On a brighter note. The 1999 report to congress on hep-c from the army

This info has been around for a while and I am only posting it for those who may not be aware of it.  Back in 1998 the army took all the blood samples they collected from recruits between 1948 and 1954 and checked for hep-c. After identifying those individuals with hep-c they compared liver problems with the hep-c group compared with the non hep-c group and guess what? After over 40 years there was no difference.  Also back in 1977 there was a group of Irish nurses infected with geno 1b at the same time and for the first time they had a study group of people they knew exactly how and when they got it. It appears they have somewhat more fatigue then the general population but thats about it.  Just my way of saying Hep-c is not a Death sentence.  Wishing you all a great new year and many more to come.

                                                        Ron

[Moniker]

After my first treatment, when I relapsed, I decided to just live with my hep c. I figured I'd probably live a long life and die an old man. Then, after my last liver biopsy, my doctor said my hep c was progressing; he recommended I try treatment.

I've never really understood, is this a terrible disease, or just something one could easily live with. Why do we go through this expensive, unpleasant treatment if it's really not such a serious virus?

Bob

[Upbeat]

Your right on target.   It sure is strange and I agree it must be in the genes.  I remember in 1999 when this report was given to congress and I  was concerned they would figure it was no big deal and not put Goverment money and research into the problem. Well here we are 8 years later and still no meaningful action. For those of us with the wrong gene make up lets hope this changes.
                          Ron

[mistybean]

Thanks for the posting.  I know those two studies gave me hope a few years back.

[Forseegood]

Hi, just been reading about the NM283 (Valopicatabine) (why do these guys have to pick these complicated names for these drugs? Can't they afford some decent copywriters? anyway...they should of gotten that cat who came up with "Lunesta" ha ha....) just wondering what you think of this drug, seems to have done pretty well in trials and much better than riba in the non-responders, relapser people...and I've read that it causes far less anemia...going into phase III (early this year it says) for "refractory" and treatment naive patients, just wanted to partake of your expertise! (already told you of my friend having such amazing results with it, 26,000,000 to 48,000 in one week!) Oh, and hope everyone is having a nice holiday!!!!I'm being a little "bah humbug" here at my puter, promise I'll listen to a few Christmas carols or something later, ha ha!

[couldn't think of a nickname]

Believe it or not, drug cos. are known to pay firms to come up with names. DRMD paid a firm to come up with the name Cenestin-synthetic conjugated estrogen. Premarin is short for Pregnant Mares Urine, as that is what the pill is made from-yes, pregnant mares urine, you heard me right. If anyone has it on hand, don't break it open in a glass of warm water. Been on the market for 60 years too.

I am not all that impressed with NM 283, while acknowledging it has helped some, and helped some in here. The activity of the drug is not responsible for fewer cases of anemia, however. The drug acts on a different protein of the virus, called a polymerase (forget which exact protein). Polymerase inhibitors are not as good as protease inhibitors. In the latest study, it got 25% of non-respon. to undetectable, but the control group (current SOC) got 19%. So, it was higher, but not much. There are a couple of other problems as I see it. First, it is still taking too long to go HCV RNA neg. Resistance has to be an issue.
Second, riba is still included, which might hurt what I assume would be future sales when all new drugs are out.
Third, the 12 week data was less than stellar, which is why the FDA requested 24 week data. Yes, they are non-responders, but so far, it only barely beat SOC.

In the next generation of tx's, it is my humble opinion this will NOT be a big player. I don't think docs or patients will want that triple drug combo for 48 weeks or longer, when the PI's might do it in 12 without Riba. Yes, of course, more data does need to be seen on the PI's that are behind it in trials, and that will be important. But, present indications are they will work better and faster.

I think we sometimes forget that in the first VX-950 1b trial, 23 of 30 in that trial were non-responders, so we have had a peek.

I believe the 24 week average VL drop was 3.3 logs. We all know by now that 950 got 4.4 logs in only 2 weeks, and that was WITHOUT IFN.

The stock chart of the company is not that good, and that tells me that market participants and institutions are probably not that positive on the drug, as it is very important to the co.
Many biotech analysts are docs and PHD's, but some don't seem to live up to that at times (Bank of America, for example). Bottom line, they are used to analyzing this data as much as or more than most.

[Forseegood]

hmmmm, thought the study I just read

http://ir.idenix.com/phoenix.zhtml?c=131556&p=irol-newsArticle&ID=795791&highlight=

the biggest arm was with this and interferon alone... and another one said that it did have less incidence of anemia, but then again, the words start to swim for me sometimes, because my work involves so much reading as well...I'll take a better look...I still think I'd prefer this to riba and interferon alone, study or no study. Your thoughts on that? thanks so much!

[couldn't think of a nickname]

You are right, that trial was with 283 and only IFN, besides the control arm. Still, the difference in anemia was related to the substraction of riba. Basically, 283 and IFN is slightly better than IFN and riba, with the exception being the anemia. Under that scenario, Viramadine would lessen the anemia dramatically as well. 283 does not go after the best target on the virus. That should be proven shortly, when the IFN and 950 data comes out. 283 and IFN got an avg. of 3.3 logs in 24 weeks. I have a feeling IFN and 950 will likely exceed 5 logs in 2 weeks. Just a guess on my part based on what I see right now, but that would mean 170 times more potent in 1/12th the time.
I probably should keep my expectations to myself, as only time will tell, but we should know shortly. I do have thoughts on what the data might look like, but I will keep them to myself for now.
Again, 4-12 weeks of IFN would be much better than 48-72.

Bank of America has said that they feel VRTX may need to do 48 week studies, since they think the FDA wants a control arm (similar to 283). They said this before the Fast Track status was granted.
Here is why that is likely wrong:
1. In the USA, safety and efficacy are the requirements to be shown.
2. If a drug works in 4-12 weeks, why 48 week data? All it does is delay trials for a needed drug. It won't work WORSE the longer you use it.
3. Volumes have been written on the standard of care. If the FDA wants to see numbers, pick an abstract. It is well-established in practice. This is basically the argument against a control arm.
4. Fast Track status allows for surrogate endpoints. That means that if an early indication of efficacy is seen, you might be allowed to proceed before data set is complete. In other words, if 950 shows EVR and RVR, that could be enough to move it forward without having the data completed yet. This makes the 48 week control arm even less of an issue.

It will be interesting to see the data when it comes out. Fast track status is not given often, I think I researched that in a recent year, about 50 were given that status, out of all the drug filings for that year. VRTX currently has 2 with that status, including an HIV drug in late phase 2. 950 is the only HCV drug with that status. There is another drug that escapes my mind right now that has fast track status, but is for those with liver transplantation.

[Forseegood]

thanks so much for this, you gave me a lot to chew on...