sitagliptin non inferiority trial

I guess the 'analysts' say that meeting the main goal of non-inferiority compared to Pegasys is not enough. They don't put any weight on the advantage of injecting bi-weekly, which I do. These analysts say albuferon must show numerically BETTER SVR rates to be commercially viable. If I had a choice between weekly or bi-weekly injections, everything else being equal, I'd choose albuferon over pegasys.

today announced that Albuferon(R) (albinterferon alfa-2b) met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in ACHIEVE 2/3, a Phase 3 clinical trial of Albuferon in combination with ribavirin in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C (p=0.0086). Albinterferon alfa-2b is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.

The difference of 4% fell well within the pre-determined 10% margin needed to show inferiority, allowing the researchers to conclude that 14 week treatment was non-inferior to 24 weeks. The relapse rate was highest among participants older than 40 years, those with genotype 3, and those with a high baseline viral load. However, prolonging treatment from 14 to 24 weeks did not reduce the relapse rate substantially for any of these groups. http://www.hivandhepatitis.

m asking please if is it possable that if i take the drug sitagliptin it would mean i could reduce the gliclazide and stop the mrtformin my Diabetes is well controlled on the whole but my nurse as requested i increase the glicazide

Sorry to hear you did not clear. That stinks that you can't find out what arm you were in. Either way you should not treat beyond 24 weeks if you still have a viral load. Your chances of clearing the virus still being detected at 24 weeks is less then 2%. So it is a no brainer to stop and wait for the PI's in the next few years or get into a non-responder trial sooner. I also have read Vertex is trying to get early FDA approval for Non-Responders.

anyone out there been on a trial for non-responders? I am starting one soon, but wondering if anyone else has been involved in one. Thanks for any info & good luck to all on treatment.

It did not work for me and other group C people who only had the Telaprevir and the Pegasys with NO RIBA. Since I now have exposure to the Telaprevir, it's hindered my chances considerably for treating in any of the other trials for protease inhibitors, such as Boceprevir. I tried to see if I could get into that trial and was told that I would not be able to be accepted into any trials that are using protease inhibitors.

Prove 3 is (was) the first trial held by Vertex for previous non-responders to SOC tx (see below announcement). I was in the 24 week arm that got VX950 + INF +RBV for 12 weeks followed by 12 weeks of SOC. Technically I wasn't a non-responder to SOC because I got a 2+log drop by week 4 on SOC, then a slow decline from 3M to 9,600. Around week 32 it went up, viral breakthrough, game over. Like dmhrdh said, Prove 3 people had previous treated (some multiple times) unsuccessfully.

Of the total number of subjects [N=3884] in Phase II and III clinical studies of Sitagliptin, 725 patients were 65 years and over, while 61 patients were 75 years and older. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

I had headaches and asymmetrical hearing loss, a MRI cleared vestibular schwannoma, but also mentioned: "Within the right cerebellar hemisphere inferiority, there is a curvilinear 1.7 cm region of T2 hypointense signal, perhaps related to old hemorrhage. No enhancement is seen with this finding of the lower right cerebellar hemisphere which is nonspecific. This may be related to previous trauma.

Is anyone familiar with this treatment drug/trial.Am possibly being offered entry into this trial around autumn time.Pretty important to me as I'm now early cirrhosis and classed as a non responder to SOC.

But I think that many of the drugs in trial now, will turn out to be good for geno 2 or 3 non-responders. The problem is that no matter what the genotype, people with late stage disease have a much less chance of responding to any of these drugs.

Telaprevir fromVertex Pharmaceuticals seem to be leading the pack of newer Protease Inhibitors (PI's) in trial that promise better SVR (cure) rates with around half the treatment course. Unfortunately, for the at least the near future, these drugs will be taken with interferon and most probably ribavirin as well. Estimates range from 1-3 years when Telaprevir will hit the market, but there are ongoing trials you may be be able to enroll in.

My consultant is offering me a trial of BI201335+SOC in april, on the face of it I should be grabbing it with both hands I suppose but if this trial doesnt work am I going to be a rersistant non responder to an entire class of PIs. Thats a scary thought. Any knowledge would be welcomed,what questions should I be asking my consultant prior to agreeing and enrolling. Any ideas on what I can do to improve the possibility of achieving a SVR ?

I figure you got a good chance of clearing if you add a protease or polymerase inhibitor to SOC, since you obviously respond to interferon albeit not enough. Getting into a trial might be a good idea, as long as you are certain you are getting the new drug as well and not just standard treatment. With such a good biopsy result you can also wait until the new drugs are approved. Hopefully that will not be too long, perhaps 2011.

This is wonderful news and very important for us to know that you were a previous non-responder. There's a big question mark hanging over SOC non-responders concerning whether the new drugs will be able to get them to SVR. I personally did get to UND on my previous attempts but then got viral breakthrough. So please keep us posted on how it works out for you. As you say, there are not many people out there with experience of R7128.

Are non-responders having any success with the new medications used to treat Hep C. Apparently, there is only a 32% chance or reaching SVR for this group.

Nothing more to add to what hrsepwrguy has said, I agree both of them drug sites have programs and are fairly liberal on what one can make... Good luck.

This tx is the only Triple Therapy which is currently running a trial for non-rsponders and relapsers. The trial is called Prove3. The results are not yet in but here on the forum we have heard of successes in this trial. To find out more about it you can search google for 'Vertex' and 'Prove3'. The website is www.vrtx.com. Vertex may apply for approval for this around the end of 2008.

how are you getting results ? the trial i was on, they told me absolutely nothing... except after 6 months i was dropped because it didnt work... and i just found this about the trial i was on http://www.natap.org/2006/EASL/EASL_19.htm so it seems it didnt work for alot of people, way less effective than the riba... which once again has me wondering to treat or not to treat...

Sitagliptin non inferiority trial

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