Gilead Announces New SVR Data for Sofosbuvir-Based Regimens in Genotype 3 infected Patients
Biggyb said
Nov 6, 2013
@Zlikster, and a jury would never convict you..lol
Zlikster said
Nov 6, 2013
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
Loopy Lisa said
Nov 5, 2013
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. :)
Zlikster said
Nov 5, 2013
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
Cinnamon Girl said
Nov 5, 2013
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
Cinnamon Girl said
Nov 5, 2013
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.
Cinnamon Girl said
Nov 5, 2013
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.
@Zlikster, and a jury would never convict you..lol
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
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. :)
85% for Riba and Sof for 24w sounds like a win (for me at least) :)
thanks Jill
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.dpufThe 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.dpufI 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.
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