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Post Info TOPIC: Cosmos Phase 11 clinical trial of Simeprvir (Olysio) + Sofosbuvir (Sovaldi) with or without Ribavirin


Guru

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RE: Cosmos Phase 11 clinical trial of Simeprvir (Olysio) + Sofosbuvir (Sovaldi) with or without Ribavirin
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Thanks for the links Jill and Wayne

Very useful to see and read the same information that our Doctors read and use for advising patients on treatment options.

Most of these doctors really rely on these recommendations and other peer reviewed publications, so knowing and comprehending  this data is critical in understanding where they are coming from when they prescribe your treatment.

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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Thanks Cinnamon Girl, I'm new and didn't understand what "off label" meant.  Now I get it...



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Me: 62 yr. old female, GT 1b, fibroscan 4.5; VL 650,975 as of 2/4/14;started Harvoni 3/6/15; SVR


Hubby: 59 yrs.; GT1b; fibroscan 25-cirrhotic; S/O for 12 weeks started tx 3/20/14; SVR56; fibroscan done 7-7-15 = 8.5



Guru

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Thanks Wayne, it`s very useful to have all this information in one place. smile



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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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Good idea, Jill. Thanks. Also, reposted for those who may be wondering why they were placed on a given treatment regimen:

http://www.hcvguidelines.org/sites/default/files/full_report.pdf

Many physicians seem to be following these guidelines.



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

 



Guru

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Hi everyone, with so many new members now doing an `off label` treatment with Simeprevir (Olysio) and Sofosbuvir (Sovaldi), I thought it would be useful to repost this information here in the Knowledge Base for reference purposes. 

Although both of these drugs have received individual US FDA approval, their use together in a treatment plan has not been, which is why when doctors prescribe these two drugs together it is referred to as `off label`.  The current treatment protocol for using this drug combination is based on the Cosmos trial data.  

`A 12-week all-oral combination of simeprevir plus sofosbuvir led to sustained virological response in 93% of genotype 1 prior null responders with mild-to-moderate liver fibrosis, working as well as a longer course of treatment or triple therapy including ribavirin, according to late-breaking findings from the COSMOS trial presented at the 64th annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, DC.

The study also showed that 100% of treatment-naive patients and null responders with advanced fibrosis or cirrhosis achieved early sustained response at 4 weeks post treatment using the same dual regimen.

The most common side-effects were fatigue, headache, nausea and insomnia, which occurred with similar frequency in both the ribavirin-sparing and ribavirin-containing arms. Anaemia and elevated bilirubin, however, were more common amongst ribavirin recipients.

Based on these findings the researchers concluded that treatment with simeprevir plus sofosbuvir, with or without ribavirin, resulted in high SVR12 rates (79 to 96%) in HCV genotype 1 null responders with stage F0-F2 fibrosis, as well as high SVR4 rates (96 to 100%) in treatment-naive and null responder patients with stage F3 fibrosis or F4 cirrhosis.

Addition of ribavirin to simeprevir and sofosbuvir "may not be needed to achieve high rates of SVR in this patient population," they added. "12 weeks of treatment may confer similar SVR rates compared with 24 weeks of treatment."`

Full details...

http://www.aidsmap.com/Simeprevir-sofosbuvir-produces-high-sustained-response-rates-for-hard-to-treat-patients-in-COSMOS-trial/page/2787623/



__________________

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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