NM283 Treatment

[DragonSlayer45]

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?

[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.

[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...

[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.

[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]

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]

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?

[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 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.

[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.

[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."