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Hep C Discussion Forum -> General Discussion -> Harvoni Carcinogenic Testing
Post Info TOPIC: Harvoni Carcinogenic Testing
Rubye


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RE: Harvoni Carcinogenic Testing
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We all know it is not all that unusal for the FDA to recall an approved drug because with greater use with more people and more time it is found to be more detrimental than helpful. I look at it as which is the lesser evil for myself. For example, right now I'm taking Cipro for a UTI. Both are bad things in that Cipro has all kinds of potential serious side effects and risks but a UTI causes a lot of pain if left untreated and can go on to create even more serious health risks.

Same with the Hep C drugs. That's why I often think people with HCV should wait for treatment if they can afford to do so. But if you're like me with cirrhosis and other complications, it makes more sense to treat now. There's always a risk and I think we have to weigh the possible consequences of each side with a lot of research and a lot of talking to others.



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UNDETECTED 5/4/15 - 16 weeks after EOT, 1st treatment - Sovaldi and Olysio, Geno 1a, 67 year old with compensated cirrhosis, over 40 years with HCV.
Brian1412


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Testicular Cancer had one of the highest rates for death. Was number one when Nixion started the registry .

over the last decade plus,  the highest cure rate was 97 plus was common treated rarely,   due to the BEP Protocol, which is the largest researched Chemo protocol  ever. To this day .

 They don't know why it works, but the know it is  very effective.  Over 20 plus years, no rise of side effects .  If everyone young man who was treated by it starting dying at 50-60, that would be an issue ,  They are not. The are survivors because of the BEP protocol  



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mikeinco


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Agreed.



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Dx 2001, tx naive, started Harvoni 12/26/14, GT 1a. Viral load on 12/26/14 3.4 millionIU/ml.
Cinnamon Girl


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I would say that`s probably a valid comment about chemotherapy drugs, Mike, and maybe understandable from your viewpoint and experience.  Again, it comes to down to weighing up the benefits of using those drugs to cure the cancer and save lives against the potential risks. 

 



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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.

 

 
mikeinco


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Cinnamon, I hate to disagree with you about drugs being released that are considered "safe." Almost every drug used in chemotherapy are known carcinogens, its sorta like treating cancer with drugs that can cause cancer. You must excuse my jaded point of view, comes from spending years in the ER and the ICU.

Mike



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Dx 2001, tx naive, started Harvoni 12/26/14, GT 1a. Viral load on 12/26/14 3.4 millionIU/ml.
Michaele


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Trip2   Im so OCD with this reinfection scare , that I try not to think of the long term effects.  If I wash my hands or use 1:10 bleach on anything else I may melt.   Michaele



-- Edited by Michaele on Saturday 3rd of January 2015 04:53:16 PM

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Cinnamon Girl


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Hi Nick, the subject of carcinogenesis is mentioned in the full prescribing information for Harvoni, published by Gilead, which is maybe where you`ve read about it.  Scroll down to section 13.1. page 20, to read the full details...

Here`s the link...

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

Basically it indicates that Ledipasvir and Sobosbuvir (the 2 drugs in Harvoni) have both been extensively studied in a battery of `in vitro` and `in vivo` tests, and that while 2 year carcinogenicity studies were conducted using Sobosbuvir in mice and rats, similar studies are `ongoing` for Ledipasvir which is possibly what you read.

All drugs which are to consumed by humans have to be rigorously tested for toxicity and carcinogenicity, first of all in vitro, in laboratory test tubes, and then on animals such as rats and mice or dogs.  Only when they are considered safe will they be allowed to be used on humans and then the drugs have to go through the phases of clinical trials to thoroughly test the effectiveness and safety aspects before they can be approved for marketing.

You could say that there is a minuscule risk with any medicinal drug you are prescribed, but we have to weight that up with the potential benefits of ridding ourselves of a health threatening disease like Hep C. 

I honestly don`t think you or anyone else need to worry about this, Nick.  These drugs would not be allowed to be marketed if there was any known or significant risk to humans at all. 

Hope that helps!  Jill

 

 

 



__________________

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.

 

 
Trip2


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I read somewhere that the ingredients in Harvoni have yet to undergo testing as Carcinogens, i have been looking for that article again but cannot find it. Sorry for letting my neuroticism kick in but i would hate to think that i will be cured of Hep C and get something worse from the treatment...Anybody see the article?



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