null responder

[almawe]

Just got the phone call, that after 4 weeks treatment with SOC and telaprivir, that l am a non responder. have to cease all medication at once.  Am in a  bit of shock.  dont know were to go from here.,  I am genotype 1a, CT and have mild to moderate fibrosis. it will be ery har sitting around doing 'nothing' for the hep c.  am already ready a healthy life style.  feeling very depressed.  l know there are others in my position.  

[mykids247]

recent diagnosis, type 2 viral loads of 2 mil. Low white blood count and low platlets. Md wont consider treating me :( cant even get a good answer from any md. Not sure where to turn. Very depressed today :(

[burned74]

Copyman 80 per cent SVR still means 2 of every 10 dont respond


Almawe.  I think I saw this study ( no resistant virus after 2 or 3 years) from the spring European Liver conference and it is one reason I was going to try tele over boce. Don't take my word for it of course.

I was a null responder to SOC (drop or over one log but never 2 log drop) several years ago

[copyman]

This is exactly why I did my own PCR's when I was in the Telaprevir study. I want to see my own results not the word of the trial nurse.

I think something has changed with Telaprevir. Very strange to hear of two people that did not respond in same week. In all the years I have only heard of maybe one person that didn't respond to Telaprevir. There were a few people early on that had to stop due to severe rash but they had responded to the PI.

I hope Telaprevir didn't tweak the drug or make a bad batch right from the start.

[almawe]

thanks for the response....am taking vit d, and my levels are good, always have been.  The 2 to 3 years on the resistant virus is good news!...and yes, 3 years wait after having hep c for 30 years is not too long to wait!

[burned74]

I was wondering if you were taking any Vit D and whether you had blood level tests for that.

On the plus side. I have seen studies that show that 90 per cent of treatment failures with Tele have no resistant virus at either 2 or 3 years so you would be able to try the newer drugs at that time. 3 years is not a long time for most of us with HCV

You would want to Google and check this out yourself.

[almawe]

Thanks to all.

Up beat...l am a CT

[somuchmore2]

Sorry about your recent news....

However, one thing to keep in mind  2 fibrosis is not so bad. Most livers will compensate with HCV for years or decades. All the stuff your're already doing is important to continue....good exercise, good intake of stuff, control other healh stuff.

Your input does bring me to pause on whether to wish for Tela or Boce.  With stage 4 cirrihois I am thinking one of these will likely be my final shot at the HCV prior to TP listing.

[willbb]

  Hi there...I also had less than stellar results in a trial....therefore discontinued tx. There are a number of us here.


However with aprrox.40 new drugs in the pipeline there will be something for us in the future....so as nygirl says...treat that thing like gold for now and   and as Magnum says.."try try again"

Positive thoughts your way....

Will

[nygirl7]

I['m sorry what a damn crappppppy thing to happen.  But I agree with Magnum once the tela and boce get out there into the mix you should try with a doctor not in a trial where you can see all the info and act accordingly. I mean what if your VL was down to 50 or something - they'd still kick you because of their rules but would you stop if it was that low? I sure wouldn't.

Or maybe you needed more riba or a different interferon there are a lot of things that could be tried that they wouldn't have done in a trial.  And I agree with Upbeat you should get that test and see what it says.

They are working on non-ifn/riba drugs and hopefully one will come out soon as a stage 2 you do have time just treat that liver like it's gold and you certainly have time to wait for them.

I'm so sorry my thoughts are with you.

[Upbeat]

Just curious.  Did you ever have a Ll28b test done?  

[Magnum]

"If at first you don't succeed, try try again", a great man once said. This will be my 5th attempt, and if that doesn't work, refer to the start of this paragraph. A fact that many should understand about this disease, is that many many more go to their graves with it  rather than from it.

Never give up, never give in....

Magnum

[almawe]

Another question...is the protocol on length of time to decide if treatment is not working ( ie 4 weeks in my case) the same for all those about to start treating with the new drugs...and wishing all the best of luck..exciting times for you.

[buggs1]

just have regular liver dr prescribe it  you are only a nonresponder after 4 weeks in that particular outrageous trial  not in real life

[almawe]

A question...can anyone enlighten me on why my liver function tests where all normal, for the first time in decades, after 4 weeks of non responsive triple combo treatment.  Doctor said it meant nothing.

[almawe]

Thanks for your info.  It is a blow to be out of the study so early.  I tried to find out what the drop inmy viral load had been from baseday...withheld info!...and of course am now freaking out about the mutant strains and my fear that l haave ruined any other future tratment results.  Of course i dont think there is anyway of  knowing  how you will respond to the tela until you do it.

Will be interested in what you find out on the 14th, my follow up day is the 17th, or though l did insist on seeing the trial doctor yesterday...basically, l asked him what he would do if he was me...he said wait until there are new drugs!

Will be asking that 'type of virus' question too!

What shape is your liver in, if you dont mind me asking.

Trying to have happy thoughts...bit sad and upset actually...but thanks

[txgirl360]

Well I just found this forum and thought I would commisserate with you.  I just got kicked out of the same Tela study on Tues.  Week 4.  They did tell me  what my VL was, still 298,000.  My Doc says she thinks we all get the immediate drop down to low VL probably in the first week of treatment, from the ones that are going to respond to the Telapravir, and that leaves the ones that are resistant and they continue to do their thing.  That the SOC doesn't seem to work too good in my body to kill them - and that is what they are counting on to kill the mutators. She also says that they are finding that people that only have VL of 100 at week 4 are relapsing.  My question is can I find out what type of virus that I had left in me that was resistant.  She says they did do a test and they know what it is but she doesn't think they will tell us, because the study is still going.  But we can ask.
She says there are 4 drug studies around the corner and just wait because we don't want to make what mutators more resistant than they are.  Would be glad to share any more info I get when I go back on the 14th to turn in my drugs and talk with them face to face.  I will give you a follow up.  Til then, think happy thoughts and just know that His eye is on the sparrow and I know He watches over me.

[JAY0914]

sorry to hear about the trial...i think its bs that they wont let you know anything about your VL since your out of study....i mean if you were having good enough results but not good enough for their study at least you could have possibly continued with soc with private doc...im in this trial taking 2 nd shot in an hour...ive had a crazy rash pop up last monday all over my neck...took benedryl last 3 days and its calming down...however it did go some on both arms and my thighs...im hoping it doesnt go crazy after this shot....once again sorry about your trial...keep your chin up it will work out for you!

[Aaron57]

Is there a time that they will "unblind" the study ? There usually is ... Perhaps you would be able to get your results at that time ?

If I understand correctly , with current Interferon/Riba Tx , a "null responder" would be a person who would still have a VL at Tx Wk. 24 of 48 Wks scheduled... stopping Tx at that time.

To get a 2 log drop or more or become Und at Wk. 12 is a more common indicator of SOC Tx Response at this time.

I'm very sorry to hear Tela did not work for you ... inside the guidelines of this trial.

If this trial was your first attempt at it .. it's not like you actually failed Tx , you didn't meet their clinical trial guidelines ... which are usually quite strict ... biz first ..

You might consider first informing yourself more than you are , about Telaprevir re-treatment options and SOC Tx,

Then find one or two respected Hepatologist who has a history of treating HCV... and consult with those doctors.

Maybe your Doc was trying to be nice .. however folks with a lower level of fibrosis have a better chance of clearing .. there are too many unknowns to try to predict fibrosis progression . Some folks it will progress and some not ...

Best of health and good luck whichever your decision.

[Aaron57]

The OP was dropped from the Tela/Trial she was in and is concerned about the future ..  

Copyman said " Well I hope you can try the other PI and it works for you"

I was referring to .. after a failed PI Tx  ...  have not seen anything on trying both PI's in one course of Tx .

From what data there is, the mutated/resistant strains could be activated within a few days after initially starting Tx ...

Unfortunately getting the genetic testing for which mutated or naturally resistant strain is interfering ... not going to happen for most folks ..

[almawe]

Saw my trail doctor today for some follow up information.  There was very little he could tell me.  I wanted to know if my viral load had dropped at all in the 4 weeks.  Trial protocol does not allow this information.  Doctor said no point trying the Boce and basically l have to wait around for new drugs in the making.  Feel very unsettled.  I had planned the whole year around being on treatment, and now after only 4 weeks...no treatment!

I am stage 2 fibrosis and do wonder if l had tried SOC how long l would have been allowed to show a response before  being named a 'null responder' ...

Does anyone have any info on their own experience with those sort of stats?

Am feeling the need to do something to hold back the decline of my liver...no alcohol, good eating etc, just does not seem enough.  The trial doctor was quite cynical about any alternative anti-fibrotic treatments...he said that at my satge of fibrosis l had time to await new drugs...am thinking he was juist being kind!!!....been a bad few days...

[Trish77]

"For switching PI's ... look around I'm pretty sure you will find it is not recommended due to mutation factor's .. if however you find study data supporting that approach ...  I would appreciate it if you would pass the links along so we could read those studies. "

Just wanted to make sure you're both talking apples and apples?

Aaron, you're meaning within the same one course of treatment, correct? and Copyman, you seem to be referring to over various courses of treatment - yes or no?  

Aaron, I'd like to read this data that suggests not to switch PI's over the one course of treatment due to differing resistance issues, you're the second person to refer to that and if you could post some links, I'd appreciate it.

Copyman - if over various courses of treatment, I agree - the drugs need different resistance profiles though.  You wouldn't have a full course of treatment fail with Telaprevir for example and start in with Boceprevir on the next round of treatment in a relatively short period of time as they're the same resistance profile.

[Aaron57]

Copy,

I'm pretty sure that "Doc" didn't mention SOC SVR odds .. at best, as we know it is 50% .. in the best case scenario .. if we add NPV's like insulin resistance , fibrosis, age 50 > etc ... the odds drop off pretty fast ...

Regarding Tela, what data is available from Illuminate & Advance phase 3 clinical trials results .. yes 80% is attainable , but only in the best of responders (best case scenario)  those 65% who attain eRVR (extended rapid response Und wk.4 - 12 ) ...

For all others, those not able to eRVR, which is about 35% of patients ... for those 35% who do not eRVR .... SVR odds for them are closer to 65% ...

An overall average of 72% SVR ... better than 50% but still far from 100%.

Overall efficacy analysis for all patients treated with telaprevir in ILLUMINATE (ITT or intent-to-treat analysis):
SVR Rate: 72% (388/540)
Relapse Rate: 7.7% (36/469)
Rapid Viral Response (RVR) Rate: 72% (389/540)
Extended RVR (eRVR): 65% (352/540)

For switching PI's ... look around I'm pretty sure you will find it is not recommended due to mutation factor's .. if however you find study data supporting that approach ...  I would appreciate it if you would pass the links along so we could read those studies.

[susan400]

It all depends on what doctor you talk to!!  I was in the Prove 3 Telaprevir trial (it will be 4 yrs ago that I was kicked, this July) and I was randomized into Group C, the no Riba group.  A very reputable hepatologist that I saw a couple of years ago, told me that with my only being exposed to Telaprevir for such a short period of time and having only received the 2 drugs, Pegasys and Telaprevir, that I may not have resistance and a period of a few years.  Being as, it has been almost 4 yrs, I will in fact, take my chances and try again, using all 3 drugs and the Boceprevir.  (If I'm able to get it, due to a financial situation).  I've been living a very active lifestyle for the past few years off of all TX's.  I've been working out at a gym, I'm a good weight for my height and I don't have cirrhosis yet.  I don't see any reason to not try Boceprevir.  I honestly don't want to sit around and wait for another 5 yrs for all these miracle drugs to finally make it through the FDA approval process.  It takes SO long.  I don't know that I want to take another chance with another trial and risk being randomized into another arm that doesn't give me all of the drugs.  That's my situation, but I wouldn't base my opinion on one doctor's opinion.  Susan400

[copyman]

Aaron,  
you wrote "but attain nowhere near 100% effectiveness". I disagree and it wouldn't be the first time a doctor is wrong,
Actually the doctor has it backwards, SOC is nowhere near 100% for SOC (around 40-50%),  adding the new PI's up the odds of SVR to around 80% for GT 1's.

Of course there probably haven't been any studies on it but I thought I read that a patient can try the other PI if one don't work. I will try and find article(s).