Hi Jimmy,This is the trial I was going to get into. Gilead Polaris 4. GS-US-367-1170. It's a great trial for any geno type. Hope your friend gets into the trial. RC
Hi RC.
She has 9 days left. This is an oldie but goodie thread.
robertsamx said
May 12, 2016
Hi Jimmy,This is the trial I was going to get into. Gilead Polaris 4. GS-US-367-1170. It's a great trial for any geno type. Hope your friend gets into the trial. RC
Tig said
May 12, 2016
Hey Pablo,
96% SVR rates for the 8 week protocol isn't half bad Brother! The number of participants in this reference aren't large, but there's so much good news coming in from this protocol, it's hard to dispute the effectiveness. The FDA has approved this for breakthrough therapy status in GT 1's, and that indicates confidence. With it's pangenotypic activity, it bodes well for everyone.
2-3 years ago we were thrilled to have 70% SVR rates. When I treated the first time, the SVR rates were 20% and we were pumped at the opportunity. Most failed, but when you let doubt cloud your optimism, the Dragon wins that day's argument. Never give that green bucket of lizard poo the time of day! You're going to have good news to share, we'll be waiting to hear it...
I started this thread back in Jan. Yes she did get on and got the whole enchilada. 12 weeks trio arm. She currently has 10 days remaining on treatment.
What I find absolutely incredible is she is smoking pot and the Dr. knows it and no problem! On a trial no less! Freakin California. LOL
JimmyK
Pablito said
May 12, 2016
Hi Jimmy
I am on a similar trial of sof/vel/GS-9857 for 8 weeks. She should jump at this opportunity. I would love to be in the 12 week arm of the study.
After extensive reading of the research I've concluded that sof/vel for 12 weeks is the most effective DAA combo currently on the market with large studies showing 99% SVRs across all genotypes. Better still, she has a 50% chance of being in the arm that adds in the experimental drug GS-9857 which gives SVR rates of 99% in the most difficult to treat patients, i.e. cirrhosis and past failed DAA treatment, when used for 12 weeks.
It's a win-win for her. No brainer.
Pablo
Tig said
Jan 22, 2016
If I'm not mistaken Jimmy, this is the same study that Rich (TK) is just now starting. I'll have to look up some names and info and get back to you. It's a fabulous protocol and has shown excellent results. Just ask Rich, he was <15 in 7 days.... BAM!
Here's the clinical trials website with all of the various Sovaldi/Vel/GS 9857 trials. This may help enlighten and inform. I'll keep digging...
The woman is about sign up in Californaia for a Clinical Trial. She has no Insurance and has failed a previous trial.
The trial consists of the following and if there are any thoughts, as always, they are greatly appreciated.
Gilead Sciences, Inc. / Protocol Number GS-US-367-1170 Page 2 of 23 Sergio Rojter, M.D. Chesapeake IRB Approved Version 30 Oct 2015 Revised 24 Nov 2015 WHAT IS THE PURPOSE OF THIS STUDY? The purpose of this study is to determine the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 in comparison with SOF/VEL in subjects infected with HCV. Information about any side effects that may occur will also be collected. HOW DOES THIS STUDY WORK? If you agree to take part in this study, you will be one of about 380 subjects in this study. The study will take place at about 120 centers located in the United States, Canada, New Zealand, Australia, France, Germany, and the United Kingdom. Your study doctor will ask you to come to the clinic for a screening visit to see if you are able to take part. This is a randomized, open-label study. Open-label means you and your study doctor will know what study drug you will be taking. If your screening lab results indicate that you have HCV genotype 1, 2, or 3 you will be randomized to receive either SOF/VEL/GS-9857 or SOF/VEL for 12 weeks. Randomized means the study treatment you take will be chosen by chance, like flipping a coin. You will have 1 out of 2 chances to receive SOF/VEL/GS-9857 for 12 weeks and 1 out of 2 chances to receive SOF/VEL for 12 weeks. If your screening lab results indicate that you have HCV genotype 4, 5, or indeterminate which will include those that have genotype 6, you will not be randomized. Instead, you will be given SOF/VEL/GS-9857 for 12 weeks. SOF/VEL/GS-9857 (400/100/100 mg) FDC and SOF/VEL (400/100 mg) will be supplied by Gilead Sciences, Inc., which is also the Sponsor.
I am totally in the blind on this stuff but I told her I know a family of folks that are quite interested.
Hi RC.
She has 9 days left. This is an oldie but goodie thread.
Hi Jimmy,This is the trial I was going to get into. Gilead Polaris 4. GS-US-367-1170. It's a great trial for any geno type. Hope your friend gets into the trial. RC
Hey Pablo,
96% SVR rates for the 8 week protocol isn't half bad Brother! The number of participants in this reference aren't large, but there's so much good news coming in from this protocol, it's hard to dispute the effectiveness. The FDA has approved this for breakthrough therapy status in GT 1's, and that indicates confidence. With it's pangenotypic activity, it bodes well for everyone.
2-3 years ago we were thrilled to have 70% SVR rates. When I treated the first time, the SVR rates were 20% and we were pumped at the opportunity. Most failed, but when you let doubt cloud your optimism, the Dragon wins that day's argument. Never give that green bucket of lizard poo the time of day! You're going to have good news to share, we'll be waiting to hear it...
Sov/Velpa/9857 = Results!
Hiya Pablito.
I started this thread back in Jan. Yes she did get on and got the whole enchilada. 12 weeks trio arm. She currently has 10 days remaining on treatment.
What I find absolutely incredible is she is smoking pot and the Dr. knows it and no problem! On a trial no less! Freakin California.
LOL
JimmyK
Hi Jimmy
I am on a similar trial of sof/vel/GS-9857 for 8 weeks. She should jump at this opportunity. I would love to be in the 12 week arm of the study.
After extensive reading of the research I've concluded that sof/vel for 12 weeks is the most effective DAA combo currently on the market with large studies showing 99% SVRs across all genotypes. Better still, she has a 50% chance of being in the arm that adds in the experimental drug GS-9857 which gives SVR rates of 99% in the most difficult to treat patients, i.e. cirrhosis and past failed DAA treatment, when used for 12 weeks.
It's a win-win for her. No brainer.
Pablo
If I'm not mistaken Jimmy, this is the same study that Rich (TK) is just now starting. I'll have to look up some names and info and get back to you. It's a fabulous protocol and has shown excellent results. Just ask Rich, he was <15 in 7 days.... BAM!
Here's the clinical trials website with all of the various Sovaldi/Vel/GS 9857 trials. This may help enlighten and inform. I'll keep digging...
https://www.clinicaltrials.gov/ct2/results?term=sofosbuvir%2Fvelpatasvir%2Fgs9857&Search=Search
https://www.clinicaltrials.gov/ct2/results?term=sofosbuvir+and+velpatasvir&Search=Search
Greetings,
It's true I actually have a friend. LOL
The woman is about sign up in Californaia for a Clinical Trial. She has no Insurance and has failed a previous trial.
The trial consists of the following and if there are any thoughts, as always, they are greatly appreciated.
Gilead Sciences, Inc. / Protocol Number GS-US-367-1170 Page 2 of 23 Sergio Rojter, M.D. Chesapeake IRB Approved Version 30 Oct 2015 Revised 24 Nov 2015 WHAT IS THE PURPOSE OF THIS STUDY? The purpose of this study is to determine the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 in comparison with SOF/VEL in subjects infected with HCV. Information about any side effects that may occur will also be collected. HOW DOES THIS STUDY WORK? If you agree to take part in this study, you will be one of about 380 subjects in this study. The study will take place at about 120 centers located in the United States, Canada, New Zealand, Australia, France, Germany, and the United Kingdom. Your study doctor will ask you to come to the clinic for a screening visit to see if you are able to take part. This is a randomized, open-label study. Open-label means you and your study doctor will know what study drug you will be taking. If your screening lab results indicate that you have HCV genotype 1, 2, or 3 you will be randomized to receive either SOF/VEL/GS-9857 or SOF/VEL for 12 weeks. Randomized means the study treatment you take will be chosen by chance, like flipping a coin. You will have 1 out of 2 chances to receive SOF/VEL/GS-9857 for 12 weeks and 1 out of 2 chances to receive SOF/VEL for 12 weeks. If your screening lab results indicate that you have HCV genotype 4, 5, or indeterminate which will include those that have genotype 6, you will not be randomized. Instead, you will be given SOF/VEL/GS-9857 for 12 weeks. SOF/VEL/GS-9857 (400/100/100 mg) FDC and SOF/VEL (400/100 mg) will be supplied by Gilead Sciences, Inc., which is also the Sponsor.
I am totally in the blind on this stuff but I told her I know a family of folks that are quite interested.
Regards
JimmyK