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]

Will they tell you the results of your PCR's all along?  How blinded is the trial?

maxy, you are completely right.  At some point you decide whether to go for it or not - whether it's treatment or treatment on a trial -  and then you hope for the best.  I did a Phase II trial too and thought about it very hard and hoped for the best also - so you are in essentially the same position now that I was then.  I sincerely wish you all the best and I will be very interested to see how you make it and hoping like he!! for you.

Trish

[maxygirl]

They will be taking blood weekly for the first 3 months to monitor anything and everything..I trust them...but I sure hope I am not being foolish or naive.  You need to trust at some point.  My hepotologist recommended this for me.  So anyway my first shot was postponed to next friday because I am in the 3rd week role out.  I am doing it anyway...I want this virus gone!

[Trish77]

Sounds like they're being very upfront with you and providing you alot of information, that's great.  Interesting to note that they *will* be monitoring the cardiac effects, I'll be interested to see how the results come out.  A bit odd that you were able to get those results but Roche has yet to post anything on it's site and I had a hard time coming up with any posted information other than insider scuttlebutt.  When I headed into my Phase II trial, there was definitely Phase I data to go and easily available.  

"They will stop or reduce dosage regarding side effects." - they flat out said they would not use rescue drugs as a first step to prevent having to reduce treatment drugs regardless of what week of treatment you're in?  Personally, I'd check this out and talk to them about this but I've already brought this up a couple of times and I'll leave that with you.  

Good luck with this.

Trish

[newleaf09]

English is my native tongue.  I write in english.  I am not responsible for readers who cannot read english.  You must actually read the post to get the meaning.  No where did I say 'all trials are good'.  Nowhere did I say all trials offer crossover.  The word 'many'  does not equate to 'all'.  Use a dictionary to decipher the posts if you need to.  Do not go into attack dog mode until you have actually read the posts for sense.  That behavior just brings discussion to a halt and kills the thread, an unfortunately frequent occurrence on this forum.

FYI, crossover information appears in the informed consent for for a trial, which I referred to repeatedly (crossover that is, trying to be as clear as possible here) in my 2 posts.  People in some of the current phase 3's in progress right now, trials with placebo arms, are offered crossover.  The information has appeared in the posts numerous times.  To be even more specific, I am referring to the current treatment-naive trials for Boceprevir and SCH 900518.

[FlGuy]

Proceed with caution when you report potential side effects of the meds. If the doc tells to "take two bananas and call me in the morning" watch out!

[maxygirl]

Yes I did have an EKG.  They will stop or reduce dosage regarding side effects.  Also RO5190591 was given to monkeys for 14 or 28 days, damage to the heart muscle was seen in 3 out of 50 monkeys given very high doses. However the same findings were not seen in a different study when monkeys were dosed with RO5190591 for 3 months.  In all studies in humans to date, no damage to the heart muscle has reported in all doses including the highest 1600 mg single dose in healthy volunteers. My heart will be monitered (cardiac troponins test) throughout the study.  yes they do give the known sides for the drug as it has been tested in 2 other separate studies.  Not  all in humans are comletely known at this time.  They have been very good to me and call back if I leave a message very quickly and encourage me to ask them anything at all.

[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.

[maxygirl]

I am assured I will get standard care no matter what.  Yes we spoke of sides and they will deal with them as they arise.  Fig:  what do you mran by bottom feeders?

[newleaf09]

Thanks for posting.  Several on this forum have been in trials with good results (self included) and follow the folks in the latest trials with interest.  I know that many of the pharmas allow "crossover" in phase 3 trials but, of course, I don't know the specifics of your trial.  "Crossover" means that if you were in a placebo arm and did not clear the virus in a specified time, you will be allowed to move to a different study that adds the experimental drug.  "Different study" just means that your data goes into a different file, no change in anything else except for the addition of the experimental drug.

Your informed consent should detail the expected side effects of the trial drug, which in a phase 2 trial may not be entirely known yet.  It's safe to say that more participants will get the first side effect on the list than the others.  My first week on treatment was with the peg & riba only.  I felt odd but had no actual side effects until at least the second month.  Most folks have a flu-like reaction to the interferon that moderates or goes away after the first 2-3 shots.  The trial drug was added at 4 weeks and had some obvious side effects of its own, like odd taste in mouth and GI effects.  The most obvious indicators that you are on the trial drug instead of placebo are in the bloodwork, particularly a dramatic drop in viral load.  Good luck; hope it all goes well.

[FlGuy]

If this is it....

http://www.clinicaltrials.gov/ct2/show/NCT00963885?term=NV21075%2FA&rank=1

[FlGuy]

For those who like to play with numbers (and many people here like to do so).  This trial seems to have an enrollment of 300 and 6 arms.  Two of the arms are placebo.  So, if of equal size, a participant would have a one in 3 chance of getting the placebo.  The other arms get the study drug, in varing doses with varying durations.  The placebo arms are also 24 or 48 weeks.  Limited to Geno 1, I'm thinking the bottom-feeders are those who get peg/riba for 24 weeks and since it's Geno 1 only, that's kinda of risky.  I haven't looked at any published reports for prior results.

[Bill1954]

Very well put, Trish.

[Trish77]

I'm going to echo what FlGuy said:

"The mystery drug should not be a mystery to you.  In addition to knowing what the drug is, you should have some ballpark concept of what the chances are that you will receive the mystery drug versus the placebo.  In addition, you should also have some idea about what addititional drugs (for the side effects) may be allowed, or disallowed, based on the trial protocols.  Did they cover this stuff with you?"

Your trial is a Phase II trial - which means they're still working out the kinks and what dosages are most effective.  Phase III is the final phase of a drug trial progression.  Do you have any information on the side effects that were found in the Phase I portion?  Did your medical team go over that with you, what side effects were found from the "mystery drug" in Phase I ?  That's something you should be looking into and asking them.  I did a Phase IIb trial and side effects from Phase IIa were a weakening of the immune system at certain dosages.  Since you have no idea which dosage you're going to get on this trial - you get what you get - I would at least ask for details on the results of Phase I. I did do a quick look for this and got "no results available."  However, your medical team should know *something* I would think.

Some of the typical side effects from the treatment drugs themselves aside from the trial drugs is that the ribavirin can drop your hemoglobin - HGB - and the interferon can drop your white counts - ANC - Absolute Neutrophil Count.  You'll want to keep an eye on those two counts - HGB and ANC.  On pretty much every trial, they have a requirement to reduce your treatment drugs if your HGB or ANC drop below certain levels.  You'll want to ask about that and at what levels they'll reduce your drugs.  That requirement is much stricter usually than if you were on regular treatment.  Since reducing your treatment drugs can threaten your outcome if reduced too soon, you'll want to know at what point your medical team will be forced to reduce your drugs due to trial requirements.

If HGB or ANC drop too low, that can be harmful if not monitored and managed.  Everybody has different tolerances for what they can handle.  An HGB of 10 might lay somebody out while someone else may be able to function reasonably as long as they get sufficient rest periods.  There are what we call "rescue drugs" that can bring up those levels and particularly in the early stages of treatment, specifically the first 12 weeks, you want to keep your treatment drugs at full strength as long as it's not detrimental to your overall health.  So this is when the rescue drugs come in.  Procrit brings up your HGB and Neupogen brings up your white counts.  Both are injections.

So...the question you also want to ask your medical team is...are rescue drugs allowed and will they introduce them first to avoid having to reduce your treatment drugs?  Does the trial pay for them or is this something you'll be expected to pay for if they use rescue drugs?

You'll also want to know at what frequency they'll be doing your PCR's.  Trials are pretty good about frequent testing but still, a good question to ask and this might be in the documentation you've signed.

I hope I'm being clear. I don't want to burst your bubble but these drugs are serious business and you'll be on them for up to 48 weeks.  You should make an effort to know as much as you can about the drugs you'll be putting into your body the next while and what the potential impact is.

Sorry if it seems I'm being a killjoy.  Just want you to know what you're getting into.

Trish

[maxygirl]

Ok I am going with that...making a little ritual or routine and stroking each one of my calendar.

[Marcia2202]

Wishing you all the best with starting treatment. At first I was weary about having to do my own shots... ewww, I found it kinda gross.... but after the first shot I started having my little routine and was actually looking forward to it. Tx is a strange thing!

[Bill1954]

I’d like to offer you good luck with all the rest. Regarding what to have on hand at the house, I think you’ll find the most important item is a sense of humor… this is critical, and will help you through the difficult times better than any Rx drug available. Having the capacity to laugh at one’s own situation is paramount to survival.

There is an old webpage floating around that you might review; it’s dated, but the basic principles are intact:

http://www.hepcsurvivalguide.org/comboguide.htm

Best to you—

Bill

[maxygirl]

Thanks so much.  I get standard treatment along with the new drug (which is numbered) RO5190591.  I have signed the consent.  The study in now on line it is at govtrials.com and it's ref is NV21075/A.  It just went up.  It is phase 2.  My only restictions are grapefruit juice, apple juice and Seville oranges.  I feel I can handle that. lol.  

Yes the first shot angst is crazy.  I want the treatment asap so I can clear it and get on with the fun side of life.  Traveling, horse riding, etc...

I have copies of everything in a binder and I understand so much more doing due dilligence on my own with results in hand.  

I will keep my wonderful friends informed and thanks again!

[nygirl7]

Good lucky Maxygirl.  Treatment isn't fun but for the most part you will find it doable....and it works!

The best thing to do is get prepared for everything but expect nothing.  You could easily be one of the people who hardly experience any side effects at all.  so.....don't run out and buy things assuming you'll need them cause you just might not! :)

I had none of the flu symptom stuff till about week 30 (of 72 weeks). I did take two tylenol with each shot to help make sure I didn't get any fevers or anything.  Seems to have helped.  That was my biggest fear that first shot - what are the flu symptoms going to be like how bad?  Got nothing. :)

Make sure you get a copy of every single test that you have and put them in a folder. Learning what the results actually mean can really really help you so much.  Plus it's kind of fun later when you get obsessive later in treatment to compare compare compare LOL.

Ask all the questions that you have.That's the best way you can learn and believe me with this disease the more you KNOW the better your chances are. Docs still say 50/50 but around here no the odds are SO much higher because everyone is informed and knows all the little 'tricks of the trade' and it DOES help.

Good luck!

[HCA]

FlGuy is right.
You will have to sign consent forms which provide disclosure on the drugs involved in the trial.
They won't tell you if you are randomized to placebo,but the drug will have a name or number,and there will be a wealth of info already available
As the drugs are being trialed in combination this sounds like a phase 2 trial  at least.
You don't have to know this stufff,but most of us like to know all about the trial drug-some of them are very exciting.
Also,as previously mentioned you will be given a list of medications (and maybe even food) to avoid.