It appears VX-950 will only be doing trials with interferon

[Upbeat]

This came as a surprise to me.  I guess this is their way of getting a faster approval. Always easier to get a ad on drug approved.  Here is a copy of the email I received from them today.



Our primary clinical development path is with VX-950 in combination with interferon.  We have not ruled out the possibility of monotherapy studies in the future, although none are planned at this time.

                                                   Ron

[NYgirl]

Well I guess at least it's not Interferon AND Riba right? ;-)

As long as it WORKS that is what matters.  

Everything else is gravy - although for those waiting for an easier treatment that really isn't the greatest news I shouldn't be such a wise guy I know some people will be bummed.  But...as long as you don't have RibaRash ;-)

Can't help it...

[Fisheress]

Don't mean to jump into your thread with a different post than your post.  I have not kept up with the VX-950, just concentrating on what I am treating with now.  If the VX-950 is what you have been waiting for, sorry it is not working out for you or anyone else waiting on new meds to replace what we are treating with now.

I am terrible when it comes to postings.  Not a good writer....

My question....what to do with this cough!  It is driving me to the point of a very sore throat.  Lozengers are not even helping and all I do is cough & cough!  Sounds terrible too!  Should I try some cough syrup or do you just live with it?  My coordinators warned me that I will get a cough but forgot to tell me what to do about it.  I had been lucky not to have it untill I got the crud, now it just won't go away.

Any redmedies or suggestions would be greatly appreciated

Thanks.......Fisheress

[Tyree2005]

Rebrash? you know I got my first shot Sat and had little sx. I am on 1000 mg of copegus per day. I switched to taking 300 in the am and 200 in the pm due to sleeping problems. I have no rash but I itch like hell.  I here you all talk about the reb rash. I do have benadryl cream and pills.  I what I have reb rash?  What can I do.

[NYgirl]

Sooner or later you are bound to notice these tiny little dots and they itch like ant bites or mosquito bites or chicken pox or something.  Well you don't even realize how much you itch them...then they bleed a bit and sort of scale over or something with little tiny scabs. I feel like an alligator all over!

Hydrocortisone .10% is what I put on the KILLER ones.  Aveeno Moisturizing lotin is what I've been using all over my body - it helps them really well.

Copegus, Rebetol, Ribavirin all the same stuff.  Leads to that riba rash.  Not everybody gets it but I did - the longer tx goes on the more I am getting.  Fortunately they are just mostly on the trunk of my body or I'd look like alligator girl!  ;-)

Since you just started if you don't notice the actual BUMPS probably what is starting up is the dry skin - which is not as itchy at all but none the less just as much as a pain.

Literally!  Stay hydrated, drink water and use lotions as much as possible...that is the oNLY things that have helped me!

[NYgirl]

Wow it's plus interferon and riba! OUCH!  OUCH OUCH!  

Well as I said as long as it WORKS that is what MATTERS right? None of us like treatment but liking it is not the GOAL!  Killing these freaking cooties IS and anything that works it good for ME!

I'm honestly so glad I didn't wait now (not that I was ever going to mind you!)

I am keeping positive but last night as they were drawing the blood oh MAN I wish I had a voodoo doll I was talking to those vials so HARD the tech laughed at me! As the blood was pouring in I ws yelling at it NEGATIVE NEGATIVE UNDETECTIBLE and of course the guy is like whoa lady you are freaking NUTS!

But...I figured every positive (or NEGATIVE) thought counted!

;-)

[Tyree2005]

Yes I am drinking lots of h2o, I started pre treatment.  I am very worried about my doctor also she does not have a nurse in her office at least the one I go to.  Med tech only which does not seem to be enough support for this type of treatment.  She has the second largest practice in the Wash DC area.  I did call yesterday because of the itching and being very cold and was told she was out of the office until Wed. So I ask what do we who are on treatment do in case of emergancy and she said call the 1800 # on the pagas/copegus med information package. After I fell to the floor and got up from the shock.  I mad an appointment to see her when she returns tomorrow.  Maybe I am over reacting but I would hope I would be able to speak with someone in the treating physicians office who knew me or at least had access to my chart to help me with a problem.  I love my dr. to death she is very knowledgable but I would think with all the knowledge she has she would know we need support.  The other thing and I think I ask this before How offen should I be seen and how offen should I have blood work done.
Thanks so much

[Forseegood]

I heard they will have different "arms" some with riba, others with only interferon (that will be in the main if i'm not wrong) and some as stand alone. Hey, if I could avoid riba I'll be more than happy.

[FlGuy]

When you say 300 in am and 200 in pm you mean 3 ribas and 2 ribas for a total of 1,000 - right?  You didn't reduce dosage for sleep?  If sleep is an issue, I'm with the Ambien campers - best stuff since...nevermind, old life.

[Fisheress]

I agree w/NYgirl, the hydrocortizone works best.  I use it during the day if I develope rash, been pretty lucky so far though now that it's winter.  Seemed to me the heat and humidity brought it on like I had rolled in insulation!  That was terrible!  At night I like Eucerin, Dry Skin Therapy, Calming cream.  Has no alcohol in it and trust me, I have spent many hours at the store reading labels on these lotions!  Works well for me as I do get really itchy on my back at night and the Eucerin really soothes it allowing for a nights sleep w/o itchies!

Good luck to ya!  Fisheress

And has anyone read my post above about the coughing?  It's driving me crazy!  HELP!

[NYgirl]

I hardly ever see my doctor anymore.

After the first few weeks I think I saw him at week 4 after my PCR.  Now it's week 12 and I will see him after I get back the results from this one.

I really don't have any need to see him though - when I have a question or a problem I call the Nurses in the practice and they are VERY helpful (so much can be said for buying them a box of candy for Christmas and dropping it off LOL - seriously I got one because they have turned out to be lifesavers).

They are the one's that have proved invaluable - him? Not so much.

So once you are done and started...if you don't see your doctor often don't sweat it.  You don't really need to unless something is BAD ( I went when I got the anemia around week 3 or 4 at pcr time that was it).

But you HAVE to be able to get ahold of someone via phone if you need them! That is straight up NUTS isn't anybody covering for them or anything? A Service for a message? I'd call constantly if nobody called me back in a day or two.

Regarding the itchies try lotion - how long have you been on the Riba now? Do you see the bumps?

[woodbeegood]

i found that a humidifier helped with the cough (well actually i boiled water on the stove don't have a real one:) ) anything to moisten up the air-also for some weird reason crushed ice chips helped-you mentioned just getting over "the crud" and how bad your cough sounded-if it's real deep in your chest you might consider bronchitis-don't mean to be a arm chair dr here-just something to consider-we are more suseptible while on tx
also for the itchies-i found for me-i started taking benadryl the day after my first shot and continued up till about 3 months or so post tx-really worked wonders for me & i could really tell when i forgot to take it-not sure how well it will work once the rash as started-might be worth a try-course ck with your dr. BTW my stats 1b starting vl just under 2 mil bx was grade 2 stage 3-clear 6 months post-yearly test will be sometime in jan (fingers crossed) all yall hang in there-YOU WILL MAKE IT!! keep your eye on the prize!

[Tyree2005]

Flyguy yes 200 mg or 2 pills. I did not reduce my riba i just switch the way it say to take it. My bottle reads 3 pill in the morning and 2 at night and I switch that.  I just started Sat so only been on the Riba for 4 days now. other than itching and being cold I am fine. I will get something otc for the itching.  As for my md office I do reach the people in the office which are Med Techs and they will get the messages to my doctor.  So I am just worried that there is no nurse.  I am a worrie buff at times.  Beleive me; this board and you guys have taken a lot of the anxiety awau up help me not to worry about what's next and how to deal with beating this virus.  I thank you all from the bottom of my heart.  I love my new family.
Much love and peace to you all
Tyree

[couldn't think of a nickname]

I talked to someone at the company just yesterday, and here is the information I got. VX-950 plus combo was THEIR decision to find out how it works early, rather than late. Just because it is in the early phase 2 trials (in arms only, not the whole trial) it does not necessarily mean it must/will be included later on. When data from the latest 1b comes out early next year which is interferon and 950, that will help set the course for the rest of phase 2.
There will be monotherapy arms in the trials. It has worked much better than the combo combined in 1/6th the time. I really see no need for riba at all at this point, but it is being included because it is current SOC.

VRTX has said on the record, that the fastest way to market is with interferon. Not interferon and riba. That may change, but it is what it is right now.

There is nothing that requires 950 to be added on to both to get approval.

Also, keep in mind, that not all of the trials are designed yet. It might not be designed now, but in a few months from now, maybe it will be. I think we are reading too much into it.

[Forseegood]

Once again, youre such a great resource...it's hard for me to call on my electric bill though I do keep up on the press releases.

[couldn't think of a nickname]

I should also add that the company has not said anything at all about the NDA course of this drug being with interferon AND RIBA. Their email to upbeat about interferon and 950 is indeed what is in the public domain. It wouldn't be accurate to assume that the drug only gets approved with combo.
I should add, that they cannot tell us what they have discussed with the FDA, but there have been many meetings, and will be many more. The FDA is very interested in this drug, as it is the only HCV therapy fast-tracked.

On a side note, they requested 24 week data on NM-283, possibly because 12 week data only showed an average 2.77 log drop. One analyst thought that investors were concerned that 24 week data would be required by VRTX, but that has no bearing, as it is more likely due to the disappointment in NM-283's activity, as 950 was much, much stronger is 2 weeks.

He also mentions there is a lot of flexibility in the phase II designs. This analysts expectation (and he is a PHD) is that in 2007, 950 will enter phase III with Pegasys.

[couldn't think of a nickname]

thanks, I will do my best to keep everyone up to date. It is funny how the questions/speculation have changed over the last few years with this drug. In a way, I can almost write the next set of headlines based on expected data from now. In fact, I did that in one post a few weeks ago, and erased it! LOL

[miked]

CTON:

I have a couple of questions for you; what would have to happen in the VX950 trials to get you to join one.  Also when(phase I, II, III, IV)?  Lastly what are your HCV stats?

I'm a geno 1b and started PEG+RBV tx with 3M VL; very minimal scarring and no inflamation (inflammation) at last bx).  At week 8 I got the 2log drop and continued to drop to around 7,000 copies.  At week 32 my VL drifted slightly upward and they stopped tx.  My dipshxx doctor wouldn not listen to my requests to change and/or up the PEG.  I believe that if hit hard upfront I could have been rid of this virus.  I read similar comments from a woman on the forum in the last few days who got the 2log but then rose.

Schering asked me to join their PI trial.  I declined because all arms had PEG (some with RBV) and all were for 12 months.  If Vertex was to offer a less than six month clinical trial (with or without PEG) for non-responders, I'd be inclined to sign up.  So...I'm curious about when you would be comfortable to jump on the VX950 wagon.

Thanks for all of your research and reporting.  Everyone on the forum apprecites what you're doing.

Mike

[couldn't think of a nickname]

Sorry to hear about your experience with tx and your doctor. I am geno 1b, last vl was about 3 mil, and was infected by blood transfusions as a teenager.
BTW, just for definitional purposes, phase IV studies are post market studies to further evaluate a drug. What is interesting is that the FDA "requests" them often, but many don't do it, as they are not forced to. With Vioxx being the disaster du jour, that stuff always gets attention.

For me, I have thought about the topic of getting in on a trial, and besides location, I have changed my thoughts on it. I would have done a Phase II, but now I think IF I did, I would rather it be a phase III. The reason is that in phase II, companies are still trying to optimize dosing and technique, and there is more info about potential sides and tox. Their plan is hopefully to have phase III be fine-tuning for approval based on what is learned in phase II. I believe there are greater odds for success in phase III. Right now, 1 and 3 month trials are what is being planned, and the 3 month trials can be started after evaluation of 3 month tox. data in animals, which if the study isn't done now, should be done soon.

For me, riba is a non-starter. Because of its dangers as far as sides, and possible birth defects, I really don't see any incentive for VRTX or the FDA to keep it around if they don't have to. In fact, I don't think the FDA can force them to include it. If it works without it, and so far it has, the FDA's responsiblity is to evaluate that.
I told the person I spoke to yesterday at VRTX that,(and he didn't comment, I just got on my soapbox a little), that since mono trial got half undetectable in less than 2 weeks (with inferior formulation, and without food, since food makes it 2-3x more bioavailable), if interferon does it in a week or so, why on earth would I want riba? What would it do, drive the virus to undetect. status a day or two sooner? Not worth the risk to me.

If I didn't know what I was taking, I might not do it. I wouldn't want to be in the all interferon arm, nor would I want to be in the triple combo arm, which may not even exist in phase III according to some analysts.

One question that isn't being asked now, but will be asked later, and is legitimate, is what about the other geno's?  NS 3/4 is a more dominant target for geno 1, and maybe 4, but (and I could be remembering wrong) a different one is prominent in 2 and 3 (NS 5 or something?)

[miked]

Any speculation when phase III will begin?

Also, are any of your contacts talking about SVR?  I'm with you, if it's hit hard early and goes undetectable early, then the chances of SVR are good...under these conditions it doesn't make sense to rebound.

Time will tell.

[couldn't think of a nickname]

I forgot to ask about SGP asking you to join their trial. In my talks with VRTX, they have told me they can't recommend people for trials, as it would not be proper for them to pick. They keep telling me to watch the www.clinicaltrials.gov web sites.
Do you know if they were able to ask you to join since you were on one of their products?
Also, from what some analysts speculate, they might need to do another phase 1b to look for a more optimal dose, as they might not have found it yet. I don't blame you for not wanting do 48 weeks of that.

Getting below the limit of detection quickly is definitely an important marker. An analyst said after AASLD, that he feels the FDA agrees with HCV experts that EVR is a significant factor in determining the course of upcoming trials. I guess Bank of America and SGP don't agree with that based on their comments at AASLD, as SGP criticized VRTX's timeline, and BofA (who btw has a price target of 19 on the stock that hit 27+ today and has never been bullish on it) said something that has no basis in fact, and I will quote it from a PR:

"The research analyst noted Vertex's goal of filing for U.S. Food and Drug Administration approval in 2008 is "aggressive" and assumes additional safety trials will not be required. "However, we believe the FDA will be conservative with these agents and that it is quite possible that a 48-week Peg-IFN + Ribavirin (RBV) control arm would be necessary for approval," he said. "This could delay an FDA filing by up to a year."

Fast track status argues against his belief of them being conservative, and no control arm is necessary as the data is published and available to all. In the U.S., safety and efficacy has to be proven, that's it. The analyst should be realize that they have had many discussions with the FDA already, and will have many more. Fast track greatly increases communication between company and agency.
But, then again, BofA has not done well with biotech picks this year.

Phase III is scheduled for 2007.

[jaroman]

I am so sorry you were pulled off tx.  It feels like a punch in the gut to see the increased numbers....
The doc wants me to keep going.  I plan to fight one more time for an increase in Peg.  If he wont do it, I want one more PCR. Guess I am grasping at straws. If still detectable(or G-d forbid, up), I quit.

[cougareyes]

I think alot of patients are looking for a replacement for current combo tx, not a hitch-hiker. If I'm not misstaken this isn't the first drug that's jumped on the back of interferon(and/or riba). For me this is a clear sign that we are a long ways away from replacing current tx.
These new drugs may help current tx be more effective and/or shorten tx duration. But for those waiting to not have to take interferon and/or riba, please don't hold your breathe.   Peace

[Upbeat]

You haven't heard by chance how the europe trial is going?  It seems to me that the data from that trial should almost be done and they should know how it worked in combo. Why the need for this riba adventure is beyond me.

                                                              Ron

[couldn't think of a nickname]

I agree with you except for the last sentence. There is no doubt the fastest way to market is with interferon (I am intentionally leaving riba out).
What is likely to happen, is, tx will evolve over time AFTER approval. For example, if this were to get approved tomorrow with interferon, I would take it. I would take it knowing that in time, a future set of patients would likely take it alone. The best evidence of that is how current tx has evolved. 12 weeks to get SVR was unheard of, and likely HIGHLY doubted several years ago and criticized, but for some, it does happen.
2 years ago, VRTX announced stunning data from an in vitro arm. greater than 4 logs in 9 days. Many said "we won't see that in humans, besides, BILN looked good and couldn't get out of phase I). We did see it in humans, and we are now in phase II. Naturally, I worry that things don't go smoothly, that cannot be discounted.

What I am saying is, that even though the data set was small, and early, I think it is being dismissed to quickly-just like that initial in vitro data.

[couldn't think of a nickname]

I am with you on riba, but the scientist in me feels that all comparisons are good to look at.

Data from that trial should be out very early next year. It is odd how things are looked at. 950 in early testing did what current SOC can't do, yet there seems to be a desire to want to hold onto current SOC.

SVR data is the most important thing to see, of course. Early data indicates that is possible as a mono, no question. I don't personally want interferon, but if it only took 4 shots vs. 48, I think that would alleviate some of its problems. By then, it is quite possible Albuferon from HGSI would be out, which would be taken once every 2 to 4 weeks. So far, it is doing quite well in trials. I would hope that if both got approved at the same time (and I am not sure of Albuferon's timeline), docs would be allowed/want to use that plus 950.

[couldn't think of a nickname]

I decided tonight I wanted to research hydration a little more. We all hear how important it is, and my massage therapist and chiropractor both told me my fascia had become gelatanus, probably due to lack of fluids, but improved after increased intake.
I cannot vouch for this web site (guess I don't need to state that) but there is some interesting info on it.

http://www.watercure.com/wow/wow_pain.html

My concern is whether claims are overstated or not, but they also reference a book I might look up on amazon called "Your Body's Many Cries for Water".

Looks interesting.

BTW, on the VRTX board, there is someone who tx'd interferon, ribavirin, and Merimepodib (MMPD from VRTX) who failed prior tx at least once, maybe more. He was in phase II which was 24 weeks of triple combo, and another 24 of SOC. He is almost finished, and still undetectable. MMPD showed a significant enhancement to current SOC in early phase II's, but they have discontinued it. They will complete this trial and report data, but I think the problem was that it would be out around the same time as 950, and it didn't make sense to spend money on something that would instantly be obsolete. I always wondered why they were moving ahead with it anyway. They at one time thought they would combine MMPD with 950, but I don't think that is on the table any longer.

[GoofyDad]

One big mystery with current SOC seems to surround what happens after apparent clearance in the blood. I guess common wisdom is that virons living in the somthin-cytes in the liver take much longer to eradicate, possibly because they are protected from drug delivery.  

Can you shed light on VRTX's extrapolation techniques that take them from in vitro studies to projecting the number copies in the body? Are they able to mimic body tissues other than blood cells in vitro? What about drug delivery to those tissues? Will they biopsy and perform viral amplification to see what's happening in vivo?

Thanks as always for you comments!

[couldn't think of a nickname]

Wow, man, you ALMOST make me wish I paid more attention to my chem classes in college! LOL
Almost.
"One big mystery with current SOC seems to surround what happens after apparent clearance in the blood. I guess common wisdom is that virons living in the somthin-cytes in the liver take much longer to eradicate, possibly because they are protected from drug delivery."

That one is easier to answer, as the drug targets the liver, so virons are exposed to the drug which will "unhide" the virus so the macrophages can "eat" them. I say it like that because sometimes (me included) forget that these drugs don't actually kill the virus, our immune systems kill them. The drugs prevent them from hiding so our immune system can then see them.

"Can you shed light on VRTX's extrapolation techniques that take them from in vitro studies to projecting the number copies in the body?"

I think the accepted technique is to follow the slope of the decline out in time, as that is how it is currently modeled. I think SGP uses a similar technique to estimate how long it would take them to get undetectable.
Since vl is in copies/ml, even 5 copies in a LARGE number of mililiters means there is still virus circulating. That means, of course, that more drug is needed to kill those (high TOTAL numbers) off, even though the vl/ml is quite small.

I don't know if they can mimic body tissues, but the person I talked to says the clinicians he speaks with feel that undetectable means no virus. More studies need to be done on remnant RNA strands, but if one is SVR, and liver histology improves, then that should speak for itself.
I don't know about the biopsy study question. I also don't think they would tell anyone either, since that would have to be kept quiet until any studies would be finished.

By the way, that info on hydration and that book look very interesting. I am going to order that book. I was going to now, but my wife tried to tell me to wait.....seems I've got an Amazon gift cert coming weeks! LOL
Doesn't matter, I think I have the Library of Congress in my wish list anyway.

[couldn't think of a nickname]

I wasn't going to post it, as I guess I didn't consider it much of a player, but SciClone announced disappointing results from a phase III Zadaxin trial for HCV (although there was activity for melanoma). They were testing in non-responders, and in a very curious move, they only tested it with interferon. That drug is an immunomodulator, NOT an antiviral, so they would need ribavirin (I would think), but didn't include it. It seemed to have better activity when used as part of a triple combo in an earlier trial.

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh60074_2005-12-14_15-23-31_bng320673_newsml

Since their drug isn't designed to attach to the virus, I think of it as an interferon booster-I think it might have been poor planning, as this is a case where riba should have been included-JMHO.

[vegas777]

G'morning:

You know anything about resistant virus with the PI'S?

"When a relatively high concentration of HCV PI
was used at the beginning of selection, a 4–5 log10
reduction in HCV RNA levels was observed and
no replicon cells were recovered after two weeks
of treatment (41). It remains to be seen whether
treatment of hepatitis C patients with a single
HCV PI or a combination of different PIs will be
able to suppress the virus so that no resistant virus
will appear."

Thanks - *dip*

[couldn't think of a nickname]

First, I was going through email trash today, and there was a drug I followed that I had forgotten about. It was called IDN-6556 from Idun Pharm., but they were taken over by Pfizer. Now, there is little, if any info on this drug. It is used to protect the liver, and was in phase II trials last year. It gained orphan drug status for transplant patients, but was doing well in significantly reducing liver injury for HCV patients. I may need to call PFE sometime and ask them.

Veg: I can answer some resistance questions. First, that statement looks like it is based on 950, based on activity and short time frame, but, where did it come from? Just curious, I haven't seen that paragraph before I don't think.
The way to avoid resistance is to drive the viral load down as fast as possible. This way, there is no chance for adaptation. I can't off of the top of my head name the resistant strains that VRTX identified, but this is what I do know:

Trough Concentration (TC) is key. TC is the MINIMUM drug that is in the body between doses.

In the rebound group, TC was 719 nng/ml, thus there was a rebound, and viral variants did appear, although, they were less fit, meaning the virons were not as strong as their predecessor.

In the plateau group, TC was about 850 nng/ml. Enough drug to not get a rebound, not enough to keep driving it down. Viral variants were found here. Some viral variants were also determined to not be able to replicate if I remember correctly.

In the continual decline group, TC was about 1050 nng/ml. There were NO VIRAL VARIANTS found. The reason, is, there was enough drug in the body, even at minimum levels during the day, to keep affecting the virus. It is this TC level that will be targeted in future trials, as they were IMO lucky to find this level in Phase I. I don't think SGP has actually found theirs yet, which means maybe another Phase I study to find it.

Here is the arguement for using interferon (not both, just interferon). Interferon did remain sensitive to some of the variants that were found in the SUBOPTIMAL dose groups. Therefore, IFN could pick up the slack if it needed to. The reason Riba is left out of that statement is that it doesn't directly affect variants, it works with IFN. Riba won't do anything by itself to a variant, the way I understand it.

In the data that was presented, the devil is in the details. For example, not everyone in the 750 mg dose group achieved optimal TC levels, while some in other dose groups did. MOST in 750 mg. did, though. There was 1 patient who, for whatever reason, didn't really respond well at all, and he actually in a way prevented the data from looking even better.

Why? Could be many reasons, but in that trial, an oral suspension was used. That is basically drug disolved in water-not a very good way to deliver a drug. What if some drug is left in the bottom of the glass? Or not fully swallowed? Or even spilled? One thing that has been learned is that the new pill formulation is 2-3 times MORE ACTIVE when taken with food in animal models. The first study was taken on an empty stomach. As good as phase I was, and I think it exceeded expectations, there are still things that can be improved upon. I think phase II has the chance to do that. So, IMO, that data can be improved.

Finally, the longer it takes to go undetectable, the longer the virus is circulating and the more chances it has to create variants. That is why I believe RVR and EVR is so important, and the consensus from AASLD had that same opinion.

[vegas777]

thanks, I was hoping you would see my thread and answer it, it was a shocker when I got that resistance message this morning...

Do you ever go to Delphi Forums?  It's the forum that Janis site is on...Well if you go there, go to the Hepatitis Unity Forum...There is a nurse there by the name of Silvia, she's got quite a bit of training in HCV and I really like her style and knowledge...She posted it there for me today...I am not sure if it is someting that only medical professionals get, or if she found it elsewhere, but at any rate if you want to read the entire article (a lot of it was over my head)go there and go to the thread that says "I have a present for veggie"...

The article was about 950, sorry I didn't mention that...I will ask Silvia where she got the article and get back to you...

Oh, BTW - I booked an appointment with a reiki massage therapist...I had a dickens of a time finding one that was not only reiki trained, but a licensed massage therapist as well...I had to go that route becasue my husbands insurance wouldn't pay if he/she was not massage therapy registered...

What can I expect on the first appointment, any questions I should ask, etc..?

Thanks for your help, as usual you know your stuff!

*dippers*

[couldn't think of a nickname]

I have never been on that site, and I couldn't find the message. From the blurb you posted, it sounded to me like she basically said "we need more data", which is true.

You are lucky to have ins. coverage, we pay out of pocket. I am not sure what you should expect. Your person is probably a Reiki master. Our CMT is Reiki level 2, which is one step below. You should probably tell her what your issues are, but I am sure she will be able to find imbalances anyway. I was told I had an energy weakness in my middle area (front and back stomach area) which is not unusual for anyone with a digestive disease. My wife and I will get an hour of Reiki sometime soon, as our CMT was nice enough to send us a gift card for 1 free hour each. If she didn't we would end up asking for more body work and cancelling the Reiki, as that has happened.

Ask her about her experiences with healing, etc. and some reactions from people to it. Ours told us she has seen some people hardly react, and some get extremely emotional as the process went on, and old injuries, events, etc., were being "reached". It might be a good idea if you both know what you are looking to accomplish.
Good luck with it, and please let me know how it goes.

[GoofyDad]

Yupp - It sure can be tough finding that provider who practices your desired 'interests' and who's also a licensed therapist - YIKES! And if you care which side of the tracks they're on - it only makes it harder, errrr... more difficult.

[vegas777]

okay thanks..

Yes, sure I will let you know...You're the one that got me thinking about reiki...I have high expectations as to the results after talking to my ND about it...She said she is sure I will see almost immediate results and is very much an advocate of reiki herself...So, we shall see how it goes, I am anxious to go...

*have a great day dip*

[vegas777]

hey you goofball!!

I didn't inquire as to what side of the tracks I will have to go...maybe I will need a police escort to enter the world of massage, he he he...But it's for therapuetic reasons only, of course...

*massage a dip*

[GoofyDad]

"But it's for therapuetic reasons only, of course..."

I think this is generally the point.....

one man's high colonic is another man's 'theraputic reasons only' ....... (whooo-hooo!!!!)

*the plumped up goof*

[vegas777]

you just can't get away from the s-h-i-t can you...lol

[Forseegood]

Anyway, don't want to be a big nudge, and I don't mean this in a confrontational way (although delicacy isn't always my strong suit, I try though) but sometimes when we discuss these new treatments -I get a little whiff of a neener neener when there is less than exemplary news about them...from some people... As if to say, hey, where do you get off waiting for these new treatments? I gotta suffer through the stuff we have now, type of thing. And I can understand that sentiment< I completely understand why someone on current tx would feel this way.  I also understand that many people who are treating or who have treated are afraid for people who are "watching and waiting"...that’s completely understandable as well. The present treatment is no walk on the beach for most people, and I completely commend all the people who have gone on this journey ...But let’s not forget that some people have no choice but to wait for the new treatments...let's all remember that some of us "can't" take the present treatments, it's not always a question of "won't."

Not "just" because we don't want to suffer the bad side effects, who does? But some of us have pre-existing conditions that actually prevent us from taking current treatment; and/or some of us are multiple non-responders and relapsers and obviously these various factions have a very big interest in these new treatments working out and are following them very, very closely. When and if they do work out is beside the point I’m trying to make...Just that we should all be mindful that new and better treatments will benefit everyone with this disease. Just thought I'd throw that in there, don't mean to offend anyone and I apologize beforehand if I did...

[GoofyDad]

Hi Foresee -
Hope you're well. You've been quiet of late.

I know the sentiment you're describing - no need to get into a disussion on human nature here.  

Anyway - as I've always said: I'm on this particular bus only because I have to be. Given a choice, I'd be waiting for the Express that I hope is just around the corner.

[GoofyDad]

Non-offending subject matter dwindles, I'm afraid.

[beamishboy]

not that my energy levels are optimum or any such,but i am certainly willing to help,encourage,nudge,march,become a web-base gadfly...If & when we can help please post.....This new trx seems so promising..I was told not to watch&wait by 2 heptologist (univ, Vt. burlington& Upstate med. univ, syracuse) soo i took the plunge.......but it all seems like nothing but GOOD NEWS for All concerned......Beat the devil of a Virus--Our only Enemy-the enemy of my enemy is my FRIEND.......Thanks so much for all the information

[couldn't think of a nickname]

I have many thoughts on the topic of "profile", so to speak.

The HCV community either isn't as good as others at getting the proper attention, or the general public, congress, etc., doesn't understand or see it as important. We need a high profile advocate that commands respect, and someone like Bono who speaks so well for the HIV community and has made a real difference. For that, he should go to sleep proud every night.

Here is a point I made to the person I was speaking to at VRTX (I needed a ladder to get down off of my soapbox when I was finished).
The FDA web site has links to various (and worthy) causes, BUT NONE FOR HCV. The gov't has never followed through on promises to notify those who might have been infected by a tainted blood supply (I would have known if they did). Maybe doing so had nothing in it for them. Forgive my cynicism, but there is failure there in my opinion (All parties).
There needs to be a demand for accelerating the process, or whatever can be done to prioritize drug development and review.
Having said that, the FDA does seem to be taking things more seriously. With NM 283, when 12 week data didn't look as good, they said they would re-evaluate at 24 weeks instead of waiting for 48.
They have accelerated 950, and without knowing anything, I get the sense that there has been a lot of communication between the company and FDA. They granted Fast Track status pretty quickly.
In fairness to other therapies in development, most are designed to improve SVR rates, and aren't really designed to also shorten tx time, so it would naturally take longer to get the data. Not much can be done about that I think.
FT status does allow for surrogate endpoints. The question is, even if 950 showed tomorrow that it can cure more in a much shorter time span, it is still a HUGE job to get the drug to market. They couldn't get it out soon. Do they need help? Can someone provide it? I have no idea, I am just thinking out loud. That might be an issue with them more than others because their timeline is shorter.

Not only should we get better info on all drugs in development this year, but we may get a better look at how serious the FDA is as well.

[jmjm530]

Forsee said prev: "I get a little whiff of a neener neener when there is less than exemplary news about them...from some people..."

--------------------------

Yup. I don't think any of us should throw caution to the wind regarding newer treatments, however enough "meat" has been demonstrated in current trials that we all should be cautiously optmistic and hopeful.

One thing I'm convinced of is that this barbaric treatment many of us are on will one day be ancient history. What will replace it and when is another story but hopefully the first breakthrough will be one of the protease inhibitors within the next 3-5 years. Let's all say a little prayer to that end.

-- Jim

[Forseegood]

hey woman, let me get a rung on that latter as well, whodathunk it? some of these peeps on this board know a little sumpin sumpin about this stuff...sometimes I'm like huh????

sometimes the mental midget...

[debdeb47]

I believe that at this stage in the development of the basic virology, a cocktail approach is superior to any monotherapy of any sort.  There are yet-to-be-refined sub-classes of the little monsters, and most will succumb to one drug while nearly all of the leftovers get attacked by another, and the last diehard copies may get toasted by the synergy of it all.