New here- starting study with valopicitabine combo therapy

Hi everybody.  I have hep c/ 1b/ 2mil vl.  I have not had a liver biopsy and I am starting treatment on Friday.  It is with the new drug valopicitabine and interferon.  I am very nervous bc I am worried about the possible long term side effects of valopicitabine.  Does anybody out there have any information?  Has anybody taken treatment with this drug?

My doctor is overseeing the study and they are having very positive results.  Most people are clearing the virus after week 12 of treatment.  

Should I change my mind and go with traditional treatment?  Anybody know the pros and cons?

I am very worried and scared.

[keepsmiling]

my approach to worry is to dig for data.  start by going to this link - "http://www.hivandhepatitis.com/hep_c/news/2005/011905_a.html"  and when looking for information, you will find quite a bit if you use "NM-283" when you search.  this is the drug code name in development before it gets named.  the data does look promising but this belongs to a different class of drugs (nucleoside analogs) and it is hard to know how they are going to compare to protease inhibitors (PIs) down the road.  hang in there.

[crushed]

i don't know how much sound information you can get on it being it's in trials now. from everything i've read it sounds like magic compared to peg/riba. it would be hard for me to say because i haven't made it a point to study valopicitabine but off the top of my head i'd be inclined to give it a shot. it seems overall the medical community doesn't have a very good handle on this disease so imho even the current "accepted" treatment is a gamble. as for pros/cons it's hard to say i guess the pros of peg/riba would only be more data from it's wider usage, as for peg/valopicitabine it sounds very promising.

good luck with your decision

[jmjm530]

As a stage 1b (hardest to treat) I'm interested why your doctor decided not to biopsy you prior to making a treatment decision? For me, a biopsy (or at least a similar blood marker test) would provide valuable data in proceeding forward.

So let's say you biopsy and come out stage 0 or 1. You legitimately might decide not to treat. But even if you decided to treat, the question then becomes as a stage 0 or 1 do you want to try a new drug in trial or a proven approach?

That said, I really don't know anything about valopicitabine, and maybe after some studying I'd be more bullish. Which begs the question how much do you know about the drug and trial you will be entering? If at all possible, learn as much as possible beforehand.

-- Jim

[Alady1620]

Thanks for your replies.

I talked with the doctor about a biopsy and he said that since I probably haven't had the disease for an excessively long time and since I'm young, he doesn't recommend a biopsy.  If we treat and I do not respond, he will give me a biopsy.

I have done a lot of research on this new drug and it all sounds very promising.  I haven't found anything negative except in the research documentation where, in one study, lymphoma turned up in a few rats.  It has not been found in any of the human or monkey studies and none of the subsequent studies on rats.  

I have twin babies that are turning one next week.  I chose the valopicitabine combo therapy study bc it is the most likely to cure me of this disease.  I want to be around for my babies.  Also, it feels good to do something that could help people that have not been responsive to the traditional treatment of hcv.

I am going to a hep c support group in my city on Wednesday.  I am hoping that I will be lucky enough to find another person that is participating in this study.

Any thoughts on this?

[Alady1620]

I guess I should add that I am going for treatment no matter what the condition of my liver.  It is very important to me to take care of this matter.

[jmjm530]

Depending on your comfort level of going ahead as planned -- as someone who is being treated for the first time -- consider a second opinion from an independent hepatologist on whether to treat conventionally or with valopicitabine. I'd also have a sit down with your own doctor and have him outline the pro's and con's of either approach. My first doctor initially proposed I entered a trial until I Q&A'd him on risk/reward. We both ended up agreeing that a trial did not fit my needs. That said, maybe if the trial had some sexier drug I was excited about I might have bit the bullet.

-- Jim

[LvdByGod!]

is the valadictine replacing the ribaviron or is it in addition to the interferon and ribaviron???  in otherwards a three prong approach???  if it is the 3 together, if i were in your shoes i would jump at the chance to do the 3 together...

if only val and no riba...then that is probably not the best idea...the 3 together is what you want...

i may try this someday, if i don't clear. the valdictine sounds promising...  did you read the latest about it from the aasld 2005 conference...i'm sure you did...

GODS BLESSINGS TO YOU, I PRAY YOU KILL THAT THING...AND CAN BE VIRUS FREE SOMEDAY HAVING A BALL WITH THOSE KIDDO'S...

sandi



ps i would INSIST ON A BIOPSY...

my dr tried to convince me i didn't need one and i just insisted on it and he was shocked to discover the level of damage i had and now because of the damage found i have to get ct scans to check for emerging tumors every so many months, in order to be safe...there are many reasons getting a biopsy before tx.  it is necessary for you but perhaps not necessary for your dr...why should he care if you get one or not? but you should care...

what if at your 12 week pcr...the virus has not had its 2 log drop? the dr will be saying he is going to take you off treatment...now if you have zero liver damage then you may say fine, i'll wait for better treatments... but if you have stage 3 then you may want to switch meds, strengths or treatment ideas and push harder...how will you know what's right for you??? what if the treatment is really hard on you and they try to pressure you to come off...well you will not know what to do because you have no idea what condition your liver is in...see?

you cant be sure you are going to clear and coast through on treatment.  you could need this info to base tx desicions on durring tx...make sure you get one so you will have all the information you need for the future...

not to mention that it is just better to know what condition your liver is in for your own well being...

are you afraid to get one? if so they are not that bad...esp if you get the twilite sedation...i had that and it was a breeze...i didn't even know i had the biopsy...if it is the dr saying no...than you just need to put some pressure on him...

insist on one...it will show you exactly how damaged your liver is and provide alot of info on its condition, stage and grade...you will want this info!!!

[NikoS]

just wanted to wish you all the best !

[Alady1620]

The study combines NM283 and Peg-IFNa-2a together.  There is a random selection for the dosage amount with no placebos.  There are 5 groups.  Each group increases the dosage of NM283 at different intervals.

I think you guys are right about the biopsy and I am going to insist on one.  My appointment is Friday.

I have been mulling this over for several weeks now.  I have done a lot of research and I can't see anything to stop me other than the unknown.  With the success rates of val, I think I would be crazy not to give it a shot.  I am a naive patient and this is my only shot to try it.

I have a feeling that this drug, valopicitabine, is going to be successful.  I hope it will be available to all of you soon if it works.

If my treatment is unsuccessful, I will try the standard treatment but I am not very optimistic about it given my genotype.

I am also concerned about depression.  I have been feeling down for months.  I am going to get a script for an antidepressant to go along with my treatment.  

What do you guys take for side effects?  I am expecting the worst but hoping for the best.

[crushed]

on the sx it's really tough to say as it seems to be a case by case basis. i think you've got the right frame of mind expecting the worst and hoping for the best...maybe you'll be fortunate. remember you're not likely to see many posts/feedback from people who are tolerating tx well cause they're out living life rather than on the web searching for answers. some people get through tx without much problem some must discontinue because of sx. i've had a number of different sx, some come and go, some are continuous, some happened in the beginning and subsided, some have cropped up later in tx (i'm about 24 wks in). the #1 sx for me has been fatigue i believe due to exisiting anemia. there have been quite a number of others (hair loss, loss of appetite, dry skin, minor oral bleeding ect.) but remember you're going to be on different tx. depression is common with exisiting cases/tx so sometimes ADs are prescribed. many develop some level of anemia, and some require epogen/procrit but this is due to the riba which you won't be taking. i believe overall the sx from the treatment you're looking at aren't as bad as the current tx, you'll just have to see what crops up and contend with it at that time.

[crushed]

the valopicitabine replaces the riba and from the study results i've seen pretty much blows away the current treatment of peg/riba with less sx claimed. i seriously don't think you'd want all three. my gut instinct is that the riba is pretty toxic and is like hunting a mouse with a shotgun whereas the valopicitabine is more specifically taylored to the hcv virus...who knows time will tell.

[LvdByGod!]

i didn't realize the valadictine was to replace the riba...hmmm...that's very interesting...i just assumed it was an add on...thanks for the info. has it ever been concidered as an add on or always as a replacement for riba i wonder???

Alady, sounds like you really have a great handle on your treatment...i think your making a really good choice to do the biopsy...the twilite sedation is nice...

prayers and blessings to you for clearance,

sandi

[NYgirl]

I started taking Paxill about a month before tx.  I have had no bizarre depression except one day I decided I didn't need the Paxill and just stopped it. Well a few days later I was CRAZY!

as soon as I went back on........I was just fine again.  No depression at all.

BEST of luck on this new exciting treatment!

[cuteus]

it seems that a big chunk of the sides is due to the anemia from the riba, so they might not apply to you at all. Fatigue is common with the interferon as well as flu-like symptoms.
If I would have been younger, I might have tried the research studies, but I wanted HCV gone by the proven method. 50 to 60% SVR sounds good enough for me. and it did work. I had great insurance also so I did not need the help from trials. If you want hcv gone for good yesterday and have good insurance, go for what has been proven to get you SVR. None of the new meds have SVR rates as far as I know, only viral clearance.
Whatever you decide, good luck and hope for your SVR

[rudy222]

I'm in week 28 of the Phase IIb NM283 trial.  I'm in the low dose 283 (400 mlg) plus pegasys arm.  I'm GT 1a, non responder to peg/riba, baseline VL was 5,000,000.  My VL dropped 4.4 logs in 4 weeks,  then <50 at 8 weeks, and Negative at 10 weeks.  I've remained negative.

I don't notice any sides from the 283, but the peg sides can hide most anything else.  All I do know is that it's much easier to handle without riba.  There's no anemia, no riba rage,  less weight loss...less sides.

Good luck and let us know how it works out.

Rudy

[msa1633]

Hi, new here also. Going to Dr tomorrow to start the trial on NM283. Looking forward to reading and posting comments to others currently on the trial. Got my fingers crossed.
Mark

[tedw]

Appointment with the Doctor tommorrow for screening for
valopicitabine trial. It looks like the best thing going right now.