NM283 Treatment

I am looking for anyone who has participated in any of the NM 283 trials. I am geno 1a with a very high VL and stage 2 fibrosis. I was diagnosed several years ago and opted to not go with combo peg + ribavarin after researching it a lot. My doctor agrees with my decision as I fall into the most difficult category to treat. I am always looking into new treatments and reading up on the trials. My doctor who is the top guy in my State has asked me if I want to participate in a new trial coming up that he is involved with that uses NM283 in combination with peg and riba. It is very intreging to me as it looks to be very good. He feels this is the best one to come along to date. The sides are supposed to be very mild I believe due to lower dosing with peg and ribavarin.

My question is to anyone who has participated in NM283 before and do they still have SVR? Can you share your experiences with treatment?

[jmjm530]

I'm not that familiar with the NM283 trials and hopefully others will have more info here. But from what I've heard, Vertex seems to be the most promising of the newer trial drugs in the pipeline.

You might therefore ask your doctor why NM283 versus Vertex? Another question you might ask is the feasibility of waiting another year until more trial data is out. Vertex, for example, should have SVR data flowing in all throughout 2007.

Not surprisingly, doctors tend to recruit for the trials their institutions are affliated with and often receive monetary and other benefits. Nothing really wrong, this is how the system works, but to me this sometimes can cause a conflict of interest.

I'm not saying this is the case with your doctor -- and in fact he may be running Vertex trials as well but thinks NM283 is your best option --  but if I were in your shoes I'd independently research out your options including the NM283 trial, the Vertex trials, or watching and waiting for more trial data.

All the best.

Jim

[jmjm530]

I'd also like to add that if you're considering a NM283 trial -- or any trial for that matter -- ask your doctor for complete trial information. It's also a good idea to ask for any written documents, including consent documents, in advance of your decision, for you to read over.

Among the things you might want to know are: whether you'll be taking the drug by itself or in combination with Peg and/or riba; how long will treatment be; will there be a placebo arm (meaning you might just end up on peg and riba again); will they allow "helper" drugs, etc.

[FlGuy]

You are in an interesting position. If there is good news in your situation it is that (at least for trial purposes) you are geno 1 and haven't treated before. Liver condition may set some urgency. The question is if you elected not to treat in the past, because of the meds, what is different now since NM is peg/riba also - even is the doses are lower. In a similar position (except g3 relapser) I'm looking to see if there are any trials available near me.  As Jim mentioned, I might be inclined to try VX950 even if it includes peg/riba,and it still does in the US. But, the results data (including svr) is still not complete. The quandry is the other PI's that are out there in trial, including and especially NM. So, (and assuming that I might qualify for trials) which is the way to go?  Like you, don't know yet but trying to get any info I can.  I grudgingly realize that there might not be an escape from peg/riba given my need to treat pretty soon.  Not sure if you have a timeline to poop ot get off the pot. If you haven't yet done so, do a trial search on clinicaltrials.gov to see what might be available in your neighborhood.

[FlGuy]

A very big ditto to Jim's comments in C2.  On the other hand, I'm wary of percentages when it comes to anything related to hcv.

[GrandOak]

I agree with Jim in that you may not want to be placed in the control group for a trial.  As for VX950 and other such trials, I'm of the understanding that they do not replace current tx but rather augment them as another med to through into the anti-viral cocktail.

I'm not sure of the logic on not treating because of difficulty to treat. As a Geno 1A stage 4 with a 72,000,000 VL (which I'm told is *very* high) I figured that dragon wasn't going to die if I left him alone.  So might as well tx and if SVR is not reached, at least liver gets a vacation until that magic silver bullet overnight cure pill Jim often talks about is found.

[jmjm530]

GO:"...until that magic silver bullet overnight cure pill Jim often talks about is found."
-----------------------
I must have been talking in my sleep cause never said that :)

What I did say is that they're some very promising drugs in trial, and in the case of Vertex, we should have some decent SVR data by the end of 2007. For those that can/choose to wait, this should be factored in.

In any event, Vertex or not, "overnight cure" is unfortunately not in the cards at present. However, what is being tested are *shorter* treatment periods -- possibly as short as 12 weeks -- using a drug like Vertex in combination with Peg and Riba. To me, a 12 week exposure to peg and riba is significantly different from a 48 or longer week exposure. In Europe, one trial arm is/will? be testing Vertex with Peg and without riba. In the future, it's possible they will test Vertex without Peg and Riba or possibly in combination with other Protease Inhibitors. At the moment lots of hope but still uncertainty as no SVR data has come in. In another year we should have a lot more info.

-- Jim

[Kalio1]

One thing that is not mentioned often here is that when and if the "new drugs" are available to the public there is nothing that says insurance companies will be willing to pay for these new drugs for patiennts to use. I very much doubt they will be on the "formulary" of insurance companies right away. They will be brand new drugs with no track record and that fact might very well make them unavailable to most. We also do not know what the cost of these "new drugs" will be to the patient. INF/Riba is a very expensive treatment as it is, I imagine new drugs will be even more so. It is likely the cost of these "new drugs" will fall to the patient and we have no clue what they will cost. Someone has to pay for all that R&D they are doing and it will be the patients. After they are on the market and have proven to be successful then we MIGHT see insurance companies willing to add them to their "formularies."

[jmjm530]

I would think (using a hypothetical example) that if a new therapy demonstrated in a large trial that geno 1's could be more effectively treated in 12 weeks than in 48 -- that the insurance companies would be quick to put the drug on their formulary list. Forget the pressure by the medical community, it would seem to me that a shorter treatment would be to their financial advantage. It's not just the cost of peg and riba they would be saving with a much abbreviated treatment time, but possibly the cost of helper drugs as well such as Procrit and Neupogen.

[couldn't think of a nickname]

IMHO, the subject of paying for new HCV treatments is very much overblown. New drugs are added all of the time. It is not unreasonable to expect that VRTX could even charge more than current therapy, and it not be an issue. Consider:

On SOC, half fail, and have to re-treat. Half of those half fail again. Cumulative costs are quite high. If VRTX gets 80% plus SVR, you can see why a higher cost might be justified there all by itself.

Other costs to having the disease. Liver transplants, at 350K+, plus a lifetime of expensive meds.
Disability due to either disease or tx, which has a cost to society and ins. cos.
Lack of productivity has a cost also, which is an issue with the disease for those who are the most adversely affected by sx's.
Hospital admissions and costs.
SOC also requires many other drugs to be rx'd also, which really adds to the cost.
Add 1 year of an SSRI vs. 3 months.
Procrit.
Neumega possibly?
And other meds many have to take for an entire year vs. 3 months.

The equation isn't just 30k for SOC vs. 30K for a new drug. In fact, I believe that SOC is much more expensive than a newer drug with higher SVR in a shorter time would be.

The real magic bullet IMHO comes in the second generation drugs, none of which are in the clinic yet. VRTX is clearly the leader, and there are those in the industry who acknowledge that readily, and are looking for a way to better it. VRTX already has a second gen compound in development, 2 years behind 950.

Can you imagine the outcry if a cure for HCV were not covered by insurance? You won't find a politician around who wants to stay a politician rule against coverage.

[cuteus]

Rudy finished NM283 tx and is awaiting PCR results for SVR information. He reported manageable sides and early response.

alady is also on NM283.

[Kalio1]

There isn't a " public outcry" now for people to be tested let alone treated for this disease, I doubt there would be a sudden outcry if patients couldn't get brand new meds. Many patients aren't even able to get medications covered at all that they have gotten in the past for ongoing illnesses, heart medications for instance. Many people have difficulty getting the CURRENT meds covered or their copay is so prohibitive they can't afford treatment.
You have a lot more faith in insurance companies  than I do.
Insurance compaies are covering fewer and fewer medications for their paying public as time goes on, and putting more and more limits on what they will cover.

[Kalio1]

There isn't a " public outcry" now for people to be tested let alone treated for this disease, I doubt there would be a sudden outcry if patients couldn't get brand new meds. Many patients aren't even able to get medications covered at all that they have gotten in the past for ongoing illnesses, heart medications for instance. Many people have difficulty getting the CURRENT meds covered or their copay is so prohibitive they can't afford treatment.
You have a lot more faith in insurance companies  than I do.
Insurance compaies are covering fewer and fewer medications for their paying public as time goes on, and putting more and more limits on what they will cover.

[DragonSlayer45]

To answer a few of he posts, which seem to mainly be talking about VX-950, I also have been reading all the info on VX-950 and felt it looked to be the most promising drug out there. The one really small trial they had where 12 out of 12 had significant reductions was remarkable. I spoke to my doctor about it. That is when he told me about NM-283 and said to do my homework because he knows I will research it. He also stated that with protease inhibitors there is some concern about the virus mutating and then becoming resistant. He said the early indications are that is not he case with NM 283. At that point I really did not know a lot about NM 283. It is not a protease inhibitor but a polymerase inhibitor. The have done trials with peg with very good results. This next trial, which he feels is going to be the preverbial ticket is with peg and riba.

The reason I never treated befor is the fact that being only stage 2 level 2, and my ALT AST levels always coming back normal there was no rush. My only concern is the peg and riba. I am going to call him back and go in to talk aout it more. Like I said he is a doctor on the front lines and is really up on all the latest (unlike my original doctor who was clueless). As far as doctors who are paid by pharmaceutical companies and push patients toward a particular treatment as a result, I am sure that happens but do not htink that is the case but will heed the advice and look into it.

[DragonSlayer45]

Cuteous,

Did your friend who took the NM trial come back non detectable? Would they be willing to talk about it? I am very interested.

[NYgirl]

I am BOTH a geno 1A and a 1B - and my doctor wanted me on PegIntron ASAP.  He feels that included with the Riba is the best chance.

Having two strains gives me a worse chance of SVR I guess.....so I take his advice and have found that it's tolerable although not pleasant (doing tx).

I can't imagine a doctor telling a 1A not to take Peg it is our best chance - dam* the sides and that is what matters

(PS 1B is supposed to be the very hardest strain...so at least you caught a tiny tiny tiny little break there :)

[cuteus]

alady is still on tx and drops by from time to time. Rudy will test at the 6 month post tx mark, I think he still has a few months to wait. His post may be in archives here in MH. those are the only two i remember. I think there might have been one more person but did not become a regular here. Rudy was negative after 48 wks of NM283 plus, IFN, I think. See if you can find him in archives, he might have posted in the threads titled NM283.

good luck

[cuteus]

I almost sent one thru the tristate area!! I missed you!

[FlGuy]

While you are researching, you might take a look at results for Viramidine.  Appears to be intended as an alternative to riba. In the big scheme of things, from my view, the two bogeys seem to be length of traditional combo (looks like 48 weeks if I do that again) and the riba.  Although you will read here about the experiences of many people post-tx and their experiences with IFN, I personally would like to avoid riba more than IFN. Good luck in whatever direction you take.

[FlGuy]

Good to read you again.  I was beginning to think that you were thrown in the slammer for holding up a Good Humor truck.

[cuteus]

here is the thread where Rudy comments
http://www.medhelp.org/forums/Hepatitis/messages/40395.html

[way]

Kalio--Hello I have BC/BS also and am coming up on my 8th wk of tx. So far so good but will know more tomorrow after doctor visit about blood work etc.

You said BC/BS wouldn't cover procrit at all.(did you get any rescue drugs) Did you call and ask, or your doctor or hemotoligist or what? Do you mind elaborating?

Frijole-- what about you-- did you have a problem with BC/BS covering rescue drugs??

Thanks. Way

[Kalio1]

There are probably dozens if not hundreds of different group programs and individual programs offered by BC/BS. Mine is a group coverage program thru the workplace, we pay 800/month and they do not cover rescue drugs for Hep C "normally" and never if your Hgb is above 10.0. I have not fallen below 10 so I have not had to fight with them to get those drugs. The doctor is willing to challenge them on this issue if/when necessary but when I asked them they said Procrit was not covered under "normal" circumstances,whatever that means. There are many people here on this board who do need them and are able to get them, I am not saying it is not possible but they are not as readily available as one might think. I would call your company and ask, BC/BS do have some of their formularies online so you can possibly look it up and see if it is on your policy. Also you can speak to your doctor and find out his stance on the subject and see if he/she would be willing to use them if needed and fight the ins. company for you if need be. My policy also changed the formulary from whe we first joined the company and took away many drugs that were previously covered last year.
Although they do cover the INF/Riba, they did not consider IFN a "pharmaceutical" beause it is self administered and injectible so the cost was prohibitive. Although I am fully insured, my drugs are provided for me by Commitment to Care and NOT BC/BS because it was much easier and cheaper that way and they qualified me for the program. I don't want to discourage anyone but just want people to be realistic when it comes to insurance companies and their willingness to pay for drugs their patients need. My coverage has decreased dramatically in the last decade and the costs have increased in equal measure with fewer and fewer drugs being covered. I am sure what state you live it has some impact on it and also the policy you have will weigh into the equation.

[couldn't think of a nickname]

A couple pieces of news. I hated to post this before, as I could not confirm the rumor, but BMS is no longer pursuing it's PI program, which was similar to BILN from what they say. That info is out in public now. Hopefully, ITMN's isn't affected, as there are supposed to be similarities. ITMN's is also thought to be the best in class, but there is no patient data yet, so I am not sure if that is a fair statement. It has excellent pre-clinical data though.
PI's are the most effective route, more effective than polymerase inhibitors. All data shows that. However, I said this many months ago, and now believe it has been proven, that SGP made a big mistake by not doing another Phase 1b dose escalation study. I had previously stated that their data didn't indicate they found optimal dosing, and now they have rolled over their patients in Phase 2 into a higher dose group, to get better efficacy. Their goal of Phase 3 by the end of this year, obviously, is out the window.
And, there is something to consider with NM283 and ribavirin. ALady touched on the side effect profile. 283 and riba are both nucleoside analogs, and one of the potential problems is synergistic GI side effects. Out of the major analysts that follow this space, Piper Jaffrey has been the one out in front of that potential issue.

Back to SGP, their drug was pretty potent in vitro, so it was suprising their data wasn't better initially. Let's hope they can find optimal dosing.
950 was given a name (can't recall, starts with "tel" and ends with "vir").

[Alady1620]

I forgot to add that I cleared HCV somewhere between week 8 and week 12.  I had a 2 log drop by week 4.  I am in week 33 and I am still clear.  Also, I have not needed rescue drugs cept for the Zofran.  All my lab tests come back fine.

IF you do this study, INSIST they give you a 'script for Zofran.  It is the best thing on the market for nausea.  You will thank me later. :)

[jmjm530]

I guess I'm even more confused why your doctor is so keen on NM283 in light of Alady's post suggesting that the trial is for 48 weeks and might include both Peg and Riba. In your first post you indicated that both you and your doctor agreed to wait because the only alternative then was treating with Peg and Riba then. The difference here with NM283 is potentially a better chance at SVR but not less exposure to Peg and Riba -- unlike with the Vertex trials where some arms are doing less than the 48 weeks.
Something definitely to check out and querry the doctor about.

[Alady1620]

I asked my nurse about this, jmjm, and she said it is a very low dose of riba.

[DragonSlayer45]

To aLady:
First of congratulations on being clear and I pray that you you have a SVR!
From what I had been reading they said that some people experience mild nausea from the NM 283 and those were one's on higher doses (like yourself). It also sounds like the peg was causing your other sides. I also understand that the riba is the rougher of the two. My biggest concerns are with using the peg and riba. The sides can be rough for some and downright toxic for others. I know there are people who experience little to no sides with them but I can also name a few (some personally) who had an awful time with them, not to mention the chance of becoming anemic and phantom other symptoms after TX. I know that everyones experience is different but did not like the success rate of the original combo (peg and riba). I have heard from all the people over the years who go right for the treatment and doctors who tell them to go right for it, but it is a personal choice for me. i do not just follow blindly I want to do my homework always. I figured I would wait and then if something better came along I would be a TX niave patient. Like I said in an earlier post I had really been watching and hoping the the protease inhibitors were (and maybe still are) the future of treatment until My doctor told me about the polymerase inhibitors. Now I am researching them and trying to talk to people such as yourself to get first hand experiences about it. I have still held out before calling my doctor back as I am a little nervous as I do not know as much as I want to yet.

[Kalio1]

I am so glad you brought that up, sounds like you have a wonderful pharmacist. That's great your pharmacist went to bat for you. I too had great treatment from my pharmacist who went above and beyond the cal of duty when my meds didn't arrive in time. She gave me Riba to  hold me over until Monday when I was panicking on Friday when the package of meds had't arrived.
Pharmacists can be another helpful assistant for people facing difficulties with insurance companies, thaks for bringing  that up!
Hope you are feeling OK with sides and not being affected by the power outages in your state, in the news here they make it sound like it is a widespread problem but they tend to exaggerate!

[Pdilly]

Check this out. You may find out some info.

Click on the one your are interested in for the info.

http://www.hcvdrugs.com/

[Pdilly]

My doctors NP called my perscription coverage and got them to accept another area to supply my tx drugs.  The cost is only $55 a month.  I was expecting so much more.  I guess I must admit I like my drs office more and more.
Insurance companies can make thins so complicated and hard for people to do what they need to do.  I really  feel for some of the people that can't get much help.

How you feeling NYGIRL?   Had not seen you post in a few days and was wondering if you had a blackout there in NY or somthing.  Have you heard from DogLover28?  She was to have her bx on monday or tuesday but have not seen hide nor hair of her for about 2 weeks now.

[DragonSlayer45]

jmjm,

Here is the link to the article I was refering to earlier today that the HCV advocate conducted with Dr. Pockros. It is a good read and he explains why they are using the new drugs with peg and ribavarin.

http://www.hcvadvocate.org/hepatitis/hepC/Pockros_interview.html

[DragonSlayer45]

Thanks for the link, I had been to that one earlier. This is a great forum, with a lot of great people with really good information.

[DragonSlayer45]

The doctor told me that they are lower doses of both the peg and riba and better tolerated. He also said that the best chances of SVR and not having the virus mutate and become drug resistant is to hit it with all three. He is the leading HCV Doctor in NJ and on the forefront of HCV treatment. He recently chaired a major conference with one of the worlds leading doctors on HCV (can't think of the name). Having said that I still do not follow any doctor blindly. That is part of the reason for posting here to see about others experiences so I make an informed decision. I also read an interview online with another leading doctor who talked about both VX and NM. It was pretty good article and he pretty much echoed what my doctor told me. If I can find it I will post the link. It was not really an in depth interview but he talked about both drugs. Like I said I was really excited about VX 950. I feel like they are getting really close to a cure now to rid the world of the Dreaded Dragon.

[Alady1620]

There is one thing that you can be sure of if you do decide to treat on the study.  That is you are monitored very closely.  For the first month, I went to the doctor every week.  I now go once a month.  Each time, they draw a bunch of blood and run at least 20 different tests to make sure I am ok.  They also to EKGs periodically.  

I understand your hesitancy.  I felt the same way.  I think we all do and I think you are smart for learning as much as you can before you go on ANY treatment.  Has your doctor given you the paperwork for the trial?  It will give you a lot of information about the research with NM283.  

I forgot to add that I have also been very fatigued throughout treatment.

[NYgirl]

Great advice.  On the spot again.

I don't want to discourage anyone but just want people to be realistic when it comes to insurance companies and their willingness to pay for drugs their patients need.

With Epogen being OVER $6,000 a box - no wonder I had to fight for it (and I was well UNDER 10 and fit in ALL categories) turns out my pharmacist is the one who fought for me and without her I wouldn't probably have gotten it for a while and I have AWESOME insurance.

But it's a MONEY thing in the end.

I seriously doubt my insurance would presently cover NM or Vertex (which since I'm not treatment naive doesn't matter).  Maybe when / if they are finally approved by the FDA.

[Alady1620]

I was 1b.

[DragonSlayer45]

Thanks for all of your input. It is very helpful. You say you have been very fatigued? Is that because of the TX or the HCV? After you finally cleared did you begin to feel better? I know I like most experience times of fatigue, some times more than other times. I have a very active life and keep busy running youth programs in addition to work and running the kids around. I would hate to have to give them up. When I was first diagnosed I refused to let this stop me from being involved.

[Alady1620]

I don't know if my fatigue stems from the treatment or the HCV.  I will say that even tho I am now clear, I still feel fatigue.  It is nothing that I can't overcome.  I am still able to take care of my twins and do what I need to do.  There have only been a handful of days that I couldn't take care of my business but I've had a lot of support.  Support is key no matter which treatment you do.

Have you gone to any support group meetings for HCV in your area?  I found the meetings very informative and helpful.  There may be people at the meetings who are on NM283.  Ask your doctor.

[DragonSlayer45]

I used to belong to a support group a few years ago then I moved over an hour away. I have not rejoined since then. i did see some around but to be honest I am so busy these days I don't knwoif I could ever fir it in.

[Alady1620]

Hi!  I'm in an NM283 trial.  I will be happy to answer any questions you have concerning the drug.

I started on 800 MG of NM283 and the prefilled pegasys shot.  I had severe cramping, nausea, vomiting, and diarrhea at the beginning.  I found it could be controlled with Zofran and Immodium.  Later, the FDA reduced my dose to 400 mg and, now, I have occasional diarrhea, cramping, and vomiting.  This usually occurs when I take my medicine at night.  I don't have a problem when I take it first thing in the morning.  I also get body aches, hair loss, dry skin, and headaches.  I think that is from the peg bc many people here report the same symptoms.

My doctor reports that 70 percent of people in the study have cleared the virus but nobody knows our chances for svr yet.  I know of one guy in the study that was taken off bc he did not clear by 28 weeks.  He did get very low.  He said our doctor told him that they think the virus became resistant to the drug.  It was very bad news but this has only been seen in a few patients.

I think they are combining riba in the new study bc they are looking for 100 percent svr from the participants.  I am sure that the doses will be lower than what I started on bc of FDA requirements so the gastro issues may or may not be an issue.  I also hear the study pays around $1000.

In addition to the study meds, I am also on a daily dose of zofran which is VERY expensive.  My insurance DOES cover that drug and it also covered my antidepressant, xanax, and restoril when I was taking them.  They are aware that I'm on treatment for Hep C.  I think the company is happy not to be paying for that! LOL

Anyway, that is all I can think of right now.  I will check back in a bit to see if you have replied with more questions.

[DragonSlayer45]

I am fairly new to this site and love the input so far but as a newbie, sometinme the acronyms you guys throw out are tough to figure out. You used a bunch in this post could you possibly elaborate?

BMS?
PI (peg intron?)
ITMN?
SGP?

I can usely figure out a lot of them on my own but am having a litle difficulty this morning. (Could be the early mornig brain fog). Can anyone help out here?

[couldn't think of a nickname]

sorry, I get so used to using them, I don't even realize it.
BMS=Bristol Myers Squibb
SGP=Schering Plough
ITMN=Intermune
PI=protease inhibitor

[DragonSlayer45]

Thanks for info. As far as acronyms go I work at a gov't lab and we use them all the time and I can be guilty of doing the same thing.

Piper Jaffrey- is someone who post's here?

[couldn't think of a nickname]

Piper Jaffrey is a brokerage house who has analysts that follow this area. Analysts do come under their fair share of criticism, but at times, there is good info they pass along. In fact, Piper Jaffrey might have been the first of the firms that mentioned Bristol Myers cancelling their program.

[Forseegood]

Just wanted to say I think this is an interesting discussion< I agree with your tenor of thought- that if the insurance companies feel that Vertex will cut the treatment times in half, or less, whatever....and have better SVR outcomes (we're all hoping)...they'll want to jump on that puppy right away... cause from where I'm sitting, that protocol will "save" them money from the current one...logic dictates that the longer the treatment protocol (and there are plenty of people now beginning to extend from a long 48 weeks as it is - for geno 1's, the most popular genotype) the more cash outlay to them....

There's also the question of "popularizing" a drug out of the gate, they want a lot of good public relations on Vertex for stock considerations just to begin with....so I would think they would make this as easily available as possible, to as many people as possible, during the first stage of the proceedings at any rate...

Not to mention pressure from the Fed (these other protocols at the current rate are draining the Fed programs like nobody's business...the current treatment protocols are easy to get if youre on public assistance programs....and with more and more people getting diagnosed, they are seeing this as the giant pandemic it really is.....and for all their efforts, they are only SVRing 50% of the geno 1s....not a sterling track record.....

If you look at the the arc of what happened with AIDs and how the Fed went into a panic pre-protease inhibitor cocktails, thousands were dying....these HIV treatment protocols came out and started saving thousands....and those were made pretty damm available (relatively speaking) to people suffering with HIV, at least in THIS country....

Current treatment protocols are less then perfect...to say the least....I would think that any treatment protocols that would improve on them to a great extent...would be expedited....

Of course, got some wishful thinking here but this is another scenario that I feel should be considered...

[DragonSlayer45]

I decided to call my doctors office today about the trial. I spoke with the Nurse Practicioner that handles the trials for him. She said that part of what they are looking at is when taking the 3 drugs in combination is how people respond. It has already been established that polymerase inhibitors (NM283) can cause GI problems especially in larger doses and the riba can also have that effect (along with many other problems). They want to investigate the effect of both together in treatment along with pegasys and how well it is tolerated. I will go down and talk to them some more and go throught he screening process to see if I qualify, then I will decide if it is for me. I will post more later when I find out more. The trial begins in September. I am a little apprehensive at this point but yet still interested.