Watch and Wait

[frijole]

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

[FlGuy]

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.

[Proactive]

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

[Bill1954]

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

[susan400]

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

[frijole]

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

[FlGuy]

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?