Results Cosmos trial EASL UK now 2015

[candyce1953]

http://www.businesswire.com/news/home/20140412005023/en/Medivir-Final-Data-Phase-II-COSMOS-Study#.U0nEiym9LCS

Cosmos trial results from EASL 2014
Now

All I can say is Wow and feeling blessed
Xoxox C

[Pamelajean1]

Wow! I didn't realize we were that close with tx! I'm 1a, cirrhosis with ascites and meld 7 too! We are tx sisters! :)
Since my labs for VL are on Friday, it'll probably be the next Thursday/Friday before I know results. I'm trying not to think about it....just so happy to being tx without any significant sx! As good as I feel, I can't imagine not being UD....
How are your sx? Let me know when you hear from your labs! xoxo

[Pamelajean1]

Thanks nan! I certainly feel blessed to be able to tx and at least stop further damage from occurring. One step at a time. :)

[Pamelajean1]

Thanks candy...and right back at cha! X

[flyinlynn]

Hi Pamela
Wednesday is 4 weeks for me so also hoping my viral load is zero when I get the results later.
I am GT 1a with cirrhosis MELD 7 my doctor never tested me for the Q80K polymorphism but either way I hope I am in the majority of results.

Best to all
Lynn

[nan535]

I am truly happy for all of you who are on the road to SVR.
You are truly blessed that this nightmare is almost over for you before major complications set in.  

Nan

[candyce1953]

My Fingers are crossed for you ( and everyone ) in this amazing time of cures!
Xoxo

[Pamelajean1]

I'm right behind you....this Friday will be week 4 for me with Sovaldi/Olysio. I am Q80K positive and there have been many discussions about tx with this combo with that mutation. Needless to say I'm quite happy with the results shown.
Friday I'll have VL checked and hope to be same as you...UD! The recommendations regarding retreating look promising as well. Hopeful that that won't have to be a consideration though.
Like you, I am grateful and feel very blessed! X

[candyce1953]

I am 8 weeks into Sovaldi and Olysio and undetected at 4 weeks

I am 1b and very very grateful and blessed with hopefully these results!
Xoxox ch

[Pamelajean1]

Interesting see the results concerning Q80K .....

http://www.businesswire.com/news/home/20140412005023/en/Medivir-Final-Data-Phase-II-COSMOS-Study#.U0mY4GYo7rc

Final phase II data from the interferon-free COSMOS study

Cohort 2

Final results from cohort 2 of the phase II COSMOS study demonstrated that 93 percent of prior null responder and treatment-naïve patients with genotype 1 HCV and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir and sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). The addition of ribavirin did not improve SVR rates and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks.

SVR12 Among Patient Subgroups with Genotype 1 HCV and Advanced Liver Fibrosis/Cirrhosis in Cohort 2 of the COSMOS Study*


12 Weeks of Treatment

Regimen Simeprevir/Sofosbuvir (%) Simeprevir/Sofosbuvir + Ribavirin (%)
Overall 93 93
Genotype 1a HCV without the Q80K polymorphism 88 93
Genotype 1a HCV with the Q80K polymorphism 100 88
Genotype 1b HCV 100 100
METAVIR F4 86 91
*Excluding non-virologic failures.


The most common adverse events reported during the study were fatigue, headache, nausea, anemia, pruritus, dizziness, rash and photosensitivity. One patient discontinued treatment due to adverse events.
Cohort 1

Previously presented data from cohort 1 at AASLD in November 2013, demonstrated that 96 percent and 93 percent of prior null responder patients with METAVIR F0-F2 scores treated with simeprevir and sofosbuvir without or with ribavirin, respectively, for 12 weeks achieved SVR12.

SVR12 Among Patient Subgroups with Genotype 1 HCV and METAVIR Scores of F0-F2 in Cohort 1 of the COSMOS Study*


12 Weeks of Treatment
Regimen Simeprevir/Sofosbuvir (%) Simeprevir/Sofosbuvir + Ribavirin (%)
Overall 96 93
METAVIR F2 100 94
*Excluding non-virologic failures.

In genotype 1a patients with the Q80K polymorphism at baseline, 83 percent and 89 percent achieved SVR12 after 12 weeks of treatment without and with ribavirin, respectively. The most common adverse events reported during the study were fatigue, headache, nausea and insomnia. Two patients discontinued treatment due to adverse events.