Aa
Clinical trial GS-7977 and BMS-790052
I started this clinical trial yesterday, 12 weeks, all oral. (NCT01359644)
There were two arms - one with and one without Ribavirin. My arm is (unfortunatley) without.
I know some people here are contemplating and/or screening for this trial. I'd love to keep in touch and exchange feedback.
Good health to all...
Kat
There were two arms - one with and one without Ribavirin. My arm is (unfortunatley) without.
I know some people here are contemplating and/or screening for this trial. I'd love to keep in touch and exchange feedback.
Good health to all...
Kat
What txt did you do? i am suppose to start the Sofosbuvir GS 5885 txt soon. It is phase 3. thanks, Reen
Given that 1/3 of the population has genotype 2 and 3, the 7977/5885 will not be useful for them. I still do not understand Gilead's thinking! The sofosbuvir/daclatasvir combination cured not only 100% of GT1, but 94% of genotpye 2/3...without ribavirin. No other drugs in the pipeline are pan-genotypic and from what I see most all will still require ribavirin, other than the one Abbott study.
What am I missing?
What am I missing?
BTB, you make a lot of good points. But the acid test will be the effectiveness of 5885. If it fails (and look what just happened with BMS' nuc purchased from Inhibitex for $2.5 million and now abandoned) or produces modest results instead of 100% success with Gt 1's, then it will be essential to continue the combination of 7977 and daclatasvir. Then there would need to be real and sustained outrage if Gilead won't work with BMS.
Hi Jimee, good to hear from you. Best of luck with your SVR2 results. I'm pretty confident all of you on the 24 week trial are very likely to make SVR2, then 4, then 12. Every GT1 completing our trial that I've heard about has made SVR12 - Katia, Lowbid, now myself, plus others in the original 24 week trial. Now it's your turn to show that partial responders can do it too! I remember the day we met when I said if we can complete this trial successfully, we'll blow the hep c world's mind. I think we're on track to do it!
I have a different take on what is optimal.
The course Gilead is taking was clearly articulated in its 7/26/12 earnings call (transcripts available online) and seems like a "grand slam homerun" approach to me. Gilead has gotten approval from the FDA for a Phase 3 study using GS-7977 and GS 5885 (like declatasvir, an NS5A inhibitor). Other parameters will be set after the results of a small confirmatory Phase III study are reviewed (around the end of this calendar year, it would appear). The time schedule is very aggressive -- if everything goes as planned, the fixed dose combination regulatory filings would be made in mid-2014 -- much faster than could be achieved if the study had to be coordinated between two different pharmaceutical companies, as would be the case if GS-7977 were paired with the Bristol Myers drug declatasvir rather than with the GS-5885.
Granted, there are some question marks (most notably whether GS 5885 will indeed prove to be the equivalent of declatasvir), but that will be known very soon. I'd put my money on the notion that the GS- 7977/5885 combo will be the silver bullet and that will be borne out with lightening speed.
BTB
The course Gilead is taking was clearly articulated in its 7/26/12 earnings call (transcripts available online) and seems like a "grand slam homerun" approach to me. Gilead has gotten approval from the FDA for a Phase 3 study using GS-7977 and GS 5885 (like declatasvir, an NS5A inhibitor). Other parameters will be set after the results of a small confirmatory Phase III study are reviewed (around the end of this calendar year, it would appear). The time schedule is very aggressive -- if everything goes as planned, the fixed dose combination regulatory filings would be made in mid-2014 -- much faster than could be achieved if the study had to be coordinated between two different pharmaceutical companies, as would be the case if GS-7977 were paired with the Bristol Myers drug declatasvir rather than with the GS-5885.
Granted, there are some question marks (most notably whether GS 5885 will indeed prove to be the equivalent of declatasvir), but that will be known very soon. I'd put my money on the notion that the GS- 7977/5885 combo will be the silver bullet and that will be borne out with lightening speed.
BTB
Wow....it is true. I'm so happy for you. I was thinking about you last week and wondering when that blood test was. We (Vicky, Al, and me ) go this Thursday for our 2 week post tx blood work. We all hope to follow in your footsteps. God bless!
Margaret is keeping up a lot of hard work fro others who need this cure-
can you all help by signing the petition- it is free and we are going nationwide with this issue.
can you all help by signing the petition- it is free and we are going nationwide with this issue.
We are all so happy for you Hopinghepster and Lowbid! Now we need to use these success stories to convince Gilead Sciences & Bristol-Myers to make the life-saving drug combo of GS-7977 + Daclatasvir available to all of us! This is the only cure out there that does not require interferon or ribavirin! And only side effects reported from people in these trials (in the NO ribavirin arm) were headache, nausea, fatigue during treatment. Think the entire HCV population would treat if we could have these kind of results - 100% genotype 1 cured and >91% genotype 2/3 and little or no side effects! This is the treatment millions have prayed about for so long now. Please help us in our efforts to get Gilead & Bristol back together on this. If they don't then too many will continue to suffer and die when there is a cure. You can help by signing the petition at link below and asking everyone you know to sign it as well. We also encourage each of you to contact your two state senators and congressmen and anyone else you may think of to get this news out to the world. We are forming alliances with other groups (HIV/AIDS, Hemophiliacs, HCV support groups, etc.) but the true work will have to be done by US!
Link to petition:
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
Warmest regards to all,
Margaret
Link to petition:
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
Warmest regards to all,
Margaret
I'm delighted to write that I am now officially SVR12! Wow! Fabulous news! I am filled with gratitude to all those who made this moment possible. Goodbye Hep C and best wishes to all!
Hey! Hope everyone is doing ok tonight- and SVR all the way- if not, we are TRYING to get a petition signed by any and all to re-open the BMS/ 7977 phase lll trial for those of us still waiting and those of us who didn't make it on triple tx.
Margaret Dudley is running that petition, if you go her page, there is much more info. We need to keep this in the forefront of the news.
Y'all chime in and let's get these meds out to all of us!!
life, love, healing,
jerialice
Margaret Dudley is running that petition, if you go her page, there is much more info. We need to keep this in the forefront of the news.
Y'all chime in and let's get these meds out to all of us!!
life, love, healing,
jerialice
I happened upon this thread again last night and wanted to urge all of you to continue helping us with our efforts to get Gilead back into collaboration with Bristol-Myers. Look back at how excited we all were when we heard the results released at EASL, 100% cure-rate for genotype 1, and more than 91% for genotype 2/3 (without interferon and ribavirin). And then much to the dismay of the HCV community, clinicians, doctors and researchers worldwide, Gilead Sciences announced shortly thereafter that they would not be going forward with Phase III trials. Gilead is seemingly intent on looking "in-house" and are forging ahead with a study of 7977 in combination with their own experimental NS5a inhibitor GS-5885. This chosen path could take years to bring to fruition and will likely require the addition of ribavirin and/or interferon.
In light of this development a patient advocacy group, the HCV Coalition for "The Cure" was formed for the sole purpose of "leveraging" Gilead back to work with Bristol to move the 7977 (now named sofosbuvir) + daclatasvir combination into Phase III trials with all possible dispatch.
We have launched a petition at Change.org and urge each and every one of you to sign it and then ask everyone you know to sign as well. We also urge you to contact news, TV, senators, congressmen, FDA, etc. regarding this urgent and dire matter. If this were the cure for cancer the world would be outraged, and we are confident they will be outraged by this as well. This is still the United States of America and we will not sit idly by and allow this. Some “naysayers” tell us we are wasting our time and cannot change the direction of a big pharma giant such as Gilead Sciences. To which we say, that it was a petition such as this that forced big banking giant Bank of America to back off $5.00 fees; and another petition targeting the USDA that was successful in having “pink slime” removed from our children’s lunches. Our lives and the lives of people we love are at stake here, so we must at least TRY.
Link to petition:
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
Look back at the comments posted by people who were actually in these trials and ask yourself the following question. Shouldn't we all have the opportunity to be cured of hepatitis C without the debilitating side effects that often accompany interferon and/or ribavirin??? So please join us in our efforts, first by signing the petition and then by asking every one you know to sign it as well.
Sincerely,
Margaret
HCV Coalition for "The Cure"
You can see more info about these efforts at the petition site.
In light of this development a patient advocacy group, the HCV Coalition for "The Cure" was formed for the sole purpose of "leveraging" Gilead back to work with Bristol to move the 7977 (now named sofosbuvir) + daclatasvir combination into Phase III trials with all possible dispatch.
We have launched a petition at Change.org and urge each and every one of you to sign it and then ask everyone you know to sign as well. We also urge you to contact news, TV, senators, congressmen, FDA, etc. regarding this urgent and dire matter. If this were the cure for cancer the world would be outraged, and we are confident they will be outraged by this as well. This is still the United States of America and we will not sit idly by and allow this. Some “naysayers” tell us we are wasting our time and cannot change the direction of a big pharma giant such as Gilead Sciences. To which we say, that it was a petition such as this that forced big banking giant Bank of America to back off $5.00 fees; and another petition targeting the USDA that was successful in having “pink slime” removed from our children’s lunches. Our lives and the lives of people we love are at stake here, so we must at least TRY.
Link to petition:
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
Look back at the comments posted by people who were actually in these trials and ask yourself the following question. Shouldn't we all have the opportunity to be cured of hepatitis C without the debilitating side effects that often accompany interferon and/or ribavirin??? So please join us in our efforts, first by signing the petition and then by asking every one you know to sign it as well.
Sincerely,
Margaret
HCV Coalition for "The Cure"
You can see more info about these efforts at the petition site.
I am awaiting news (should be any time now) for the 12 week study 7977 with 790052 in previous protease failures failures and nulls. Dosing started in April this year.
I expect some SVR 4 data may already have been collected!
I expect some SVR 4 data may already have been collected!
Hi, I live in Christchurch, New Zealand.
I am on a PHASE 3 trial, Fusion-GS7977 400mg plus Fusion-Ribavirin 200mg for 16 weeks.
The last 4 weeks are 50/50 placebo/meds double blind, although the bottles already have the /placebo labelling, which I am informed are just so they don't have to reprint the labels, which sounds a bit cheap. I'm confident it's not a trick tho!
I have type 3a, have had 2 unsuccessful six month treatments of interferon/ribavirin,- 2nd was pegelated Interferon. I had VR at end of treatment but virus came back with a vengance.
I guess I'm fortunate to get on this, most trials are done for type 1 as that is mostly -I gather- what you North American people have.
I'm in week 2 and periodically feel I have the flu and very tired..and sometimes feel great! Very optimistic. People here talk about SVR 4/12 etc. I don't just want a brief respite from HCV effects (been there, done that), I want to be virus free for evermore!
My hospital specialist has invested in a fibroscan, so I didn't have to have a biopsy.
I haven't looked yet on this site for a GLOSSARY, I hope there is one as there's a lot of jargon, some of which I don't understand. Does anyone know what Fusion is? -I will ask on my hospital visit this week.
It's great to connect with you people who have gone through similar tough life challenges, and to read the optimism due to these new promising treatments. Thank you so much scientists!
I am on a PHASE 3 trial, Fusion-GS7977 400mg plus Fusion-Ribavirin 200mg for 16 weeks.
The last 4 weeks are 50/50 placebo/meds double blind, although the bottles already have the /placebo labelling, which I am informed are just so they don't have to reprint the labels, which sounds a bit cheap. I'm confident it's not a trick tho!
I have type 3a, have had 2 unsuccessful six month treatments of interferon/ribavirin,- 2nd was pegelated Interferon. I had VR at end of treatment but virus came back with a vengance.
I guess I'm fortunate to get on this, most trials are done for type 1 as that is mostly -I gather- what you North American people have.
I'm in week 2 and periodically feel I have the flu and very tired..and sometimes feel great! Very optimistic. People here talk about SVR 4/12 etc. I don't just want a brief respite from HCV effects (been there, done that), I want to be virus free for evermore!
My hospital specialist has invested in a fibroscan, so I didn't have to have a biopsy.
I haven't looked yet on this site for a GLOSSARY, I hope there is one as there's a lot of jargon, some of which I don't understand. Does anyone know what Fusion is? -I will ask on my hospital visit this week.
It's great to connect with you people who have gone through similar tough life challenges, and to read the optimism due to these new promising treatments. Thank you so much scientists!
They should be having a conference call on the 26th. I'm hoping and praying we'll hear good news about their upcoming trials with their own NS5a.
That is the kind of news I like to hear...OVER AND OVER AGAIN. I am so happy for you. Come Gilead...please!!!!
Great news!
How many 1a and nulls are going to SVR?
How many are geno 2 and 3?
This is exciting stuff!
How many 1a and nulls are going to SVR?
How many are geno 2 and 3?
This is exciting stuff!
6 months post treatment results-UND. Treated for 24 wks. 7977 and BMS790052. Praying for all of you on these and any others drugs to slay the dragon.
Awesome! Now we have to see that everyone will have access to this life-saving drug combination of GS-7977+daclatasvir (formerly BMS-790052) without interferon OR ribavirin!
So truly happy for you!!! Love to hear if you find out anything else about results. And look forward to hearing SVR12, SVR24, CURED OF HCV!
Anyone that participated or is currently in this trial, would you please let me know how you are doing? And what drugs you are on, i.e., GS-7977+ Daclatasvir (formerly BMS-790052) and/or Ribavirin? And your genotype, etc.
http://clinicaltrials.gov/ct2/show/NCT01359644?term=NCT01359644&rank=1
Warmest regards,
Margaret
HCV Sufferer & Advocate for The Cure
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
So truly happy for you!!! Love to hear if you find out anything else about results. And look forward to hearing SVR12, SVR24, CURED OF HCV!
Anyone that participated or is currently in this trial, would you please let me know how you are doing? And what drugs you are on, i.e., GS-7977+ Daclatasvir (formerly BMS-790052) and/or Ribavirin? And your genotype, etc.
http://clinicaltrials.gov/ct2/show/NCT01359644?term=NCT01359644&rank=1
Warmest regards,
Margaret
HCV Sufferer & Advocate for The Cure
http://www.change.org/petitions/gilead-sciences-please-collaborate-with-bristol-myers-for-the-cure-for-hepatitis-c-now
i did the incivik,with riba,and interfion, undetected all the way thru last blood test came back i relapsed. hope i can get into this trial
Made it ti SVR4! Feeling incredibly grateful. The two others I know of on exactly the same trial also made SVR4. Gilead/BMS must know if 100% of those who made SVR4 on the 24 week version of our trial also made SVR12. So far they're not saying. It would be nice to know. Looks like this really is the interferon and ribavirin free 'cure.' What great good fortune to have done it!
Thanks for the support, Jimee. I've made it to SVR3 but I'm still waiting for SVR4. Feeling optimistic. I've basically felt well since I stopped the treatment almost six weeks ago now. I have a bit of tiredness and sluggishness sometimes. Nothing major. I was in the intense heat of the Middle East - mostly Egypt - for the first three weeks after treatment and it was hard to distinguish between post treatment symptoms and jet lag, minor stomach bugs etc. Sometimes I definitely didn't feel great but I think it was more likely the heat and diet etc. I'll post again as soon as I hear if I've made SVR4. How are you doing?
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