Aa
Aa
A
A
A
Close
29837 tn?1414534648

Treatment Decision - Doctor's Suggestion - My Dilemma

I need a vote from every one of you please. As I'm ready to enter my 5th treatment in January, I got back from the Gastro's visit today and this is what my dilemma is.

The Hepatologist Dr. Gish wants to treat me with a double-dose of Pegasys along with 1200mg Ribavirin daily. My Gastro thinks this is a losing proposition because I'm a 4-time non-responder and he thinks the chances of responding to this are between 15-20 %. He feels I should take the chance that I will get the Telepravir and do the 12 visits to Cedar-Sinai hospital in L.A. (650 miles round trip each visit) with my gas guzzling Dodge Durango at 13 mpg, to get the VX-950.

Here is his reasoning. If I don't get the Teleprevir, he will THEN double-dose me with Pegasys. If I do get the Teleprevir, then he feels this is the way to go for a consistent, stubborn non-responder like me to clear. He agrees with Dr. Gish that I am at the beginning stages of Cirrhosis, judging by the numbers.

So there it is. I have a 66.6 % chance of getting the Teleprevir and a 33.3 %  chance of getting a placebo. I calculate the cost of gas alone to be $2000+, and the cost to my body to be yet discovered. Would you be so kind as to take time to let me know, each and every one of your opinions (votes) on this most important matter?

Thanks,

Magnum
50 Responses
Sort by: Helpful Oldest Newest
179856 tn?1333547362
Thats ok pirate our friend magnum is still waiting for that telapravir so his being cured is still relevent and it was nice of you to answer.
Helpful - 0
Avatar universal
sorry I didn't realize this is really an old post
Helpful - 0
Avatar universal
I would go for the triple therapy the odds are better.  As for transportation check and see if you can strike a deal with the airlines for the multiple trips you will need for medical reasons.  There is also an Amtrak train pass.  Worth a try.  Good luck with what ever you decide you've been through a lot of tx. You definitly deserve a break.
Helpful - 0
1280753 tn?1367757932
you should start a new thread. this one is from 2008.

interesting question. perhaps you could elaborate a tad on your question.

do you have HCV?
Helpful - 0
Avatar universal
i have a problem in my health like my blood.  i think my white blood bigger than my red blood?..
Helpful - 0
Avatar universal
If what you said is true, that is odd. Never heard that before. Like trinity has said, there are the usual strong precautions against pregnant women touching or handling the pills (who are not undergoing treatment, obviously). Is that what you're refrring to? Otherwise, yeah I don't see how handling the pills (broken or otherwise) is any worse than actually ingesting it. The only thing I can think of is absorption rate - some pills are coated so they are absorbed at a certain rate. Is that what you're referring to?
Helpful - 0
Avatar universal
They must have a different insert over there because I've read the Roche insert front and back and doesn't say anything like that.  Maybe someone pregnant wouldn't want to touch a broken pill but we ingest it daily and I've touched and taken two halves that were broken, didn't hurt me.  If it's crushed and touches any part of your body?  Wow, that's just weird to me, especially when I'm eating the stuff everyday!!  Can't see how absorption from skin contact would cause any problems except for those that are not taking it.  
Trinity
Helpful - 0
Avatar universal
Thank you for that.  Makes things crystal clear for me.  More than you realize.  Thanks for your answer.

Trish
Helpful - 0
Avatar universal
HUH?
Helpful - 0
476246 tn?1418870914
The Danish insert of the Copegus says that one should NEVER halve or crush the pills. If a pill has accidentally been crushed and touches any part of you skin, you should wash it immediately with soap and water.

Marcia
Helpful - 0
Avatar universal
"mremeet, can you clarify at what point you got your dosage reduction, when you say you had your riba reduced to 800mg for most of your treatment?"

My dose reduction ebbed and flowed throughout treatment. And my riba reduction was never really because of excessive anemia, it was for skin itching/rash. My skin had been so tramautized and sensitized from the telaprevir rash battle I went through, the ribavirin simply literally made me want to crawl out of my skin (even many months after I stopped taking the telaprevir). My doctor never ordered a riba reduction, my HGB was about 9.5 on full dose - which ain't good, but plenty of people have tolerated 9 or even lower. I ordered my own reduction mostly for the rash and itching the riba caused. But to be sure I was dragging a$$ due to the anemia as well. I could actually feel the effect of the ribavirin pills a few hours after taking them. For me I would feel it mostly on my scalp and back, a tingly pin pricking sensation. I scratched my hair away and clawed my eyebrows clean off. I simply couldn't take it, so I lowered my dose to whatever I thought I could tolerate. Some days I missed my riba all together, I went several days without riba during the worst part of my rash episode. As I recovered, I went to 600, then inched my way to 800. Even up to 1000 for a day or two, but then always had to fall back to 800 - that's pretty much all I could take.

Now, I came close to an IFN dose reduction, but it never did happen. My neutrophils had fallen and stayed low throughout most of my tx. At one point under 500, and they almost cut my IFN when that happened. But I was retested with the local lab (instead of shipping the samples to another state), and I was found to be just over the magic threshold. Plus I ran up and down the stairs prior ot blood sampling to help increase my measured neutrophil count (using the term "run" figuratively here ;-)

And you ask how well it turned out for the others. Most of the people I know who got all three drugs came out ok and SVR-ed. All of the drugs are nasty and do awful things to you, but I have to say that together they're a potent force against HCV. I can see on the horizon that HCV's days are becoming numbered (at least in the developed world). All these new drugs and supplements, with more and more being developed/discovered all the time. We're living in a time where HCV is a fading plague. In another 10-20 years I think HCV will have gone the way of polio, and good riddens to the f**king thing.
Helpful - 0
Avatar universal
In my trial, they allow rescue drugs but are reluctant to give them.  And I'm not sure that it's trial protocol that dictates their reluctance, perhaps more of an individual trial centre thing.  Therefore, I would clarify under what circumstances they will give rescue drugs and if that's trial protocol or trial centre preference.  You just want to know that upfront if you know to ask the question.

mremeet, can you clarify at what point you got your dosage reduction, when you say you had your riba reduced to 800mg for most of your treatment?  Thanks.  

Your situation turned out very well for you in light of all your interruptions so to speak.    Wonder how that turned out for others?  Was there alot of that and still achieved SVR?  Thanks.

Trish
Helpful - 0
Avatar universal
Susan you said they have never allowed rescue drugs during any of the telaprevir trials. That's not correct, in Prove 1 they allowed us to use rescue drugs after we stopped taking telaprevir. Rescue drugs were only prohibited during the telaprevir dosing period, but they were allowed after we were on SOC alone. I was prescibed procrit and so was PDS and perhaps others. Also, I was on reduced riba (1200mg down to 800mg daily) for most of my treatment, stopped the telaprevir very early (by week 7), took tons of immunosuppressants (to control rash), and I concluded treatment early (week 41 instead of week 48). And even then I still SVR-ed. So clearly dose reductions are not necessarily the end of the world, especially if they only occur after achieving UND (which is typically what happens when telaprevir is involved). Dose reductions do not necessarily carry the same ominous consequences while telaprevir is included in the mix when compared to straight SOC alone.
Helpful - 0
412873 tn?1329174455
My vote is go for it.  Triple therapy seems like the way to go.  Willy does have a good point-not to get the treatment naive trial confused with the nonresponder trial.  I am more familiar with the protocol for the naive tx.

In the naive trial-all arms get SOC - so for people like me it is a good risk.  They seem to be very aware of developing resistance, so you will be taken off the telepravir if you do not reach the typical milestones( i can never remember them)  So my research coordinator told me that even tho they will not give you lab results, you would know where you stood based on that.  So if your trial runs the same way-couldn't you opt out at that point and double dose????

A good friend in a prior post said it quite well-(Trish is awesome!)-- so I will post it again for emphasis....

"You will know by 12 weeks how you are doing.  Then if you are not responding, DROP the trial and go to SOC at double-dosing INF and higher dosed riba right away and continue on as if starting over again.  Consider that 12 weeks as pre-dosing.  As much as I believe in being committed to a trial (I'm in one), there is a line and being borderline cirrhotic is it.  Dropping out of the trial because of non-response at 12 weeks is also a useful statistic."

Best to you with this difficult decision.

Isobella
Helpful - 0
Avatar universal
Willy, I'm just basing it on what I know from my experience.  I do know that all of the previous Vertex trials allowed NO RESCUE DRUGS.   If you had a drop of your RBC or WBC then, it was a dose reduction and that was all that was the choice, they absolutely allowed no rescue drugs.   I have no way of knowing whether or not they will change that in their future trials.  I do know that in that short time I was on it, I had the horrible rash, my white cells dropped and I had rebound in the 2nd week due to the fact that I had no Riba.  So for me, Telaprevir is out of the picture and I can't even be considering it as an option when it becomes FDA approved because it was just too much for me to deal with even w/o the Riba.

Susan400
Helpful - 0
Avatar universal
First of all.....forget about the "no riba" arm.  There will NOT be a arm with no ribaviren.

Secondly don't confuse the trial for naives now enrolling with the trial that is scheduled for past treatment failures this fall/winter.  UNTIL that trial design is read in clinical trials or the shape of it is released to the public you really can't say what it will look like.  I'm pretty sure that ALL trial participants will get riba however.
-------my assumptions about the trial are this; This is a 3rd phase registration trial; 1) there will be a SOC control arm.  2) there will be a "12&12" arm with a contingency for SOC expanding to and increased 24 weeks based on response. 3) There may be an arm with a 4 week SOC lead in followed by the triple therapy "12 &12" with the same post 24 week SOC therapy for slower responders during the 12&12 phase.
-------This a phase 3 registration trial and they want to see just how many people can be cured.  I wouldn't rule out the potential use of a rescue drug.
-------As mentioned until this is seen in print at clinical trials there will be speculation about what the trial will look like.

Susan and Dointime certainly have a point about making sure that you treat with the best means possible.  It's possible that the drug will be out soon; can you wait?  I don't expect that you'll have a resistance issue however.  IF you pull a SOC control arm you won't be exposed to telaprevir and thus will have no resistance issues.

Personally I wouldn't do double dosing over triple therapy.  You don't yet know what the trial will look like but if you get in line you could have a 2/3 chance of getting triple therapy.  I agree that if you are a past nonresponder (rather than a relapser) your chances are less.  If you ore overweight or insulin resistant your chances will also likely drop.  What are you out to "get in line" while you decide and see what the upcoming trial looks like?

best,
willy
Helpful - 0
Avatar universal
As a shining example of what's possible, check out Andiamo's profile. He was infected for 40+ years,  he's in his late 60's, failed combo multiple times over the years, and was knocking on cirrhosis' door. He enrolled in the Vertex trial and received the telaprevir and SOC. He concluded treatment about 3-4 months ago and got his 12 week post tx PCR back a little while ago: he's still UND. This means with about 97% certainty he's SVR now. As you can see things can work out. I also successfully treated in the telaprevir trial too - SVR now, thank you very much. It can happen. In fact, if you manage to get into the trial, odds are probably in favor that you will SVR.
Helpful - 0
446474 tn?1446347682
How about an easy question?! Wow this is tough! Lots of pros and cons on both sides. Only you will know what's right for you. There is the logic of it yes, but also a very important emotional side too.

Personally I would go for the trial. Mostly because all the previous treatments with interferon and ribaviron didn't work. I think you need to add something new to the mix. And hopefully you'll get it. If not UND, you can always do Dr. Gish's protocol afterwards.

You still have time. But I think it is very important to try what you can now. When the cirrhosis combines with portal hypertension odds of SVR with SOC treatment drops to about 10%. Liver fibrosis is one of the most decisive factors limiting SVR. So do whatever you can, while you can. Go for it!

...Here is presentation discussing best practices for persons retreating based on their previous experinces as non responders. At Clinical Care Options,

http://clinicaloptions.com/Hepatitis/Treatment%20Updates/Treatment-Experienced%20HCV/Virtual%20Presentations/Virtual%20Presentation%201.aspx

New Options for HCV Nonresponders:
"Navigating Emerging Data and Best Practices for Treatment-Experienced Patients"
This new Treatment Update provides a comprehensive review of the latest data and best practices on management approaches for patients previously treated unsuccessfully for chronic HCV infection.

Best of luck whatever you decide!!!
Hector
Helpful - 0
29837 tn?1414534648
In response to questions floating in many people's minds as to the protocols of the CURRENT testing for non-responders. I ppasted this earlier and the rules still apply, as I spoke to the tech today.


First, they want to do a biopsy, even though I've had three already, the last one in 2005. I am a 4-time non-responder to treatment. Interferon-Ribavirin, Interferon-Pegasys, Interferon-Ribavirin, Infergen-Ribavirin-Amantadine...

I would have a 66.6% chance of getting the VX-950. The way it's structured is like this:

If I get into Clinical Trial A, I would be given VX-950 (along with Ribavirin & Interferon) for 12 weeks. Then, 4 weeks of the placebo.

If I get into Clinical Trial B, I would be given the placebo for the first 4 weeks, then the VX-950 for 12 weeks.

If I get into Clinical Trial C, I would be given the placebo.

Unfortunately, the tech I spoke to mentioned that the feeling so far in the final release of the VX-950 to the public won't be until 2012. Let's hope he's wrong. I'm still torn in making my final decision..,

Magnum
Helpful - 0
Avatar universal
when gambling,  a good general rule is not to risk more than you can afford to lose.  Your most valuable 'asset' here, IMHO, is access to effective use of an  NS3 PI to halt further progression towards cirrhosis. As long as the conditions of the trial don't put that asset too much at risk, it seems fine to bet.

Pulling placebo, for example, would be a bummer, but you'd walk away from it having given your liver a break and still have the option to use VX in the future. On the other hand, if the trial puts you at 'significant' risk of walking away with ns3 resistance and no svr (and the amount of  risk will depend on the details of how the trial is set up ) - it may be better to stall a bit longer and treat after fda approval.
Helpful - 0
Avatar universal
Susan - You mention that the latest trials are still including riba-less groups? Are you certain of that? I can't imagine they're still including a riba-less group, although I haven't looked into it specifically. Still, I'm pretty sure they've done away with that arm.

magnum - I agree with what dointime said. I had to travel ~300 miles round trip to my trial center (through city traffic at parts). What's gotta be done is what's gotta be done. In the grand scheme of things, it's a minor annoyance and expense (yes even with $4.50 gas). I would look into finding a cheap hotel near the trial center, like a motel 6 or something. Or maybe even a cheap rental room that you can get weekly rates on (especially for the first few days of the trial). You don't want to drive 325 miles back home after your first shot (at least I sure wouldn't want to). And there will be other days where staying overnight and going home in the morning will be infinitely more tolerable. Since you've already treated, you know what these drugs can do to you. Six-hundred and fifty miles is a long way to drive with an HGB of ~9 (or worse). Throw in some sleep deprivation, brain fog, riba-fueled road rage and antihistimines for itch/anxiety - and it could get deadly real fast. Is there anyone that could take the road trip with you each time, especially as you start to deteriorate? That'd probably be best, someone to share the driving with you.
Helpful - 0
Avatar universal
I agree with the buying a cheap bike and go for it,maybe you could even find a place close to the TX centre...ya cant epend on trials...kill the  Little bastards while you can.
Helpful - 0
Avatar universal
I am biased as well.  I already have telaprevir resistance from a no-riba arm of a trial so my usual advice would be to wait for telaprevir to be approved and treat under optimal conditions.

However in your case I would change my mind because you have to treat now, not later.  So I think you should treat with whatever has the most chance of success, which I think is the telaprevir trial.  If you don't get the drug you can always drop out and fall back on your other plan.  Either option will at the very least buy you time.

Getting telaprevir resistance is a bummer but it is not the end of the world.  There are so many new drugs in development that it is only a matter of time before one comes along that can be used in combo with telaprevir and will kill those pesky resistant  mutants.  Your job is to stave off liver disease progression till those drugs arrive, anyway who knows but you could get yourself SVR with telaprevir first time around.  

The logistics of the thing, travelling, cost, etc may seem like a big mountain to climb but in relation to your future health they are just temporary discomforts.  You can work them out.  My trials centre was 450 miles away so my round trip was 900 miles.  It wasn't easy, especially when I felt tired and nauseous, but it can be done.  

Good luck,
dointime        
Helpful - 0
164592 tn?1222906774
I don't feel qualified to give you adivce as I am biased.
However, I will tell you my experience.
I am a previous non-responder who did not have a 2 log drop on SOC.
I enrolled in the Prove 3 trial and cleared early on.  Currently I am 12 weeks post treatment and still undetected.  
Susan mentioned a good point about the rescue drugs.  They were not allowed in the Prove 3 trial.  I became anemic very early and was only on full dose Riba for a few weeks of the the 48.  Most of the time I was on a reduced dose.  I had to discontinue the Riba completely for several weeks of my treatment so I was very frightened.
I didn't think they were having any more non-Riba arms in future Telaprevir trials but I could be wrong.
Good luck in your decision making!
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.