R7128 Phase 2b trial

[Bali05]

Is anybody considering this trial ?
How does this look for those experienced with trials ?

[Rockerforlife]

I guess i was lucky too,595 people im my study worldwide.

[Rockerforlife]

25 spaces world wide?....you hot the jackpot

[epiphiny]

I don't know what arm I was but my specific cohort was for Geno 3A previous non-responders. Very unusual for studies to be done for that part of the HCV infected population so I count myself incredibly fortunate to have been enrolled.  I think there were only 25 spaces available worldwide.

I was on 1500mgs R7128 daily (highest dosing regime in the study) along with 1200mgs Riba daily and weekly shots of 180mcgs Peg IFN for 28 days day.  After 28 days I achieved a >6 log drop (from 17M to <15IUL which was considered UND by the trial protocols).

After the initial 28 days with triple dosing I continued on with SOC for a total of 48 weeks.  I think if I had been treatment naive they would have stopped me at 24 due to my RVR but as I was a 2nd time rounder and it was the study drug that made me UND it was decided to keep me on SOC for 48 weeks total.

6 months after EOT I was declared SVR in October - that was 4 months ago.  I finished treatment 10 months ago.

[rexx73]

i still dont know the details of this trial.i will have a meeting in march for further infos.
i just know its a trial for nonresponders.

[Bali05]

what does your study look like and are you able to get r7128 either way ?

[Bali05]

thanks for the info.

the 5 arm study is currently recruiting as well not sure if they let soc alone
arm roll over to get r7128 if they do not respond.
the study i am currently trying to get into is an add on to the 5 arm study with a higher
dose of r7128 if you get it and with roll over option later.

what arm were you in and what r7128 dosage for how long and how long did you treat?

are you svr and if for how long ?

[rexx73]

i will hopefully participate in the r7128 trial in march/april in germany near switzerland.

[epiphiny]

I think it sounds exactly like my trial except that I had an 80% chance of getting study drug.  They also had the rollover if you did not get study drug and did not respond so that's a nice perk.  Because of that I always felt like I had nothing to lose and I know whatever happened it would not be a waste of time!  Also a good benefit for them as well of course because then they have a known stable of non-responders to study!

As you know, Viral Load fluctuates so it may be that yours is higher now (I don't know when your VL data is from) and if I recall you have been doing some alternative therapies in order to lower your viral load, is that correct?  As you are not doing those therapies any more (?) then perhaps VL has gone up.

The Alinia...  well, I don't know whether that would be a drawback or not, but probably.  We were not allowed any supplements that could affect treatment outcome including vitamins.  You could discontinue it of course, prior to screening. I presume you are taking it voluntarily anyway and not for a prescribed illness.

As to the renal functions, yes, I read the same data that you did and they include that information in their consent forms and also discussed it with me during screening.  The monkeys were treated with significantly higher amounts of the drug than used in human trials ( I was told the figure but have forgotten it and would rather not hazard a guess that would most likely be incorrect!).  During my trial they tested renal functions very regularly (I was on a Phase I trial so it was all about the pharmacokinetics and  safety of the drug) and also during screening.

I was very pleased with the care I was given during my trial, I was very closely monitored and felt very informed during the whole process.  I had easy access to all my notes (except for VL which I wasn't told about until the period with the study drug was over as the trial was double blinded) and found it very easy to discuss any questions with the study doctors.

I had to stay in the study center for the first 3 days of the trial with tests every hour, then get safety bloods and full checks done 3 x weekly for the first month, then weekly for another month and then every month for the whole 48 weeks.  I imagine that was because it was the first trial in humans and as I mentioned earlier safety was the main focus of the trial.

We did not have access to any rescue drugs, other than ADs, so I had to take a couple of riba dose reductions throughout tx, however they clearly did not affect the outcome for me. This may have been due to the country I live in but it's a good idea to check with the study center about their rescue drugs philosophy.

I also had to have a biopsy, it was no drama and it is standard procedure for all those folks enrolling for a trial. As I understand it, if you have had a biopsy within the last 2 years then you may not have to have another one.

All meds and test procedures were paid for by the trial, including all my blood tests for 6 months after the trial. I was also paid a nominal amount and reimbursed all my travel expenses from my home to the study clinic.

I'm sure you have this info but just in case you don't here is the link to Pharmasset's website that gives you the progression of the drug through trials.

http://www.pharmasset.com/pipeline/R7128.asp

Hope some of this info has been useful!  I wouldn't delay in trying to get on the the trial as from what I can see places are filling up fast, and it is unusual to get a trial that is covering Geno 4s.

All the best!

Epi :)

[Bali05]

i am going for it.

two things I need to over come:

1. I am currently on Alinia that could cause a problem

2. My viral load is below cut of 46K IU/ml  (cut of is 50)

Here are my trial specs let me know what you think.

The nice thing is even if you first get placebo should

you not respond to SOC control arm they roll you over

later so you get RG 7128 either way.

I read RG7128 also has low resistance tolerance another plus.

Only problem it showed some renal problems in monkeys but not

in humans thus far.

The study is Peg/riba vs Peg/riba plus RG7128 for 24 weeks (if patient has an RVR they stop at 24, if not SOC will continue for 48). There is a 50% chance of getting either arm, however they are going to add a roll over study. So if a patient gets SOC and doesn't respond, they will be able to roll into another protocol which will give them the study drug. RG7128 has an 85% RVR rate, no SVR data is available yet. The patient would have to undergo a liver biopsy. Viral load must be >50,000. Visit schedule is Baseline, wk 1, wk 2, wk 4, wk 8, then every 4 weeks until wk 24, and every 6 weeks after that if they continue.

What do you think ?

[epiphiny]

I was just reading another thread of yours and notice you are Geno 4.  Thought I would mention that I was Geno 3A which in some cases is as hard to treat as Geno 1 if the patient does not respond to SOC.

R7128 is filling the gap that BOC and TVR don't cover - it's true that they are not proving wildly successful for non Geno1s, but R7128 is showing great results across the board with all Genos.

I would highly recommend that you research the trial fully and try to get on it.    

[epiphiny]

I can't speak about this particular trial but I did the 1b trial of this in 2008 and it was excellent. I can't speak highly enough about R7128 - I was a previous non responder and went UND at week 4, after 28 days of the trial drug and SOC.  I am happy to say that I remain UND and was attained SVR in October 2009.

I would be happy to answer any other questions and if you provide a link to the trial protocols I can compare it to mine.

All the best!

Epi :)