Has anyone heard about the Debio study?

[susan400]

I am wondering if any of you have heard about the Debio study?  I've been, all of a sudden, been asked if I want to screen for it in April.  I'm a little bit nervous because I haven't heard anything about it.  ????

Susan

[burned74]

here is some info from HCV Advocate (Drug Pipline)

DEBIO-025 Cyclophilin inhibitor Debio Pharm Group  Phase II
Comments: AASLD 2006: In a phase I study (15 days) of 23 HIV/HCV coinfected patients found that there was HIV and HCV antiviral activity in the dose administered. The clinical profile is promising, but there were 10 patients who developed hyperbilirubinaemia and 3 patients had decreases in platelets (but no bleeding episodes). Bilibrubin levels returned to normal after cessation of therapy. DEBIO has stated that further studies are needed on the adverse events.

EASL 2007: Per a company press release in April 2007, Debio has finalized the first two cohorts of the phase II study in HCV treatment-naïve HCV patients and has initiated a trial using the highest dose combination of DEBIO-026 plus pegylated interferon. (November 20, 2007)  

[susan400]

Thanks, NYGirl for your research.  You see, the particular place where I was offered it, the study nurse emailed it to me.  I've not been to their facility before.  I had just sent them my records to inquire about any studies.  After I got this email, I called my regular gastroenterologists office, to see if he could find out anything for me.  He called me back after I had posted this.  So far, all he's been able to find out was that they were using this drug on people who had been transplanted before and were having to treat the HCV again and that it had seemed to help them, over in Europe, that is.   I still have not been able to get an answer on any type of side effects that 'human subjects' may have experienced.  

Susan

[Deb_c430]

I like the name! Susan, if I remember well you been through as many treatments as Andiamo.    agrees with  Deb Ny

[Xhrles]

I was asked to consider this drug by my doctor and went to the debiopharm website and it looks like a promising drug. Could not commit to a year follow up of soc due to low platelets and don't get to pick which arm you get. Do your homework and ask your doctor for any info they have on prior trials and any negative incidents and then make your decision. It could be the drug you have been waiting for. What impressed me was they are testing it for HIV as well as HCV. Good luck.

[nygirl7]

http://www.natap.org/2006/AASLD/AASLD_30.htm

[nygirl7]

This one is pretty "English".  I wonder if they use this WITH SOC.  For someone like you - with the strongest damn hcv in the universe it might be worth trying for at least the 15 days to see what happens........it sounds like a replacement drug for the riba if you ask me.  I'd ask them if I could do peg and debio...I still can't find any real percentages...I guess it's too new.

Cyp inhibitor, being tested in humans as a potential anti-HCV drug. debio 025 binds strongly to cyclophilins, host cell proteins thought to confer a replication advantage to HCV. Its potent inhibitory activity on the HCV replication was shown in preclinical studies.

Previous results of the phase Ib study demonstrate that debio 025 monotherapy for 15 days induced a strong anti-HCV effect (3.6 log10 reduction) in HIV-1/HCV coinfected patients. CypA and CypB levels were measured in patients' PBMCs to investigate the relationship between CypA/CypB inhibition and antiviral effect. (October 31, 2006 press release).

About HCV

HCV is the most prevalent liver disease in the world and is considered by the World Health Organization as an epidemic. Because HCV can infect a patient for decades before being discovered, it is often called the "silent" epidemic. Studies suggest that over 200 million people worldwide are infected with HCV, an overall incidence of around 3.3% of the world's population. In the US alone, nearly 4 million people are or have been infected with HCV and of these, 2.7 million have an ongoing chronic infection, the majority being between 40 to 60 years old. A fourfold increase in the number of adults diagnosed with chronic HCV infection is projected from 1990 to 2015, since most persons with chronic HCV infection have yet to be diagnosed but are likely to come to medical attention in the next decade.

About debiopharm Group

Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regula
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[nygirl7]

Oh if you google it a lot of stuff comes up I just put in Debio HCV!

[nygirl7]

Yes it's a study I did a while agoio.

Debio

(Sorry pal I haven't heard anything of this but will try to see if I can find anything for you - the doc didn't explain anything at all?????  You're just supposed to try something without knowing anything about it? That makes no sense).