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?

[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").

[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]

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]

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 was 1b.

[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]

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.

[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.

[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]

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

[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.

[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/

[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!

[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.

[Alady1620]

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

[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 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. :)

[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.