Hep C Discussion Forum

Members Login
Username 
 
Password 
    Remember Me  
Chatbox
Please log in to join the chat!
Hep C Discussion Forum -> Hep C News -> Eurpean Medicines Agency advises on compassionate use of ledipasvir/sofosbuvir combo
Post Info TOPIC: Eurpean Medicines Agency advises on compassionate use of ledipasvir/sofosbuvir combo
OldenSlow


Senior Member

Status: Offline
Posts: 380
Date:
RE: Eurpean Medicines Agency advises on compassionate use of ledipasvir/sofosbuvir combo
Permalink  
 

Ok, thanks. ;)  There seemed to be some flexibility built into the language and I was curious.  A positive step, in any event.



__________________

66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
Cinnamon Girl


Guru

Status: Offline
Posts: 5629
Date:
Permalink  
 

Hi Wayne, it`s not entirely clear but I`m reading it that the availability of this drug combo through a compassionate use programme would be limited to people with decompensated rather than compensated cirrhosis.  When cirrhosis has advanced to that point then the patient`s health is at greater risk and there is a more urgent need for effective and easily tolerated treatment.

This is certainly good news, and another small step forward in the battle against Hep C.



__________________

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.

 

 
OldenSlow


Senior Member

Status: Offline
Posts: 380
Date:
Permalink  
 

Thanks for the link, Jill. Seems like that could be construed to include all clinically F4 cirrhotics? Am I reading that right?



-- Edited by OldenSlow on Sunday 23rd of February 2014 05:52:30 PM

__________________

66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
Cinnamon Girl


Guru

Status: Offline
Posts: 5629
Date:
Permalink  
 

Press release, 21/02/2014 - Combination of ledipasvir and sofosbuvir to be used in patients in urgent need of therapy to prevent progression of liver disease.

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

Compassionate-use programmes are set up at the level of individual Member States. They are intended to give patients with a life-threatening, long-lasting or seriously disabling disease with no available treatment options access to treatments that are still under development and that have not yet received a marketing authorisation.

In this specific case, Sweden requested an opinion from the CHMP on the conditions under which early access through compassionate use could be given to a combination of ledipasvir and sofosbuvir, with or without ribavirin, for adult patients with genotype 1 HCV infection and advanced liver disease, who are at a high risk of their liver being no longer able to function normally (decompensation) or death within 12 months if left untreated.

The opinion provides recommendations to the EU Member States that are considering setting up such a programme, and its implementation is not mandatory. In addition to describing which patients may benefit from the medicine, it explains how to use it and gives information on safety.`

Link to full article..

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002032.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.

 

 
Page 1 of 1  sorted by
 
Quick Reply

Please log in to post quick replies.
Hep C Discussion Forum -> Hep C News -> Eurpean Medicines Agency advises on compassionate use of ledipasvir/sofosbuvir combo
Legal Disclaimer:

THIS FORUM, IT'S OWNERS, ADMINISTRATORS, MODERATORS AND MEMBERS DO NOT AT ANY TIME GIVE MEDICAL ADVICE AND IN ALL CASES REFER ANYONE HERE TO SEEK APPROPRIATE MEDICAL ADVICE FROM THEIR DOCTOR.