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Avatar universal

Should I take option to extend treatment?

Hi - there are a lot of really sensible people on this forum and I could do with some 'sensible' help right now - I realize my problem may be slightly different as I've been on a drug trial, and apologize for the long explanation.
I'm genotype 1, level 2 liver damage as of Dec 06 biopsy. Early last year I was on the blinded teleprevir trial. After the trial, I found out that I had been given the placebo plus standard treatment, and therefore would have had the option to continue with the peg and riba for 48 weeks. However, as I hadn't had the requisite 2 log drop in viral load by 12 weeks, the standard treatment was discontinued.

Earlier this year I was very grateful to be called back for a non-responders round up which entailed 12 weeks of teleprevir, concurrently with 24 weeks of standard treatment. Incredibly, I was undetectable within about 2 or 3 weeks - but then unfortunately I developed the teleprevir 'super rash' and was very reluctantly pulled off all treatment at 7 weeks for a 2 week period to give my body a chance to heal.  I was then put back on standard treatment for the remainder of the trial.  I so wanted to stay on this great new drug, which was clearly doing its job, but  wasn't given a choice (I looked like a burn victim, with massive blisters, and there was concern about secondary infections). I was hugely disappointed and fully expected to relapse pretty quickly as I hadn't been able to finish the 12 weeks of teleprevir, and standard treatment alone hadn't worked the first time.  The treatment had been fairly manageable before the rash, but since then it's been an uphill battle. The first blood test after all this was still 'undetectable' but by the next one it had broken through and was back to 'detectable' - I was upset but not surprised and resigned myself to waiting for the 'next big thing' - I was told to continue standard treatment until my next formal appointment and blood test, but strangely that one came back 'undetectable'. This was very odd, and so I continued and had another test at week 24 (the final week) which was also undetectable.

Clearly, my hopes are nervously back up, but as I'd had the earlier breakthrough, the doctors don't really know what's going on. This situation hasn't occurred before.  It could be that the teleprevir did the big hammer job, and standard treatment is just about strong enough to suppress the virus while I'm taking it (but that it might resurface when I stop), or that maybe I need 6 more months to take me to 48 weeks just like type 1's who hadn't had teleprevir, or I should 'taper off' slowly, or maybe there would be no benefit a all to continuing and I could stop now and 'take my chances' - they truly are unable to advise me (this was a trial, after all, and they don't have all the answers yet) - they say it's my decision to weigh up quality of life issues against unknown benefits.  I've officially finished the original 24 week trial but obviously didn't complete the proper protocol due to stopping teleprevir early and interrupting treatment.  I have been given the option of further standard meds and am continuing to take them this week while trying to decide what to do next. If I come off the standard treatment now I won't be able to go back on it if the virus comes back as it wasn't enough on its own to bring the viral load down quickly enough last time. I'm obviously allergic to teleprevir, so that's not an option. This has been dominating my life for nearly 2 years now (since the first trial) and I'm fairly wiped out - I don't want to throw away a possible good outcome for the sake of 6 more months but there are no odds at all (let alone any guarantees). Psychologically, I'd had my target 'stop' date set in my mind and it's tough to contemplate carrying on, but I don't want to be an idiot either. I'm so sorry to have gone on at such length, but would be grateful for any thoughts to help with this decision - thanks, and best wishes to all of you out there.
p.s. also, can anyone reassure me that my sense of humor bypass is reversible?
24 Responses
548668 tn?1394190822
2nd tx:
Undectable on Teleprevir - 3 weeks
Week 7 - taken off Teleprevir - 2 weeks break from all meds
Renewed SOC (week 9)
Next Blood test Undetectable (what week?)
Next Blood test Detectable (what week?)
Next Blood test Undetectable (what week?)
24 week blood test Undetectable
Is the above correct for the trial round of tx?

I'm a 3a and not up with the new trials, but if others chime in to assist you with your decision, it might help if you noted the dates of your PCR's and when you became undectable the second time around.   What a real trial you've been through;  I hope some other G1's give their opinions...    
362971 tn?1201990634
    There is always the possibility that the "Detectable" was a false positive. I say this because once you have a breakthru during treatment it usually stays that way. Also I was told by Dr Dieterich that 5% of all PCR's are false positive.  

Bobby
412873 tn?1329178055
Sorry to hear of the troubles you have had.  Now, obviously none of us here are doctors and no one can tell you what you should do.  So many other things factor in....grade/stage, quality of life, ect.....

But-I can tell you this - as a patient in a double blinded drug trial with a promising new drug.  I had plan b in place in case I had to leave the trial - and that plan was to continue SOC for 48, 52 or 72 weeks.  

Come he!! or high water....I only wanted to do this once.  

That is just my personal opinion....I am sure others will give you some good insight to help.  

Wish ya the best in all this-

Isobella
Avatar universal
Sounds like the Telaprevir did the heavy lifting and got you UND where SOC couldn't. Sounds reasonable that two weeks off all drugs caused the relapse, but going back on SOC brought the virus back down to UND. A false positive is always a possiblity but more prudent to assume the former scenario. BTW what was your viral load on breakthrough?

Anyway, now you have to make a choice. Dr. Dieterich sometimes suggests 48 weeks of SOC after becoming UND which is one reasonable approach. Another way to look at it is that you're a slow responder with SOC alone and therefore you should treat 72 weeks. The third choice, of course, is to stop and cut you losses, as you're only stage 2. In that scenario you'd have to wait for another PI that would not cause the super rash reaction.

As stated before, no doctors here, but you don't have to be a doctor to see you're case is somewhat uncharted. That's why your docs are laying the decision on your lap because they can only guess and speculate.

If it were me, I'd probably get another opinion or two from a liver specialist unaffiliated with the trial. I have no illusions they will have a definitive answer, but sometimes listening to the experts hem and haw can help you process the whole thing better as the decision will come down to you. At least that is how I approached a few decisions during treatment.

All the best,

-- Jim
Avatar universal
Just wanted to add that if you do continue on make sure you request a very sensitive viral load test MONTHLY to make sure there are no more breakthroughs. I'd go for either Quest's HCV RNA QUALITATIVE TMA or Quest's Heptimax. Both go down to 5 IU/ml. Alternatively, labcorp has a test that goes down to 2 IU/ml.
577132 tn?1314270126
Phew, you've really been doing the hard yards, respect to you.

I am a G3 previous Non Responder and I was also on a trial (R1728) and went UND at week 4.  Once I stopped the study drug the virus reappeared at 29IU, I then went UND again sometime between Week 8 and 12 with SOC and have remained that way since....  

The study coordinator said 'not to worry' about it as it was just a 'rebound' from suddenly stopping study drug and my body and the SOC just took a little time to adjust.  I did worry tho, and I pushed for a 48 week tx when they were originally only going to fund me for 24 due to my so called RVR.

I just didn't want to relapse and think: maybe, if only, why didn't I go the 48 when I had the chance  I may still relapse after 48 but I'll cross that bridge if I come to it, and if I do have to cross it at least I will know I gave it my very best shot.

And you are UND now, that's what counts, keep hitting the little buggers when they are down and out. You have come so far, it's not much further to go.

In the same position I made the decision to go for 48, and I'm glad I did!  Only 21 more shots to go!

Best of Luck to You!

Epi :)
Avatar universal
I had taken peg interferon and riboviron in 2002 for 19 weeks, I am not sure what the "standard TX " is now, but if you mix and self inject the interferon fill the syringe full I had the most resistant to TX, when I learned this I decided why throw away the med in the lil bottle, so I used it all and took the prescribed amount of riboviron, and have been undetectable since 02 I also ate canned spinach 2 times a day and drank the liquid, lots of veggies, dark green leafy vegtables, and minimal protien, avoided tylenol products
Avatar universal
Hi and thank you all so much for your practical comments and kindness (have quite a time difference here in UK so just saw them - they've been a lot of help).
First off (Kristina538), thanks for summing up and apologies for not giving all the dates etc - I was still undetectable at week 10, detectable again at week 16, then undetectable at week 20 and 24 (next test will probably be at week 28).
Bobby1952 - yes, the doctor told me it was possible to have a false positive, but as jmjm530 noted, he thinks its more likely to be the case that it was a relapse after coming off teleprevir, but that SOC was able to bring it down again. They didn't  give me the viral load number on breakthrough (I'll try and find out), but I know that the tests they use are 'less than 12' (sorry for lack of technical terms).
My feeling from all of your comments is that it might be sensible (pending monthly tests) to try and continue for a while. And I will certainly ask about the more sensitive tests that were mentioned. Thank you all again.

On a separate note, and I know it's very superficial, I wondered if there was any advice on side effects - it's just vanity but I'm quite upset about the hair loss, and can hardly bear to brush my hair everyday as so much is coming out. Also, I feel quite low, not helped by being unable to exercise - before the trial I was running about 3-4 times per week (slowly, and for about 30 minutes - I don't want to give the impression of a superfit marathon runner here) but now find I can't even walk upstairs without puffing. Muscle tone is a distant memory. In the early months I continued to take long walks, but now have given in to lethargy and ice-cream (fortunately, I only work in the afternoons, so don't have to 'shine' all day).  When I started the trial I was asked not to take any supplements at all, and I guess this applies to standard treatment too, but is there some kind of gentle health and nutrition regimen that has been found useful post-treatment?

I feel a bit cheeky asking for all this advice, but it's been quite an isolating experience (despite a supportive partner and teenage kids) and it just feels so great to talk to others going through (or having been through) a similar thing. Thanks again.
Best wishes, B
Avatar universal
Congratulations on your SVR And it's really great as a geno 1 you were able to do it in only 19 weeks. This does happen sometime -- even with normal dosing -- and usually it turns out the person had what is termed an RVR (rapid viral response). I heard of one story where a patient had only one injection, stopped treatment and didn't appear in the doc's office for another year. To everyone's surprise the person was SVR. Strange things do happen!

As I mentioned in a another post (http://www.medhelp.org/posts/show/686790)

it would be helpful if you could specify the exact dose of intereferon as well as type of interferon you took. Did you inject from a pre-filled syringe or was it drawn from a vial? As to "avoiding tynelol products" -- Tylenol is the pain killer of choice among leading liver specialists. The problem with aspirin -- you mention that in another post -- is that aspirin can be dangerous to take with the lower platelet counts many of us have with HCV and especially on treatment when those platelet counts go even lower.

-- Jim
412873 tn?1329178055
Are you taking any multi vitamin?  You may want to ask your trial nurse.  I am in a Vertex trial they have been very liberal with allowing various supplements.  As long as there are no antivirals, steroids, or antibiotics.  

Not that I would advise taking a bunch of different supplements because the interaction with our meds is unproven and therefore imho not worth the risk--but maybe a multivitain without iron or some b vitamins will help.  

I faithfully followed the couch/ice cream regime until it made my thighs swell-lol!!! In week 15, I forced myself to start walking again.  I feel so much better that now I look forward to it...just waitng to see some results  =)

Izzy
Avatar universal
"I was still undetectable at week 10, detectable again at week 16, then undetectable at week 20 and 24."

This suggests to me that you should be considered a slow responder, and thus need 72 weeks of treatment. Anyway, if I were you, I would go as many weeks as I could, certainly 48. Especially since this is your second tx and you know you can't take telaprevir again, I would really take this opportunity.

I know what it is like to have a target date and have to go past it. I started tx on Nov 8, 2006, was to go til April 24, 2007, then it became October 10, 2007, and finally March 26, 2008. My treatment was prolonged because of slow response, first to 48 weeks, then to 72 weeks. But now I am SVR and so grateful that I had the opportunity to extend my tx for as long as it was needed to win the battle!

I wish you good luck!

Avatar universal
As to the hair loss, nothing to do but get used to it. My hair is slowly growing back now.

And concerning the lack of energy, I remember another forum member saying that during tx the amount of exercise you get is laying on the couch thinking that maybe you should raise your arm. The thought alone makes you exhausted. That is what tx was like to me.

Or as Comeagain said it: "I love my bed."
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