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.  

[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...

[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 ..

[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.

[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!

[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.

[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