GS-7977 and Ribavirin Clinical Trial

I found out today I AM UNDETECTABLE after 2 weeks of treatment with GS-7977 and Ribavirin.

Not bad for a previous null-responder to peg-INF and Ribavirin where after 12 weeks of treatment my viral load never went below 360,000.

"An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant"  ClinicalTrials.gov Identifier: NCT01559844

During screening my viral load was 1,200,000
On day 1                                         692,000
1 week                                                   581
2 week                                                   <25

COBAS TaqMan HCV Test
week 1 dropped 3.06 logs
week 2 dropped 4.44 logs

Cheers!
Happy
Hector

[orphanedhawk]

Hooo-raaay !!!
This is absolutely wonderful~ the very best news.

Two weeks and UND~wow.
Now for that transplant and a healthy, happy, hep C free wonderful life!

[HectorSF]

I told my hepatologist to start thawing out my donor liver form the hospital's freezers. (I heard that at least one recipient thought they had livers stored for transplant and they were wondering what "the wait" was about).
One young, shiny, nutmeg-brown liver coming up.

I am ready for my transplant. Let's do this thing! Before my cancer comes back with an attitude. (AFP still rising since beginning of April).  :-O

;-)
Hector

[orphanedhawk]

I'll come to the hospital to see you:)
Why I might even bring flowers.

[belle19]

awesome news hector!!!!!  i'm so happy for you.  you really deserve it.  best wishes.  belle

[HectorSF]

Flowers? I like flowers. Just please don't smoke them in my room...
haha

H

[orphanedhawk]

Don't you know I'm the brownie queen not the flower child ? LOL !

[fretboard]

Wow!!  That's amazing Hector!!  Many Congratulations!!!!  WTG!!  

[1swimmer]

Awesome news Hector!
C

[Idyllic]

Hector I am so happy for you. I can imagine what incredible releif you must feel. I could not believe my eyes when I saw the first lab report (ever) the words "Not Detected." Part of me thought I never would. You are well on your way to getting healing!

[Kristina538]

Awesome news Hector, Congratulations!!!  You've given so many people hope here and are still doing so with this fabulous result - kudos plus to you, and a celebration for us all.  Words don't do this justice!

[HectorSF]

So the first part of the trial is done. YES!
The true test will be if I/we remain virus free 12 weeks after transplant. I may not know this until 9 months from now depending on when I get my transplant.

There are also many other things they hope to learn from this study.

* For those that don't get a transplant by week 24, will they be cured of hep C after 24 weeks of treatment?

* To assess safety and tolerability of treatment (levels of side effects if any)

* To evaluate the HCV RNA viral kinetics during the treatment phase and following liver transplant and correlate results with the duration of study treatment prior to liver transplant. Will how long you are undetectable effect if the virus comes back post transplant?

* To explore the presence or absence of HCV RNA in the liver explants (in the old cancerous recipient's liver) and correlate with plasma HCV RNA viral kinetics during therapy, plasma GS-7977 and metabolite exposure (if possible), duration of therapy, duration of plasma HCV RNA negativity. They will take a piece of my liver for study along with all of my blood tests throughout the study.

* To explore the dynamics of non-tumor MELD score during the study. My blood level MELD score has already gone down (MELD score 11) indicating my liver is more healthy than before which will help me to bounce back from transplant better.

* To determine concentrations of GS-7977 and metabolites (if suitable analytical methods can be developed) in the liver explants in a subset of subjects who cease GS-7977 therapy within 24 hours of liver transplantation. We will take our treatment drugs on the day of our transplant. And a viral load will be taken before transplant to show if any has virus present and how that might effect recurrence in the donor liver.

This is a phase II study, which is why there are only 50 people world-wide in it. If successful, there will be a Phase III study including a much larger group of patients.

Cheers!
Hector

[BoceprevirGal]

  Wooot!!!  Doesn't that Undetected feel great??  I have read vitamin B12 shots may help, in sustaining SVR, have you looked into this?

[BoceprevirGal]

  Wooot!!!  Doesn't that Undetected feel great??  I have read vitamin B12 shots may help, in sustaining SVR, have you looked into this?

[orphanedhawk]

Hector is not SVR, he is und.
He is also awaiting a liver transplant.

[nygirl7]

Hector you go my friend wahoooooooooo! Und at 2 weeks that is freaking fabulous wonderful spectacular marvelous incredible news!!!!!!!!!!!!!!

YAY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!  ♥

[mikesimon]

Congratulations Hector!!!!!!!!!!!!!!!!
That is really wonderful news!

Good luck,
Mike

[BoceprevirGal]

I know, OH, I was thinking of the future. He wants to be 12 wk SVR before the Transplant (he mentioned in his above comment).
   I wasn't sure if vitamins were allowed, once
cirrhotic, etc. My Doctor ordered me off all my vitamins and supplements during my Tx, so I was wondering what other Txing people were doing, in terms of that~

[BoceprevirGal]

If you reread my reply, I congrat him on his "Undetectable" status, in my first sentence. Why would you assume I thought him to be SVR, and not know he is waiting for a Liver transplant??  

[LadyHep2]

That is wonderful!

[8nickers8]

I am so happy for you, Hector.  Now you see why I am so amazed at 7977 and riba?  I was never told my viral load, that's why I just recently ran my own Heptimax but I did see my ALT drop like a rock and by week 2 it was normal!  So, you have a ways to go.  How many weeks are they planning on giving you the medication?  It says under the study up to 24 weeks.  I forget what genotype you are but if you are type 1 I'd want all 24 weeks.  Otherwise, well, as you know I am type 2 and so far so good.  I can't wait to hear that your new liver is safe and sound for the monster virus.

[slideman]

You are the man!! I am so happy for you. If anybody deserves good news its you......and all of us that you have helped for so long. You must be on top of the world!! Good luck my friend and I will be praying for more good news from you!!

[coraggio]

It is truly amazing to know that GS-7977 has the ability to bring someone with a ravaged liver down to an undetectable level in 2 weeks.  It's incredible stuff when compared to SOC and even the PI's, which can be long a brutal treatments.  

Congrats HectorSF, wish you the best.

[HectorSF]

"How many weeks are they planning on giving you the medication?"
24 weeks or until I get a liver transplant whichever is first.
SVR for this treatment is 12 weeks after end of treatment. Or 12 weeks after transplant.

I forget what genotype you are but if you are type 1 I'd want all 24 weeks.
Good question! I am genotype 1b. I am also IL28B C/C. Even though I was a previous null-responder to peg-INF and Riba treatment. So much for C/C predicting response to interferon in all people.


Hector (Nice to be undetectable after 43 years of infection)

[dointime]

Gosh this is such an exciting trial!  You must be over the moon to have got on it.  How interesting that you are a CC.  Thanks for posting,
dointime

[8nickers8]

Hector request all 24 weeks.  Also, I have a favor to ask.  I don't know if you remember but I just did my own Heptimax just so I could see the VL with my own eyes and 9 weeks Post Treatment I am UND.  I go on Monday for the 12 week post treatment blood test but it is a double blind study so I will not get the results but I believe, based on what has happened so far, that if anyone relapses, they will be pulled from the study as happened a short while ago.  I am so scared.  I wonder when this terror will end and I will relax. Maybe at 24 weeks post.  ANYWAY - I have a favor to ask of you.  Now that you are doing the same treatment that I did, 7977 and riba and I had no side effects except for the hemoglobin dropping but they gave me the supplements and that took care of that.  I realized in retrospect that I was more emotional during those 12 weeks and a bit angrier than my normal self but nothing that was outrageous.  SO would you please confirm for everyone that ribavirin is an easy drug to take and it has no terrible side effects the way people have been saying it does.  The only time that happens is when it is taken with Interferon.  Truly, of all the people on the study with me, NONE of us had any side effects to speak of.  Can you please confirm that because no one seemed to believe me.  Thank you.

[rivll]

The reason no one believes you is that you are incorrect.
True, people have different responses. Some people don't suffer from serious side effects. However, you cannot make a blanket generalization based on your personal experience.

[Marcia2202]

Amazing news!!!! Congrats!!!! Finally, after all these years. Wishing you all the best!!!!!

[BoceprevirGal]

  Hector, you are on Incivek, and NO complaining?? It just goes to show me how much education(and the necessity to get well) can ease  our side-effects...you Dah Man!

[rog1958]

Congrats Hector!! Pulling for you.

[orphanedhawk]

Hector is not on Incivek. He is doing a trial with the new oral med GS-7977 and ribavirin.
Read the first line of his post.

8snicker8~
Hector is in a unique situation as he is doing this trial pre-transplant. Once he is undetected he can get his new liver.
The reason we continue to do treatment beyond being und, is because although we may be und in our blood, the virus can still be in our livers.

I agree with Rivil. If you had no side effects from ribavirin, you were fortunate.

[HectorSF]

Remember GS-7977 (sofosbuvir) is in trials for data is hard to come by as many of the studies are ongoing right now.

What we do know is that GS-7977 + RBV in the ELECTRON trials with 35 genotype 1 patients...

* Had No discontinuations
* No grade 3 or 4 adverse events
* No grade 2 adverse events in more than 1 patient
          - 1 null-responder had  (anxiety, depression)
          - treatment naive patients 1 experienced headache. 1 experienced                nerve pain. 1 experienced chest pain and 1 had vomiting.
* Low rates of laboratory abnormalities
- In null-responder arm. 1 patient had hemoglobin 7.0-8.9 g/dl
- In the treatment-naive arm. 1 patients had WBC<1000/mm3

This is similar to our group's experience. None has had anemia which is commonly linked to Ribavirin. And no serious side effects.
So 8snicker8 experience seems typical at least as far as I know at this point. Although we all know ribavirin when taken with peg-interferon treatment can wreak havoc with anemia, rashes, and other nasties. But I don't think anyone has taken ribavirin by itself, without some form of interferon. So what side effects come strictly from ribavirin? Who knows.

As orphanedhawk said "The reason we continue to do treatment beyond being und, is because although we may be und in our blood, the virus can still be in our livers."

I am undetectable down to <25.
From what I know, no virologic Breakthrough has been seen during treatment. Also all patients are undetectable by week 4.

We may have more information on this issue of HCV in blood vs HCV in the liver from the trial I am in. I have chosen to give my blood samples while on treatment and after treatment and a sample of my liver after transplant so Gilead can study the correlation between viral load and the GS-7977 in my liver. I hope this will ultimately help scientists better understand HCV and liver disease and help others in the future with this additional knowledge.
As far as I know this is the first study to take samples of the liver and blood for study post treatment.
"To explore the presence or absence of HCV RNA in the liver explants and correlate with plasma HCV RNA viral kinetics during therapy, plasma GS-7977 and metabolite exposure (if possible), duration of therapy, duration of plasma HCV RNA negativity."

This study will also study any improvements in liver function caused by the treatment. "To explore the dynamics of non-tumor MELD score during the study."

Okay, enough work for today. I had 3 hours of school tonight and an essay on Medicare. I am beat...
Hector

[working dog]

great news hector!!

[frijole]

School and an essay on Medicare??????

Not sure what that is all about, but your UND is tremendous news, hector. I see a bright shiny liver straight out of the frying pan for you.  Not the freezer (how weird that anyone would think that)!

[HectorSF]

I want my liver with lots of onions!

H

[Naya888]

Wow,very impressive Hector,you are now getting seriously closer and closer to your goals!!!Very Best to you!!!

[Isobella]

Wow!!!  What a wonderful surprise to pop in and see your good news.  Congratulations on your UND.!  Thank you so much for sharing the details of your trial and treatment.  After all you've been through, you continue to help and inspire others.  And it's no surprise to see that you're going above and beyond to help the HCV community even more by continuing to donate blood and tissue samples after the study for further evaluation. You are awesome!!!!  

Onions in your honor!!!  Wishing you the best!!

Isobella

[Dawn703]

Hector, That is great news. You must be so high you're in the clouds. Great job.

[tiredofhepcII]

Really Kool!
Great news............I wish you the Best!

[JasmineT]

And there it is!  Great news hector!

[HectorSF]

¸¸.•*¨*•*´¨)
¸.•´¸.•*´¨) ¸.•*¨)
(¸.•´ (¸.•`  Thank you every one!!!

[flcyclist]

I almost missed this.  Just browsing through the post and see this wonderful news.  Hector UND @ 2 weeks!!!  Friggin fantabulous!!!!!!  What a wonderful way to start the day.  Puts a big smile on my face to hear our Hector is well on his way to SVR.  
☻ღ˚ •。* ♥ ˚ ˚✰˚ ˛★* 。 ღ˛° 。* °♥ ˚ • ★ *˚ .ღ 。~♥~
~♥~˛˚ღ •˚ ˚…just sprinkling a little Love on your page. ~♥~˚ ✰* ★
˚. ★ *˛ ˚♥* ✰。˚ ˚ღ。* ˛˚ ♥ 。✰˚* ˚ ★ღ☻~♥~* ♥ ˚ ˚✰˚  :-)))

[Revalation]

Wonderful news.
You deserve some good news.
Wishing you the best.

Reva

[Dee1956]

Hey there!  Day late $ short Dee here to say congratulations!
I am so very happy for you, this is the best news!
Woo HOO!
Dee

[child24angel]

Hector!!
This is WONDERFUL,!!!!

All my very best moving forward!!

Many Hugs
Elaine

[stormy456]

I had such a good feeling about this treatment for you, and here we are.  I'm so very very happy for you, H.  This is a significant milestone on your road to living a healthy, full life.  Wishing you a very easy remainder of tx.  - H

[gene53]

Like I always say, YOU ARE DA MAN.... Congratulations and very best of luck

[katla]

I don't come around here much and just came across this. I was delighted to read this, truly.

Wishing you the best of luck with this trial.

[IAmTheWalrus]

Amazing! This is appropriate for such an amazing guy. This definitely makes my day!

[JDB1964]

Happy for you and so anxious for this great med to become available to all who need it!

[lapis]

REALLY late to this party but it continues!!!  Such fabulous news, I am so very happy for you, Hector.  Still cheering from the east coast!!

Lapis

[GINGERPAL]

Hector....This is wonderful news.  I wish you all the best !!  You deserve it.  gingerpal

[LookingForward12]

I may be late to the party, but heartfelt congrats are here for you now!

You are, undoubtedly, one of the most brave and stickwithit people on this forum. When you are ready, let me know, I'll send you a bushel of onions for that new liver!

Cheers!

[revenrick]

congrats hector, i my self just finished 24 weeks of gs7977 and riba,and awaiting tx ,im a type3 null responder 3 times ,over last 10 years..my viral load started at 300.000 by week 3 it was >25 undetectable ,i just moved up to #2 on tx list ,have had 3 calls for backup transplant,over last two weeks,my meld score is 25 should go to 28 next week,looks like ill have a rebirthday with a new year .... from here in texas   good luck  hectorsf     !!!!!!!!!

[gerard11]

How was your treatment on the GS-7977 / RIBA ?  Side effects? If you could talk about the experience I am sure many members would appreciate it. I know I would be one. Thank you...and good luck on your upcoming transplant. I

[MeWithC]

Glad it worked for you Hector....maybe my turn will come soon.

[revenrick]

i really had no  side effects with gs7977,normal side effects with riba ,like rash and itching,having took interferon three different  times with riba ,48 weeks each time ,over a ten year period,only to relapse each time around the six months checkup.......,the gs7977 was an open label trial,took two  200 mg each day, 400 mg total a day with riba,1200mg a little dizzy at times,but nothing like what i went thru with the  interferon,the only negative thing of gs7977 was the taste ,taste like sulfur,ill take that over interferon any day

[libnic84]

that my friend has to be one of the best feelings in the world... congrats!!!  i'm so excited for you

[fran4702]

Congratulations Hector!  You have been so kind to everyone on this forum.

[revenrick]

i was transplanted dec 30,2012.only spent 5 days in hospital,all levels look good,i go to clinic twice a week,they 2x my prograf since start,some blood markers from old liver show  some lymphoma of unknown type waiting for bone marrow test to find out more will update later, hector are you out there?

[gerard11]

Very happy to hear your transplant went so well. I too was out of the  hospital after 5 days!!! I find that amazing, to have that surgery and spend such a short time in hospital. Hope you remain Hep free. Hope all is well with bone marrow tests. You have been thru the mill and its time for you to mend and get your life back!!!!! Congrats on your gift of life!!!!!!!!!!!!!speedy recovery!

[jojim55]

Congrats Hector

[creewoman]

There are rare human beings that persevere against all odds and come out as victors.I have not been on the forum long,but it is obvious you are one of the blessed ones going on for all too sick to make it and for the rest of us just beginning the journey a Pioneer.Thank you.I curtsy to you!
  Snow