First shot

[maxygirl]

I start my first meds in a trial by Roche on Sept 4.  The drugs are Pegasys and Copegus and either a placebo or some mystery drug.  I  just want to now if the side effects start right away?  I am geno 1a stage 2.  Any suggestions are welcome as to how to prepare....or what I should have on hand in the house.  I wonder if I will be hungry...

[Trish77]

FlGuy - I don't think this trial has 6 arms.  I think it's 4 arms for Phase IIa and 2 arms (Potentially more) for Phase IIb.  The last two arms seem to depend on how the first four arms make out with 12 weeks of the trial drug.  The next Phase will be 24 weeks with the trial drug at a dosage to be determined based on results in Phase IIa.  That's how I read it.

Newleaf:  I have read you saying more than once that many trials will allow you to roll over into another treatment phase with the trial drug if your treatment is not successful.  I don't think this is entirely true and I would hazard to say that most trials don't allow that.  My trial and many others offer/ed another round of treatment of SOC only but not the trial drug.  

Just because a trial is free doesn't mean it's always good.  In retrospect, I took quite a chance with mine and my interferon was at half dose for the first 12 weeks and ended up not getting full dose interferon for much of the trial and then getting pulled at 34 weeks. A number of people on my trial were dose reduced much sooner than me, others had their interferon stopped entirely and then we were all pulled from the trial when it was cancelled before the full trial was done.  It was Phase IIb even and was considered very promising at the time.  There are alot of things to consider in trials and I wish you would be more discriminating about your blanket statement that all trials are worthwhile.  

Each trial needs to be examined on it's own merits taking into account the details of the arms, the amount of liver damage the person going into the trial has, the personal circumstances of the person, etc.   Trials have regulations they are bound by and dosage reduction rather than rescue drugs are too often the approach and at marker points for HGB and ANC that would not be considered an issue on regular treatment - but because they're trialling a new drug, they take less chances.  Trials have to go by hard and fast lab results, not on the individual circumstances of the participant.  Sometimes undergoing regular Standard of Care - SOC - is a safer bet than a trial depending on the overall circumstances and sometimes being able to customize your treatment with a willing and experienced hepatologist is even more superior than a trial - again, depending on the overall circumstances.

Okay...getting down off of that soapbox ..for now.

Maxigirl - the dosages in the arms of your trial look good.  You get full SOC treatment on each arm, no compromising there.  The amount of the trial drug is then bonus so it doesn't matter what arm you get, it's simply a lesser or greater bonus.

The concern is not knowing the side effects experienced in the previous Phase I trial.
Here is a link to trial results for all Roche trials -  Your trial - RO5190591 - is on the list but Roche has not posted any results yet so it doesn't really tell you that much.  Just posting it for your reference and for anyone else interested.  Again, I would ask your trial team about this and see what they have to say to you.

http://roche-trials.com/patient/trialresults/drug.html

  I'm curious if they gave you an EKG?  I read on one site where there was chatter between prospective Phase II participants in your trial that there was found to be cardiac muscle damage in monkeys who were tested with the drug and the non-official comment of the poster is that they had resolved this but were still monitoring this in participants of the trial just to be safe.  

http://hcvsupport.org/forum/index.php/topic,7287.msg59590.html

Will they be monitoring your cardiac functions?  Is this in your documentation?  Just curious if this chatter is reflected in the tests they'll be running on you throughout.  I do note that one of the exclusions in your trial IS cardiac disease - period.  So there may be something to the comments of the chatter of those posters.

Your trial:

http://www.clinicaltrials.gov/ct2/show/NCT00963885?cond=%22Hepatitis+C%22&rcv_d=60

Again - if I were you - I would ask the question if the trial dictates that they would have to reduce dosages if your HGB or ANC drop below certain levels and if your team would use rescue drugs FIRST to avoid those dosage reductions particularly  in the first 12 weeks.

You want to get back to your life as soon as possible - well then, I would suggest you learn as much as possible to maximize the benefit of being on this trial or consider if regular treatment is a better option for you.

If you decide that this trial is your best option, hopefully this is a one-shot deal for you.

Trish

[newleaf09]

I looked forward to the shots, too (and always felt a little strange about the excitement).  Every shot was knocking down another time marker, and the shots always made me feel like I was really doing something about being sick.  Kind of odd, since they made me sick and I knew it.  Every one was another week down.

[mpace6983]

MAX, If you start to have chronic depression,you might ask your M.D. about an SSRI (paxil ect.) but Im taking Ultram for body pain ect. It is a very unique pain med in that it not only provides analgesia sort of the way a narcotic does(with much less sedation and less problems with respratory depression. It also has effects similar to the SSRI's effects on depression/anxiety. but you are not supposed to take the 2 together (SSRI's and Ultram, that is) Good luck and dont forget:"its a marathon,not a sprint"

[newleaf09]

I don't think he means it the way it sounds.  I think he just means those that get the least opportunity (no study drug).  Several posters on this forum (self included again) went into trials with low viral load and cleared on SOC (no study drug).  Don't ever think that getting SOC is a wasted opportunity especially if there is crossover built in (see informed consent form).  After all, the entire care will be top-notch and absolutely free.  Costs for drugs alone if you pay yourself is $30,000.  Then add in all the labs and doctor visits if not in a trial.

24 wk. treatment would be part of "reponse guided treatment", meaning that those who clear early would have a chance at stopping at 24 weeks.  Your informed consent form will spell out the details of that.

[FlGuy]

read more about trials at clinicaltrials.gov

PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.

PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.

[FlGuy]

Poor choice of terms, maybe.  What I mean is that with only 24 weeks of peg/riba/placebo treatment a Geno 1 (which normally has treatment for 48 weeks) seem to me to be a longshot for success with 24 weeks. And, if arms are equal you have a 16% chance of placebo and 24 weeks.  A reality to keep in mind is that the goal of a Phase 2 trail is not necessarily to cure people.  As a trial it's to determine the dosage, duration, effectiveness and safety.  Although the endpoint is svr at 24 weeks post treatment, it's what's learned along the way that's important to the sponsor.