treatment quandary...

[attagrl]

Hi all,

I'm new to this group and first just wanted to introduce myself. I was diagnosed with 1a in 1996 at age 19; no idea how long I had had it for but was diagnosed after a severe cholestatic response to oral contraceptives. I have been putting off treatment for years waiting for a treatment combo that would have a reasonable response rate as well as because of worries about resistance mutations (I have a degree in molecular biology and sometimes that kind of knowledge is a bad thing :P). This past month I finally made the decision to start telaprevir/ifn/riba combo therapy in the fall, and then as coincidence would have it, received an informed consent packet for the Pharmasset PSI-7977/BMS-790052 study. After doing a fair amount of research on advances in these antivirals, I scheduled an initial screening (July 22nd) to at least get some questions answered and keep my options open.

With all this going on, I decided it was high time I pull my head out of my @ss and join the online HCV community to get a much clearer sense as to the direction of HCV research now, not 3 years ago when I did my last "deep dive". Although it's been easier in a sense to stay clear of all the discussions and pretend like I have all the time in the world to treat this, I know I don't. It's time to get clear of this disease once and for all.

Soooo... I guess my question is: anyone else considering the Pharmasset study? Any discussions already going on here that would be helpful for me to jump in on? I did a search but just found one about resistance mutations (which was incredibly helpful, btw).

Thanks in advance. :D

[willbb]

Hi there and welcome...The question on when is the best time to treat .is always a personal one  and more specific to your question of  :should I enter a trial or not" has been discussed here many times.

One of our members(specta) posted a thread a number of months ago ..and members listed all the questions they thought would be appropriate when thinking of entering a trial. I have put the link to that thread below...maybe some of those questions will be helpful when considering this trial

I am not sure if anyone here is in the PSI 7977 /BMS 790052..or contemplating it .. if someone is.... hopfully they will chime in.

As you probably already know from your research this  a small trial   that is Interferon free  and some arms without Riba.,

As you have mentioned ...always good to have your "head out of your a$$ " when it comes to HCV  :)  won:t go away on its own.

Again welcome ..and nice to have someone on board with a degree in  "molecular biology"

link to trial questions below..

Will

http://www.medhelp.org/posts/Hepatitis-C/Things-to-ask-before-participating-in-a-trial/show/1497138?personal_page_id=1008846#post_7021261

[willbb]

Spectda  ..... not specta ...... is the member....but we just call him Dave..

.sorry Dave  :)

Will

[elpasolady]

First, I want to say welcome to the forum.  I am new as well and I have observed that any question or thoughts you may have, it has been addressed in this forum.   People have been great.
I don't know much about the Pharmasset study but many on this site do. Would you be in a blind study where you are not sure if you are getting the 'best' treatment?  Unfortunately, I don't live in an area where I can participate in any studies. so have never considered them.
What I want to tell you is that your profile and mine are very similar, with the exception of our ages.  I , too, found out in 1996 that I have the virus but I was 39 at the time.  I have put off treatment because I just was not sick, in my  opinion.  My levels have not been elevated much, if so, just crept into the high range. My biopsy in 2006 showed not complete bridging and not cirrhosis, Stated I had mild activity. So, for the most part, I have lived my life since then somewhat in denial, forgetting I have the disease.  However, like you, I know, now that I should do something and that I am probably sicker than I think I am. My VL is now at 7mil,  up 5 mil from 2006. I have been waiting for something better to come along, and that time has come. I would LOVE to wait to see if the Pharmasset trial is successful, but I hear that could be 3-5 years down the road.
I will be starting treatment sometime in the next couple of weeks, with Incivek, along with pegusys and copegus.
Good luck with your quandary.  I totally understand how difficult that is!

[cbw36]

I was/am in the same boat. Except I
am 36 and stage 2, gt 1b. I have opted for the boc/peg/RIBA as I really want this "journey" over with stat, and I don't want to f around. I figure 70% are pretty good chances. and, if it doesn't work, I hope the trials at that point will expand to nonresonders. Not sure if that's the smartest thing, but probably the safest bet....I hope.  

[attagrl]

Thanks for the welcome. :) I did already find the one post suggesting "questions to ask" and I'll be arming myself with those when I head to my screening appointment. I worked for quite a few years in clinical research so I'm pretty comfortable with the process and how to maneuver myself through IRB documentation, and thankfully with my education I've been able to get up to speed pretty quickly on the new developments in treatment. Where I'm hoping to find out more information is on the "anecdotal" side, the kind of things you can't search PubMed for. :)

Thanks for posting the link!

[attagrl]

Regarding the study, I would be getting a combination of PSI-7977 (nucleotide polymerase inhibitor) & BMS-790052 (NS5A inhibitor), with or without ribavirin. No PegINF unless there is no SVR24 at which point rescue therapy is initiated. That's one of the biggest pros of me doing the study -- avoiding injections and the serious side effects associated with the INF. I have a prior history of severe depression and that's been incidentally one of my physician's biggest concerns about me initiating treatment, so that's a definite factor. It's definitely scary going down the experimental path, though. Feeling very torn...

Best of luck to you as you start down the treatment path... *hugs*

[attagrl]

That was exactly how I felt when I made the decision to start treatment this fall -- just biting the bullet, so to speak, and getting it over with as soon as possible. Finding out about this study has thrown a wrench into it, though -- I'm not a gambling person so the prospect of going with what's already tried and tested is what feels more comfortable. The more I read about these new DAAs, though.... Aggghhhh. It's tempting.

Good luck to you!

[willbb]

One Thing that comes to mind...and you no doubt have given this some thought.
You are 34 and the likelihood of having no  significant damage is good ( I take it you have had a biopsy) Would it not be a consideration to possibly wait and do these drugs in a few years when they are tweaked and approved. If insurance coverage is not a problem and you have no significant symptoms from HCV.. it may be you have somewhat more control over your treatment regime once the next set of drugs are approved.

Just a thought ...

Good luck with your decision...
Will

[willbb]

Sorry   meant also to add.....It would seem likely that   by the time these meds are approved, they will have a better handle on resistance issues also.
Will

[attagrl]

You are dead on with the thoughts I've already had -- it's a gamble for sure. Where it gets complicated is that my liver enzymes have been slowly but surely climbing, and I've had three decompensatory events in the last 8 years that took their toll on my liver health (obstetric cholestasis with both pregnancies -- the worst they had ever seen -- and severe HELLP syndrome with my 2nd kid). I am petrified of missing that window of opportunity before my liver finally becomes cirrhotic. I've put off treatment the last ten years with that same mentality -- "something better will come around soon" -- but who knows where I'll be in another 3-5 years. :(

Then again, it really DOES seem like something better IS coming around soon... It's just so frustrating to not know when!!! :P

[willbb]

It is almost assured that the efficacy will get better and better as time goes on..yes it might be 3 -5 years  or even longer... that is the gamble for sure...you have not mentioned fibrosis stage?

[attagrl]

I'm not sure of my stage level; I've had two biopsies, one about 10 years ago and the other about 3 years ago. Both showed fibrosis but I have no recollection of what the stage was other than there was definite progression between biopsies.

In other news, both biopsies were just about the worst pain I've ever experienced (and I've had two kids), so if they require one for this study, it might be a dealbreaker... :P

[desrt]

Not quite sure why you're trying to make these decisions without knowing what stage fibrosis.you're at. What's right for someone who has just progressed from 1 to 2 might be totally different than what's right for someone who has progressed from 3 to 4. Seems sorta cart-before-the-horseish.
Also, I've never heard of a biopsy being more painful than childbirth unless you had some seriously incompetent doctors practicing on you. I've had two biopsies and helped deliver one kid and we're talking orders of magnitude difference. If your biopsy experiences have been bad enough to effect your tx decisions, change doctors/hospitals.

[babs824]

i agree that biopsy info should inform u as to how fast u should consider tx. i have had 3 biopsies the first in 1975 in colorado. it hurt like hell and i felt the doc did not want to give me meds for personal reasons. at the time addiction and alcohol abuse were more stigmatized. my recent biopsies in the 90's and in 2008 were painless  as i had a competent and compassionate doc. having been sober and drug free for decades may also have helped but i sure dont think pain should compare to childbirth. something is wrong here. best of luck, babs

[attagrl]

@desrt - I appreciate your confusion; I guess I left out some important qualifying information. :) The reason is because I had already decided with my hepatologist to start treatment this fall; he did not feel there was a reason to do another biopsy since my liver function tests had not changed significantly from my last bx a few years ago. So it's not an "arbitrary" decision to consider doing the study at this time; it's more an alternate decision on a path I was already on.

As for the biopsy pain, there were a few mitigating factors. Number one is that I am highly anesthesia resistant (I'm a redhead) and there are certain local anesthetics that just simply don't work on me, but I have a &%$#@ of a time convincing doctors of it. Whatever they used for the first bx didn't work beyond the first few layers of skin, so I felt everything and ended up passing out. My second bx was done at my current hospital, which is a Top Ten medical facility; they are aware of my anesthesia resistance and tried a different drug and a different bx method. Long story short, the new drug didn't work, and the pain was so bad I had a panic attack and ended up overnight in the hospital. They now know I will never have another one unless I'm drugged outta my gourd. Will likely need GA. Fun times. :P

[nygirl7]

I'm really unsure why your biopsy was so painful, most of us do them without any serious medication and are fine. The liver has no nerves in it to feel pain - the capsule surrounding the liver might but the liver, no.  did you have an ultrasound guided biopsy? I think honestly you mostly must have just panicked because if the needle didn't even break through your skin it is most likely there could not have been that much pain.

If you can you should at least get ahold of the records you have to find out what stage they were at.  Liver enzymes are not always a reflection of what damage is being done - you could have low enzymes but have advanced liver disease.

[willbb]

The local freezing is always given...however it is the sedative they give you IV that  for most takes the stress and anxiety away...sometimes they will give you enough that you barely remember the actual test Of the 3 I have had  only 1 was a slight discomfort as they did not give me enough . Some  clinics and hospitals do not give you this   ..however if not you can request it... find out ahead of time ,makes the whole experience so much more comfortable.

Best

Will

[attagrl]

I'm not sure why it was so painful. I'm seriously not a baby when it comes to pain; I laboured and delivered both kids with little to no pain medication and lived to tell the tale. :) Both biopsies felt quite literally like someone took a letter opener and stabbed me between the ribs. Whether it was the technique used, my stress level, the anesthetic (or lack thereof), a combination of all those things, who knows. All I know is that they'll have to tie me down to a table or drug me like crazy to get me to do it again!

[desrt]

Something else to consider when weighing IFN based tx against a non-IFN trial is the IL28B test, especially if there might be an issue with severe depression..
The IL28B is generally used to predict tx outcome but there has been at least one study that shows people with CC genotype are more prone to having psych issues when using IFN alpha.

[kutza4]

i'm with you...i had bx 2001 and it hurt so bad...my thought was why did i ok this stabbing....swore never again 2011 my second bx same pain  ultra sound guided inserted between my ribs... the progression was from stg 1 to stg3...waiting for something better as my anemia is in the way of tx. just treating the symptoms now..hope your tx goes well..thanks for the info..