Hep C Trial drug TMC 435

[Wendywuu]

Hi
I've been offered a trial with TMC 435 for 24 weeks.  I'm Geno type 1 and have done treatment twice. I relapsed soon after stopping last treatment (48weeks). I guess the trial is to see if treatment weeks can be reduced.  Has anyone got any info about this drug and what is the communities thoughts of only doing 24 weeks?  Are there any results post 24 weeks?
Thank you Wendywuu

[HectorSF]

From the phase 2b study....
http://www.hivandhepatitis.com/hep_c/news/2011/0520_2011_b.html

Huddinge, Sweden -- May 20, 2011

TMC435 Boosts Hepatitis C Post-Treatment Response

SPIRE Results -- Efficacy

In this Week 48 interim analysis, all subgroups of treatment-experienced patients who failed previous peginterferon and ribavirin treatment, achieved substantially higher virologic response rates following treatment with TMC435-containing regimen at all doses and durations, compared with pegylated-interferon and ribavirin.

There was no relevant difference in virological response between the TMC435 150 mg dose groups who received TMC435-based triple therapy of 12 weeks, 24 weeks or 48 weeks. At end of treatment (EoT) 92%, 83% and 71% of relapser patients, partial responder patients and null responder patients taking TMC435 150 mg once daily and placebo, respectively, achieved undetectable HCV RNA levels compared to 70%, 17%, and 25% in the placebo PegIFN/RBV groups respectively. At week 4 after cessation of treatment (SVR4) 88%, 77%, and 57% of prior relapser patients, partial responder patients, and null responder patients taking TMC435 150 mg once daily and placebo, respectively, achieved undetectable HCV RNA levels, compared to 50%, 11%, and 23% in the placebo groups, respectively.

About TMC435 in other clinical studies

TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Tibotec Pharmaceuticals and, to treat chronic hepatitis C virus infections.

Three global clinical phase 3 response guided studies were recently initiated by Tibotec:

TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients
TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients
TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment
In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011. Phase 3 programs for TMC435 are also ongoing in Japan.

Cheers!
Hector

[Wildorchid1121]

I too am on the trial drug (9 weeks now), and this is my second time on treatment. If you are taking the real drug and not placebo, you will be on the TMC 435 for 12 weeks, and on Riba and interferon for 24 weeks, then you continue your doctor visits for blood work for the rest of the 72 weeks. If you are on placebo, you stop placebo at week 12 and continue other meds until week 48, plus visits until week 72. If you are on placebo the first time you are on the study, you are guaranteed the real drug next time at no cost.

Since it's a double blind study, no one knows what you are on until week 24. So far there have been excellent results, like cakes8267 said, read previous posts, this is very promising!

Good luck. Carmen

[cakes8267]

yes, read previous posts, I am on the trial drug along with others.