Telaprevir did not work on Phenotype tt

[Renee543]

At the suggestion of a friend on this forum, I have decided to post my experience in the past 5 weeks in the Telaprevir trial. I waited 15yrs and had much hope for this new drug to cure my hepc. When I started my VL was 13million. At week four my VL was 1600. I was notified at this point that because my VL had not reached between 0 and 1000 that I would not be able to stay in the trial. I went in for another re-test to make sure there were no lab errors. My final VL was 1220. I was 220 over the protocol for remaining in the trial. Even though I was obviously responding to the txt, I did not meet the criteria of under 1000 at week four and forced to quit. I was told it was because of my phenotype tt, which is hardest to  clear. I am also genotype 1.
I thought about doing it again once it is approved by the FDA but the nurse told me that it would not do me any good...I would have to try something else like Bocaprevir or one of the newer drugs coming down the pike.
Needless to say I am very disheartened over the whole experience. I could be very bitter because I feel like I was little more than...a number. I feel like if I could have just stayed on a bit longer, I may have been clear.  Going into this I was stage two fibrosis. Hopefully I still have time to find the right medication for me. I am happy for all the people that were cured by the Telaprevir....I guess the numbers have to match up.
And I met some great people who helped me thru this....thanks to everyone. For anyone else who is thinking of doing Telaprevir, make sure you know your phenotype and go in with reasonable expectations and know the limitations of the trial.
Renee

[Renee543]

Yes, but if you get cured along the way....how great is that? Especially when there are no other choices...I did know pp who were cured from the reg INF and Riba but they were a different genotype and phenotype than me...they were what is called the "easy" ones. I was happy for them just the same. Everything is about money....we all know that. But still there is always hope. I also feel certain the future holds a cure for us all...very soon.
I am going to stay on this site and hopefully when there is news of any breakthroughs, we will all know. I went in with a list of questions for the trial doc and she told me I was very well informed compared to most of the people in the trials....and that is thanks to this site...but then again if things would have worked out, I'd probably be less informed..ha.
Renee

[FlGuy]

One of the pitfalls of involvement in a trial.  The intent is not necessarily to cure people.

[willbb]

I agree with Dave that the future looks very bright for us and because of all the reasearch happening presently ,the meds  are just going to get more and more potent .

Having also had a less than good response in a trial,I  am excited about what the future holds,...our time will arrive,so stay positive and keep yourself as informed with developments as much as possible.

Keep the great attitude....we will win this fight .

Best  to you..
Will

[spectda]

You have a great attitude about your experience. I feel confident that you are gonna beat this thing before it beats you. We are entering a renaissance period for research and development of more effective hcv drugs and I doubt it will be long before something will work for you.
-Dave

[Renee543]

Susan, I was very bitter and disheartened for a few days. I seconded guessed myself over and over.  But I am not sure that the Tela, Riba and INF were enough for me. I am convienced that it is because I am one of those that unfortunately has both the genotype 1 and the phenotype tt together. The virus loves it's home in my bod.  Maybe if I could have stayed on the INF and Riba it may have cleared it (and you too) but it also may have come back, who knows? I think they are doing these studies to find this kind of needed info to txt in the future. Labrats...yep have to agree there. That's why before I ever embark on this again, I am going to learn as much as I can about the txt and it's perimeters. Unfortunaately it's hard to know the questions to ask until you go through something like this. I was very naive(no pun).
Until you put your body and mind through something like this and then fail, it's hard not to be bitter but for myself, I just can't stay here. I never give up!! And I am glad you haven't either. Right now working on repairing my abused body. I had the rash on my elbows, knees and hands but since I was only on the Tela 5wks, it seems to be going. Still Anemic but I hope that improves soon too. I am taking supplements again and eating healthy (juicing), all the things I did before to be healthy. I am still a stage two fibrosis, so hopefully I have some time to find what is best for me....and I am sure you will too.
Renee

[susan400]

I share your pain!  I was in the Telaprevir Prove 3 clinical trial.  I was randomized into Group C, the no Riba group.  I got Telaprevir and Pegasys.  I had a huge drop in my viral load as well, but it did not last even 1 week because I didn't get all 3 drugs (I think).  I was bumped at week 5 as well (based on not clearing on week 4 labs).  I also got the most horrendous, God-awful rash starting on week 2.  The cortizone cream barely even made a dent in the suffering that the rash caused me.  It's been almost 4 yrs since I was exposed to the Telaprevir and since I was only on it for 5 wks and did not receive all 3 drugs, I was told be a reputable hepatologist that I may not have resistance.  They never ran any kind of "TT" test on me, to my knowledge.  If they did, nothing was ever said to me about having any strain of virus such as this.  I plan to try and get the Boceprevir, hopefully start TX sometime in Oct.   I all depends on whether or not, I'm even able to get it.  I also feel that I should have been able to have a rollover after week 4 and have the Riba added in, to be able to see if it would have pushed me over to SVR.  However, the trial wasn't set up like that and they (unfortunately) don't change the trial protocol to make us happy.  Believe me when I say this, I wish that they could change the protocol for the good of the patient, on a case by case basis.  But, I don't make the rules.  If I've learned anything about these trials and big Pharma after all these years, it's all about them and they hold all the cards..., it's not about the good of the patient..., we're just their guinea pigs..., a means to the end, it's the way that they hope to get their product approved to the market, so that they can make $$$$.   Do I sound bitter?  I don't want to be, but I also have been to the school of hard knocks and I've also undergone TX 10 times w/o SVR., so, perhaps my viewpoint is a little skewed.   Don't give up.  If I haven't given up, then, you shouldn't either.  Take care.  Susan400

[Renee543]

Thank you Dave. I think the key word is "expeienced" doctor. GI's deal with so much more than hepc. The trial doc I had was head of the Liver Inst. in Dallas and has been dealing with these trials for the past 10yrs. But you are right....she still answers to the drug companies and  is constricted by their rules. I think if it would have just been left up to her, she would have kept me on INF and Riba for four more weeks just to see if it mopped up the 220 VL I had left. She asked me if I was willing to do it alone and my thinking was, what have I got to lose at this point, only four more weeks? But the drug company protocol once again said NO. So whatever.....so many variables:  good insurance, good experienced doctor and a sprinkle of good luck.
Renee

[spectda]

There are times when a trial is the best option for treating. Lack of insurance or money and advancing disease, or disease which has been previously treated unsuccessfully are some of those reasons for participating.

We are all different and the issue of the unknowns connected with any particular trial and the minimal amount of discretion allowed by an experienced doctor are some of the reasons that a person would be better off not participating in a trial.

Your point about not using a "regular" doctor is well made. Regardless of whether a person is in a trial or not they should find a hepatologist or GI who has vast experience with treating HCV and understand the new drugs thoroughly.

I hope that you recover quickly and that on the next attempt you will have success.
-Dave



  

[Renee543]

Well actually with the new meds I think a trial is better than a private doctor in the respect that that is all they do. They have been doing this for over 10yrs. The reg docs don't know as much about the meds, only what they read.
I went and talked to my trial doc yesterday and learned a lot. The reason they take you off the Tela at week 4 if you do not clear is because they have found with all these studies for years now that if you do not clear to at least 1000, the virus replicates to a new strain. And they do not want this to happen. They are doing new studies for pp like me with genotype 1 and phenotype tt (and ct) who are not clearing on Telaprevir. They thought about keeping me on the IF and Riba alone but the drug company said no, that it would not work. IF and Riba alone have shown unsuccessful for geno1/phen tt. So she said there are more med trials coming, the 3-4meds plus SOC and adding something to the Boca. But for now I am just going to wait and give my body time to recover from the assault. Then if something promising that will work for me comes along, I may try it. But one thing for sure is I will do the research first, know the perimeters of the trial and ask questions first. Yes, the trials are great, they have helped a lot of people....but that's what they are trials and they do not work for everyone but that is how they are learning about this disease. When the Tela comes out in a few weeks it is going to be very expensive, even if you have insurance.
That site www,clinicaltrials.org is where I found this one luckyluss, so I will keep looking.
Thanks to all, Renee

[luckyluss]

I'm so sorry for you.
I was always told that being a patient for research is not the same as being a regular patient even though you receive the same med.
But since you were mentioning you didn't have adequate insurance, I know that there are some trials that have 4 meds - 2PIs plus SOC.  They're on the site www.clinicaltrials.org.
I'm sure you probably don't want to hear about trials right now, but if you ever, check it out.   The 4 med trial right are very promising, some with close to 100% efficacy.
There is hope on the horizon, so don't give up!

[frijole]

Phenotype tt

I am not familiar with this term.  What is it?

frijole

[Renee543]

Thank you all for your great answers. I am going to see the trial doc this morning and I wrote down a lot of the questions you presented and I want to know the answers. I did read some of the older trial results with Tela (Vertex) and they did not use the 4 week RVR when they first started, that was added recently in the later trials. There was questions about whether or not tweeking the dosages would be better because some people are slow responders.
Dave I was in the every 8 hrs dosing....3 times. The nurse had told me I should try the Boca but I do have questions about going from Tela to Boca. After this experience I am much more concerned about the effects, timing and dosing of all of these very powerful drugs and what they may do to my body and health in the future. I was very healthy when I went into this but now I feel 10yrs older after only 5 wks of txt. I hope I am able to get my health back. I am going to do more research and talk to this doc to see what my best future plan can be at this point. But I do know it is not jumping into something without knowing the facts next time. I will let you all know what the doctor says after I meet with her this morning. Thanks again.

[copyman]

Sorry, you know how bad I feel about you having to leave the trial.

Regroup, feel better then make a new plan with a good Hepatologist.  Maybe one that did studies with the new drugs.

Hang in there you will beat this.

[SusieS2010]

I am so sorry that they made you come off the study being only 220 points over the limit. I know your frustration....been there done that. Your title "Telaprevir did not work on tt" might be a bit misleading. While tt's have the worst outcome for SVR, about 30% should reach that elusive goal. Also, because of resistance overlap as one researcher put it, you should not go from telaprevir to boceprevir until more is known. They will be studying this in the very near future. Genotype 1b's have less of a resistance problem than genotype 1a and that needs to be taken into consideration as well.

Dave makes some good points about trials and waiting as you are a stage 2. I'd go a step further and say perhaps waiting for a 3 or 4 drug combo without interferon may be the ticket for you.

[spectda]

I am very sorry to hear of your news, I can imagine how frustrating it is for you. If you were treating privately you would have had the option to continue longer before deciding to stop treatment.  If treating privately and your doctor would work with you other options might include increasing your ribavirin if you were not anemic, changing your interferon to pegintron or daily infergen, and maybe adding alinia to the regimen.

One of the issues with Telaprevir and Boceprevir is that if you don't succeed you might develop long term resistance that could effect your success with future treatment. Even a short gap in time from now until you could get boce or tela privately could cause a resistance problem.

Both drugs work in a similar manner in stopping the virus from replicating so it would make sense that switching from one to the other if there was no gap in time would be okay. At the same time if you don't succeed with telaprevir there is no point in using boceprevir (victrelis). Boceprevir was just approved and may be available right now, I would guess that telaprevir will be approved in the next few days to a week. At this point I think it would be worth talking to your treating doctor ASAP about possibly continuing privately.

Your situation really brings home the point in about using a soc lead-in to determine interferon response before adding a PI, even if it adds exposure time to interferon and Ribavirin.

At stage two you most likely have time to wait for a drug combo that is less dependent on interferon response. The average movement from stage to stage is 6 years. Although it varies quite a bit from person to person irreversible damage to your liver is most likely still in the fairly distant future. Waiting for a 2 pi combo plus SOC may be your best bet.

Which arm of the trial were you in? I would imagine that you were stopped so early because Vertex and the FDA are concerned about participants developing resistance, especially in the twice a day telaprevir regimen since this is uncharted territory. Every trial has some sort of risk and unknown that they are studying, in your trial the unknown was using a twice daily regimen.

It is true that we are a number when participating in a trial so they can maintain as much objectivity as possible. As I imagine is common in all trials my labs in my boceprevir trial only contained my subject number, not my name.

A trial is about studying the drug and it's assets and defects, and your success as an individual may not be it's primary function. That's why its important not to jump into a trial without understanding the parameters and constraints fully. Even if we know all the possibilities before hand it doesn't make it any easier when it doesn't work out and I am sorry it didn't go better for you,

Take care,
Dave