop out at any time and the decision to do so is at our full discretion. That's what we agreed and signed up to. Obviously, ideally all participants should continue on with their full course of assigned treatment, and most will. But there are cases with mitigating factors that make it very reasonable for the patient to discontinue. And it isn't "unethical" or in violation of the word or spirit of the contract to do so. Of course everyone who signed up started out fully intending to finish their full course (as I do), both to maximize their chances of SVR-ing (obviously) and to do our part to help develop this drug for others with HCV. But I've found that as things have unfolded in the last ~20 weeks, the reality of treatment and its side effects may very well make that not possible (speaking for myself). No one has the right to directly or indirectly condemn me or anyone else for possibly making that decision either. That's also why a fair percentage of trial participants have already dropped out before reaching their full treatment cycle. And there will be more dropping out early as the trial continues on due to intolerable sides. It's to be expected; it happens.

"i thought the vx950 was stopped after about 12 weeks and just the peg/riba was continued?????"

It is. I guess what you're getting at here is that since it's just SOC after the first 12 weeks, it isn't any worse for the trial participant than it would be for any other SOC patient. And therefore that participant should just "suck it up"? Well, first off it isn't that rare for SOC patients to discontinue early due to sides (especially attempting to go for 48 weeks or more). Secondly, the dropout rate for VX-er's was triple that for SOC during the first 12 weeks, and that should tell you something. VX was shown to exacerbate anemia, diarreah (diarrhea) and RASH (in some),and at a rate/severity well over and above SOC sides. If you think going through the early phase of treatment and dealing with some of these severe problems (again, which are over and above SOC sides) doesn't weaken you and suck out some of your reserve for later, you're mistaken (especially when you have to work and don't have the luxury of staying home). Each of us has a finite amount of endurance in regards to what we can tolerate, and it can only go so far. Especially in regards to the after effects of a bad rash. Believe me, it just doesn't "go away" and end altogether as soon as you remove the allergen (VX in this case). It has lasting effects that stay with you long after the VX dosing cycle ends. In fact, I'm not so sure the after effects will ever completely go away once I stop these drugs. After seeing what SOC can provoke in some in regards to permanent AI problems, it makes me fearful of what could happen even after stopping.

Lastly, it's been bandied about that if a participant did leave the study early (or extended beyond their pre-assigned duration), this would automatically negate and void any and all data coming from that participant. And because this is "true", it's personally unethical for that participant to "waste" his/her trial slot by selfishly squandering that precious data. And this is true because it effectively slows/obstructs the development of the drug for the benefit of others. This is absolutely NOT true! The complete side effect profile (including how those side effects were managed), all of the bloodwork and the huge amount of critical data that comes from it, is retained and used and remains useful regardless if the participant stops or not. Also, follow up SVR data also remains completely useful. The data doesn't magically evaporate into thin air, and it doesn't magically become scientifically invalid or useless simply because the particpant stops at an earlier than assigned duration (or extends beyond). That's a blatant fallacy, I have no idea why people are thinking and saying that.

Furthermore, there's nothing "magical" about a duration of 12 or 24 or 48 weeks. There isn't any "rule of 12" that's scientifically meaningful in terms of trial duration. The breakdown of groups in multiples of 12 is really somewhat arbitrary (other than dividing it into desirable intervals of reasonable length). Fact is, is that the ability of an *individual* patient to SVR using a mixed dose-duration combination of VX950 and SOC will continue to vary just as it does with SOC. It's not like they're going to find out that everyone who wants to SVR has to go precisely 12 or 24 or 48 weeks. The statistically likely required time and dosage schedule will continue to vary from person to person depending on their specific criteria (stage, geno, VL, weight, age etc etc) just as it does now with SOC. And if you think Vertex is going to throw away the data of anyone that stops early or will not be willing to continue to track and monitor that participant for long term SVR data, you're wrong. I can assure you that the trial is specifically designed to accommodate early dropouts, and also that their data is just as valuable as anyone elses (i.e. "full termers"). Vertex is fully expecting that there will be a fair number of people who will dropout before reaching their full pre-assigned course, and will still use those patient's SVR data as "in between" points. Also, if a patient who was assigned to 48 wks and then stopped at precisely the 24 week mark, that patient's data would be absolutely indistinguishable in every way from any other 24 week participant. In other words, sure they would lose a 48 week data point, but they'd gain a 24 week data point in return (which could be used to replace one of the early 24 week dropouts, incidentally).

As a further example, lets say a person meeting a certain profile (age/sex/fibrosis/BMI/VL/ect) was assigned to the 48 week group and only made it to 35 weeks before dropping out because of intolerable sides. Does anyone honestly think that all of a sudden that patient's side effect profile, all of their bloodwork data leading up to that point and their long term follow up SVR status is useless just because they didn't make it to that arbitrary 48 week mark? Of course not! All of that data is still completely useful, it will still be incorporated into the study and eventually be used to fully contribute to the development of the drug. It just adds a data point in between the 24 and 48 week marks, including the holy grail of long term SVR data. These data points are still very useful, and the reason they are is because the required dose/duration of treatment will undoubtably vary from patient to patient just as it does now. These "in betweeners" will help to flesh out a more complete understanding of just how long it is likely to take to achieve an SVR.

[lab-rat]

Hi. I was just wondering how the SVR data would be followed for a hypothetical person that drops out of the study prematurely...i.e. who would be following up on this patient?  I assume that if you drop out of the study, you're on your own.(Or am I wrong?)  I read somewhere that the 24-week arm is followed up with weekly blood tests to check for viral breakthrough.  Would the study still want to do this for a patient that just stops the meds?

[mremeet]

pds - Thanks for the kind words, but you're butterin' me up with flattery when you say I'm more articulate than you are! ;) I know how much you've been through, and it's tough to keep going on. But like you said, it's the best thing to do for the study and for yourself. I'll be talking to you soon, hope you're doing well.

labrat - I don't know how Vertex plans to track the SVR/relapse status of early dropouts. I briefly tried to breach the subject of early withdrawal from the study with my study nurse, and for a trial participant to still come back for testing to provide long term SVR data. She either didn't know offhand if that was possible, or was simply not telling me in order to discourage thoughts along those lines. As long as the blood sample was collected by a trusted source (via your study center), and sent to the same lab (Covance in this instance) used for all of the other testing, then there's no reason in the world why long term follow up viral standing (SVR/relapse status) couldn't be achieved and incorporated into the final study report. Now, if Vertex or the study doctor or whomever in authority declares "we ain't gonna do it" for whatever logistical/bureacratic/programmatic/esoteric etc reasons they might have, then that's up to them. But there is no scientifically legitimate reason to flatly exclude that data as long as it is properly processed, interpreted and reported within the final (mixed) dataset. In fact, as previously discussed, there's every reason to capture and retain that data. The only caveat would be that the 12, 24 and 48 week groupings would have more statistical significance because they'll be of a much larger size than the relatively scattered few falling in between the major 12, 24, and 48 week groups. And clusters of larger size are (in some ways) more statistically meaningful (and easy to analyze and therefore derive predictive conclusions from) than the smaller groups of outliers falling in between those major groupings. But again, the "outliers" can still provide very useful "interpolative peeks" between the major groups.

btw, hopefully you're coming along well? Sounds like it, and you must be getting close to your unblinding too? I'm both psyched and worried about mine, but one way or another this too shall pass. In the meantime wishing you the very best of luck, glad to hear you're doing well.

[lab-rat]

Thanks for answering...I was curious about the logistics.  Of course its in the drug company's best interest to keep track of everybody who has taken their drug, including any dropouts.

I'm doing well, thanks for asking.  The doctor told me he's confident that I'm responding well to tx (current ALT 13) and I'm almost afraid to say how "normal" I feel.  I've had none of the anemia or skin issues reported by other trial participants (or others on SOC).  My hgb did drop down to 10.9 at around week 8 (or so) but it was back up to 12 the following visit - I didn't really feel it.  I also had a bit of a rash for about 2-3 days at week 13, just after stopping the vx/placebo dosing.  But that was almost like hives...I had just returned from a trip to the Carribean and my allergies kicked in as soon as the plane landed in Atlanta.  I think it may have been just that - allergies.  Another curious thing is that I expected to have skin problems while down there.  But frankly I forgot all about tx and hung out in the sun way more than I should have (one of my vices).  Given what you've been through I'm sure you don't want to hear any of this!

I feel very fortunate to be tolerating treatment so well, but the true picture will come from the VL. My week 20 visit will be on 1/26 - and I'm trying not to stare at the calendar.You must be getting your unblinding information any day now, right?  I hope you're feeling better now that you've got the vx out of your system. I'm keeping my fingers crossed for us all.  Please let us know your numbers when you get them. Best of luck and hang in there!!!