VX-950:More positive news

During the Digestive Disease Week meeting in late May, Vertex reported highly anticipated clinical trial results from a study that examined its hepatitis C (HCV) drug, VX-950. VX-950 is a small-molecule drug that directly hits the virus and stops it from replicating. Hepatitis C can be difficult to control with existing therapies, so innovative drugs like VX-950 are sorely needed.

The clinical trial data for VX-950 looks very good, particularly in the highest doses of the drug. Using highly sensitive assays to measure the presence of the HCV virus, four out of eight patients were HCV-RNA negative, and two of those four patients had undetectable levels. Considering that these patients took the drug for only two weeks, this is an incredible result.

While this data is exciting, the drug is still very early in development. The next big step is the initiation of phase 2 trials, which should start later this year. While the drug moves through further clinical trials, cautious optimism is warranted.

[artgal]

You are exactly right "cautious optimism is warranted". I spoke with my doctor about this drug this week -- the pharmceutical companies really like to get people's hopes up and get financial support for their drug. BUT even interferon and ribavirin can show a clearing of the virus as early as 21 days. What matters is the long term result -- will this drug provide long-term SVR results? Will people have to continue taking it long term to remain clear form the virus? None of these questions are even close to being answered.
It is great that new drugs are being explored and hopefully sometime in the future we will have better and more successful drugs. But I would not base a treatment decision on VX-950.

[BronxRican007]

Dude,

Old news ...was published on the net around 14 May 05...like artgal says...it's too early to tell. Vertex is trying for phase 2 trial later this year so hopefully there's more clinical evidence and great news to come.

[BronxRican007]

You say that TX "took so much" from you; are you talking about SX? Could you elaborate? I have my first GI appt next week and I think I'm in bad shape from HCV; I have gallstones, mild pain under my right ribs which seems to be getting worse, major skin problems, vision problems, CRS (Can't Remember Sh*t) and elevated ALT/AST numbers which keep rising. Tha ALT/AST numbers may be from the gallstones, but who knows. My biopsy will be done when they remove the gallbaldder. I'm  GT 1b, no viral load numbers yet. With all that in mind, I'm very interested in knowing about how bad your tx was. I intend to go thru with tx so I need to be prepared mentally.

Thanks in advance for sharing your experiences.

BronxRican007

[twotells]

It would be absolutely wonderful for a new drug to be approved.  I, personally, probably won't need it since the INF+Ribavirin appears to have worked for me; but so many do because the Inf+Ribavirin hasn't for them or they can't tolerate it.  The Pegasys+Ribavirin took so much from me, I'd like to see a newer and kinder treatment.    Unfortunately, it doesn't appear to be right around the corner for all the reasons others have posted.  The only treatment option out there now that works is INF.  Let's keep hoping,  Dave

[snook_man]

Reesink and Schiff both warn patients with chronic hepatitis C infection not to stop their current treatment or to delay starting current therapies. Even if everything goes perfectly -- and drug development rarely does -- it would be more than five years before VX-950 could be available to patients.

"It would be a mistake for people to stop their current treatment to wait for this stuff," Schiff says. "That would be a big mistake. What we heard today could represent a major advance in treatment. But I used to chair an FDA drug-approval committee, and I can tell you that when a new drug comes along everybody gets turned on -- and then they find side effects of something and the drug has to be withdrawn. I don't think that is going to happen here, but it's too soon to tell."

[twotells]

Sorry I didn't respond right away- had a family emergency and haven't been around much.  Cuteus is right, my most troubling problems were related to Cryoglobulinemia and a rare (I repeat- rare) worsening of that condition after starting treatment.  My nerve damage is probably permanent and prevents me from working full time and doing some of the things I loved (backpacking, home repairs requiring alot of strength, long bike rides for 20-40mi, etc.).  My experience shouldn't deter anyone from undergoing treatment because very-very-very few people have this happen (1% of people with chronic HCV).  Even with this, it appears that I've saved my liver (6mo PCR clear) and would treat again if I had to- that's how important my liver is.  I hope things go well for you,  Dave

[cuteus]

twotells had more than HCV to contend with, he was also dealling with cryoglobulinemia, and the tx aggravated that condition. If you test positive for cryoglobulins(you have to ask for the test) then twotells experience with tx can be related to your case.

[BIOPHIL]

Bronx- what do you eat everyday. do you juice? make healthy teas?
do you smoke?

for my brain I cut out simple carbs, juice and use L-tyrosine, Ginko, green tea, and sam-e.

[Susan from NY]

I am very excited about the VX-950 also. As a matter of fact just invested some moeny in Vertex figured it is a win win situation.  I have been depressed for years ever since I found out that I have hep C. The treatmenet did not work for me which was determined after being on it for 4 months (Pegasys and Rebetol).

I am genotype 4, between stage 2 and 3, and grade 2. My viral load in just under 1 mill. and by alts and asts are btw 50 and 100. Have had this for about 35 years. Doc thinks I will die with this not from it and doesn't seem terribly concerned. He had said if I wanted to go onto the Infergen trials he would set me up-but the odds there are 40% and you take shots everyday and I have opted to wait for something better since he was not very insistant anyway. I hope I am doing the right thing-so much uncertianty with this thing-gets me so angry that I am so powerless and am at a stand still so to speak. God I hope this VX-950 comes soon and works! It is supposed to be for all genotypes - that is my understanding even though right now they are testing geno 1.

Any feedback would be greatly appeciated and you can Email me anytime at ***@****,

Thanks,
Susan

[BIOPHIL]

When will we have better druggs to wipe out this demmed virus with? vx950 for example, when will it be "go" for the market?

[Susan from NY]

I amn ot sure when it will be on the market-my guess? in conjunction with Interferon 5-8 years maybe sooner though, 10 years to take it without interferon.

[cuteus]

I don't understand why your dr will only offer you infergen as tx. That tells me that this dr is not up in his knowledge of hcv. The standard is to do pegylated interferon and ribavirin for at least 48 wks. That tx gives a 50 to 56% chance of erradication. I strongly suggest that you speak with another dr before choosing to wait. Stage 2-3 is not the best position for waiting. Remember it is not his liver he is putting at risk. My first GI was very non chalant about hcv, did not offer a biopsy because my enzymes were normal, I had to insist.

Waiting is fine if you are less than stage 2, and younger than 50. The disease progresses faster as you age and quite a few have posted being stage 0-1 and three yrs later they were at 3-4. Liver cancer risks also increases.
Please get a 2nd opinion. It is a lot easier on our minds to get a dr that does not seem worried, but I don't think it is the best dr to have.
GL to you