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Higher platelet counts during GS-7977 + RBV trial
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Higher platelet counts during GS-7977 + RBV trial

I am on week 8 of GS-7977 + RBV. I have had cirrhosis since 2007 at least and developed ascites and HE in 2009. In 2011 I was diagnosed with HCC (primary liver cancer).

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
Conditions: Hepatitis C;   Hepatocellular Carcinoma
Intervention: Drug: GS-7977+RBV

I had a CBC last week to check for anemia. My hemoglobin dropped a bit but I am not anemic.

What was very surprising was my platelet count.
I have never had a platelet count above 70,000 since 2007.
Pretreatment in August my platelet count was 57,000. Typical for me.
Last week during week 7 of treatment my platelet count was 89,000!!!

Unbelievable! I don't know of anyone commenting about this.
Probably because us 50 people in this trial are the first cirrhotic patients ever treated with this treatment.

This could be huge for cirrhotics! As many patients with cirrhosis have platelet counts too low to even start current treatments. So there only option is transplant.

I will talk to my hepatologist on Tuesday about this and she what she says as far as others responses. This treatment is so different than current treatments.
Minimal side effects even in cirrhotics, undetectable by week 4 even in prior null-responders to IFN treatment AND higher platelet counts!

Hector
9 Comments Post a Comment
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1475202_tn?1388955435
Hector that is truly amazing news, I am very excited for you! So does this mean it’s likely that post-transplant you will not need further treatment for Hep C? Now that the HCV is undetected, this would mean a reduction in inflammation hence a higher platelet count as the liver is able to perform better?

Thanks for sharing the good news and I wish you all the best!

Randy

I found a couple of links concerning GS-7977 and posted them below, I hope this won't be confused with the study and it's parameters you are a part of but I was curious if you had saw them.

http://presentations.gilead.com/downloads/presentations/15/10-gane-JAnderson_ELECTRON-GS-7977_EASL%202012_Poster.pdf

http://www.natap.org/2012/EASL/EASL_30.htm

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446474_tn?1404424777
Thanks Randy.

Well my doctor that is conducting this study is very optimistic about this treatment and so am I. We 50 are the first cirrhotics ever treatment with this treatment and from what I hear through the grapevine all are doing well at least at our TP center.

An interesting thing my hepatologist told me is that folks that  are scheduled to have a living donor transplant will treat with HCV therapy (for example peg-IFN and RBV) and if they are undetectable for 4 weeks before their transplant they will likely not have recurrence of hep C in their new partial donor liver. I never knew that. Certainly that raises our hopes as everyone treating with GS-7977 + Ribavirin are undetectable by week 4 and there are no viral breakthroughs that I know of.

I will have a blood MELD score taken in December plus my 3 month surveillance MRI to look for any HCC tumors. It will be interesting if my MELD score does go down. I am having side effects do to my drop of hemoglobin so I feel worse but I am sure my liver appreciates not having hep C replicating and causing more scaring. So that is a good thing.

My current MELD score is 30 with my HCC exception points.

Whether this is the case with GS-7977 + Ribavirin only time will tell. That is one of the purposes of the trial. How long does a cirrhotic patient need to have undetectable HCV viral load and not transmit the virus to the new donor liver. But it certainly is encouraging. I have been undetectable for 6 weeks already.

I will continue to monitor my hemoglobin and platelet counts to see what happens as more time on treatment passes. But it is a relief not have to worry about platelet transfusions as many of my friends have had (which is only a temporary fix) that needs to be repeated) or the use of Promacta which has its own risks.

So many potential upsides to this treatment. I imagine the study will be published sometime next year. Probably toward the end of 2013.

Thanks for the studies! I think I have them all but I will check.
Cheers!
Hector
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1654058_tn?1376739127
You're an amazing specimen Hector. Truly. This one is for the textbooks. Which is what got YOU in the study in the first place. There's just no explaining it. I'm happy happy that you don't have to face rescue drugs.
Raining joy,
Karen :)
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Hector
I believed before ant clinical trials,that 90% was what I saw and hve been following this drug for somr time I think we hep c prople need to get this to the wider community,as soon as possible as many people are suffering trough outdate dangerous treatment to get rid of hep c I lovre the tranformation you are going through please encourage these reseachers to move as swiftly as possible if possible there will be many greatful people,It sounds fantastic for you I am so happy for you my friend,it's truely a miricle,
good luck and the future looks a little bit brighter.
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163305_tn?1333672171
A rise in platelets~ wow what good news.

The future of hep C treatment is bright.
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317787_tn?1373214989
As Hawk said the future of Hep C treatment is bright

I am so happy for you, thrilled would be a better word, this is fantastic news
Dee
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This Sofosbuvir is amazing!  My platelets are higher now post tx, but I had to wait to get rid of the inf to see that result of UND since inf is a platelet killer during tx. Evidently 7977 doesn't kill platelets and you get to see them rise during tx as the virus is eliminated. Awesome! That must have been a real thrill for you to see those results so soon, and after so many years?!?

How long does it take to go from newly compensated cirrhosis to decompensated, or is their no time table? Also, I was looking at the pictures/diagrams on your page and was wondering how they can tell how cirrhotic a liver is by taking the small specimen from one area when another area could be more damaged, or doesn't it work that way?

I'm looking for a hepatologist closer to home to monitor me outside of the trial as I'm feeling very "iffy" about this whole cirrhosis thing and want to watch it carefully. The trial will continue to check my vl and a few other blood labs for six months, but other than that, and after that, I'll be on my own and I still wonder about low platelets. I am suspecting I was very close to cirrhosis, but did not have a new biopsy prior to tx. I'm concerned that I may have "crossed over" if you know what I mean. Would SVR stop cirrhosis?

Oh my....as usual, a million questions for our "go to" guy, Hector. Sorry about that, lol.

Take care, keep us posted!

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446474_tn?1404424777
How long does it take to go from newly compensated cirrhosis to decompensated, or is their no time table?

- Every individual's advanced liver disease has develops differently. Although there are certain common common complications that do occur, when and how they may manifest can be different for each of us. That is why no one can say exactly when someone with decompensate in the future. There is no set timetable. There are many factors involved some we have control over most we do not have control over.

"How they can tell how cirrhotic a liver is by taking the small specimen from one area when another area could be more damaged, or doesn't it work that way? "
A biopsy is not used to tell how cirrhotic that liver is. It is used to indicate where someone is or is not cirrhotic. Yes or no. Not degrees. Stage 4 liver disease is cirrhosis. That is all a biopsy can do. The degree of cirrhosis is usually determined from blood tests or blood tests and degree of complications. The MELD score and the Childs-Pugh or CPT can also be used.

"Taking the small specimen from one area when another area could be more damaged, or doesn't it work that way? "

That is taken into account when the sample is taken to minimize sampling errors.

Liver Biopsy
This position paper has been approved by the AASLD andrepresents the position of the association.

http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/Liver%20Biopsy.pdf

AASLD Recommendations

25. Because diagnosis, grading, and staging of nonneoplastic, diffuse parenchymal liver disease is dependent on an adequate sized biopsy, a biopsy of at least 2-3 cm in length and 16-gauge in caliber is recommended (Class I, Level C).
26. It is recommended that if applicable, the presence of fewer than 11 complete portal tracts be noted in the pathology report, with recognition that diagnosis, grading, and staging may be incorrect due to an
insufficient sample size (Class I, Level C).
27. If cirrhosis is suspected, a cutting rather than a suction needle is recommended (Class I, Level B).
28. In clinical practice, use of a simple (e.g., Metavir or Batts-Ludwig) rather than complex (e.g., Ishak) scoring system is recommended (Class I, Level C).

"Would SVR stop cirrhosis? "
- Yes
- Don't worry about "I was very close to cirrhosis".
- Being SVR will stop further damage.
If you have cirrhosis and monitored for HCC. talk to your doctor and see how many more years you should continued to be monitored.

By achieving SVR you prevent further damage to the liver caused by the virus. Cirrhosis is partially reversible which is all you need. Since you were still compensated your liver was still able to perform all of its functions so your liver is still functional. Unlike a person with decompensated cirrhosis.

"I still wonder about low platelets."
How low is your platelet count? If it is less than 50,000 then there is something of concern. If your plate count is 50,000 then you must have cirrhosis and portal hypertension  and all the risks of cirrhosis.

It is late if I missed something let me know...
Hector
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Yes, you answered my questions and concerns very well. I have a better understanding of cirrhosis, it's dx, bx, etc. There is just so much to friggin' learn....I will no doubt be bugging you after I see a gastro. I'm going to do a prelim with him and get a referral to a hepatologist. I think he will be ordering some labs and a liver ultrasound. I'm thinking it's okay to let him start the process as I can then take those results to the hep dr.  I just want to make sure I find a good one and hope he can direct me to one.

My platelet count is not that low (i.e., medically dangerous). I've never bruised easily or had problems with blood clotting/healing. It was in the low 80's pre tx and now it's been 92-98 post tx. (Of course during tx it went to 40.)   I'd just like to know why it has been historically low (always dropping and always flagged on labs) for thirty years. Maybe I'll never know, but I'm going to keep a close eye on it.
Thanks for all of your help!  
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