Harvoni class action lawsuit

[Kelly6549]

Is anyone aware of a class action lawsuit against Gilead for undisclosed Harvoni side effects? i.e. severe joint pain, vision loss, liver cancer, etc.

[Lynn K]

Hi Kelly

Haven't heard anything about a lawsuit for side effects just one for the cost of Harvoni.

Liver cancer is a possible consequence of liver cirrhosis from long term infection with hep c. Liver cancer is not a side effect of Harvoni.

In general it takes decades of continual damage to the liver to cause cirrhosis and HCC vs a mere 12 weeks of Harvoni treatment.

As far as undisclosed sides I would think any sides not included in the prescribing information sheet would be more likely undiscovered sides found after Harvoni was released to the general public.

If you are experiencing side effects Gilead and the FDA want you to report them.

This information comes from the prescribing information sheet

https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Good Luck

[CHepCFree]

Levin Papantonia in FL.   They are looking at liver cancer post Harvoni.  1-800-277-1193.  Pass the word. 

[Hep Forum Moderators]

About Levin Papantonio
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Since 1955, we have earned a reputation as one of the most successful personal injury law firms in the nation. Our attorneys handle claims throughout the country involving prescription drugs, medical devices, medical malpractice, car accidents and business litigation.

[I fightis thetitis]

Levin Papantonia in FL.   They are looking at liver cancer post Harvoni.  1-800-277-1193.  Pass the word.

Any news or latest reports out re liver cancer post Harvoni?  My Dr.s office has seen an increase in new occurrence hcc, and other cancers, colon and sarcomas post tx and stepped up the screening process to Ultrasound every 3 mos for F4's post viral eradication via all DAAs.

Any insight or news as to why this particular attorney's contact info is listed? This post seems cryptic or curious.
I am skeptical of any poster that claims there is no connection between Daa and cancer in F4's for the "fact" no one knows for sure yet. Optimistic, however not based on any concrete evidence.

Best always,

Greg

[Lynn K]

Ambulance chaser looking for clients

I just saw my doctor at the University of Washington Seattle last week asking about this. She is following the protocols of the AASLD and will continue to follow me every 6 months.

She said the studies with increased cancer were flawed and there are more studies with the opposite findings that treating help c reduces liver cancer risk.

[Mugwump]

Let's see so far we have seen, RA, HCC, Hair loss, itching, joint pain, weight gain, re- activation of Lyme disease, migraines and the list seems to keep on growing.
Certainly we are going to see a number of people develop HCC post treatment. And it scares the crap out of me that I have seen quite a few HCV victims die of this disease already.

BUT I still do not want HCV back and firmly believe that my chances of developing HCC have been decreased by removing HCV from the equation. Again by successfully treating those who are f3 and f4 we are going to see more cases HCC post treatment that is just the way it is. Until there is a way to treat early onset HCC there is little that can be done. HCV is a real btard in this regard it obviously is one of the major causes of liver cancer and the longer you wait to remove it the greater the chances of developing cancer.
END OF STORY

I would not at all be surprised if this bunch of fly by night ambulance chasers asks for a nominal retainer to be refunded if there is a settlement. Of course the process of them suing Gilead will take quite a few years. To which I say put up or shut up! GRRR!!!! 

[Mugwump]

Ambulance chaser looking for clients

I just saw my doctor at the University of Washington Seattle last week asking about this. She is following the protocols of the AASLD and will continue to follow me every 6 months.

She said the studies with increased cancer were flawed and there are more studies with the opposite findings that treating help c reduces liver cancer risk.

Lynn it will be interesting to follow the upcoming AASLD meetings scheduled for Oct 20-24. The work of Alberti will no doubt be discussed in much greater detail. Also the work done recently in Japan. It seems that what they are targeting is getting a better grip on the early assay of  epigenetic and transcriptional changes that occur in those who are more prone to developing HCC during and early post DAA Tx.

As we know the early treatment of the less aggressive forms of HCC can be very effective so catching the cancer before it becomes established HCC cell colonies might hold a great deal of promise.

Here is the site with the latest article on what the AASLD medical community is up to with HCC caused by HCV

Broken link removed by moderator

Interesting times ahead for all of us ex-heppers.

[Lynn K]

"As we know the early treatment of the less aggressive forms of HCC can be very effective so catching the cancer before it becomes established HCC cell colonies might hold a great deal of promise."

Well I guess I am out of the loop on this because I know nothing about this. I don't know anything about catching HCC early. I just know HCC is bad and a death sentence if it metastasized from another cancer elsewhere in the body and is really only treatable if it is a primary cancer.

"epigenetic and transcriptional" not familiar with these terms either.

Hoping to never have to learn anything about HCC like I have had to learn about hep c and liver cirrhosis.

[I fightis thetitis]

She said the studies with increased cancer were flawed and there are more studies with the opposite findings that treating help c reduces liver cancer risk.

Yes that appears to be what I have read as well, with two exceptions that science has not concluded yet.
It seems the only significant and very specific connections my Dr and other published professionals mention between cancer and daa's, are related to "cirrhotic F4" patients and patients who were "previously treated for hcc."

I have not heard or read any other connections from F1-3. Probably what you've heard or read, that the rapid hcv reduction may compromise our cancer fighting immune cells and put a severely diseased liver at greater risk. That would be me.

Perhaps there are posters on the forums that have the sky is falling hcc paranoia. I
don't buy into that.
My hope is the upcoming data will uncover the truth, or parts of. And, if there is a connection to find a treatment or method to help those that need it.

Yesterday, I found some real stories from F4 hep fighters on facebook that got aggressive tumors after Harvoni and passed away within 3 months. No prior hcc.
I'm not connecting dots. Just aware and monitoring.. hmmm. Not what I wanted to read.

For now I will stay optimistic and monitor with ultras every 3 mos as Dr ordered. Thank you for being there!

Best always,

Greg
Oh and one other thing, I also read that those new and re occurrences typically happened within the first year post tx and as already mentioned very aggressive tumor(s) appeared within 3 mos post hcv eradication. 
So I'm also hoping the longer we are post without it, our bodies have rebuilt the immune fighters.

[Mugwump]

"epigenetic and transcriptional" not familiar with these terms either.

Lynn these are the genetic changes that happen or more correctly don't happen correctly when a cell reproduces abnormally. Essentially errors and flaws in the trancriptional sequence or the extra genetic and enzyme reactions that occur prior to and during cell creation. Abnormalities in genetic accuracy can be assessed more accurately with the advent of advanced genetic assay techniques. Ten years ago we did not know what to look for when it came to many cancers, the field of cancer research has advanced faster here in BC and in the best universities in the US because of what angels like Terry Fox did to wake people up and donate.

Hoping to never have to learn anything about HCC like I have had to learn about hep c and liver cirrhosis.

DITTO ON THAT
 

[Lynn K]

Hi I fight

My doctors thinking for the de novo cases of HCC were likely already brewing in the persons body that with our without treatment the cases would have arisen which seems more reasonable to me.

All I can say is 27 months post treatment of 24 weeks of Harvoni and 38 months post 12 weeks of Sovaldi and Olysio and knock on wood no HCC. My thinking the longer post hep c cure the better my odds of not developing HCC at least that is my hope

Best to all

[Tania]

I'd heard about this. I'd not had liver biopsy only the standard scan for years,seen I was getting fatty liver about 10 years ago, 3 years ago again normal scan my GP said your liver looks so good you might not even be accepted for treatment! Yay. Did treatment, now late 2017  I had my first fibro ultrasound that said I had some fibrosis. We are finding out tomorrow if it's getting less ...... or not.
I find all this stuff bloody scary! Yes it's possible the old scans could not pick up fibrosis, but still, these people put the shits up me!!

[Mugwump]

I'd heard about this. I'd not had liver biopsy only the standard scan for years,seen I was getting fatty liver about 10 years ago, 3 years ago again normal scan my GP said your liver looks so good you might not even be accepted for treatment! Yay. Did treatment, now late 2017  I had my first fibro ultrasound that said I had some fibrosis. We are finding out tomorrow if it's getting less ...... or not.
I find all this stuff bloody scary! Yes it's possible the old scans could not pick up fibrosis, but still, these people put the shits up me!!

Tania it is entirely possible that HCV did more damage over the period of time you have had it and because you did not have a biopsy the condition that is termed "pre-cirrhosis" was not caught by your doctor. I was diagnosed as pre cirrhotic in 2003. I really do not know how long it actually took to go to full blown cirrhosis because I did not have another biopsy before treatment and cure in 2015. But my level of fibrosis by scan before treatment confirmed the state of cirrhosis in 2014 before Harvoni treatment and cure.

I really do not want to know how bad what little is left of my liver really is, call it survivors denial if you like. But my enzymes, bilirubin are all the other critical blood count readings except for platelet levels are perfectly fine.  I don't feel too bad and am doing things that I have not done in years! So if I suddenly go into liver failure from cirrhosis or die from the associated strain it puts on the heart and the other essential organs, I highly doubt that my wife would have a case against Gilead and my doctors.

Yes a high fibroscan reading might indicate greater liver damage done by HCV than a standard ultrasound. And indeed you may have low level cirrhosis, which is by definition the scaring of the internal structures of the liver to the extent that the internal cells can no longer regenerate. HOWEVER this does not mean that your liver is about to fail! And it certainly does not indicate that your DAA treatment caused the damage to your liver.

Suing Gilead for their megabucks is a dream of many HCV victims and lawyers, good luck with that!

[Lynn K]

Hi Tania

The standard scans you mentioned I assume are abdominal ultrasounds which are not able to pick up on fibrosis. I am a little surprised your doctor made that remark just on the basis of an ultrasound report. The best tests for fibrosis are liver biopsy, Fibroscan, and Fibrosure (a blood test). An ultrasound can confirm a coursened echotexture consistent with an existing diagnosis of cirrhosis but really can't detect minimal fibrosis. Fatty liver just by itself can cause liver scaring (fibrosis) as can having hep c for many years.

I had liver biopsies every 5 years after I was diagnosed with hep c. On my first biopsy after I had probably been infected for 10 years I had some liver scaring fibrosis F1 and with each liver biopsy my fibrosis score continued to rise to after 30 years of being infected my score was F4 cirrhosis.

I had a fibroscan done before I treated my score was 27 which I would guess is a lot higher than yours. Having some liver scaring with hep c and fatty liver is not uncommon. Also the fibrosis test is not perfectly accurate in mid ranges of fibrosis it is most accurate with significant scaring as I have.

The good news is that with cure most people with only minimal scaring can see improvements in their liver with time. We had several folks here who were even diagnosed with fibroscan at F4 who have returned to F3.

However, if you have other factors for development of liver scaring lke having a fatty liver due to carrying excess weight or by excess alcohol consumption this can cause continued liver damage despite being cured.

There has been some discussion that eating before your fibroscan can effect your results so when you have your next test try fasting before hand it may give you a better and more accurate test.

What was your fibroscan score? Had you fasted beforehand? How long did you have hep c? Were you treated with Harvoni or one of the other new medicines?

Best of luck

[Tania]

Ok. Well, now I'm back from the doctors and I'm told my liver post harvoni is now doing the job!! My fibrosis has been steadily reducing! This to is one thing I recalled reading. Once HCV is gone your liver can start to repair! And that's what myne has been doing! Because of improvement they have said "bye bye have a nice life and don't come back!
Clearly depending on damage done, if there is already some cirrhosis damage may continue . My liver just last year was a readable amount of fibrosis via fibroscan, but since than has been reduced to almost normal numbers.
For that I can thank harvoni! And the fact I quit drinking helped to I'm sure.

[Tania]

I can't even remember my numbers. There was a 7 in there ! Lol
I'd had hep c for 20 years. And was a heavy drinker!
It was only ten years ago when pregnant I had a scan done that showed I was getting fatty liver... that's pretty much around the time I quit drinking!
So I'm not surprised at all there was some fibrosis!

[Lynn K]

OK yeah there’s a huge difference between seven and 17 and 27 did they give you a fibrosis score that would’ve been at F1 F2 F3 or F4?

[Tania]

No they never did. Heighest number on the list I read was a 9.2 or some such. From what guessed not being a doctor to read scans, is it was one particular spot on my liver, not wide spread.

[Tania]

They really don't seam to say a lot about it at all here. I just remember the guy that did the first fibroscan was weirdly calling me sweet heart after he finished.
The last one, it was the same guy and he didn't repeated that behaviour lol

[Lynn K]

He was just the technician maybe a nurse. Technicians are not supposed to discuss your results with you. They are not normally permitted to determine test results or discuss a diagnosis. Whatever their findings were they should come to you from your doctor. Have you discussed your results with your doctor? What has your doctor said about the health of your liver?

Most of us here have either physical copies of our test results or have online access. My doctor uses a web page which is also an app called MyChart. I can see my lab results going back years. It is also often how I communicate with my doctors office. Does your doctor have something like that?

My ultrasounds and Fibroscan results aren’t available on MyChart so I have copies of those.

If you do have fibrosis greater than F3 you will need to be monitored by your liver specialist with blood testing every six months and annual ultrasound along with whatever additional testing your doctor feels is needed. If you do need continuing follow-up you may want to start getting copies of your labs and other test reports.

[Lynn K]

This is a link to a Fibroscan scorecard

http://hepcbc.ca/wp-content/uploads/2016/04/Fibroscan_Correlation1.jpg

A score of 9 would be about F2

I haven’t seen them say 9.2 for a Fibroscan score the test is just not that precise. They take a number of readings and just report the average.

My first was 27 and my one year post was 33 but essentially those are the same score.

[gnatcatcher]

All 3 of my FibroScans have had a decimal place: #1 = 19.5, #2 = 11.4, #3 = 9.4 kPa.

Because I went down from F4 to F3 to borderline F2/F3, my hepatologist is having me take one final FibroScan (next month) so that if I'm down to F2, he won't have me get an ultrasound every six months.

The last two times, I asked the person performing the FibroScan if I could have a copy of the printout and was given one on the spot. These last two each show ten little color charts with a kPa label on each chart. For example, the 9.4 kPa average had readings ranging from a high of 10.9 to a low of 7.9. The machine was a FibroScan 502 Touch.

Tania, congratulations both on your repaired liver and on your years of sobriety.

Gnatty

[Lynn K]

Really Gnatty gee I dodnt know that about decimal points very interesting. Congrats on your greatly improved Fibroscan results that is awesome.

Like I said I was only told 27 no decimal point before treatment and 33 one year after treatment. Coming up on 3 years post in May but since my platelet count is still about 110 which is unchanged since I finished treatment I don’t see much point right now in having another Fibroscan. I really don’t expect any change based on my platelet count. But maybe my hepatologist wants to check anyway.

Yes I was remiss not to say congratulations on the positive steps you have taken to improve your health. Quitting drinking is so hard for many people great job.

[Lynn K]

I was just thinking maybe since a Fibroscan is an average of several readings. So maybe on yours they told you the decimal point of the average value and my doctors office rounds the result to the nearest whole number.

They never gave me the printout just told my the value.

[gnatcatcher]

Could be.

[Mugwump]

Ok. Well, now I'm back from the doctors and I'm told my liver post harvoni is now doing the job!! My fibrosis has been steadily reducing! This to is one thing I recalled reading. Once HCV is gone your liver can start to repair! And that's what myne has been doing! Because of improvement they have said "bye bye have a nice life and don't come back!
Clearly depending on damage done, if there is already some cirrhosis damage may continue . My liver just last year was a readable amount of fibrosis via fibroscan, but since than has been reduced to almost normal numbers.
For that I can thank harvoni! And the fact I quit drinking helped to I'm sure.

What has helped me the most sometimes post treatment is thinking of myself as being HCV negative. For those of us who have more liver damage the first year post treatment can be difficult indeed. What I have tried to do is not deny that I had HCV but share the joy of the fact that there is finally a real cure!

It is amazing what I have found, even a fishing friend of mine, who is a practicing physician did not understand the concept of "cured" for those of us who failed with interferon treatments. He asked if the disease was in remission!

I told the company that I cook for that I had just been cured of HCV and the reaction by the food service manager was tears.

These aspects of the journey are what made the fight and the faith all worth it. If I had not been cured of HCV in 2015 I am almost certain the despair would have taken me by now.

Cheers and tears:
Eric

[Lynn K]

Ok. Well, now I'm back from the doctors and I'm told my liver post harvoni is now doing the job!! My fibrosis has been steadily reducing! This to is one thing I recalled reading. Once HCV is gone your liver can start to repair! And that's what myne has been doing! Because of improvement they have said "bye bye have a nice life and don't come back!
Clearly depending on damage done, if there is already some cirrhosis damage may continue . My liver just last year was a readable amount of fibrosis via fibroscan, but since than has been reduced to almost normal numbers.
For that I can thank harvoni! And the fact I quit drinking helped to I'm sure.

Oops I missed this comment I see you are now doing great that is wonderful!!!

Congrats on being cured and having a relatively healthy liver that will continue to improve with time as long as you are nice to it!

Even people like me with more advanced liver scaring and cirrhosis they say we have about a 50/50 chance of liver improvement like what Gnatty and several others have experienced. For me because I have so much damage maybe I will also but it will take longer.

Congrats again on your wonderful news

[morab]

Is anyone aware of a class action lawsuit against Gilead for undisclosed Harvoni side effects? i.e. severe joint pain, vision loss, liver cancer, etc.

                 

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