ITMN-191/RO5190591 protease inhibitor trial modified due to 3 participants w/high enzymes

The highest-dosage arm of this Phase 2b trial of Roche/Intermune's new PI was halted because 3 people had seriously elevated liver enzymes.  Is anyone here on this trial? If so, hope you are all on one of the other arms.  With luck the issues will resolve with discontinuation of the PI, but it's very unfortunate.  Hope the lower-dosage arms don't have any such issues.

http://www.redorbit.com/news/health/1787116/intermune_announces_modification_to_ongoing_phase_2b_study_of_itmn191/index.html?source=r_health

It's a little wake-up call to me, since my husband is on a trial of a similar PI (both non-covalent reversible inhibitors, whatever that means, as opposed to Telaprevir and Boceprevir which are covalent reversible inhibitors). So I'm going to keep an even closer eye on his labs.  Happy that his enzymes have been normal for a while now.

[rockportbill]

I am on that trial, I was told to discontinue the trial meds,   I had only taken the meds for 5 days.   Now  I am only on the SOC,  just my luck

[WriteItDown]

Wow, Rockportbill, that's a shame, I am very sorry to hear that.  It really *****.  At least you get SOC for free, and maybe even the 5 days of the PI will be of help to you.

When my husband started his trial it never occurred to me anything like this could happen.... it really is scary, but then again, trials are the only way right now to get anything other than SOC.  What a **** shoot.  I certainly hope you get SVR and that if you don't, they offer you something like a rollover once they get their dosages straight.

[newleaf09]

That is the unfortunate side of Phase 2's; they are held to work out the best dosing times and rates.  You might get too little or too much, which looks like the case with 900mg twice a day.  When people make a big fuss about how grateful they are to those who participate in trials, they should really be thanking those in the Phase 1 safety trials and in the Phase 2 trials that work out dosages for best, safest effect of experimental drug.  I was in a Phase 3 and am grateful to those who were on the bumpy road of Phase 1 and Phase 2.  Also makes you glad there is so much outside oversight of trials.

rockportbill, wait and watch.  You may still have gotten a beneficial effect from the 5 days with 1800 mg per day.  I've heard stranger stories about trials.

[maxygirl]

I am on that trial.  I started Sept. 4 and my last day for trial drug is Nov. 27. I am anemic, have headaches and strange cravings.  They don't want to lower the dosage for anemia so they monitored it very closely. They also don't give anything to build you up as it is not part of the protocal.  I did have a very good result from it.  I started with a vl of 6.9 million and was UND by week 4.  They tell me I would not have received such a result from just the SOC.  I will remain on SOC until the 24 or 48 weeks.  Not sure yet.  Hanging in!!!

[WriteItDown]

UND by week 4 -- that is great!  Congrats!  That's what make the trials worth it, despite the potential dangers. I think only like 5% of people get RVR on SOC.

You're lucky your trial isn't blinded, and that you're on one of the two lower-dosage arms.  I don't know whether to say hope you get the 24 or hope you get the 48 -- I know some people want to go as long as possible for insurance, and I respect that, but I'm sure hoping my husband gets to stop at 24.

In the trial he's on we get no PCR info until 24 weeks. They also don't want to give anything for anemia if they can help it.  Luckily my husband isn't so anemic.  He also has headaches, but no strange cravings (just the usual -- sugar and junk food, LOL), and he's really tired, but I'm sure you are, too.

In any case good luck on the rest of your ride and enjoy the sweet sound of UND.