Aa
Polymerase inhibitor R7128
Just thought I would pass along some info. I just read that the early results from AASLD conference said R7128 had a 90% clearance rate at week 4 for geno 2 and 3 non responders when taken with Peg and riba. This comes with no additional sides other than from SOC.
For those who don't know me I am a genotype 1 with high VL who participated in this trail. My portion of this trial was for geno 1 treatment naive patients. I cleared by week 4 also from a beginning VL of 8 milllion. I am currently at week 22 of 48 with the SOC and yes the peg and riba is a blast. The R7128 had no sides, all of my sides are from the SOC drugs.
I was recently told the I did indeed get the trial drug but that was not a news flash for me. Geno 1's don't usually have a 6 log drop to UND by week 4 on SOC.
For anyone who is not familiar with this drug, it is a polymerase inhibitor that is in early trials. It is given with peg and riba for the first 4 weeks. After that it is stopped and the peg and riba (SOC) continue alone for another 4 weeks. After the 8 week point you then had the option of continuing on with SOC for the next 40 weeks.
This is another great future weapon in the arsenal of new drugs. It has shown a 85% EVR for geno 1's and 90% EVR for geno 2 and 3 non-responders. Very encouraging news.
For those who don't know me I am a genotype 1 with high VL who participated in this trail. My portion of this trial was for geno 1 treatment naive patients. I cleared by week 4 also from a beginning VL of 8 milllion. I am currently at week 22 of 48 with the SOC and yes the peg and riba is a blast. The R7128 had no sides, all of my sides are from the SOC drugs.
I was recently told the I did indeed get the trial drug but that was not a news flash for me. Geno 1's don't usually have a 6 log drop to UND by week 4 on SOC.
For anyone who is not familiar with this drug, it is a polymerase inhibitor that is in early trials. It is given with peg and riba for the first 4 weeks. After that it is stopped and the peg and riba (SOC) continue alone for another 4 weeks. After the 8 week point you then had the option of continuing on with SOC for the next 40 weeks.
This is another great future weapon in the arsenal of new drugs. It has shown a 85% EVR for geno 1's and 90% EVR for geno 2 and 3 non-responders. Very encouraging news.
You are right Epiphany, it was all disclosed and the dosages were much higher than ever planned for use in humans.
The original article that Co-writer linked is from an investment site, saying that because of Pharmasett disclosing that information about the monkeys investors would hold back before investing. The entire gist of the article is in her first post.
The Natap link states exactly what I have stated in the 2 articles about R7128. Geno 1's with this latest treated with 1000mg showed an 88% RVR at 4 weeks and geno 2 and 3 nonresponnders showed a 90% RVR at 4 weeks.
I want to make sure that everyone understands, I am not an investor, nor do I have any plans on innvestinng in it. I am just an HCV patient like the rest of us. I happen to chose this trial after spending a few years looking at many others. This appealed to me the most. I am just trying to make sure that other patients get information first hand who may be interested in this or participating in future trials.
I think that if someone has any information that supports or disproves any misinformation that I or anyone else posts it is important to post it for all to see. However you have to be able to show scientific proof to your claim. I do not put investor reports in that category. The information in them can and using is misleading and is not about the drug or disease but rather the invest ability in it. Peer reviewed scientific papers are much more accurate sources of information.
Like I said if Co-writer or anyone else has any information that I am unaware of please do share it as I am interested in it. To my knowledge the FDA has not stopped any human trials with this drug. No one has suffered any serious adverse effects.
The original article that Co-writer linked is from an investment site, saying that because of Pharmasett disclosing that information about the monkeys investors would hold back before investing. The entire gist of the article is in her first post.
The Natap link states exactly what I have stated in the 2 articles about R7128. Geno 1's with this latest treated with 1000mg showed an 88% RVR at 4 weeks and geno 2 and 3 nonresponnders showed a 90% RVR at 4 weeks.
I want to make sure that everyone understands, I am not an investor, nor do I have any plans on innvestinng in it. I am just an HCV patient like the rest of us. I happen to chose this trial after spending a few years looking at many others. This appealed to me the most. I am just trying to make sure that other patients get information first hand who may be interested in this or participating in future trials.
I think that if someone has any information that supports or disproves any misinformation that I or anyone else posts it is important to post it for all to see. However you have to be able to show scientific proof to your claim. I do not put investor reports in that category. The information in them can and using is misleading and is not about the drug or disease but rather the invest ability in it. Peer reviewed scientific papers are much more accurate sources of information.
Like I said if Co-writer or anyone else has any information that I am unaware of please do share it as I am interested in it. To my knowledge the FDA has not stopped any human trials with this drug. No one has suffered any serious adverse effects.
I can't seem to find the article that you quote from regarding the renal studies in monkeys. I'm wondering when it's dated. Could you post the complete link to the article, please? Thanks!
It is true that a study of R1728 in monkeys was stopped at 13 weeks due to renal complications in the animals. However, the chimps were being given twice the highest amount given to humans at any stage of the trial. These studies were very early on and were prior to the FDA giving approval to the human studies this year.
All this information was disclosed to me, in writing, before I signed up for the trial and I was carefully monitored thoughout however I would be most interersted to know if there have been serious adverse events that I am not aware of.
It is true that a study of R1728 in monkeys was stopped at 13 weeks due to renal complications in the animals. However, the chimps were being given twice the highest amount given to humans at any stage of the trial. These studies were very early on and were prior to the FDA giving approval to the human studies this year.
All this information was disclosed to me, in writing, before I signed up for the trial and I was carefully monitored thoughout however I would be most interersted to know if there have been serious adverse events that I am not aware of.
Thanks for the link to the reports.
Maybe it is just me being tired but I read through the reports on R7128 and they all stated what I posted. I did not see anything about renal toxicity. It also did not say anything about the FDA stopping any human trials. If there is something there about it I do not see it.
Maybe it is just me being tired but I read through the reports on R7128 and they all stated what I posted. I did not see anything about renal toxicity. It also did not say anything about the FDA stopping any human trials. If there is something there about it I do not see it.
My understanding was and still is that the toxicity with Renal problems in monkeys was at dose levels much greater than will ever be given to humans and it has not been documented in human trials.They did test and monitor kidney functions during the trial and it has not been a problem to my knowledge. I read the article you referred to and it is from an investment web site not a research website. Investors may have just heard this news but it was all disclosed to me prior to starting the trials. If you have some new data please do share it.
When I said it has no sides other than with SOC meaning it does not have all the nasty sides you get from peg and riba. They gave this drug to 40 healthy volunteers (no HCV) and they did not have any adverse side effects from it. All of the sides I have experienced from this trial are from the peg and riba.
When I said it has no sides other than with SOC meaning it does not have all the nasty sides you get from peg and riba. They gave this drug to 40 healthy volunteers (no HCV) and they did not have any adverse side effects from it. All of the sides I have experienced from this trial are from the peg and riba.
"This comes with no additional sides other than from SOC. "
Actually the FDA stopped some of the human trials on this drug because of possible kidney toxicity. The drug company is gone back to doing safety tests on monkeys.
Co
"Pharmasset
Pharmasset's drug R7128 hasn't been as broadly tested as those from Vertex and Schering-Plough, but the data generated so far has shown the drug to be very effective at tamping down the hepatitis C virus.
The biggest question mark hanging over the drug to date is toxicity. At an investor event Sunday, Pharmasset officials for the first time discussed in some detail the emergence of kidney toxicity seen in a safety study in monkeys.
According to Pharmasset, the monkey kidney toxicity is reversible and did not cause permanent damage. More importantly, no such problem has been observed in the short human studies of R7128 conducted to date.
Pharmasset is conducting a longer, six-month safety test of R7128 in monkeys, but at this point the company doesn't believe that the Food and Drug Administration will stop further human studies from starting in the first quarter of next year.
Still, judging by the volume of questions from investors at Sunday's meeting that began with the words, "I'd like to get back to those monkey studies ..." the issue isn't one that Wall Street is ready to put entirely to rest.
Pharmasset is developing R7128 with partner Roche, which just last week was forced to halt development of a rival hepatitis C drug derived from its own laboratories because of unacceptable safety problems.
This Roche setback upped the value of R7128. If the drug's safety can be verified, Pharmasset will be a hepatitis C company to watch."
http://www.thestreet.com
Doingtime,
Yes I did thanks for the well wihes.
Epiphany,
I am surprised we missed paths on this. I also had posted about this drug a few times before. When I first posted my that i was UND at 4 weeks I had someone raise the question the fact I had could make this claim if I was not unblinded. It was a valid point but I can now validate that.
I did too much research of this drug before deciding to participate. I looked at all the drugs out there. Many, including telaprevir, which is having great success had/have some issues associated with them. From increased severity of rashes to evidence viral mutations, neutropenia, etc.
Maybe someday they will have drug that can be used without peg and riba!
Yes I did thanks for the well wihes.
Epiphany,
I am surprised we missed paths on this. I also had posted about this drug a few times before. When I first posted my that i was UND at 4 weeks I had someone raise the question the fact I had could make this claim if I was not unblinded. It was a valid point but I can now validate that.
I did too much research of this drug before deciding to participate. I looked at all the drugs out there. Many, including telaprevir, which is having great success had/have some issues associated with them. From increased severity of rashes to evidence viral mutations, neutropenia, etc.
Maybe someday they will have drug that can be used without peg and riba!
I also did that trial and was UND at 4 weeks (G3 non responder) and also had no sides other than those associated with SOC. I am currently on week 26 of 48 and still UND. My docor was one of the ones giving the presentation at AASLD San Francisco.
I'm just so happy that other people are finally talking about this trial and drug as I've been a lone voice in the empty wilderness for the last 6 months!
Btw, I applied to extend my tx out to 48 weeks even tho protocol is 24 for G3 because I want to give myself the best chance at SVR as possible. Also, I had a slight rebound at week 8 and had a VL of 29IU/mL.
Ideally, add on drugs like this are designed to get people to UND faster and shorten treatment.
All the best Dragon, here's hoping for SVR!!!
Epi :)
I'm just so happy that other people are finally talking about this trial and drug as I've been a lone voice in the empty wilderness for the last 6 months!
Btw, I applied to extend my tx out to 48 weeks even tho protocol is 24 for G3 because I want to give myself the best chance at SVR as possible. Also, I had a slight rebound at week 8 and had a VL of 29IU/mL.
Ideally, add on drugs like this are designed to get people to UND faster and shorten treatment.
All the best Dragon, here's hoping for SVR!!!
Epi :)
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