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Vertex PROVE 2 Trial conclusion

by nick m, Aug 12, 2007 02:35AM


Quick factual update - unfortunately the low positive on the 85th and final day of treatment was a presage of things to come. The virus came back with a vengeance (1,450,000 IU/ml) one month later. On Thursday 14th June I discussed it with the Professor and elected to wait until (and if) the new treatment is licensed in 3 or 4 years' time or so before I try treatment again (as long as my LFT's don't go through the roof, ie 200 or above). I had a fibroscan while I was there(a non-invasive biopsy) which confirmed mild fibrosis. My latest Liver Function Tests read -

ALT 102
AST 85
HCV RNA 757,969 IU/ml.

Pre-treatment (Dec '06) they were 162 and 129 respectively.

My conclusions? The VX950 clearly worked and was a massive improvement on current standard of care treatment consisting of interferon and ribavarin alone but suppressed rather than eliminated some variants of the virus.

It needs the ribavarin to eliminate these variants - and it needs longer. I've no doubt that if I'd been able to consolidate my earlier apparent clearance of the virus with another 6 months of conventional SOC Peg/Rib treatment I'd be genuinely clear. Initially I was emotionally over-invested in the Vertex... bought into the excessive cure-all hype... 'cause I wanted to believe. But now, from the sober perspective of 4 months on, despite the initial disappointment of the viral return, I'm glad I got the opportunity to take part in the trial. What I gained was a wealth of information, not just about the mechanics of the virus but also about myself - a modest lesson in stoicism.

I had negligible side-effects during and after treatment (none from the VX950) and remain in good health with improved liver function. My treatment at the Hampstead Royal Free Hospital was (and remains) superb. And, although it was never my first priority, I'm experiencing the novel glow of altruism (thrust upon me so to speak) having - albeit unwittingly - infinitesimally increased the pool of available information about hepatitus (hepatitis) C.

If the result of these trials is an effective 6 month treatment for people with genotype 1a/1b hep c (with or without Ribavarin)- a result that currently appears highly likely - then Vertex will have achieved a major breakthrough in the treatment of Hep C that could spell the difference between life and death for thousands of people. If the result is simply a more effective 12 month treatment with improved outcomes... the same applies; though having analysed all the available information, my money's on the former, ie 6 months Peg/Riba plus 12 weeks VX 950 with massively improved outcomes for genotype 1a/1b sufferers. Having said that, thats my last word on Hep C for the next few years. Best of luck to all my fellow trial participants.

Member Comments (30)

by zazza, Aug 12, 2007 04:05AM
To: Nick
So unfortunate you did not reach SVR this time. I am certain you will get there in the future, just add riba to the mix and that will be it I believe. Zazza

by dointime, Aug 12, 2007 06:14AM
To: Nick
Hi Nick - great to hear from you and get the news that your tests show improvement.

Were you actually offered the choice at week 12 to switch to SOC, seeing that you cleared late into the 12 weeks?  Or did Vertex make the decision to stop your tx at week 12 anyway?

I too have little doubt that with another 6 months SOC you would have been SVR.

Wishing you all the best,
dointime.

  

by nick m, Aug 12, 2007 09:38AM
To: dointime
Hi good to hear you. No, I wasn't offered the choice at week 12 to switch to SOC because in theory I was clear. In practice I wasn't 'cause the result on that final day (Day 85) was positive - but I didn't receive that result for 4 weeks ( mislaid - lab or hosp... I don't know) and by that time I'd had another negative from the Safety follow-up (Day 99) so SOC wasn't offered then either. That first positive on Day 85 was just regarded as a puzzling anomaly and I in my ignorance, naivete and denial colluded with that interpretation. Still, as you can see, my LFT's have remained improved ie better than pre-treatment... and my VL has gone down from 1,450,000 IU/ml (June '07) to  757,969 IU/ml 2 weeks ago. Obviously, like you, I had a viral breakthrough on the final day of the VX 950 (Teleprevar) but I've only really understood that with hindsight.

by willows, Aug 12, 2007 11:21AM
To: nick
You've added more info to the arsenal we are trying to build to blast the virus.  So treat yourself well for being the front-line soldier you are.  Vertex is all you've stated and more, I believe, but I also believe it needs the interferon and ribavarin to completely do the job.  I have wished for a magic pill in my lifetime, but I will settle for teleprevir and SOC by about 2009.  Only 24 weeks is a big benefit and you are someone I can genuinely thank for taking me one step closer to that day.

May I be so bold as to ask if you like the new Dr. Who?  I only say that because Dr. Who is so obviously a wonderful concoction that could only come from the BI, but I love him all the same.  We do not have the same sense of humor here, unfortunately.  And speaking of that, are you a "Red Dwarf" fan?  I miss it all.  

by Lady Lauri, Aug 12, 2007 11:25AM
To: Nick M or anyone!
Hi, I just found this forum. I am a young (always been very healthy?) 49 year old woman, just dignoaed with Hep C, type 2b., stage 2-3 fibrosis.  (After 2 years at Dr.'s & being told "nothing's wrong with you", My Eastern medicine, acupunture Dr.told me 'somethings wrong with your liver" on 1st visit so , technically, she found it!) ) Immediatly quit all social drinking, was already a 'health nut' that smokes! (TRYING!)
I need some help from people in my same situation. You guys!?
My decision has to be made quick becuase of a study going on, and lack of good insurance, mine covers.... not much. My Dr. at Shands University, Gainesville, Fl. is quite 'happy' with type 2b (as I am) and that I can be 'cured'. This study is with the bi -weekly shots of the pending drug Albumin Interferon Alfa 2-B, with lower dose of Ribavirin. On approval ( of me in thier trial. I will pass, otherwise healthy, don't do drugs, alcohol, etc.) they call and I get put in either the test drug plan or the standard of Peginterferon w/ Ribivirin. Have any of you done the 'trial' drug? Know anything about it? I really don't want to be a guinea pig here! This drug is in final testing stage. I am told it is just as, or more, successful than the other, tolerated better and as safe?? I need to add that I have TOTAL 'drug phobia' for years, can barely take a pill so this will be hard! My sister is in her 7 year of chemo (yes 7th!) with 'chronic' cancer so I will use her for my strength/phobia, as in 'quit whining!')
Also, do you feel 1st shot, as in right away. Quit scared here, while also quite happy I am lucky enough to be type 2 instead of type 1.
Any help/ knoweldge shared is greatly appreciated and God Bless all of you in your treatments and health.      Thanks, Lauri

by nick m, Aug 12, 2007 12:05PM
To: willows
Alas, my real passion for Dr Who was back in Tom Baker's day though I've enjoyed the Billie Piper partnerships with my 27yr old son who's a fan. Its a strange mixture of adult sensibility, optimism, wry humour and of course peculiarly English. I love its depiction of London. Red Dwarf was strictly my sons dept though Craig Charles is from the same manor - we're both from Liverpool 8. Anyway, apologies for posting not strictly matters hepatitic...best wishes nick m

by dointime, Aug 12, 2007 12:17PM
To: nick
Yeah, aint hindsight a wonderful thing.  I sorely wish I had had the foresight to get off-study PCR's for myself every 2 weeks.  I really didn't figure on a breakthrough either and for the same reasons as you.  So that cost me an extra 16 weeks of taking meds, ie. 8 weeks still on the VX for nothing then 8 further weeks on SOC to get to UND again (after first UND on VX in 15 days).  Needless to say, although I have high hopes for the success of telaprevir I am very unhappy with Vertex for not calling time on the breakthrough and starting me on SOC earlier.  I think it was unnecessary and therefore unethical to keep me on VX after the breakthrough when it was obviously doing me no further good at all.  

dointime      

by miked, Aug 12, 2007 12:29PM
To: nick m
At a Prove 3 participant into my 15th week, your post cleary got my attention.

Susan400, dointine (I think), you and othershere have experienced a viral break-though during the Vertex trials.  Correct me if I'm wong but all of you were not given Ribavirin, right?

Because of my research here & elsewhere, I made a fundamental decisiion going into the Prove 3 trial.....If no Ribavin, I'm quitting the study Day 1, period.

Unfortunately we are all learnig from the Prove 1, 2 and now 3 data of what seems to be working, what isn't; new symptoms like the rash from hell and strategies to battle it.

I'm truely sorry that this tx did not work out for you and how dissppointed you must feel.  My first tx I had a viral break-through at Week 32 and took the news pretty hard.  I suffered and struggled or 32 weeks to end up with the same problem.  It took  me a while to get past it and I was pretty bitter.

Actually we are riding on the backs of the people who first tested INF, then Peg-INF, then RBV and now Prove 1, 2 and 3 clinical trials.  

Thanks.

Mike

by nick m, Aug 12, 2007 02:29PM
To: lady laurie and miked
First, Lady Laurie, welcome to the forum. I'm surrounded by people here in London who where same genotype as you ie 2's and cleared in 6 months ( and remain so to this day). My prejudice would be for the peg/riba 'cause it already has a high success rate with genotype 2 but sounds like thats what the trial's offering anyway in a possibly more efficient less harsh form. In fact, if I've understood correctly, sounds like you can't lose - its either the new version or conventional combo. For me the first injection produced a dramatic 'flu-like episode - fever, chills etc but it subsided after a few hours never to re-occur again with such severity. I actually found it quite exciting like tangible evidence that the fight was on after all the fear and anticipation. Good luck again and welcome.

Miked, I think you've hit the nail on the head re the ribavarin. And you're right about the people who went before us. It is "reconnaisance by battle". I got off light in that I only did 12 weeks and, of course, the infuriating paradox - no riba so less to recover from. The more I soberly analyse it the more I learn from it. But in the immediate aftermath it was a different story - i was consumed with rage and despair and desperately wanted to blame somebody. The usual demons of pride and self-pity came zooming in. But I kept sharing all that as honestly as I could with people I trusted and the pain and disappointment diminished. Although I seldom post now I still follow the progress of yourself and others ( some who I know from my trial) and its a real buzz beginning to sense that intoxicating "smell of victory" . Best wishes, nick m

by GrandmaA, Aug 12, 2007 03:31PM
To: nick m
So sorry to hear you relapsed. But thanks very much for sharing your interesting story. You will clear next time I'm sure. You know so much more about the treatment now. You have helped all of us by being in the clinical trial.

by APKhaos, Aug 13, 2007 08:59AM
To: nick m
Can't help but be deeply struck by your stoicism, Nick. This trial dodge is a journey into the unknown for all of us, but to have been so close must have been wrenching! I was among the first echelon of Prove 1. Dumb luck put me in the magical 12+12 arm, which resulted in SVR at 30 weeks post-tx. Needless to say, I'm a cheerful chap these days. The gathering body of data is showing that riba is still an essential element, and that the 12 +12 dosing profile is the business. Good thing is that much of the conjecture will be over by November, after Vertex release the major findings from Prove 1 and Prove 2 post-tx data.

Its cold comfort now, but if telapravir pans out and becomes generally available in 2009 or so, I suspect you will be at the head of the queue for another joust with the dragon, eh?

by susan400, Aug 14, 2007 02:29PM
To: Nick and all
As you all know, I did not clear on the VX/Pegasys.  So what now?  I haven't really been able to figure out what I may want to do, or not do in the future.  Some days, I think that I'd possibly like to retreat down the road w/the VX + Peg-Intron(not Pegasys!) + Riba.   Other days, I really don't even want to try the VX again.  I ended up getting the rash early on and I'm not sure that I want to go through it again, w/the result that I ended up with.  It was a pain in the butt having to wear sunscreen + long sleeves and long pants + a hat, just to walk out in my parking lot to the grocery store, when it was 90+ degrees outside.  And then, I had to also coat myself with cortisone cream and moisturizer just to get some degree of less itching, but I still was itching so bad that I wanted to scream.  I know it was the Telaprevir and not Riba since I wasn't on the Riba.  I just really am not sure that my pschieeeeeee can handle going through that again.  And then, there's other days when I just want the virus gone no matter what.   It's all so absolutely frustrating to me.  If I wasn't already at bridging stage, I'd just quit trying.   There is always the possibility of maintaining on maintenance therapy, too.  My Dr. in Lakeland brought that up to me the other day.  He said that they'd know more after the fall conference.  I could do the Interferon maintenance w/NO Riba and I think I could maintain on that pretty well.   I really haven't had a whole lot of sides on the Inf., especially when it's at such a low dose as maintenance.   I'm also not sure that I'm real thrilled with the concept of going through the trial experience again.  The whole 'blinding experience' for me is too hard to cope with.  The only positive for me in a trial is that everything is paid for, and that's a big plus.   Anyway, I just felt like sharing.  Thanks.

Susan

by mremeet, Aug 14, 2007 02:35PM
To: nick
Nice to see you and hear you've come out of the woods with a positive attitude. You're a better man than me, wishing you the best for the future. Take care of yourself in the meantime, with all that's happening in the HCV anti-viral drug development world, your time for SVR will come soon enough.

by nick m, Aug 14, 2007 04:00PM
To: mremeet
I'd challenge that "better man than me" statement. Your story encouraged me and made my treatment experience seem like a walk in the park (which it was - whatever the outcome). I'm also aware of how much real support you gave to others in my cohort, I've followed your story with bated breath to SVR, so thanks and best wishes for the future. nick m

by dointime, Aug 14, 2007 04:19PM
To: susan400
I am with you on everything you wrote.  There's a small but growing number of people who have not met with success on the trials and are asking the same question - what now?  I think I am in that boat too (waiting for confirmation).  I got horrible rashes on the VX and the riba separately so I don't think I could survive the two together.  I'm not up for any more trials either.  If another tx comes along in my lifetime then I'll wait and get the optimum shot at it.  I would be interested to find out about the maintenance therapy.  Anyway please keep writing and posting your ideas.  After experiencing the devastation of a couple of breakthroughs myself I have nothing but respect for you and what you have survived,
dointime.  

by Forseegood, Aug 14, 2007 04:44PM
To: Nick
What a beautiful post...you Brits have such an ease and fluency in this language!...Indeed, you did a wonderful thing in taking part in these trials, you trial participants are all altruists in that regard.....I'm sorry it didn't ultimately work out better for you, but as you say, you still have low liver damage which I'm sure will hold you in good stead until you decide what to do next.....I wish you every happiness and the best of luck...

by mremeet, Aug 15, 2007 08:27AM
To: dointime
"There's a small but growing number of people who have not met with success on the trials...I think I am in that boat too (waiting for confirmation)."

If you don't mind my asking, what do you mean? Hopefully you didn't recently score one of the dreaded "29's" or an outright quantifiable VL recently?? Whatever's going on, hang in there. Keeping fingers crossed for you.

by dointime, Aug 15, 2007 06:18PM
To: mremeet
Thanks mre.  I just got the news that my VL had shot back up to 200,000 - no false positive with that number.  I'm waiting for the 2 week confirmation before posting my own thread with this news.  I'm consumed with grief at the moment, like somebody close had just died - me I guess.

dointime    

by susan400, Aug 16, 2007 06:52AM
To: dointime
I am so sorry to hear this.  I can honestly say that I know how you're feeling.  You get so excited thinking that this time, 'may be it, I may be done w/this' and then, it's like you're balloon has been popped.  Once again, I'm sorry.  It will be better for us one day, we'll get our clearance!

Susan

by mremeet, Aug 16, 2007 09:09AM
To: dointime
Jeez, real sorry to hear about the positive test. After all you've been through that's got to be tough to swallow. On the other hand, I believe false positives (and mixed up results) are more common than many would like to admit. It is possible this result is wrong, so keep your chin up until it's confirmed.

If it does turn out to be a true rebound, try and look on the bright side in that you get to stop now instead of grinding on to the bitter end, only to relapse after a full course. You have enough liver left to last for years and years until a better mix of drugs comes along. Plus I don't think you're going to have to wait years and years to access them either. Also, I know you're worried about PI resistant strains that were bred as a consequence of no ribavirin during the early phase of treatment. Here's my two cents on that: It's true that those who take a PI as a monotherapy end up very quickly with PI resistant strains (usually within 2 weeks or so). And it certainly appears true at this point that most of those that take IFN+Telaprevir end up in a similar boat, with the exception that IFN tends to significantly depress/subdue/delay an outright full rebound to baseline VL levels (which is what happens during PI monotherapy after just a few weeks). But what's also true is that after all drugs are stopped, the virus will no longer be selectively bred. The PI resistant strains will no longer have an advantage over all the non-PI resistant strains and they will no longer selectively survive. Considering (1) how fast the virus replicates and (2) how rapidly it can mutate away from a parent virus, the resistant strains can end up being replaced predominately with "wild types" pretty quickly. And most wild types aren't PI or IFN resistant. On the other hand, the viral population will probably retain some vestige of the PI resistant species. The PI resistant strains may no longer dominate the overall population (as they did during drug therapy), but some small number of them will persist in some manner, shape or form, probably long after stopping the drugs. The viral populace will retain a certain memory of those strains - those warehoused remnants would be there as breeding stock in the event another PI assault was experienced.

But that doesn't mean that another attempt at treatment using either Telaprevir or another PI along with IFN and riba down the road won't be successful at all. The reason I say that is because Telaprevir will still kill off an awful lot of the viral population after the virus has recentered its population back to wild type (away from the PI resistant type). Plus this time around, you'll be getting a full course of IFN AND riba right off the bat (i.e. during the most critical part of treatment). You can even increase your dose of riba and/or IFN above normal levels initially to really kick it in the pants from the get go (with procrit and neupogen as your friends). The relatively small number of PI resistant "memory" viruses will still be there waiting to flex their muscles as they did before, but this time they'll have to contend with both IFN and riba simultaneously (unlike what happened before). And they're not resistant to those drugs, so there's every reason to be optimistic that they'll go the way of the dodo bird right along with the rest of their non-PI resistant friends. There's plenty of people who failed SOC treatment once and then later went on to succeed on their second shot around. So it shouldn't be hard to believe that you can do it too, especially considering that you didn't even really fail a true attempt at SOC. The peculiarities of this trial (and the lack of riba early on) is likely what jinxed your later SOC performance (assuming you truly have rebounded, which we don't know yet).

Lastly, although protease inhibitors have similar modes of efficacy, there are different proteases to inhibit. The various PI drugs being developed are not the same and just because you may now be partially resistant to one, that most certainly does not mean that you won't perform stupendously with another (provided it's dosed with IFN+riba, of course). And as previously discussed, I haven't seen any red flags popping up on SCH503034. I don't think it's quite as sexy as Telaprevir, and hasn't been getting too much publicity, but I wouldn't underestimate what it might flower into. Plus its developmental cycle is concurrent with Telaprevir, it may be commercially available around the same time (i.e. within a few years). So there's lots of reasons to be optimistic, even in the face of such a crushing blow after all you've been through (and continue to go through). Probably doesn't help much right now, but it's important to think ahead and keep your spirits up. Whatever happens, always know you can beat this thing. You're a smart person and you've gotten yourself a first class education going through this friggin' trial. If there's one thing I've learned, it's that educated and proactive patients who actively work with their doctors before and during their treatment are the one's most likely to eventually get their SVR's. You're one of those people now - I'm willing to bet big that next time will be the charm.

by dointime, Aug 16, 2007 07:20PM
To: susan / mremeet
Thanks for your kindness Susan.  It is the loneliest experience in the world to get the news that tx has failed, but knowing that you and others have been there too helped to make it just a tiny bit less lonely.

And you mre, you just have the knack of putting your finger on the one and only question that really matters, in this case - do I have any hope for the future, or will this effing virus just take my life, slowly and horribly?  

I've noted all that you wrote and really appreciate it.  I'll be questioning the doc when I go for my result.  He uses protease inhibitors for HIV so he may have some knowledge about resistance, which I will ofcourse post if I learn anything.

I'll let you know when the final verdict is in.
dointime.  

  

by cba51, Aug 16, 2007 09:47PM
To: Lady Lauri
Lauri,

sounds like you are considering the same trial i have doing since March. Of the 14 people in my trial group all have been UNDETECTABLE at 12 weeks which is a pretty amazing stat.

I have about 6 months to go and this will undoubtedly be the longest year of my life. The side effects are definitely no fun .  ( anemia=low energy, riba rash, riba cough, most food tastes lousy; these are currently the most prevalent) However i would say the reward of possible obtaining SVR and beating this freaking virus clearly outweighs the risk and inconvenience of 48 weeks of treatment.

Don't worry about feeling like a guinea pig. The clinical nurses are very good and provide good care. Plus you only have to inject Albumin Interferon every 2 weeks instead of weekly, a definite plus.

Best wishes and take a kick *** proactive approach towards wiping out the virus. I had it for many years unknowingly and am Stage 4 Grade 3 Liver Damage ( not good) but I am taking revenge on these viral bastards.

Big Al

by kben, Aug 22, 2007 01:33PM
To: mremeet dointime
Thank you for the information on resistance. Does anyone know anything more about the future and how these PI and polymerase inhib work?  (a lil biochemistry lesson) I am writing cause I need some hope to get out of bed after a devastating blow. (VL going back up)

I think I am in a similar boat, I feel like someone just died. I am going through all the stages of grief-especially anger. I am 29-got hep c at birth and have been on every trial and medication so far (4 different attempts, even back when it was daily injections). I just ended the stage 3 trials and feel like knocking out my doctor who convinced me against my better judgement to continue with the trial even after finding out I wouldn't be getting Ribo. Only one other person in the group is out of the study...they were also not getting the Ribo. I feel a bit robbed of my chances and as if I continue to be a test for things they already know. (I was in the original trials to prove the combo was better) I am losing the optimism and faith. Help!!!!!!

by susan400, Aug 22, 2007 02:50PM
To: kben
I know how you feel as I was in Group C of the Prove 3 trial and I did not get the Riba either.  I have viral rebound and was taken off the study at week 5.  This was my 8th attempt at treating.  So...  I understand the frustration.

Susan

by dointime, Aug 22, 2007 05:59PM
To: kben
How cruel to have this disease so young.  On the other hand, you can fight HCV better the younger you are - when the right meds come along.  I am with you on taking a baseball bat to the head of any doc who would support a trial arm without riba, except for the riba-intolerant who have no other choice.  I was in the first ever no-riba trials when nobody knew what would happen if riba was omitted, but there's no excuse for carrying on with that now.  

I don't know if these thoughts will help you but they are all that I have which help me right now.  
-
Don't think too much about the really big issues until you are out from under the cloud of the meds.  Ofcourse you can't help it, but try to change the channel when you are dwelling on dark thoughts and remember that it will all look less gloomy once you have shaken off those horrible neurotoxic meds.
-
Start thinking about looking after yourself and how to live well with HCV and preserve your liver health.  We know we have the virus and we are on the clock, so it is all about staying healthy long enough for meds to arrive which will work for us.  You asked about the new meds.  I am watching the progress on anti-fibrotics (eg. Pancaspase Inhibitor PF-03491390).  I would not be too concerned about living with HCV if these drugs could prevent the liver damage.
-
I am not a quitter and I can tell from your story that you are not either.  But there's no point in just spinning your wheels.  You don't say what state your liver is in but I hope you have time to take a break, regroup and live a little.  That's what I am planning to do when I finally can pick myself up off the floor.  I'll let others do the trials from now on and watch the progress from the sidelines.  When something that works gets on to the streets I'll have another go.

Out of all this mess I think you can still believe in one thing - yourself.
All the best,
dointime.            

by copyman, Aug 22, 2007 06:45PM
To: nick m
hey nick, sorry the tx did not work all the way. better luck next time. you said you had the fibroscan what was the results. do you have the actual #'s. wishing you the best.

by mremeet, Aug 22, 2007 08:47PM
To: kben
Sorry to hear of your situation, that's got to be discouraging. I'm not sure I understand what trial you're in though, but it sounds like you're saying you're in the Prove 3 trial and you did not receive ribavirin? If so that sucks, sorry to hear it. So what to do now? Hard to say without knowing more details, but it really depends on what you want to do and especially what condition your liver is in. What were your biopsy results?

In a nutshell, what I said to dointime above applies to you too if you didn't get the riba. And like I said there are other drugs being developed like SCH503034 which you might be able get access to in a similar timeframe as Teleprevir when it is approved (assuming it gets approved). Here's what I would probably do if my liver had significant fibrosis (F2-F3):

1. Wait until you had a clean shot at accessing some type of PI, be it telaprevir or preferably one of another type like SCH503034. This will probably happen within 3 years or so. And by "clean shot" I mean access to it without any strings attached - NO blinded groups, NO blinded PCR's, NO denial of ribavirin or interferon, NO imposition of only "standard" interferon/ribavirin dosage, NO limitations on treatment duration, and NO denial of rescue drugs.

2. Then I would get with a talented and renowned hepatologist. If you have to drive a good way to see one, then so be it. You want a real pro who knows how to custom tailor an aggressive course of treatment for you. Someone who understands the importance of maintaining full dosage and the use of rescue drugs. Don't settle for any Dr Stanley Standard outta the yellow pages, get yourself a pro.

3. Discuss with your doctor the possibility of getting some neupogen and procrit prior to starting your treatment. Have it on hand in your fridge before you start. Discuss with your doctor about doubling up on IFN dose for at least the first 1-3 months of treatment, and/or exceeding your standard weight based dose of ribavirin (to whatever level you and him think is advisable). Bottomline is that you want to get more of those nasty drugs into your system during the critical early phase of treatment, make sure he's on board and you're on board (assuming you're sufficiently motivated to take this risk). Also discuss the possibility of treating longer than 48 weeks if your performance during treatment dictates that. Make sure yor doctor is on board with that.

4. Make sure your doctor will allow you to be PCR tested at frequent intervals AND that a sensitive PCR test is used (<10 IU/ml minimum). Ideally I would want to be tested weekly until I became UND. And then maybe bi-weekly and then once every 4-6 weeks after that. You want to know when you become UND and that you stay UND - it's an important piece of information when deciding when/if to back off on the elevated drug dosage and ultimately when to stop treatment. Also have your regular bloodwork checked more frequently too, especially considering the elevated risk of severe anemia and neutropenia that comes with high doses of IFN and riba.

5. Make sure your doctor is ok with pre-emptively dosing procrit as soon as you start taking the high dose ribavirin. Procrit has a lag time of about 2 weeks before it kicks in, you don't want to have your HGB drop under 10 right off the bat causing you to crash and burn right out of the gates. Examine your response to ribavirin in your earlier courses of treatment (from your labwork, get copies if you dont have them) to get an idea of high quickly your hemoglobin drops off; this can help interpolate how much procrit may be appropriate before your HGB actually drops to undesirable levels. Neupogen is fast acting, so you shouldn't need to take anticipatory doses of that drug, but you do want it handy if and when your neutrophils (ANC's) tank.

6. If you know of any peculiar vulnerability you have to the drugs, then use that knowledge to custom tailor your elevated dose plan. For instance, if your skin is especially sensitive to ribavirin and/or your HGB really plunges in response to it, then go easy on ramping up riba too high. If you have a real problem keeping your neutrophils above, say 500, during a normal course of treatment, then consider going easy on the double dosing of IFN. Also, if you have sensitive skin and a lot of dermatologic problems, hook up with a really good dermatologist before starting treatment (preferably one that has experience with hep C patients). Discuss what you're going to do and have him/her on your team from the git' go. Also look into getting on some A/D's before starting treatment (if you think you might need one), and find one that works for you. The only way to find one that might work for you is by trial and error, which can takes months and months or even over a year. So start early on that one and try and find one that will help you through what will almost certainly be a tough fight.

Anyway, that's about it for starters. You just gotta keep on keepin' on. You can beat this thing, in fact you probably would have beat it if you had been allowed to take ribavirin. It totally sucks that your a-hole doctor kept you going without it, but the bottomline is that you're a young guy with resilience to spare. Next time make sure YOU'RE in the driver's seat and yhave a plan to WIN!  Good luck...

by dointime, Aug 23, 2007 06:12PM
To: mremeet
Hi mre, this is a great roadmap.  You sure you wanna stay with the job you've got?  There's not a lot of docs out there know this stuff.  :)) dt.          

by mremeet, Aug 23, 2007 08:00PM
To: dointime
Ha! You wouldn't want me as your doctor. But if I was up for another 4 years of school, I'd emulate this guy ;-)

http://youtube.com/watch?v=rCCJ8n3RgzQ

by dointime, Aug 24, 2007 05:02AM
To: mremeet
Ha ha, good one.:))
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