Aa
new study
Does anyone know anything about RO5024048, a drug for HCV made by Roche? I have been asked to participate in the study. Any info is appreciated. R1
Yes they provided me with all my lab results, I asked for them. However, During the initial part of the trial I was given nor were the doctors any results on viral load etc. That is all explained to you as it is a double blinded study. Neither you nor your doctor know whether you received the trial drug or a placebo. If you did it would compromise the results of the trial. After that part was unblinded I was provided my test results.
As to how I feel now I am near the end.....like SH!T LOL. I feel a little beat up. As I mentioned in my earlier post the peg and riba are still part of the equation. You will still get all the sides from those meds. Some people get more than others. Having said that, ending at week 24 will be nice. As treatment went on is when the sides worsened for me. Now at the end I am anemic leaving me tired, cold hands and feet and short of breath. That is fairly common.
I noticed you have inquired in earlier posts about lots of different treatment options. That is a good thing in my opinion, including natural alternatives. I did all the same things. It will help to you to try and wrap your mind around all of the information. It is a tough to sort through all of this. Just know this, to my knowledge, there is no natural cure for Hep C. There is some support that some supplements and alternatives may help to prolong or alleviate symptoms or progression of the disease to some extent. Like I said to my knowledge there is no known Natural cure.
It is also important to realize that the peg and riba is not a picnic. Some people seem to tolerate it OK, I was not one of them, this is strong medicine, the interferon in particular has a serious side effect profile. There are some here who have gone 72 and even 96 weeks with treatment. Another member did higher doses. God Bless each and everyone of them. I am not sure I could have. I give them all have some pretty deep respect. Anyone who goes through this deserves some respect. It is not easy.
I was at the point where I was getting symptomatic from the Hep C. my liver biospy had remained unchanged for 5 years (maybe from supplements I took?) but I was feeling much worse as time marched on I had a few doctors poo-poo my symptoms as not having to do with Hep C. I knew better and I know my body. I could tell things were changing. As a side note, many of the complaints I had prior to treating are gone. Granted they were replaced by new pharmacologically induced ones LOL. They should all be gone soon (I can't wait)
I waited to treat initially because I did not like the SOC success rates vs. side profile. This medicine increased the odds of successful treatment to make it more palatable for me. I think 24 week will be successful but only time will tell. Not to mention you take the trial drug longer in this phase (8 weeks).
Good luck in your decision, I know it is never an easy one to make.
As to how I feel now I am near the end.....like SH!T LOL. I feel a little beat up. As I mentioned in my earlier post the peg and riba are still part of the equation. You will still get all the sides from those meds. Some people get more than others. Having said that, ending at week 24 will be nice. As treatment went on is when the sides worsened for me. Now at the end I am anemic leaving me tired, cold hands and feet and short of breath. That is fairly common.
I noticed you have inquired in earlier posts about lots of different treatment options. That is a good thing in my opinion, including natural alternatives. I did all the same things. It will help to you to try and wrap your mind around all of the information. It is a tough to sort through all of this. Just know this, to my knowledge, there is no natural cure for Hep C. There is some support that some supplements and alternatives may help to prolong or alleviate symptoms or progression of the disease to some extent. Like I said to my knowledge there is no known Natural cure.
It is also important to realize that the peg and riba is not a picnic. Some people seem to tolerate it OK, I was not one of them, this is strong medicine, the interferon in particular has a serious side effect profile. There are some here who have gone 72 and even 96 weeks with treatment. Another member did higher doses. God Bless each and everyone of them. I am not sure I could have. I give them all have some pretty deep respect. Anyone who goes through this deserves some respect. It is not easy.
I was at the point where I was getting symptomatic from the Hep C. my liver biospy had remained unchanged for 5 years (maybe from supplements I took?) but I was feeling much worse as time marched on I had a few doctors poo-poo my symptoms as not having to do with Hep C. I knew better and I know my body. I could tell things were changing. As a side note, many of the complaints I had prior to treating are gone. Granted they were replaced by new pharmacologically induced ones LOL. They should all be gone soon (I can't wait)
I waited to treat initially because I did not like the SOC success rates vs. side profile. This medicine increased the odds of successful treatment to make it more palatable for me. I think 24 week will be successful but only time will tell. Not to mention you take the trial drug longer in this phase (8 weeks).
Good luck in your decision, I know it is never an easy one to make.
In the phase I, did you receive copies of your labs at week 4 and so on? I have a copy of the study Godofsky sent me but I cant find where it says we would be notified of our results at whatever interval. And also now that your almost done with your meds, how do you feel? Congrats to both on clearing! Is there anything else I need to know as far as your experience, I go for screening mid May. Tanks, R1
I agree with everything that willing said.
To elaborate a little more R7128 is a polymerase inhibitor. In an earlier trial it showed a success rate of 88% when combined with pegasys and copegus (standard of Care SOC). It is still too early to give SVR rates but my guess is they will be fine. The drug itself has show no adverse side effects and no viral mutations. Having said that you take the peg and riba and still get all the wonderful sides from them.
Myself and Epi participated in the phase I studies (later part of them). I was a geno type 1 treatment naive, she was a genotype 3 non-responder. We both, as have others were undetectable by week 4, but continued SOC treatment for the full 48 weeks with peg and riba. The trial drug was only given the first 4 weeks. From what I have seen and heard others have cleared by week 4 also.
Epi finished a few weeks ago and I have one more shot to go (can't wait). I can not comment for her and her experience but will be glad to give you mine.
I have felt all along that this treatment would be shortened to 24 weeks...and still be successful. The 48 weeks of peg and riba totally stinks (as it does for most people)
Willing is also correct that there was some talk about combining it with Telaprevir but that is years away and not anything other than an article with a doctors opinion (Dr. Pockros maybe?)
I do not know your situation but If you are thinking about a trial, and realize that trials include the chance of placebo (but you still get SOC). You also need to educate as much as you can so you understand about the drug and what you are getting into, keeping in mind that in clinical trials you are the human guinea pig. This is the drug companies final testing grounds to determine if a drug is safe for humans and get FDA approval so it can go to market.
I can not and will not advise you as to whether you should participate. That is a decision only you can make. If you ask me my personal opinion of the drug I would agree again with Willing. I think it will be better than Telaprevir or Boceprevir, but that is nothing more than my opinion based on my experiences and all the data and research I have read. I am not a doctor, nor do I have any vested interest in the company.
I waited several years before treating, did a lot of reading, and came close to participating in a few trials. I backed away from all of them including telaprevir (then called VX-950) for various reasons. I read about R7128, was convinced of its potential and sought out a trial site to see if I could qualify to participate.
To elaborate a little more R7128 is a polymerase inhibitor. In an earlier trial it showed a success rate of 88% when combined with pegasys and copegus (standard of Care SOC). It is still too early to give SVR rates but my guess is they will be fine. The drug itself has show no adverse side effects and no viral mutations. Having said that you take the peg and riba and still get all the wonderful sides from them.
Myself and Epi participated in the phase I studies (later part of them). I was a geno type 1 treatment naive, she was a genotype 3 non-responder. We both, as have others were undetectable by week 4, but continued SOC treatment for the full 48 weeks with peg and riba. The trial drug was only given the first 4 weeks. From what I have seen and heard others have cleared by week 4 also.
Epi finished a few weeks ago and I have one more shot to go (can't wait). I can not comment for her and her experience but will be glad to give you mine.
I have felt all along that this treatment would be shortened to 24 weeks...and still be successful. The 48 weeks of peg and riba totally stinks (as it does for most people)
Willing is also correct that there was some talk about combining it with Telaprevir but that is years away and not anything other than an article with a doctors opinion (Dr. Pockros maybe?)
I do not know your situation but If you are thinking about a trial, and realize that trials include the chance of placebo (but you still get SOC). You also need to educate as much as you can so you understand about the drug and what you are getting into, keeping in mind that in clinical trials you are the human guinea pig. This is the drug companies final testing grounds to determine if a drug is safe for humans and get FDA approval so it can go to market.
I can not and will not advise you as to whether you should participate. That is a decision only you can make. If you ask me my personal opinion of the drug I would agree again with Willing. I think it will be better than Telaprevir or Boceprevir, but that is nothing more than my opinion based on my experiences and all the data and research I have read. I am not a doctor, nor do I have any vested interest in the company.
I waited several years before treating, did a lot of reading, and came close to participating in a few trials. I backed away from all of them including telaprevir (then called VX-950) for various reasons. I read about R7128, was convinced of its potential and sought out a trial site to see if I could qualify to participate.
RO5024048 is better knows as R7128; I assume this is the study with clinicaltrials.gov id NCT00869661, a phase II for r7128. You can get more info about about the various arms of the study by looking on that site
http://clinicaltrials.gov/ct2/show/NCT00869661?term=RO5024048&rank=2
If you need to treat now, I'd say you're a lucky dude. This is a promising drug, better, on the strength of the available data, than either telaprevir or boceprevir. Epiphny and dragonslayer can give you more information.
If you can delay tx for two more years the situation is less clear, as you could then wait for tv/bc fda approval. The plus side is that this removes the 1/5 chance of getting the placebo arm and will allow you to supplement your tx with other drugs, eg alinia, which will strengthen your svr odds. The minus side, apart from the delay, is that you'd be waiting two years for drugs with lower SVR odds, higher escape mutation rates, and worse sx.
The optimal choice of course is combining r7128 with tv/bc but it seems that won't be on the menu for 4-5 more years.
http://clinicaltrials.gov/ct2/show/NCT00869661?term=RO5024048&rank=2
If you need to treat now, I'd say you're a lucky dude. This is a promising drug, better, on the strength of the available data, than either telaprevir or boceprevir. Epiphny and dragonslayer can give you more information.
If you can delay tx for two more years the situation is less clear, as you could then wait for tv/bc fda approval. The plus side is that this removes the 1/5 chance of getting the placebo arm and will allow you to supplement your tx with other drugs, eg alinia, which will strengthen your svr odds. The minus side, apart from the delay, is that you'd be waiting two years for drugs with lower SVR odds, higher escape mutation rates, and worse sx.
The optimal choice of course is combining r7128 with tv/bc but it seems that won't be on the menu for 4-5 more years.
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