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Post Info TOPIC: European Medicines Agency advises on compassionate use of daclatasvir/sofosbuvir combo


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RE: European Medicines Agency advises on compassionate use of daclatasvir/sofosbuvir combo
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Hi John, well early access though compassionate-use programmes will only apply to European member states, and at this stage it`s only a recommendation.  It will be interesting to see what happens after daclatasvir has been given FDA approval, which should be some time next year.  Let`s hope that many more people will be able to benefit from this very effective drug combo at some point in the future..



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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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Hmmm, wonder if this will have any effects in United States?



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John


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Thanks Jill,

It is great to know that the Gilead/BristolMeyers combo that was so successful before the breakup of the companies will be available for those in dire need of treatment. 

SuziQ



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Geno 1A  Age 82 Treatment naive Cirrhotic Told I had liver disease in 1966. Diagnosed as Hep C 1999.Started Merck clinical trial with Riba on 9/9/2013 Week 1 and 2 <25  Weeks 4, 8, 12,16,18 UND.  EOT Jan 14,2014  EOT +12 UND   JULY 1 2014 EOT+24= SVR



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Hey Jill

Thanks for the info. it's good to see that this combo won't be ignored.

It shows that compassion can over rule greed for the good of mankind.

Also it will give needed hope for many people that really need hope.

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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22 Nov. 2013 - The European Medicines Agency`s Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the use of daclatasvir in combination with sofosbuvir in the treatment of chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use programme.

The recommended compassionate use is intended for adult patients at a high risk of their liver being no longer able to function normally (decompensation) or death within 12 months if left untreated, and who have a genotype 1 infection. Further, it is recognised that the potential benefit of such combination therapy may extend to patients infected with other HCV genotypes.

Full press release...

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001971.jsp

 



__________________

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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