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Author Topic: FDA  (Read 19732 times)

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Offline Mike Conwell

  • Member
  • Posts: 43
FDA
« on: September 02, 2016, 07:05:06 am »
Where do we go to report our side affects to the FDA?
Logged

Offline AllShookUp

  • Member
  • Posts: 30
  • "itching like a man on a fuzzy tree" - Not anymore
Re: FDA
« Reply #1 on: September 02, 2016, 02:48:44 pm »
I reported via the link provided by Iporterrn on April 07 discussion topic of "Bell's Palsy?"  I did receive a generic reply from them.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/

Logged
Male - BabyBoomer
1995 - diagnosed HCV
2002 - Peg + Riba - quit after 5 weeks severe anemia
2015 Nov -start 12 weeks Harvoni +Riba + Procrit
Gen 1b - VL 1,500,000 -ALT93-AST143
Comp cirrhosis - enlarged spleen - platelets 35
Week 5 of Tx - HCV undetected - ALT/AST normal
End Week 12 of Tx - HCV UD - ALT/AST normal
Jan. 25, 2016 EOT
April 4, 2016 - SVR10 UD - ALT/AST normal
May 5, 2016 - SVR14 UD - ALT/AST normal
Aug 5, 2016 - SVR28 UD - ALT/AST normal

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,546
  • Get tested, get treated, get cured, fight Hep c!
Re: FDA
« Reply #2 on: September 03, 2016, 02:11:13 am »
On the prescribing information sheet for Harvoni that you should get with your prescription this information is listed:

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.
Logged
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline morab

  • Member
  • Posts: 232
  • Lives in the woods
Re: FDA
« Reply #3 on: September 03, 2016, 09:37:29 am »
http://www.fda.gov/Safety/MedWatch/
I just reported to them yesterday! All of us who were symptomatic on treatment and those who continue to be symptomatic should report to the FDA!
Good Luck
Morab
Logged
3/2016 G 1a
Alt 84
Ast 62
Fibrosis score lab 0.66
quantitation 894,670
4/23/16 day 6, naive Harvoni 12 week treatment
5/27/16 week 4 lab results UNDETECTED AST 23 ALT17

Offline Mike Conwell

  • Member
  • Posts: 43
Re: FDA
« Reply #4 on: September 03, 2016, 09:54:57 am »
Thanks!!!! I'm reporting on it today
Logged

Offline morab

  • Member
  • Posts: 232
  • Lives in the woods
Re: FDA
« Reply #5 on: September 03, 2016, 10:04:58 am »
Mike
I am no longer posting what my symptoms are after treatment. I don't need other people on this forum telling me it is all in my head, and how wonderful Harvoni is. Just because it has no side effects for the many, does not mean that the few of us who are still suffering must be the brunt of other peoples opinions that we are making this all up.
Good Luck
Morab
Logged
3/2016 G 1a
Alt 84
Ast 62
Fibrosis score lab 0.66
quantitation 894,670
4/23/16 day 6, naive Harvoni 12 week treatment
5/27/16 week 4 lab results UNDETECTED AST 23 ALT17

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: FDA
« Reply #6 on: September 03, 2016, 10:36:21 am »
I am glad Lynn posted the FDA info, it's been posted throughout this forum several times over the past year, so hopefully now everyone has this info.

Morab, I am sorry you're feeling people are "telling me it is all in my head" and "making this all up", as I don't see anyone saying that on here. Where is that post?  We are all trying to understand your issues.  No one has accused you of being crazy and I am very sorry you're feeling like this.

I am glad you've reported to the FDA and that this will help in the research to figure out why some people have such terrible experiences with these drugs and others don't.  I sincerely hope you feel better soon, FT
Logged
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline morab

  • Member
  • Posts: 232
  • Lives in the woods
Re: FDA
« Reply #7 on: September 03, 2016, 11:15:02 am »
FT
There is another person on the forum who has been treated that way, I figure I am next.
morab
Logged
3/2016 G 1a
Alt 84
Ast 62
Fibrosis score lab 0.66
quantitation 894,670
4/23/16 day 6, naive Harvoni 12 week treatment
5/27/16 week 4 lab results UNDETECTED AST 23 ALT17

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: FDA
« Reply #8 on: September 03, 2016, 11:20:13 am »
Well, let's hope that is not the case, as it serves no purpose. FT
Logged
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Mike Conwell

  • Member
  • Posts: 43
Re: FDA
« Reply #9 on: September 03, 2016, 11:56:08 am »
Morab just message me and keep me up to date on how things are going. You and I are on the same boat. This drug needs to be labeled BAD DRUG. I don't give a shit what anyone says. I know for a fact what it has done to me.
Logged

Offline Luna7

  • Member
  • Posts: 179
Re: FDA
« Reply #10 on: September 03, 2016, 12:19:28 pm »
FT...congrats on your SVR!  What was it I read....12 or 24 weeks?

Morab....if I can give a bit of advice...just try to ignore anyone who says it's all in your head.
I don't know what it is about people who seem to think the way they experience things must apply to everyone else :(.
They are really in the minority here on this forum though and I hope you don't feel you can't say what you need to because of it.

I experienced just the weirdest symptoms when I still had HCV, and I felt reluctant to tell others what I was feeling because I felt they wouldn't believe me...so I do understand how you're feeling.
Logged
Between F2 & F3
Alt & Ast nearly 100
Viral load over 8 million
Gt 3a

Treated 12 weeks with Sovaldi & Daklinza, start date mid-April 2016
Undetected at 4 weeks into treatment
Alt & Ast  normal
Treatment completed July 14
Most likely will be undetected at 12 weeks (mid October 2016) as symptoms are gone

Offline FutureThinker

  • Member
  • Posts: 711
  • Onward and upward!
Re: FDA
« Reply #11 on: September 03, 2016, 12:27:47 pm »
Hey Luna and thanks -- it was my SVR 12. And, dare I say it -- I am slowly feeling stronger with each week, so I am very hopeful others will experience improvement, and soon.  Take care, FT
Logged
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline dragonslayer

  • Member
  • Posts: 873
Re: FDA
« Reply #12 on: September 03, 2016, 12:29:59 pm »
Luna, I dont think its the way people experience things that is the issue. And, Im not saying what anybody is experiencing is all in their head.  .But  I think its the positive assertions that Harvoni has caused these problems directly that is whats being questioned.    Without taking offense, please google 'causation vs correlation', and then tell me how anybody knows, for sure, that Harvoni had anything to do with the current health issue they are having.  And then try and understand that, until a positive correlation can be definitely made and objectively tied to the illness, these claims will be scaring off people who are currently considering treatment from getting what they need to survive. 

Thank you.
« Last Edit: September 03, 2016, 12:31:41 pm by dragonslayer »
Logged
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline KimInTheForest

  • Member
  • Posts: 1,972
  • Believe in yourself
Re: FDA
« Reply #13 on: September 03, 2016, 12:34:37 pm »
Quote from: morab on September 03, 2016, 10:04:58 am
Mike
I am no longer posting what my symptoms are after treatment. I don't need other people on this forum telling me it is all in my head, and how wonderful Harvoni is. Just because it has no side effects for the many, does not mean that the few of us who are still suffering must be the brunt of other peoples opinions that we are making this all up.
Good Luck
Morab

I hear ya, Morab. I too have largely stopped discussing what has happened to me and my health post- treatment - and for the same reason. The invalidators (and there is more than one) are at best clueless and at worst mean-spirited. Life's too short. Invalidation is toxic. Healing requires the elimination of toxins.

kim
Logged
Kim Goldberg (Nanaimo, BC)
1970s: Contracted HCV (genotype 3a)
2015: Cured with Harvoni + ribavirin (12 weeks)
MY STORY: https://pigsquash.wordpress.com/2016/01/28/undetectable-my-hep-c-story/

Offline dragonslayer

  • Member
  • Posts: 873
Re: FDA
« Reply #14 on: September 03, 2016, 12:39:31 pm »
Quote from: KimInTheForest on September 03, 2016, 12:34:37 pm
I hear ya, Morab. I too have largely stopped discussing what has happened to me and my health post- treatment - and for the same reason. The invalidators (and there is more than one) are at best clueless and at worst mean-spirited. Life's too short. Invalidation is toxic. Healing requires the elimination of toxins.

kim

Hi Kim... Are people actually claiming that you are not experiencing some lousy health issues?  That would be entirely presumptuous... Nobody can tell you youre not feeling what youre feeling!  To me, the only question would be, how do people know for sure that their health issues, since treatment, are definitely caused by DAA treatment?
« Last Edit: September 03, 2016, 01:37:59 pm by dragonslayer »
Logged
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,546
  • Get tested, get treated, get cured, fight Hep c!
Re: FDA
« Reply #15 on: September 03, 2016, 01:35:07 pm »
There was one poster recently who did go after a member about their symptoms and Ina very abusive manner several of that posters comments were deleted and that member was given a suspension.

If someone violates the forum rules there is a link to report their comment to the moderators. If necessary we can and will take action.

We don't all have to agree but we are all in the same basic situation with having hep c. One planet one people we should all be respectful of each other.
Logged
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline Luna7

  • Member
  • Posts: 179
Re: FDA
« Reply #16 on: September 03, 2016, 02:23:25 pm »
Quote from: FutureThinker on September 03, 2016, 12:27:47 pm
Hey Luna and thanks -- it was my SVR 12. And, dare I say it -- I am slowly feeling stronger with each week, so I am very hopeful others will experience improvement, and soon.  Take care, FT

Great...glad you are feeling stronger each week :)
I am too, and even bought a cheapie lawnmower and trimmer to do my own lawn. If my knee would just get better I'd be good to go. Am looking up some stuff to help that, and am determined to repair a bone spur without surgery!  Started the chondroiten stuff and looking into diets.

Going to start those juice drinks I saw posted here -- will be good to add more greens (up until now I just shoved a glob of kale into my mouth from time to time, so no wonder I didn't like the stuff..lol).
TC..
Logged
Between F2 & F3
Alt & Ast nearly 100
Viral load over 8 million
Gt 3a

Treated 12 weeks with Sovaldi & Daklinza, start date mid-April 2016
Undetected at 4 weeks into treatment
Alt & Ast  normal
Treatment completed July 14
Most likely will be undetected at 12 weeks (mid October 2016) as symptoms are gone

Offline Luna7

  • Member
  • Posts: 179
Re: FDA
« Reply #17 on: September 03, 2016, 02:24:42 pm »
Quote from: dragonslayer on September 03, 2016, 12:29:59 pm
Luna, I dont think its the way people experience things that is the issue. And, Im not saying what anybody is experiencing is all in their head.  .But  I think its the positive assertions that Harvoni has caused these problems directly that is whats being questioned.    Without taking offense, please google 'causation vs correlation', and then tell me how anybody knows, for sure, that Harvoni had anything to do with the current health issue they are having.  And then try and understand that, until a positive correlation can be definitely made and objectively tied to the illness, these claims will be scaring off people who are currently considering treatment from getting what they need to survive. 

Thank you.

I am googling and trying to understand, dragonslayer....but those are awfully big words..."causation"...."correlation"....and putting them together, well my mind is just spinning :)

But on a more serious note, I feel you are mostly coming from a good place....that you don't want people scared off of life-saving treatments via DAA's when there is no proof they are harmful. However, what should one do when the evidence (albeit anecdotal evidence) mounts that they are harmful to some people?  There are just too many people reporting an increase in joint problems after treatment with DAA's to ignore now. Perhaps I'm seeing more 'smoke' than you are, and am becoming convinced that there really is a 'fire'? Or do you totally dismiss what anyone says 'on the internets'? Or does it just bug you when you perceive people are making this very common error in logic by confusing correlation with causation (I have to admit, it is ludicrous when people misuse logic to arrive at a supposed logical conclusion, and I can become irritated too).
 
Yes, we require proof to know for sure, but we can't forget that one has to prove that those of us experiencing symptoms during/after treatment were NOT caused by the DAA's too. In other words, sometimes correlation DOES equal causation.
We may never know if DAA's have the potential to cause joint problems, or it may take a very long time to prove it. Sometimes there are just too many variables involved to get definitive proof about so many matters.  In the meantime, I will look (cautiously and with a critical eye) toward my friends on the internet and not wait for scientific proof.
Logged
Between F2 & F3
Alt & Ast nearly 100
Viral load over 8 million
Gt 3a

Treated 12 weeks with Sovaldi & Daklinza, start date mid-April 2016
Undetected at 4 weeks into treatment
Alt & Ast  normal
Treatment completed July 14
Most likely will be undetected at 12 weeks (mid October 2016) as symptoms are gone

Offline dragonslayer

  • Member
  • Posts: 873
Re: FDA
« Reply #18 on: September 03, 2016, 05:48:23 pm »
Luna, that's the problem with anecdotal evidence; it doesnt prove anything.  One may 'feel' that rain comes from the rain gods instead of clouds or that man walked with dinosaurs; obviously, it doesnt make it so..Proof is needed.   I fully believe there are people who are not feeling well after treatment, and I feel for them.  There are days Im not a bundle of energy either, and insomnia is a big time issue for me.. The difference is, I dont turn to scapegoating Harvoni as the cause of my problems. I guess its just that some people need more proof before we start blaming this or that. Im afraid Im one of those people.  Someone has to show me a properly done study that A causes B before Ill have any part of it. 

If it werent for the fact that novitiates and those considering treatment scan these forums for info where  they read some of the threads which make Harvoni sound like Interferon for which, as we all know , there were proven and dangerous side effects, I wouldnt care so much...   

But I feel like we have a responsibility not to pass off anecdotal evidence as fact, Not to demand that Harvoni be considered a 'Bad Drug' as some have unequivocally stated, and not, in other words, to predispose those who need treatment against the best treatment out there for a large group of people based on anecdotal reports and uncertain evidence.

What should one do when they think they are experiencing negative after effects of the drug?   Report it to Gilead and to the FDA through the links that have been suggested here!

"There are just too many people reporting an increase in joint problems after treatment with DAA's to ignore now. "

What's too many?  How can one know there are 'too many', a relative term, until you know your sample size?!  I for one had unbearable joint pain before treatment, which I lay at the feet of HCV.  Once treated, this joint pain completely vanished for me.  Ive been interested in this forum so Ive stuck around past SVR, but most just leave and get on with their lives, and you never hear from them again....  What's largely left are those that have had problems.. But that does not a legitimate sample make when you are trying to draw conclusions.

As an aside, about a week into treatment, I came down with a fever (which I almost never get, and was sick in bed for a day or two). I was very tempted at that point to say it must have been some kind of side effect, since this has never really happened to me as an adult; I just dont get fevers.  But it disappeared as suddenly as it arrived, and that was that. Im not equating this incident with any of the long term symptoms people have been describing, but Id just be very careful about scapegoating a drug, without any evidence  that it had a causal effect, without first considering how it might scare off people who really need this drug now.. I know I wouldnt want that on my conscience.
« Last Edit: September 03, 2016, 07:27:09 pm by dragonslayer »
Logged
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline morab

  • Member
  • Posts: 232
  • Lives in the woods
Re: FDA
« Reply #19 on: September 03, 2016, 06:54:41 pm »
Wow dragonslayer
I am at a loss for words with your statements. I don't have the time to ponder such ideas.
What I do know is that I was extremely symptomatic during tx. And I still am after with issues I did NOT have before Harvoni. Call me a liar and I will be ok with that, all I have to do us unlog.
Others will bash me for talking herbal supplements, oh and that is a global moderator.
I no longer feel this is a webpage of support thanks to you and a few others.
Over and out
MORAB
Logged
3/2016 G 1a
Alt 84
Ast 62
Fibrosis score lab 0.66
quantitation 894,670
4/23/16 day 6, naive Harvoni 12 week treatment
5/27/16 week 4 lab results UNDETECTED AST 23 ALT17

Offline Mike Conwell

  • Member
  • Posts: 43
Re: FDA
« Reply #20 on: September 03, 2016, 07:39:04 pm »
You go Morab tell them like it is!!!!! A lot of us are sick from the medicine
Logged

Offline dragonslayer

  • Member
  • Posts: 873
Re: FDA
« Reply #21 on: September 03, 2016, 07:40:13 pm »
Quote from: Mike Conwell on September 03, 2016, 07:39:04 pm
You go Morab tell them like it is!!!!! A lot of us are sick from the medicine

You are sick, but you dont KNOW its from the medicine.
Logged
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline morab

  • Member
  • Posts: 232
  • Lives in the woods
Re: FDA
« Reply #22 on: September 03, 2016, 09:53:22 pm »
dragonslayer
     After 657 posts, I would think you would have some compassion and tack by now.
I will  gladly leave a place that I thought was a support group. Man was I WRONG.
              So I was reading another thread, on this forum,
 and came across a poster who owns stock in Gilead.....
How many of you are riding that boat?
Lynn K global moderator
  Is it OK to post our own experiences with herbal supplements and juicing? If people can be rude and it is acceptable, such as dragonslater, surely a few herbal experiences should be OK> Let me know
Accept me or not I have made many friends here.
Morab
Morab
Logged
3/2016 G 1a
Alt 84
Ast 62
Fibrosis score lab 0.66
quantitation 894,670
4/23/16 day 6, naive Harvoni 12 week treatment
5/27/16 week 4 lab results UNDETECTED AST 23 ALT17

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,546
  • Get tested, get treated, get cured, fight Hep c!
Re: FDA
« Reply #23 on: September 03, 2016, 09:57:47 pm »
Hi Morab

I hope I am not the person you said bashed you for using herbal supplements if it was me that was, and is, never my intent so I will try to work on that.

While I personally believe from all I have read there is little to no value and possibly some harm with some supplements I only speak for myself. If you find value in taking supplements it is not for me to judge it is your life, your health, and not my place to tell anyone that if they want to take herbal supplements it is up to them.

While I don't agree they are worth the money it does me no harm if that is the path you want to go.

Again if I said something to offend you about herbals or anything else please accept my apology

Wishing you and all nothing but the best
Lynn
« Last Edit: September 04, 2016, 12:40:38 am by Lynn K »
Logged
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline dragonslayer

  • Member
  • Posts: 873
Re: FDA
« Reply #24 on: September 03, 2016, 09:59:51 pm »
Morab, I have deep compassion for those who are sick.

That is not the issue, and its not what Ive been talking about.

Once more... Its one thing to be sick; its another to blame it on Harvoni..    Without some sort of verification that goes beyond, 'it must be the Harvoni; my condition which I had before became worse during treatment, etc, etc', there is no way to KNOW that Harvoni was the culprit.   

Its got nothing to do with compassion, and everything to do with accuracy..  People are being scared away from treatment because of these threads.

And to be clear, I dont own stock in Gilead..   Just let my words as written speak for themselves.. Lord knows, Ive written enough of them on a couple of threads here today! Clearly, without ambiguity, I have compassion for sickness, but I dont believe its possible to KNOW that Harvoni is the culpret.  'Feeling' its to blame is not the same as KNOWING its to blame. That's all.
« Last Edit: September 03, 2016, 10:05:05 pm by dragonslayer »
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Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline morab

  • Member
  • Posts: 232
  • Lives in the woods
Re: FDA
« Reply #25 on: September 03, 2016, 10:04:37 pm »
Dragonslayer
 You want control
without compassion'
I do not need this from you or anyone on a forum.
Those of you I have bonded with I will always care, I can no longer take part in this BS that you put on innocent people needing comfort.
You are a menace to POST Symptomatic Harvonia' land trainwrecks
morab
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3/2016 G 1a
Alt 84
Ast 62
Fibrosis score lab 0.66
quantitation 894,670
4/23/16 day 6, naive Harvoni 12 week treatment
5/27/16 week 4 lab results UNDETECTED AST 23 ALT17

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,546
  • Get tested, get treated, get cured, fight Hep c!
Re: FDA
« Reply #26 on: September 03, 2016, 10:05:10 pm »
Ok I see apoarently it was me

Nope no Giliead stock don't have that kind of money to buy anyone's stock

Just a person who suffered with hep c for 37 years enduring 3 rounds with interferon treatment and relapsing with Sovaldi and olysio. Living with cirrhosis for 8 years and wondering if I was going to die soon from liver disease and finally cured by 24 weeks of Harvoni and 15 weeks of Ribavirin from which I had minimal sides and only the expected ones of ribavirin.

So I went from waiting to die to looking forward to living a normal life span with luck.

I feel for all who are suffering whether from treatment or whatever the cause and I wish you all nothing but the best.
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Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,546
  • Get tested, get treated, get cured, fight Hep c!
Re: FDA
« Reply #27 on: September 03, 2016, 10:35:01 pm »
I do believe there is a significant difference in having a difference of opinion on a subject and being personally offended because someone does not share your opinion.

Certainly we can all just agree to disagree?
Logged
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline jberlin

  • Global Moderator
  • Member
  • Posts: 322
  • Contracted Hep C in 76, treated 2004 & 2012, cured
Re: FDA
« Reply #28 on: September 03, 2016, 10:54:01 pm »
I think i will lock this discussion down for the night and let everyone reflect a bit. This is a support forum and none of us are MDs, just people that have fought or are still fighting Hepatitis C - with opinions. Go relax for the weekend, and hopefully be well.

jack
 :)
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