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223152 tn?1346978371

Watch and Wait

Hello old friends and new friends.  These are comments on my trip to the hepatologist last week….

My history – geno 1a , grade 1, stage 1, probably infected about 1969 -1972 (IVDU)  but maybe 1977 (blood transfusion).   Treated with Peg and Copeg (1200) for 56 weeks (June 05 to August 06).  I had detectible virons – 40 IU/mL at week 12 – so decided to tx 36 weeks after I reached a UND by sensitive testing (week 20) but it was not enough and  I did relapse after treatment ended.

I transferred from my local GI to a hepatologist in Dallas and my first visit was May 07.  At that time,  we decided watch and wait.  I had another biopsy Dec 07 which was a little short of the 3 years, but did that for insurance purposes.

Although my bx results were faxed to the heppo, I wanted her to read the slides.  Since I had not been able to get  through to her medical assistant before the appointment,   I signed the papers at the appointment so she will now have the slides sent to review. When she read my 2005 biopsy slides she  changed the dx from a 1/1 to a stage 1, grade 1-2.  My new bx was also a 1/1 so I am  anxious to see how this one is re-graded.   I want to know if 56 weeks of treatment did anything at all, and my reading of the reports says no.

The bottom line is watch and wait given my “mild hepatitis” as they call it.  She said I have a 20% chance of becoming cirrhotic (I am 60).  She said it is totally my choice to treat or not, but I need to weigh the adverse effects of treatment with the benefits to be gained by clearing.  She also said the trade out my by QOL.

She does feel Telaprevir is the strongest thing on the horizon.  She thinks 3 years before it will be out.   I asked her about heresay that Vertex will ask for FDA approval for it to be released to relapsers before treatment naïve, and she said it is already on the expedite track and that, if anything, drugs are usually released for treatment naïve first.

I did visit with the trial coordinator who brought up papers for me to sign for the Omega Duros trial.  I am not interested in that one because research shows (me)  that omega interferon does not have as  high a SVR rate as interferon Alpha 2a & 2b.  So I didn’t think the injection method (an implant in the arm that releases interferon over a steady rate for months) would be enough to counteract the inadequacies of the Omega interferon.

I am scheduled to come back  for the Hepatitis C Clinic to sign up for the next Telaprevir study for nonresponders maybe in the fall.  It will depend on what Vertex’s definition of non-responder is and whether that includes relapsers.  But again, the heppo want me to think of the cost and time versus benefits.  Weekly flights to Dallas for first mo, then maybe monthly, and quarterly.  Lots of time off work and travel expense.

So that’s it, my friends.  I shall remain a fly on the wall for now.
frijole
27 Responses
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544172 tn?1216520164
??? I think you misunderstood...my liver enzymes have always been normal until a check up in May 2008...and my Hep C was positive...and liver bx was stge 2/grade 2  this is all new to me.

I was rejected for the Pase 3 telaprevir study because I had to have documented proof that I had Hep C for at least 6 months.  Now, I am trying to decide whether to try for a Phase 3 boceprevir study or start the SOC.

From what i am hearing ...maybe SOC is the best option???

What is a PCR?
Helpful - 0
408795 tn?1324935675
Yes, I was a telaprevir hopeful, and as other ppl were getting started and I was being left out I talked to a friend of mine who is on the current study which ends in December.  She hooked me up with her nurse and I asked her if I was ever gonna be sent consent forms, as I keep getting the same answer which is 2 to 4 months.  I went over my meds with her and she said, the protocol won't allow that.  I said ok, wish I would have known sooner, but I thought that was the problem.  So I'm fortunate that I have insurance and I will start SOC soon.  Are you currently on tx dointime?  Oh frijole, sorry about that sometimes I forget things, I had to update my pic to share with everyone.  Duh?  Anyways like I was saying, I've put this off for way too long.  Truth is I should have tx'ed a long time ago.  good luck and God Bless      
Helpful - 0
223152 tn?1346978371
dancegirl, How are you?  Your son - had some ED or MH problems, I think -- not downs, but maybe slow? I remember you were worried about him being picked on.   He was a real champ, I know that.  I am so glad he is done and made it through it SVR.  What a relief.  Now your daughter has not treated yet, right?

fretboard - don't see your hand pictures. No, I don't have a problem with water retention.  Is it a kidney thing or maybe a collapsed vein problem?  As far as treatment,  you are focused and it is time for tx.  My sides weren't that bad except for the white and red blood drops, but, of course there were some that adhere to the "no pain, no gain" philosophy around here and were not surprised that I relapsed.  Good luck to you.  ps - you qre qute the photo artist.

zazza -- ?Wonder if you have your results yet.  I have my fingers crossed.  Are you feeling pretty good now?  Riba sides gone?

sandbash, interesting about the Vertex rejection.  Kind of currious why you never had a PCR with all those nasty liver enzymes.  Did you not really want to know?

tallahasse - what about you?  Did you clear?  I will look on your profile after i post

dointime - food for thought (PI resistence).  Since I started this post Vertex has opened the trial for relapsers and I will probably get the call.  So now I really have to get my two column paper out - why to treat -- why to wait -- and go after it.

FL - You pose valid points but there are always opprotunities for blood transfers.  I talked to my surgeon about it when I had the biopsy, and he said it goes with the territory.  But next month I am going to do a tooth implant.  I already had one dds reject me for the hep C (probably not legal, but I wouldn't want him now anyway).  And there is the (maybe stupid but true) guilt factor that I have already infected countless unnamed people because I was a blood donor for about 4-5 years regularly, in the late 70s.

r4c7 - sorry you have had bad sx.  I hope it proves worthwhile and you clear.

frijole


Helpful - 0
94007 tn?1224762736
Great to see an update from you, you were so helpful to me when my kids and I were first dx.  Sounds like you are doing OK, doesnt seem like we have as long a wait as it seemed a few years ago
Lisa
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Avatar universal
I understand what you are saying.  When I was diagnosed in 2006 there was no way that I wanted to wait for years for tx.  I didn't SVR but at least I now have the peace of mind of knowing that I tried and knowing how my body reacted.  If I hadn't done tx I would be driving myself crazy every day thinking about whether I should go for it or not.  

One thing I do regret though is coming out of my trial with telaprevir resistance.  Maybe it is better to do your first tx with SOC alone.  Then if your virus is going to be 'easier' to kill the SOC should do it.  Now that we know the telaprevir is a one-off shot I'd say that - all things being equal - it is better to go for it under optimal conditions, ie. not in a trial.

dointime        
Helpful - 0
408795 tn?1324935675
Yes I've heard that opinion before from a couple of other ppl.  I've waited long enough and since it bugs me so much I've decided to tx.  I also believe everyone should try it b/c how are you gonna know if you're gonna clear if you don't try?  Also, how you gonna know how bad the sx's are gonna be if you don't try, meaning it may not be as bad as all that.  I mean I'm sure it's very difficult and nobody wants to tx, but in order to clear things up you gotta give it a shot.  (No pun intended)  Also, I think the more ppl who try tx the more educated the rest of society will become.  I really don't believe that technology moves that fast, the tx started with interferon and it's still being used.  Sure it's a new improved mix, but my point is there is nothing new.  Sure there are some drugs on the horizon, but first availability will most likely be for relapsers or null-responders.  With that said, those drugs will still be used in conjunction with the Peg and the Riba.  That doesn't look like a good wait to me.  Sure as far as frijole is concerned, watch and wait is a logical option, but for me it isn't.  later
Helpful - 0
Avatar universal
Having almost completed treatment (in week 46 of 48) and now having firsthand experience as to what its like to live in a living hell, if I were a stage 1 or 2, I would wait as long as I could.  Who knows, with technology advancing like it is, you would think that eventually a drug will become available that will dramatically slow the progression of hep C, making it possible to live with the disease and without the awful side effects of treatment.  FOR MANY OF US, THAT MIGHT BE A VERY SUCCESSFUL OUTCOME!

r4
Helpful - 0
408795 tn?1324935675
If you look at my pics you can see a pic of my fat hands, it's just a sample.  I mean it's not a sample as in they get fatter.  LOL  I hope they don't, but I've been to a couple of different doctors and they said that it's from IVDU.  My feet and my hands swell daily  and I do know that they (my hands) swelled since I was in my late 20's or early 30's.  I get a diuretic, but I seldom use it.  Do you happen to swell?  It's a strange thing, but I ran into my ex-wife a few years back and her hands swell too.  She is also HepC positive.  Anyways, just wanted to get back to you on that, see what you thought?  Or anyone else.  God Bless    
Helpful - 0
Avatar universal
Ditto all folks recommending VX with SOC (western omelet with the eggs, onions, and beans!)

All the best to you, my friend!!

Hugs
Helpful - 0
Avatar universal
The fly in the ointment with telaprevir is that it seems to be a one-time shot because after that you develop resistance, not just to it but maybe to all the protease inhibitors that target the NS3 protease.  

On the other hand, the results coming out of the Prove3 trial are showing very good results for relapsers, so there's a good chance that you would nail the virus at the first shot.  

I soooo understand the feeling of just wanting rid of that f****** virus.   Maybe by the time you have to decide about the trial we will have more results from Prove3.  Also we might find out if Vertex will get early approval for telaprevir for non-responders.

You have the liver time so I guess you really have to weigh up the risks of the trial with the time you will have to live with the virus if you wait for the drug to be approved.  Another factor might be that other drugs will be coming onstream by then too, giving a combo of 2 active agents and an even better chance of SVR.  It's a tough one but at least you have the choice.  I was in the Vertex no-riba arm of the Prove2 trial and had breakthrough so I have PI resistance already.  I feel that living with the virus really ***** but so do the drugs.  I have liver time so I'll wait for a real killer combo to come along.  

Best wishes
Dointime
Helpful - 0
96938 tn?1189799858
Some hcv'ers have inate responses like 'get these buggers out of me' and 'I don't want to be contagious'.  If you look at the contagious aspects, I'd imagine it would be pretty difficult for you to pass it on.  I imagine that you might be beyond veritcal transmission to an offspring, you know not to attempt blood donation and I'm guessing that that you are not involved in needle-sharing and IVDU so much. So, that limits the number of possibilities for outbound virus from you to others.  No one can tell you 'oh, don't worry about it' but you probably realize that you are no Typhoid Mary either.  Even in the course of your occuppation, the blood extraced for the benefit of the IRS isn't yours either.
Helpful - 0
Avatar universal
Good to hear from you, Kathy! I went for my 3 months post PCR today, so I will be in touch in about a week from now and tell you how it went. My liver enzymes are still really low since tx and AST is like 1.5 times greater than ALT, which is a good sign, so I am hoping for the best.

I totally agree with FlGuy's opinion about Telaprevir and SOC being your best option. I am positive you will beat the dragon with this 3-drug combo.

Take care!
Helpful - 0
544172 tn?1216520164
To All:

Vertex just rejected me for the Phase 3 Study because I could not produce proof that I had Hep C for at least 6 months.  ALT and AST normal in 1997, 2003, 2006, went into 90's in May 2008 and Hep C pos.  After attending the consent class and getting all geared up for TX.....I was devastated.  I have been asymptomatic, but have had it for years as my liver BX was stg 2, grd 2.  The protocol is in place to weed out anyone who is having an acute crisis that may clear itself (what luck!  has that actually happened to anyone here).

Now trying to decide whether to start conventional TX, wait for protease inhibitor to hit the market (I just turned 57 and am relatively healthy), or try another study....
Has anyone been in the Schering Plough Boceprevir Pase 2 Study?

This may be an option:  "Schering Plough Initiates Phase 3 Studies with Experimental Oral HCV Protease Inhibitor Boceprevir in Treatment-naive HCV Patients and in Those Who Failed Prior Treatment "

Helpful - 0
223152 tn?1346978371
love drawing my old buds out.  Hey goofy - fisheress started a thread a couple of days ago.  Have you found it yet?

orleans -- just left some comments on your Vertex post.  Oddly enough, the news broke the day of my appointment.  Per the news...

"Boger said Vertex expects to take the final data from the trial to the FDA late this year or early next year.

Should the agency agree to review it, he said the application would be only for patients who have stopped responding to other therapies."

So scuttle but was better than the professional.. Maybe, just maybe we relapsers and nonresponders can be in business in 2009!


Bill -- Hi, guy.  Glad you concur on the Omega Duros.  There was a relapser in Houston who keyed me into the study in San Antonio and I went as far as getting the sign up papers sent, but never sent them back.  Just didn't like the statistics.  I don't know if she - Magtx on the forum - ever went thru with it.  I am surprised your doc is not high on Telaprevir.  They do a lot of trials at The Liver Institute at Methodist Hospital in Dallas.  That's where I go and that is why she is in tune with it.

Goofydad - how the heck are you?  Hope all is well in sunny cal.  Is young goofyboy doing well?  My grandkids run me ragged but we are getting a break from them right now and I miss them.

Susan -- aren't you in another trial right now?  Good news for you if Telaprevir hits the market in 09!  Hang in there

greatbird -- I think windows of opportunity are one of the best reasons to treat.  Time and place and job security and all that stuff matter a lot.  I will look for your posts on the trials.  Good luck.

Pro - thanks for the support.  I am sooooo glad you cleared.

fretboard -- read your profile and your stats are similar to mine.  I even new in 1993 that I had hep C when I tried to give blood.  Never did anything until 05 when I decided the time was right.  Good luck on your journey.  Explain the swelling to me.

frijole

Helpful - 0
408795 tn?1324935675
Much kudos for sharing your story, it's really close to mine.  Everything you wrote except I'm a little younger and I have yet to tx.  Not much younger, I'll be 55 this year.  Fortunately you aren't too bad off, I am the same grade and stage or really close, you can check my profile.  I'm thinking you're even a bit better off than I am b/c I swell.  Anyways, much hope and prayers for you.  God Bless    
Helpful - 0
9648 tn?1290091207
I am looking into one of the Telaprevir trials--the one for treatment naive geno 1's. I've had a look-and-wait attitude about this since I was first dx in 2002 and life has been busy. I've had a job where tx issues could be a problem. But now it seems I might have a window of opportunity job-wise.

I'm almost 54. I've had this for at least 30 years. I'm a stage 1 grade 2--or was at my bx in 2002. No symptoms.

I've been so unwilling to chance wrecking my health with these strong meds, but if my odds of clearing are this much better (assuming I don't get the placebo) then maybe I should go for it?

Much to think on.
Helpful - 0
Avatar universal
Ahh, what I would give to have such options! jerry (bx1/3)
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92903 tn?1309904711
"western omelet without the eggs and onions"

Or in this case BEANS!!!

Helloooooo Beannie! Glad to hear you're well. I think you and the FLguy are dialed into the right channel. You're young, footloose, and fancy-free. No need to rush back into Hell's kitchen.  
Helpful - 0
96938 tn?1189799858
I stand corrected. I should have said  vx plus the associated soc combo.  Another demonstration that hcv tx without peg and riba is like a western omelet without the eggs and onions.
Helpful - 0
Avatar universal
Thanks for keeping us up to date on your situation Kathy. Sounds like either way, you have time to make any final decisions. I can understand your feelings of worry over possible spreading of the virus (this was very high on my list when considering tx myself). But on the other hand weighing age, tx downside ,as well as the chance of being contagious to others (probably extremely small when considering your lifestyle, knowledge of the virus,etc.)...perhaps a second tx is not right for you, and that would certainly be understandable...just something more to ponder.
Keep us posted, Pro
Helpful - 0
87972 tn?1322661239
Hi Kath,

Well, it sounds like you’re making a logical decision; and who knows, maybe you’ll get used to a watch and wait position eventually.

I’m glad to hear your doc felt good about Teleprevir… every time I press my clinic out here about it, I kinda get blank stares; like “yeah, eventually something will come along”. Nothing out there right now to base treatment decisions on, however.

FWIW, I agree with you on Omega IFN. Wasn’t that dubbed ‘Locteron’ at one time? None of the studies that I’m aware of to date showed much promise… although I don’t know what kind of effect the implantable unit might have on PK/PD.

Good to hear from you, as always, and DO stay in touch. I’ll catch up with you soon,

Take care,

Bill
Helpful - 0
Avatar universal
Actually, FLGuy YOU DO KNOW someone who was actually on the Telaprevir and did not clear the virus...ME!    Remember I was in the group that actually had the Telaprevir and the Pegasys, but w/NO RIBA??   It's become apparent that the patient HAS to get ALL 3 drugs in order to get the big clearance rates.  I did not get all 3 and didn't clear the Hep by the week 4 requirement.  In fact, I had a big drop in week 1, down to 100 something on the copy count, but, by week 2, I had a significant rebound.  Now, I'm told that I'm NOT ALLOWED to participate in any more VX-950 trials due to the fact that I was exposed to the Telaprevir.

Susan
Helpful - 0
223152 tn?1346978371
Elaine - you are right ---"choices" are everything.  Yes, I have choices at a 1 or 2.  Yet age factors in there significantly.  Do I really want to do this at 65?  Do I really want to get more tired all the time?  I went camping this weekend with a local outdoor club.  When everyone else was sitting around telling tales, I had my head leaned way back in my lawn chair, almost passed out.  Don't think I snored, but.....  so I went to bed when everyone else was up.  It happens all the time and I don't like it.

NY - I really am more of a fly on the wall, reading titles and not threads mostly.  I will pop in from time to time but not that often. Re the hep -- I don't feel a dang thing except the usual that you hear - joint aching and tiredness.  The hepatologist really would not commit one way or the other but I do think she thought I should not treat.

FL - I like your thinking--  it does make more sense that, if I treat at all, I should not get involved with something that would possibly be a placebo.  That could mean 48  mo of traditional tx plus maybe the Vertex after that.  My thinking has changed significantly too, as far as waiting goes. I used to think everyone should treat ASAP and there still is good justification for that but I do understand waiting more -- especially if you have tried it once.   Still, that is the selfish attitude.  I am, in fact contagious and that weighs heavy on my mind and pushes me to treat.  Re my picture - I have been meaning to retake that.  It is a Hepatitis C molecule!  I bought in bulk (didn't I, Deb).  pm me and I will have one to your door in a heart beat!

bean- kathy-frijole

Helpful - 0
96938 tn?1189799858
Over the past several months my  "if I were in his/her shoes thinking" has changed somewhat.  From my reading here, I don't know that I have read a person who has been on a VX trial (and actually getting VX) that did not get to svr.  There must be some, I just don't recall seeing any. So, if I were in your shoes, and I were at stage 2 or better - I'd wait for the VX bus whether it's a trial or when it's in prime time.  And, I'd be leery about a trial due to the possibility of placebo. I'm pretty sure you don't want to do another year of tx (6 months of placebo and another 6 months of real VX do-over).  I  think I'd wait for that sincere VX bus to come along.  Good luck Kathy.  BTW, I've never been able to make out you 'photo'.  What is it?
Helpful - 0
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