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Post Info TOPIC: Gilead's newest trial


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RE: Gilead's newest trial
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Hi Bill, I am glad you replied... Makes me think.

I just stared a new post Abbott trial or wait for Gilead that explains my conversation with the coordinator today...

Thanks again...Karen



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Karen

I had to think if I should tell you all that and be a negitive Nelly  but it is  what happened  I admire you bravery  Your ready for somthing with that attitude you should beat the hell out the Hep C  

I'll be totally honest If this was 7977 with ANY combo  I would say your lucky and good luck.  I would do it myself  I'd swich now if I could  But thats me.    I know nothing about the drugs you are looking at  

Maybe someone  knows how reliable these study drugs are ?? Cure rates etc. 

Looks like they have alot of arms alot of mix matching  which is the best arm to be in? Have you seen results of the past trials and cure rates ? How about known side affects?  Before you say no  try to get the information. 

A good point it that its a 24 week treatment unless placbo  The rest of the 48 week study is follow up  but  if your not getting hard med 1st 12 weeks  it might not be so bad just longer 

Good luck amigo   hope all go's OK

   

  

 



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.



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Hi Bill, thanks for your story.  I need to hear it all.  

I have copied what was sent to me.  I like how they state "like the flip of a coin"....oh my!!

Part 1

You will be randomly assigned by chance (like the flip of a coin) to one of two study arms. Neither you, nor your study doctor will be able to choose or know which study arm you are assigned to. The study doctor can get this information in case of an emergency.

You will have a 75 percent chance (3 out of 4) to be assigned to Arm A containing the study drugs ABT- 450/r/267, ABT-333 and ribavirin for 12 weeks. You will have a 25 percent chance (1 out of 4) to be assigned to Arm B in which you will receive placebos (pills that looks like the study drugs ABT-450/r/267, ABT-333 andribavirin but have no active ingredients) for 12 weeks followed by the active study drugs for 12 weeks. Be aware that this form refers to ABT-450, ABT-267, ABT-450/r/267, ABT-333, ribavirin and their placebos as "study drugs."

Arm A

             ABT-450/r/ABT-267 75 mg/50 mg/12.5 mg (2 tablets) taken once daily (a total of 150 mg/100 mg/25 mg) orally

             ABT-333: 250 mg (1 tablet) taken twice daily (a total of 500 mg) taken orally

             RBV:

             if you weigh less than 165 lbs (75 kg), you will take 2 capsules in the morning and 3 capsules orally in the evening (1000 mg)

             if you weigh 165 lbs (75 kg) or more, you will take 3 capsules orally twice daily (1200 mg)

Arm B

             Placebo for ABT-450/r/ABT-267 (2 tablets) taken orally once daily

             Placebo for ABT-333 (1 tablet) taken orally twice daily

             Placebo for RBV:

if you weigh less than 165 lbs (75 kg), you will take 2 capsules orally in the morning and 3 tablets orally in the evening

if you weigh 165 lbs (75 kg) or more, you will take 3 capsules orally twice dailyAfter receiving the placebo for 12 weeks, you wil1 proceed to Part 2 and receive the active study drugs for 12weeks.

Part 2

At the end of Part 1, the study doctor will find out which arm you were assigned to. If you were assigned to Arm A, you will proceed to Part 3 below. If you were assigned to Arm B, you must complete all visits in Part 1 in order to proceed to Part 2. In Part 2, you will receive the study drugs ABT-450/r/267, ABT-333 and ribavirin for 12 weeks (as outlined in Arm A above). You will begin taking the study drugs ABT-450/r/267, ABT-333 and ribavirin the day after you complete the Week 12 Visit in Part 1.

Both you and your study doctor will know the study treatment you are receiving in Part 2.

Part 3

After completing Part 1 and if applicable Part 2, you will enter Part 3, the post-treatment period. In Part 3 you will be monitored for an additional 48 weeks following the last dose of study drugs to see if the HCV can still be detected, and if so, whether it has become resistant to any of the study drugs.

Study Duration

Your participation in this study will last approximately 60 to 72 weeks (excluding the screening period) dependent upon your initial tr

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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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I didnt exactly read all about the trial you thinking about  But ?? are they saying 3 study drugs or 2 ??  with Ribavirin and maybe Interferon if Geno type 1?

PROJECT TITLE: M11-646: A Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I) 

For what it's worth  here is my story

I did a trial last year DEB025   A 48 week treatment.    It  was a   blind / blind  with or   without a placebo for a chosen percentage  in place of the new drug (s)  for first 12 weeks some  got it some didnt nobody  but Novartis  knew who got it

1st Blind means   I WILL NOT GET any real results on VL and other factors till the end and I didnt  None

2nd Blind my DOCTORS  CANNOT see viral load either. Only the drug company has results on how the med is working  

 

Here is the tough part. If I had been chosen to receive a placebo,  I would get Placebo  for the first 12 weeks  ( I dont get the real drug at this time Just Ribavirin and Interferon )  We are not told if we are getting a placebo Its a guessing game even for the doctor. My NP was nice enough to tell me she thinks most likely Im getting real drug because of CBC test and my side effects.    But that was her educated guess. and didn't ease my mind

 If I got a placebo it would have set me back 12 weeks. If you get placebo 1st 12 weeks. They will start giving real drug at week 13 ( they have to ) so now the clock starts ticking for 48 weeks.  Another way of looking at it they add 12 weeks to your treatment in the beginning for placebo patients only you wont know till 48 weeks and surprise you get another 12 weeks      

They did release the CBC portion of blood work  and allowed my doctors to order CBC to check platelets and hemoglobin only vitals that indicate a problem with tolerance

The study drug Deb025was withdrawn 8 months in (Pancreas troubles in some patients (1) died ) I didnt want to stop cause My Pancreas ok and I was UND   Problem was I didnt know when I went UND  I had to give up the study drugs  Novartis dragged their feet and didnt release test till May. Then in June I broke through and relapsed I continued for the 48 weeks. Ribv and Peg while the options were weighed They said we strongly recommend to continue   and do another therapy back to back.

Now triple w/ incivek so  here I am 67 weeks so far  UND  The verdict  was  in today the want the full treatment so my sentence is now looking at 96 total weeks  

I would do another trial if I needed it but  I wont do Ribv and interferon  I had enough  Ill wait if I dont clear this time



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.



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Karen wrote:

It looks like even if you recieve the placebo you will get the real thing in the next 12 weeks (see below).

(Arm B - After receiving the placebo for 12 weeks, you will proceed to Part 2 and receive the active study drugs for 12 weeks.)


 Wow, that's awesome. I've given a lot of thought about if I ever got in a trial if it was placebo possibility if I could do it or not. This makes it all worthwhile. Hopefully other trials will give the same consideration now that the time involved is lessening.



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58 yrs, cirrhotic, Genotype 1b 48 weeks Victrelis triple, SOT 7/13/12 victrelis started week 5. Starting VL 4,000,000  Wk 8 33 copies  Wk 24 UND, EOT UND 6 months post Tx DET. The battle goes on.



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Sorry about the confusion (financial) it is all tests prior and any medical complications during...My insurance runs dry at the end of the month...so if this is a go ahead I must get everything done in the next couple weeks unless they will accept past testing..

It looks like even if you recieve the placebo you will get the real thing in the next 12 weeks (see below).

(Arm B - After receiving the placebo for 12 weeks, you will proceed to Part 2 and receive the active study drugs for 12 weeks.)



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Hi Karen, You've changed 'financially responsible for ALL testing' to 'pre-trial testing'. That's different. To be eligible for a trial, you will need to meet certain criteria. These will include blood tests, probable recent liver biopsy etc. DrugCo's do not pay for this, but once accepted, they pay for all monitoring and testing.  As with any Phase 3 trial, there are a large number of participants, and there will be several Rx streams. Unfortunately, there is often a placebo stream, so you cannot be certain you will get the right drug.  Abbott are certainly doing placebo streams, but I have not seen the final data for the main Gilead Phase3 trial. I would certainly try to go the the pretrial interview-  the Abbott combination of drugs looks very good. Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Hi Malcolm,

Thanks for you insight, it is always appreciated.

I thought it odd that I would be billed/or my insurance company for pre-trial testing. It is clearly stated in my paperwork.  As Jill mentioned, I will go for the pre-screening interview and see what they say.

This is really a very difficult decision right now...thanks again for your support and any thoughts you can pass my way...

Karen



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Hi Karen, it would be unheard of for a Drugco not to pay for testing while on a trial! The Abbott Trial will finish in Oct 2014- by the time data is analysed and presented to the FDA, it will be mid 2015. If all is in order, the earliest approval would be in late 2015.  Patients should not have unrealistic expectations for release dates for these new DAA's. Phase 3 trials are just starting for some of the drugs. Sofosbuvir may get approval in late 2013, but for Geno 1's that is of little use as an NS5A inhibitor will need to be approved as well. Cheers



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Jill your an angel...Thanks again:)



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Actually I`m surprised the pharmaceutical company isn`t paying for some if not all of the medical expenses themselves, Karen.  I would definitely ask about any financial help that might be available, and it certainly would be useful to find out about the possible sx involved.

I can see your point about waiting for new drugs to become available too, especially in your current situation.  Hopefully once you have more details about the trial it will be clearer to you which is the best way to go...I hope so anyway!  smile   Jill xxx

 



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Hi Jill,

Thanks for responding.  You have pointed out some things I did not think about or know, very helpful.  

After reading the paperwork, one of the major concerns..I would be financially responsible for "all" testing, medical issues etc.  I am self supporting, no family and my dear friends mostly live out of the area (lack of work in MI has driven most to other States/Countries)...no place to fall back on. That said, I think the best option is to get back to work, get my insurance in place, continue to take care of myself and wait until 2014 when some of these drugs are expected to hit the market. My viral loads have doubled in the last year but I think I have time....who knows!!

I never thought of going to the preliminary trial interview (thanks again for suggesting that).  They may be able to provide some answers about my ability to work based on phase I II and if there are ways to get some of the medical costs covered.

Oh my!!!!

Thanks always...for your support.

oxoxo K



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Hi Karen, no, not the best timing!   Maybe you could keep your options open at this point...go for the preliminary trial interviews and at the same time wait and see if either of the job offers materialise.  This Abbott trial is a double-blind study so you don`t know whether you`d be getting the `good stuff` or not, and you know there`s a Gilead trial on the horizon.  On the other hand I`m sure you must be getting impatient to get onto a trial of any sort.

I guess it might be possible to work and do the trial but you don`t know yet how the sx would be if you were on the arm getting the actual meds and no doubt you`d need to have time off for appointments etc which could be a problem in a new job.

Best of luck with your decision, do keep us posted.  All the best, Jill xx



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Abbott's SAPPHIRE-1
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Received my "trial participation" marching orders today...

Timing is not the best...I have been out of work for 18 months.  This comes just as my insurance is ending and I MUST go back to work...Have two possible job offers..What to do..What to do!!! Interviews for the trial start Dec 17..Never easy.

PROJECT TITLE: M11-646: A Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I) 

 

 



-- Edited by Karen on Friday 7th of December 2012 11:16:05 PM

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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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RE: Gilead's newest trial
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Oh...thanks so much:)  Need to gather as much info as possible on these new trials.  Big decisions to make over the coming months...Thanks again...



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Abbott's SAPPHIRE-1
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Karen, here is a link for the Abbott trial. Cheers.

 

 

 

http://clinicaltrials.gov/ct2/show/NCT01716585?term=hepatitisc&cond=%22HepatitisCVirus%22&lup_s=10%2F01%2F2012&lup_d=30

 

 

 

 

 

 



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



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Hi Jill...

Received information today on the name/phase of the Gilead trial (337-0102 Phase II)...as mentioned below...if everything goes as planned-recruiting Spring 2013.. 



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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That`s very interesting, Karen, thanks for the update.  Gilead and Abbott pharmaceuticals are both doing amazing things!  We`ll look forward to more news as and when you hear anything new. 

Take care, Jill xx



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Just received an email from my doctor's nurse....

Gilead has a new trial that will open for enrollment in Spring 2013...

Abbott phamaceuticals has an all oral trial starting Dec 2012 "SAPPHIRE-I"

That is all I know for now...Will keep everyone posted as I know more.



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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Hi Rich...I have not heard a word.  Thanks for asking



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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update?


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Keep us posted! JoAnne

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JoAnne

Genotype 1a, Triple therapy w/Invicek started May 19, 2012

DET 4 wk. UND 2,6,12,24 48 treatment. Achieved SVR 2013!



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Hi Jill....thanks for the reply... Have not heard a word;(   Not fond of how the system works in my home town...Unfortunately-it is the main hospital in the area conducting the trials-same Doctor that blew my chance of getting on the Gilead's 7977.  If I do get any info to share-I will certainly do so...

PS...so happy to see you living it up!!!



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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014



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How exciting Karen, have you heard any more details yet? 

Best of luck!  ~  Jill xx



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Just received an email from my doctor asking for my genotype...he is considering me for Gilead's new trail.  He was not clear on exactly which one...when I view Gilead's website there are currently 4 in phase II and 2 in phase I.

Does anyone have any idea which trial this might be?  Anyone else being asked to consider a new trial?

Soon as I know-I will share.

Thanks..

 



-- Edited by Karen on Friday 28th of September 2012 02:24:52 AM

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Geno Type A1- VL 16.2m - F1-F2 Moderate Fibrosis - Started treatment 4/16/13 Sofosbuvir/Ledipasvir 6 months -  UND week 4 (5/14/13) - EOT 10/1/13 - 12wk blood draw 12/20/13 UND - 24wk/final blood draw March 2014

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