TMC 435

[Pam09]

Does anyone have any comment on this-good or bad?Someone very close to me has been offered a clinical trial. I want to give him the best possible advice. I have read some on the new drug but still don't know what to tell him. Please help if you can. (TMC 435)

[UKgirl55]

I was wondering when your tx is finished curiouslady? I believe the 12 week add on arms will be opening up in February and I'm going to be seriously considering doing it if I can.

[spectda]

Hi Pam,
Same to you!
-Dave

[Pam09]

Thanks again Will. I always trust your answers!!

[spectda]

Thanks Will,
Same to you my friend!

[Pam09]

Thanks Jules. Your comment is muchly appreciated!!!

[Pam09]

Thanks alot for the info!! Hope all is well with you.

[Pam09]

Thank you so much. I will keep researching & forward the info.         Pam09

[curiouslady1]

Is this the one?

http://hepatitiscnewdrugs.blogspot.com/2011/07/medivir-tmc435-has-received-fast-track.html

or this?

http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3370-companies-to-evaluate-daclatasvir-plus-tmc435

I think the one with the PSI 7977 is preferable because the two Pharmasset drugs PSI 7977 and PSI 638 are purported to have a higher barrier to resistance than the other drugs.  With interferon free regimens, you want to make sure the drugs involved are pretty powerful.  If the study uses more than two oral drugs (not counting a control riba arm) and it is a study for naive non cirrhotic patients, I always wonder if maybe the drugs are weak and that is why they have to use more of them.  If the study is using one or two drugs in combination with ifn and ribaviron the subjects run into the same problems they would have with the triple; that is, substantial side effects.  So, the question becomes why not go for the triple if that is the case?

[Pam09]

Thank you so much for the info. I hope all is well with you!!

[willbb]

Hey Dave ...hope all is well.. :)
Will

[jules2551]

Curr Opin Investig Drugs. 2009 Aug;10(8):871-81.

TMC-435, an NS3/4A protease inhibitor for the treatment of HCV infection.

Tsantrizos YS.


Source

McGill University, Chemistry Department, 801 Sherbrooke Street West, Montréal, Quebec, Canada. youla.***@****


Abstract

TMC-435, being developed by Tibotec Pharmaceuticals Ltd, is an orally administered, macrocyclic inhibitor of the HCV NS3/4A serine protease. HCV infection can cause chronic hepatitis, cirrhosis of the liver and hepatocellular carcinoma. The HCV NS3/4A enzyme is an essential component for viral replication, suggesting that this protein is a key therapeutic target. Biochemical assays demonstrated potent inhibition of HCV NS3/4A by TMC-435 in all HCV genotypes tested, with the exception of HCV-3. In cellular replicon models, the compound selectively inhibited HCV-1 replication and displayed additive effects with ribavirin, and had synergistic activity with IFNalpha and an NS5B polymerase inhibitor. Pharmacokinetic data demonstrated high exposure and good oral bioavailability, supporting once-daily dosing of TMC-435 in humans. In phase I and II clinical trials, the administration of TCM-435 to patients infected with HCV-1, alone or in combination with PEG-IFNalpha and ribavirin, produced significant reductions in HCV-RNA without any significant adverse effects, thus providing a basis for further development of this compound as an anti-HCV therapeutic agent. At the time of publication, phase II trials with TMC-435 were ongoing.

Pam..I just googled this.  I don't know anything about it since I am just getting ready to start treatment.  I am sure one of the warriors will chime in and help you out more.  Good luck with your journey!

Jules

[spectda]

It looks really good if you know you are getting the real drug. Otherwise if He has insurance I would personally use incivek or victrelis triple therapy. There are many threads about this drug if you use the search function and it may very well be the next approved drug. It seems to have the efficacy of telaprvir or slightly better with much less side effects.
Good luck to him,
Dave

ttp://www.medhelp.org/posts/Hepatitis-C/Medivir-Announces-Final-Results-from-TMC435-Phase-IIb-ASPIRE-C206-Study/show/1628047?controller=posts&action=show&id=#

[scoleman]

I don't know much about TMC 435 except it's a protease inhibitor.  I would suggest you search this site using TMC 435 as the search term.

That said, I have considered enrolling in a clinical trial.  The most important issue for me would be if I got the study drug at the full dosage for viral clearance.  In some studies you get a placebo, interferon, and ribavirin which is only 50% effective for curing genotype 1.

Keep reading,
Sherry