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Post Info TOPIC: Gilead Announces New SVR Data for Sofosbuvir-Based Regimens in Genotype 3 infected Patients


Guru

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RE: Gilead Announces New SVR Data for Sofosbuvir-Based Regimens in Genotype 3 infected Patients
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@Zlikster, and a jury would never convict you..lol



__________________

58 yo..Relapsed in 99 and again in 2004. Started triple therapy with Victrelis July 22,2012.  genotype 1a. week 8,12,16,24 VL Undetectable..E.O.T -- 6-22-2013,,,EOT + 24., UND. 

SVR !!!

 

~Bob~



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so this really means i need to rob some Gilead's lab somewhere and steal 180 pills of Sofosbuvir...That would be a good news headline :D 36year old bosnian male robbed Gilead's lab and stole 6 packs of Sofosbuvir ;D



__________________

GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!




Guru

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Hi Zlikster, it was based on 12 to 16 weeks the 61% and it was suggested tha G3 take no less than 16 week therapy. So I think the standard will be the full 24 weeks on this therapy until a better combination is released. Everyone will jump on it because it is still better odds than with interferon. :)



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Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 



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wow! how come they had such a bad results in previous clinical trials with GT3? (62% SVR24 if i remember correctly)

85% for Riba and Sof for 24w sounds like a win (for me at least) :)

thanks Jill

__________________

GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!




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Yes, Lisa, I think it`s highly likely that 24 weeks will be the standard treatment duration for gen 3 once sofosbuvir is approved by the FDA.  The results of this trial were included in the supporting data submitted by Gilead, see the following extract..

"The sofosbuvir NDA (New Drug Application) is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA. In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks."

 

The sofosbuvir NDA is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA. In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks. Patients who achieve SVR12 are considered cured of HCV.

- See more at: http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection#sthash.OeoqTdAJ.dpuf

The sofosbuvir NDA is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA. In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks. Patients who achieve SVR12 are considered cured of HCV.

- See more at: http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection#sthash.OeoqTdAJ.dpuf
The sofosbuvir NDA is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA. In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks. Patients who - See more at: http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection#sthash.7I5bfyaG.dpuf
The sofosbuvir NDA is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA. In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks. Patients who - See more at: http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection#sthash.7I5bfyaG.dpuf
The sofosbuvir NDA is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA. In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks. Patients who - See more at: http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection#sthash.7I5bfyaG.dpuf
The sofosbuvir NDA is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). During the review, data from an additional Phase 3 study, VALENCE, were filed to the NDA. In this study, patients with genotype 3 HCV infection were treated with sofosbuvir and ribavirin for 24 weeks. Patients who - See more at: http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection#sthash.7I5bf


__________________

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.

 

 



Guru

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I thought you`d be interested in this, Zlikster!  The difference is that the phase 3 Valence trial, launched in Europe, extended the treatment duration for gen 3`s to 24 weeks, rather than the previous 12 or 16 weeks which had a much lower overall rate of success.



__________________

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.

 

 



Guru

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Posts: 5627
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Nov. 2, 2013. Gilead Sciences announced results from two studies, the Phase 3 VALENCE study and the Phase 2 LONESTAR-2 study, evaluating the investigational once-daily nucleotide analogue sofosbuvir for the treatment of chronic hep C virus infection among patients infected with genotype 3. These data will be presented this week at the 64th Annual Meeting of the AASLD (American Association for the Study of Liver Diseases) taking place in Washington, DC.

In the Phase 3 VALENCE study, 85 percent (n=212/250) of treatment-naïve or treatment-experienced patients with genotype 3 HCV who received a 24-week regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after treatment (SVR12). Patients who achieve SVR12 are considered cured of HCV infection.

Additionally, the Phase 2 LONESTAR-2 study evaluated 12 weeks of sofosbuvir, RBV and pegylated interferon among patients who had previously failed treatment with peg-IFN/RBV, approximately half of whom had cirrhosis. In this study, 83 percent (n=20/24) of genotype 3 patients achieved SVR12.

Read full press release...

http://www.gilead.com/news/press-releases/2013/11/gilead-announces-new-sustained-viral-response-data-for-sofosbuvirbased-regimens-in-genotype-3infected-hepatitis-c-patients



__________________

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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