has anyone been on the trial study for TMC 435?

Has anyone participated in the trial study for TMC 435?

[54Marie]

I hope to be in it myself... Supposed to start end of may....

[Magnum]

Unless I'm not reading the results correctly, doesn't seem that impressive in this study...

http://www.hivandhepatitis.com/2011_conference/easl2011/docs/0408_2010_b.html

Magnum

[FlGuy]

I was wondering.  Are you teed-up for another fo at treating when the PI stuff comes along?

[willbb]

I heard this trial is 1/3 on placebo..not positive...but that would certainly be something to look at carefully

[LizLives]

Those numbers look very impressive and to date are higher than Telaprevir and Boceprevir.  Phase III trials will include 150 mg of TMC435 which is showing better results than 100 mg.  Side effects seem to be minimal.  What don't you find impressive?

Friday, April 1, 2011
Posted by New HCV Drugs
File Under EASL, TMC435
Medivir: Week 24 Interim Results From TMC435 Hepatitis C Phase 2b ASPIRE
Study Presented at EASL

HUDDINGE, Sweden, April 1, 2011 /PRNewswire-FirstCall/ --

- Results Show Potent Antiviral Efficacy of Once Daily 150 mg TMC435 in
Hepatitis C Patients Who Have Failed Earlier Treatment, Especially in Prior
Null Responders, and Excellent Safety and Tolerability
Medivir AB (OMX: MVIR), the emerging research-based specialty
pharmaceutical company focused on infectious diseases, announces that their
partner, Tibotec has presented the results of a planned Week 24 interim
analysis of the phase 2b ASPIRE study for TMC435 in treatment experienced
hepatitis C patients in a late-breaker session at the 46th Annual meeting of
the European Association for the Study of the Liver (EASL), Berlin, Germany.

Treatment experienced patients are known to be the most difficult to
treat hepatitis C patient group.

TMC435 is a potent, once-daily, oral hepatitis C virus protease inhibitor
which recently entered clinical phase 3 studies. The study enrolled patients
chronically infected with genotype-1 hepatitis C virus (HCV) that had
previously failed treatment with standard of care therapy (peginterferon and
ribavarin). TMC435 is being jointly developed by Medivir and its partner
Tibotec.

In this Week 24 interim analysis, treatment-experienced patients who
failed peginterferon and ribavarin treatment achieved significantly greater
virologic response rates following treatment with TMC435-containing regimen
at all doses, compared with placebo. Results demonstrated that the TMC435 150
mg dose group showed the highest response, particularly in prior null
responders. In this 150 mg dose group, HCV RNA levels were undetectable at
week 24 for between 82% and 91% of the patients. Results also showed that
there was no statistically relevant difference in safety and tolerability
between the TMC435 and placebo treated groups.

[Magnum]

I plan to do the Boceprevir. The doctor however, wants me on the first one released. This will be my 5th try. Arrrrggghhhh... I'm almost tempted to wait for the non Riba-Interferon treatment, but that could be years down the road. I am feeling joint pain in a lot of places. The doctor said it could be related to Hep C. I will fight through another treatment because at this point I have no recourse...

Magnum

[pcds]

Just wondering why you picked Boceprevir.  I'm starting in June, decided on Telaprevir but doc had recommended Boceeparevir. Just wondering what tipped you to Boc
pcds

[spectda]

The results look very promising to me.

Telaprevir and Boceprevir both have issues with tolerability as would be expected in first generation DAAs. Improved or similar efficacy and "no statistically relevant difference in safety and tolerability between the TMC435 and placebo treated groups. " is a development that shouldn't be underestimated.  After all, look at the discussions people are having about boce and tela and which side effects they will risk when determining what to treat with.

In addition to efficacy and tolerance to the drug, the difference in one's ability to be compliant with a once daily dose rather then 2-3 times a day is quite significant in my opinion. Vertex would not be investing in a trial to study the comparison of dosing telaprevir 3 times a day to dosing 2 times a day if it wasn't

Welcome to the forum Liz,
-Dave

[Magnum]

Tele has the horrendous rash, Boce has the Anemia (which I haven't had a problem with in the last 4 treatment attempts). I have a battle going on with my own thinking about all this now. That is, should I gamble and wait for the non Riba/Interferon treatment coming out in the future or treat again now? Decisions, decisions, decisions...

Magnum

[Magnum]

According to the phase III trials, it's still a triple therapy with Riba/Interferon. So the side effects torture is still there with the possible exception that TMC 435 has a better response rate than Tela or Boce. That's what I read into this...

http://www.clinicaltrials.gov/ct2/show/NCT01290679?term=TMC435&rank=19

Magnum

[WriteItDown]

Hi there,

My husband was in the Phase IIb trial of TMC435. He received the real stuff and cleared in 24 weeks. He had only mild to moderate side effects. It seemed to us there was not a rash or more anemia associated with TMC435 as with Tela and Boc respectively, he only had to take it once a day, and it seems as effective as those drugs. We're fans.

If you have any specific questions I'll try my best to answer.

[WriteItDown]

Sorry, I have to post again, I'm out of practice.

Magnum, as Spectda indicated, TMC435 has as good or better results as Tela and Boc, but a better side effects profile. So no more anemia than with just the riba, and no Tela rash. That's the advantage!  And a big one it is. Some people think the side effects are less because TMC435 is dosed in a much lower amount than Tela or Boc.

Also, of course I meant to write my husband achieved SVR with a 24 week treatment. He cleared in 4 weeks or less (we're still not unblinded.) It was truly a pretty decent ride for him. Best of luck to any of you treating with TMC435, and to everyone else as well.

[cakes8267]

I am scheduled to start TMC435 on May 13th.  When you say the placebo is 1/3, thats what I am told, is that considered a high risk for getting the placebo??  
I am excited to start this treatment, but am very afraid I will only get the placebo.  I am a relasper and I want the real thing.  
Thanks for your input "writeitdown" also.  

[willbb]

Hi there....Yes I had heard also this trial is going to be 33% get a placebo. To take the chance of being one in three to get a placebo world,in my opinion be fairly risk odds.especially in light of the fact  you are a relapser. I also believe you said  in a previous post you had mild st.1 fibrosis.

To me this would not make sense to enter this trial and take a 33% chance of doing exactly the same treatment that you seemed to fail before.when you have time to wait and have a 100% chance of getting the real thing in just a short while.

Always a personal desicion tho
Good luck...

Will

[willbb]

world,in my opinion be fairly risk odds.    ..... sorry meant to say   ..    "would in my opinion be fairly risky odds"

[willbb]

Someone else may chime in that is  more knowelegable about this trial..however it would seem odd to me that they would have a placebo arm in a trial for relapsers. Are they doing  a separate trial for relapsers and NR?.Then it would certainly make more sense for you.

Will

[vik97]

I was in the ASPIRE study which is TMC435 + SOC for treatment experienced patients.  I completed 48 weeks of tx and finished 23 weeks ago.  My 12-week post tx blood test was UND my 24-weeks post tx test will be next week.  My sx were milder than my first treatment with just SOC two years before.  I still have some lingering sx such as brain fog, fatigue and insomnia, but they are mild and getting better all the time.

Vik

[WriteItDown]

Yay Vik! Here's to SVR!

[cakes8267]

the reason I am considering doing the TMC435 treatment is because my specialist advised me that this treatment is 10 times better than the upcoming BOC and TELA.  And I don't think I want to wait til they are approved.  They also told me that if I get the placebo and fail, I will have the opportunity to get the "real deal" after the research is complete.  
Also.....I am a level 2 now, so I am anxious to get started and have success.  Have you heard anything about the TMC435 drug having much better results than BOC and TELA?
thanks for the input.

[spectda]

I would seriously consider participating especially if you get 4 week pcr results so you know your chances early in tx. When do you get viral load results initially and do they stop tx if not und at week 12?

-Dave

[cakes8267]

I wouldn't find out my viral load count til the end of research, but they would pull me off the treatment if I clear, so, its rather obvious what drug you got.  I can always go to my primary doctor and get tested.  They keep you on the treatment if you are not clear however.  (und)

[willbb]

Good results in prev. trials for this drug as I put below.

Make sure to get a PCR early on so you know results and can make better decisions that way. es most trials will roll over your treatment at the end if you  got the placebo and were not successful..All and all  could be a good one to participate in

Good luck ..and let us know,,

Will
http://hepatitiscresearchandnewsupdates.blogspot.com/2011/04/easl-medivir-week-24-interim-results.html

[willbb]

Sorry .. Dave had already responded basically the same thing....just my slow typing  :)

If they are not telling you VL until the end of the study ..it is even more of a reason to have them done on you r own early.

Will

[willbb]

  This is a previous thread that was discussing all aspects to be aware of and questions to ask when thinking of participating in a trial

Will




http://www.medhelp.org/posts/Hepatitis-C/Things-to-ask-before-participating-in-a-trial/show/1497138

[spectda]

"I wouldn't find out my viral load count til the end of research, but they would pull me off the treatment if I clear, so, its rather obvious what drug you got.  I can always go to my primary doctor and get tested.  They keep you on the treatment if you are not clear however.  (und)"

I am sorry to question your comment, but this does not sound correct to me. I have a hard time believing that the fda would approve a study where you continued tx if you were not und at a certain point. For most trials these days that point is 12 weeks.

I am also almost certain that they will provide you with your pcr result at a certain point in tx which again is usually no later then the 12 week pcr.

In any event, I would do the pcr privately at 4,8,12 weeks if they do not provide you with results.

Perhaps one of the people in the previous trials can comment on when their PCR result was disclosed.

Good luck,
Dave

[WriteItDown]

Dave, my husband was in the Phase II trial of this drug and received NO viral load info until the end of his tx, and we are even still blinded now as to what arm he was in (he's been done about 18 months now, but the trial is not completely over yet.)  So what Cakes says is likely true, no PCR info.

But they do stop you if you're not clear by week 12.  I think what Cakes means is that if you stop at 24 weeks you know you got the trial drug -- also true.

That is why I advocate getting a private PCR after ONE week -- this drug acts very fast and if you're getting it your viral load drops on average I think 3 - 4 logs after one week. Then you will know if you are on placebo.

[willbb]

  The trial I was in is also not unblinded until the end of the entire study as to what arm you were in that is   usual protocol,however that is somewhat odd to blind your PCR results till the end.


Do they stop you completely if you are not clear by 12 or do they use the old protocol of going to week 24?

[spectda]

Those considering the trial are lucky to have the benefit of you and your husbands experience and advice. Congrats to both of you on the great result.

-Dave

[spectda]

I guess in any blinded study the arm you were in is not disclosed until the trial data is complete.

Definately good advice from everyone to suggest private pcrs, especially the 1 week pcr to know if you are getting the goods!

Good luck cakes, knock that beast on it's A$$

-Dave

[WriteItDown]

Thanks, Dave, that's nice to hear.  So many people on here helped us when we were considering the trial -- if I can help even one other person it will make me feel good!

Will, yeah, they stopped people on my husband's trial if they were not UND by week 12, or if they had any viral rebound at any point. You stopped at 24 if you had RVR on the trial drug.

I guess now thinking about it, I must be wrong about Cakes' trial, though, since I believe relapsers have to do 48 either way....?  In any case if it were me I'd just go for it and get the PCR after the first week, hope for the best and if I got placebo then I could decide what to do accordingly.

Cakes, we're all pulling for you.

[willbb]

"they stopped people on my husband's trial if they were not UND by week 12," .

This certainly sounds more efficiant than many of the trials protocol .to continue on if you had at least a  2 log drop at Wk.12 and not stop until Wk24, if not UND(that was the protocol of the one I was in)

Thx....  and good luck to you folks....

Good luck Cakes..

Will

[WriteItDown]

Will -- you know what, this kept bugging me all day and I checked the paperwork and I was wrong.  They did not stop if you were not UND by week 12 -- it was the old 2 log drop.  My bad!  

[ASTAR1]

I am going through the prescreening for the TMC 435 right now.  Will start with 4 weeks if all goes well...I am a first timer to any clinical trial...Is this a good one to get into??

[WriteItDown]

I believe the TMC435 is great stuff. The question is mainly your chances of getting it.  In my husband's trial there was an 80% chance, pretty good odds.

He was treated very well during the trial and we were happy he did it. Of course this is easy to say in retrospect since he got SVR, didn't have anemia or need any rescue meds, etc. But I think they did a good job with the trial.

Hope it goes as well for you!

[Luckylaks]

I am child A cirrhotic. I had 1a and 1b. I cleared 1a with 48 week rib/tx treatment. But 1b remained, I am currently undergoing clinical trails for TMC435. I have got my viral load test done after week 4, found out I am now RVR. TMC435 looks to have worked for me, having brought back all liver tests to normal in 14 days. My ALT was 81 before start of treatment and now after 14 days of TMC435/rib/tx, it has gone down to 36. And what to say with RVR at week 4. Second time lucky?
Luckylaks

[Luckylaks]

I am child A cirrhotic. I had 1a and 1b. I cleared 1a with 48 week rib/tx treatment. But 1b remained, I am currently undergoing clinical trails for TMC435. I have got my viral load test done after week 4, found out I am now RVR. TMC435 looks to have worked for me, having brought back all liver tests to normal in 14 days. My ALT was 81 before start of treatment and now after 14 days of TMC435/rib/tx, it has gone down to 36. And what to say with RVR at week 4. Second time lucky?
Luckylaks