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Post Info TOPIC: The FDA Makes Hepatitis C a Priority


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RE: The FDA Makes Hepatitis C a Priority
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I am in the same boat - frustrating when I have to get sicker every year and if we had  something now I could get on with it - i am 46!  I am trying some herbal Chinese medicines and something called standard processing - they have a website.  If I had all the money back I spent on herbs! 



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 



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Well I guess it's all good Just out reach for me though

After my last sentence of 72 strait weeks of interferon and Riba and being Geno 1a the relapse.   all I can do is wait.

I feel for anyone else who is just setting on the edge wanting to do something. I just won't do TX again till it's almost a sure thing

And no Interfron / riba ever again. It's a long wait till ? Mid 2014? maybe? Viral load is back up again all the pain and numbness in my legs back and the hardest part is staying sane.  But being on this site and keeping up with all you class of 2012/ 2013 is great I learned so much from all of you got so much support laughs cry's music and so happy to see so many pass into SVR. Our day will come. There is some kind of tight bonding that happens here. Win or loose and keep going.  I'll still be around. Good luck to all of you waiting and all the newbie's Hope this place dose for you what it's done for me.

Thanks Guys

BS  



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.



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JLynch30 wrote:

so when can we expect them to hit the market?


 

Hi John, it looks likely that sofosbuvir and semeprivir will probably get FDA approval late this year, or early next year, although genotype 1`s will still need interferon and ribavirin as it stands.  Abbvie`s all-oral combo is still going through phase 3 clinical trials so will take longer, although it achieved `breakthrough therapy` status last month, which gives it a fast track designation.



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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.

 

 



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TazKat wrote:

is the gilead pharm a protease inhibitor?  i did the incivek so no more prtoease? i used to be able to research & see exactly what was what. but so much out there & my brain is getting little foggy or i am slipping into a don't care mode.. whichis not good. my hands & feet have been itching sooo bad, i take ambiens just to make me sleep to forget about. also skin is very sensitive after skin doc froze some places on me!!  feeling not so great today!! Taz


 

Hi Taz, you`re correct in saying that you wouldn`t be able to do another treatment which includes a protease inhibitor after being on incivek.  Gilead`s new drug `sofosbuvir` isn`t a protease inhibitor and so would probably be suitable for you at some point.   It`s a different sort of DAA (Direct Acting Antiviral) called a `nucleotide analogue inhibitor`.

Sorry to hear you`re still having such bad problems with itching.  Was that why your doctor froze some areas?  And do you think the Ambien is making your brain foggy?

Keep hanging in there and stay in touch...you can talk to us any time.  smile

 

 



__________________

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.

 

 



Senior Member

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Posts: 292
Date:
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so when can we expect them to hit the market?



__________________

John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 



Senior Member

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Posts: 479
Date:
Permalink  
 

is the gilead pharm a protease inhibitor?  i did the incivek so no more prtoease? i used to be able to research & see exactly what was what. but so much out there & my brain is getting little foggy or i am slipping into a don't care mode.. whichis not good. my hands & feet have been itching sooo bad, i take ambiens just to make me sleep to forget about. also skin is very sensitive after skin doc froze some places on me!!  feeling not so great today!! Taz



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 



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Thank goodness, it is about time...I saw my first commercial about this on the tv last week



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in the silence of the woods, you will not be alone- Chief Seattle

60 years on planet, Female, diagnosed 1978 as non-a non-b, VL 8mill+, Fibro f-1f-2, Genotype 1a, treatment naļve....UNTIL 7-01-18  !!!! started Harvoni 12 weeks. :)

4 weeks=UND, 8 weeks=UND, 12 weeks=UND (EOT= 09-23-2018)



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The FDA Makes Hepatitis C a Priority

Recognizing that investigational drugs from three pharmaceutical companies show advantages over existing hepatitis C therapies, the FDA has sped up its development and review process for the therapies.

With pharmaceutical companies clamoring to bring to market second-generation direct acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV), the U.S. Food and Drug Administration (FDA) has recently given a trio of companies a significant leg up. Two promising investigational agents - Gilead Sciences` nucleotide analogue inhibitor sofosbuvir and Jansse`s protease inhibitor simeprevir - each received what is known as a priority review status from the FDA over the past few weeks. And in early May, the FDA tapped AbbVie`s interferon-free combination therapy, ABT-450/r, ABT-267 and ABT-333 (which has been studied both with and without ribavirin) as a "breakthrough therapy," qualifying those drugs for an expedited development and review process in preparation for FDA approval.

Full article...

http://hcvadvocate.blogspot.ca/2013/06/the-fda-makes-hepatitis-c-priority.html



__________________

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.

 

 

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