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Gilead
Hi, I see allot of information about Merck and Vertex but nothing about Gilead and their Protease inhibitor and Polymerase Inhibitor. This is the study I will be taking part in at the end of the month. Does anyone know of this company or have any information on their drugs? This study is phase II so they must be behind the other two.
Just curious and of course very curious about the possible side effects. I guess my question on that will be answered soon enough.
Just curious and of course very curious about the possible side effects. I guess my question on that will be answered soon enough.
Search my name 'beyondmwd' to view posts about this Trial for the last months. OR you can try searching Gilead Trials. Either will work for more info. into these trials. Good Luck. I think you will be amazed at how well these drugs work. I am. Beyondmwd
I am in my 10th wk. of Gilead Trial not-blind, no placebo. It's the one they started/revised after the Tel. had to be stopped.....so everything became known. 5885, 9451, and SOC. Cleared at week 2. UND at wk. 8. 5885, 9451 do not seem to have many sxs for me. Still feeling that interferon and RIBV though. There are165 people in the study I am in across the country. Some have dropped out, some have been released. Gilead is coming on strong. I'm hanging in. Beyondmwd
Thats great, not having insurance or $$ , I would be hard pressed for that. It seems they are going to use the SOC with the PI's and this study is testing a Protease Inhibitor and a Polymerase inhibitor. I think I will get offered the PI's if I am not responding well after 12 weeks. That is if I'm in the 3rd arm which is SOC alone.
I dont have anything to lose at this point, I can opt out anytime from the study and quite honestly I would be happy going back to Tibetan medicine if it came down to that. It doesnt cure you, but can help maintain good health.
I would love to be rid of the critters though.
thanks for the thought, :)
I dont have anything to lose at this point, I can opt out anytime from the study and quite honestly I would be happy going back to Tibetan medicine if it came down to that. It doesnt cure you, but can help maintain good health.
I would love to be rid of the critters though.
thanks for the thought, :)
I was speaking to my Mom and she said in yesterdays newspaper 1-18-11...that there was and HCV article in there saying the PI's will be out in 6 months!!!
The study center, and it is just that has been doing studies with HIV for 12 years and they are happy to start the HCV studies.
I feel like I'm in good hands and my biopsy shows stage 1 at this point as well, so I will give it a try. I like the GI group, and the study ppl. But I'm an idiot I like just about everyone.
Didn't like my surgeon for breast cancer. no sir ee.
thanks Hector, I think "things" are moving in a hopeful direction. Que Sera
I feel like I'm in good hands and my biopsy shows stage 1 at this point as well, so I will give it a try. I like the GI group, and the study ppl. But I'm an idiot I like just about everyone.
Didn't like my surgeon for breast cancer. no sir ee.
thanks Hector, I think "things" are moving in a hopeful direction. Que Sera
Mary,
From biospace.com
"FOSTER CITY, Calif., Apr 19, 2010 (BUSINESS WIRE) -- Gilead Sciences, Inc. today announced the company is stopping its ongoing Phase II clinical trial of GS 9450, an investigational caspase inhibitor, in patients with chronic hepatitis C. This decision follows reports of significant laboratory abnormalities and adverse events in a number of clinical study participants."
Luckily you have very little liver damage (it shouldn't change much if at all in 2 years) so you have lots of time to treat. Depending on your age, if and when you go on Medicare you should be about to get medical coverage for a small fee to treat your HVC if your trial treatment is unsuccessful.
Good luck with the trial!
Hectorsf
From biospace.com
"FOSTER CITY, Calif., Apr 19, 2010 (BUSINESS WIRE) -- Gilead Sciences, Inc. today announced the company is stopping its ongoing Phase II clinical trial of GS 9450, an investigational caspase inhibitor, in patients with chronic hepatitis C. This decision follows reports of significant laboratory abnormalities and adverse events in a number of clinical study participants."
Luckily you have very little liver damage (it shouldn't change much if at all in 2 years) so you have lots of time to treat. Depending on your age, if and when you go on Medicare you should be about to get medical coverage for a small fee to treat your HVC if your trial treatment is unsuccessful.
Good luck with the trial!
Hectorsf
i guess I'm going for it because its a study and I will get free meds and good follow up and the drugs look good so far.
didn't know many drugs were discontinued during phase II,
The thing I like is I have gotten all my labs, bx done as part of the trial and if for any reason I dont want to continue with the study I may opt out.
I havent gotten my bx results back yet, but 2 yrs. ago they showed stage 1, grade 1, so I am curious to see the results in 2 yrs.
I do not have insurance and do not have disposable income to pay for these things myself.
As a matter of fact I'm hoping to semi retire this yr. to spend more quality time with my 88 yr. old mom. My job pretty much *****.
so.....
didn't know many drugs were discontinued during phase II,
The thing I like is I have gotten all my labs, bx done as part of the trial and if for any reason I dont want to continue with the study I may opt out.
I havent gotten my bx results back yet, but 2 yrs. ago they showed stage 1, grade 1, so I am curious to see the results in 2 yrs.
I do not have insurance and do not have disposable income to pay for these things myself.
As a matter of fact I'm hoping to semi retire this yr. to spend more quality time with my 88 yr. old mom. My job pretty much *****.
so.....
Gilead is a small company (~4,000 employees) compared to huge Merck (34,000). Vertex will be the first to market with the new STAT-C med for HCV so they get a lot of attention in the press.
I have friends that work at Gilead Sciences here in the San Francisco Bay Area. As someone mentioned Gilead is known for it drugs that manage HIV, infectious diseases (hep B) and cancer. So of course they are trying to leverage their knowledge of anti-virals to treat HIV to make in roads into the HCV treatment market.
They currently have about 5 drugs in their pipeline being tested on people with hepatitis C.
All their meds are used in combination with peg-IFN and ribavirin.
There is a phase II trial of GS 9190 and GS 9256 to see if these meds can reduce treatment time from 48 weeks to 16 weeks.
There is a phase II trial of GS 9190 plus GS 9451.
There also have trial for GS 5885 with a PI and SOC.
The trials don't have many people in them so far, so degree and number of adverse events data is minimal at this time. All the meds have side effects been mild to moderate so far. Much further testing on large populations of patience must be done to to know what the adverse events will be.
Any reason you are not waiting for Telaprevir which is proven to clear the virus? As you probably know many hap C treatment drugs have been discontinued during phase II of their trials.
Good luck to you.
HectorSF
I have friends that work at Gilead Sciences here in the San Francisco Bay Area. As someone mentioned Gilead is known for it drugs that manage HIV, infectious diseases (hep B) and cancer. So of course they are trying to leverage their knowledge of anti-virals to treat HIV to make in roads into the HCV treatment market.
They currently have about 5 drugs in their pipeline being tested on people with hepatitis C.
All their meds are used in combination with peg-IFN and ribavirin.
There is a phase II trial of GS 9190 and GS 9256 to see if these meds can reduce treatment time from 48 weeks to 16 weeks.
There is a phase II trial of GS 9190 plus GS 9451.
There also have trial for GS 5885 with a PI and SOC.
The trials don't have many people in them so far, so degree and number of adverse events data is minimal at this time. All the meds have side effects been mild to moderate so far. Much further testing on large populations of patience must be done to to know what the adverse events will be.
Any reason you are not waiting for Telaprevir which is proven to clear the virus? As you probably know many hap C treatment drugs have been discontinued during phase II of their trials.
Good luck to you.
HectorSF
Susan,
I dont trust myself, I've noticed it only takes me about 10 minutes from the time I get in my car to start cursing people for getting in my way. At least I'm noticing my reactions, unfortunately after the fact. so my tendency to be impatient may be magnified. So I am going to go for it I can always taper off. Besides, my boss drives me crazy and I need a job for a while longer, it does seem to be getting a little better, there's always something.
I appreciate your best regards and good thoughts,
I will come here for support, good information, good energy, caring energy.
Peace,,
I dont trust myself, I've noticed it only takes me about 10 minutes from the time I get in my car to start cursing people for getting in my way. At least I'm noticing my reactions, unfortunately after the fact. so my tendency to be impatient may be magnified. So I am going to go for it I can always taper off. Besides, my boss drives me crazy and I need a job for a while longer, it does seem to be getting a little better, there's always something.
I appreciate your best regards and good thoughts,
I will come here for support, good information, good energy, caring energy.
Peace,,
Yeah, someone else I know has had to up their antidepressant as well. I've only experienced any psych effects a few days ago (total loss of patience) and am hoping that it isn't indicative of anything else going on. For the time being I am still trying hard not to add any additional meds but I am only on week 6 so there is a ways to go. Trying to stand as awareness with any struggles does at least give me one additional perspective even if it doesn't alleviate the symptom. Best thing that helps is my understanding of relative vs. absolute truth. That and I think that I'll reread Viktor E. Frankl' book "Man's Search for Meaning." In trying to get through my workout this morning I thought of all he went through and I realized how minuscule my own problem is.
As for nervousness, yeah, I think everyone could relate to that. The night before I started I was very agitated but, I woke up the next morning with full conviction and looking forward to starting the study. I hope you experience a similar optimism and your fears drop away. This place can be a real help! Hey, when do you expect your trial to start? Please keep us all up to date. Wishing you great results and SVR without any ill undesired effects. Namaste.
As for nervousness, yeah, I think everyone could relate to that. The night before I started I was very agitated but, I woke up the next morning with full conviction and looking forward to starting the study. I hope you experience a similar optimism and your fears drop away. This place can be a real help! Hey, when do you expect your trial to start? Please keep us all up to date. Wishing you great results and SVR without any ill undesired effects. Namaste.
Thanks Susan,
,the nurse practitioner at the center suggested I double up on my antidepressant so I'm gonna try it to see what happens, I have had no problem with 10 mg., getting nervous so maybe its a good idea.
Love
,the nurse practitioner at the center suggested I double up on my antidepressant so I'm gonna try it to see what happens, I have had no problem with 10 mg., getting nervous so maybe its a good idea.
Love
Mary,
As I have told you the lead study doc for Telaprevir was Dr. John McHutchison. He now is senior VP at Gilead, and is quoted in your post above. I know that Gilead is also hard at work on drugs aimed for those afflicted with Alzheimer's. You may want to check these links - they are just 2 of many that are out there. McHutchison also developed/discovered the IL28B allele. You're in good hands.
http://www.dukehealth.org/health_library/news/retreating_patients_with_hep_c_telaprevir_boosts_cure_rate
http://www.gilead.com/pr_1436018
As I have told you the lead study doc for Telaprevir was Dr. John McHutchison. He now is senior VP at Gilead, and is quoted in your post above. I know that Gilead is also hard at work on drugs aimed for those afflicted with Alzheimer's. You may want to check these links - they are just 2 of many that are out there. McHutchison also developed/discovered the IL28B allele. You're in good hands.
http://www.dukehealth.org/health_library/news/retreating_patients_with_hep_c_telaprevir_boosts_cure_rate
http://www.gilead.com/pr_1436018
Gilead isn't trying to compete here; instead the company is taking a page from its HIV playbook, believing that the long-term future of Hep C treatment will be in developing combination of oral drugs --each acting against the Hep C virus in different ways -- that can eliminate the need for injectable interferon and perhaps even ribavirin, both of which can cause nasty side effects.
Just like Gilead sells a Atripla for HIV treatment -- a single, daily pill that combines three different medicines -- the company would like to one day develop a single, multi-drug pill for Hep C, said McHutchison.
Just like Gilead sells a Atripla for HIV treatment -- a single, daily pill that combines three different medicines -- the company would like to one day develop a single, multi-drug pill for Hep C, said McHutchison.
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