Protease inhibitors

[almawe]

I have had a look at all the trials that have been, or are on the go at present.  Am confused, had thought that all the new trials were with the '3 pronged' approach, as in the inclusion of a protease inhibitor.   l have had a look a a website that someone suggested on hep c drup trials and l see that there are some trials that appear to only use the protease inhibitors without the inteferon and riba.  If this is so, has anybody had any expeience, and success with such trials?

[almawe]

l am from Melbourne, Australia. All l know is that the trial is the drug combo of telepivir, interferon and the riba.  Don't know much else and am not aware if l need to have a biopsy.  They will let me know of the preliminary details come January.  
The liver clinic l am going through is the Alfred Hospital in Melbourne.  They also offered me 2 other trials, but l am only familiar with the protease inhibitor added to exisiting treament, so was hesitant about even inquiring about the other 2!..had information overlaod as it was. l Think the triple combo treatment is the way to go, given my geno type.

[blondie717]

Hi Allison, Most of the trials require a biopsy no older than 2 yrs. I got into my study real early because I already had a recent study. What study are you interested in? no placebo sounds real good.

[almawe]

Went to clinic today for my treatment discussion.  I have a viral load of 1,500,000 and am geno type 1a.  am going to be assessed for a trail that starts in January for the standard treatment plus the protease inhibitor.  Am relieved that there is no placebo involved.  Am keeping my fingers crossed that l meet the criteria.  When l asked what some of these critera were, was told anemia status and other liver diseases among other things that l have forgotten!.  Hope l get into the trial.  
Alison

[almawe]

Thanks for that nutpea, l will know more after Thursday.   Will look at that site, do want to do something!

[nutpea]

Hi I did look @ www.clinicaltrials.gov    There are some in your country.  I dont know if you would qualify as some are for non responders and some are for treatment naive. and so on...Also I dont know if you would want what is offered, but you could have a looksie. And maybe ask your liver doc about some of them...

[positude]

Hey Alison,

Yep. So far, so good. At three months post tx we will have a tentative idea, and at six months post tx it will be more definitive as to whether or not I have actually achieved SVR, though I have every confidence that I am, and will remain so. :) Stubborn. lol. And I believe that my sides will eventually fade to a dull roar as I am really pushing myself to get back to "normal". I need to get back to work and soon!

Hope things are good "down under". Take care.
~Pos.

[almawe]

That  was such a 'positive' read first thing in the morning for me (different time zone here l would imagine).  Your treatment outcome is wonderful and the waning of your side effects is also good news.

Alison

[positude]

This is to Alison and Diane who have both asked.

I was HCV 1a with a day one viral load of 12 million. I started tx with peg and riba, and added boc after a four week lead in with soc drugs. I was UND at week 8 and have remained that way. At week 27 the IRB of my trial study decided to put in an addendum based on the safety issue concerning the epo recall, that anyone UND continually from week 8 would be able to discont. tx at wk 28. If they were past the 28 wk mark, they must continue until wk 48. I hit the timing just right. One more week and I would have been over the 28 wk cutoff.

I am doing really good! I am right at 4 weeks post tx. and my energy levels have increased, though I still get a little short of breath if I do too much. I still have some hair falling out, but I have some new hair coming in too. My skin is still very thin, and occasionally itchy, so I have cut my fingers in several places just doing everyday things. I am having some anxiety and tachycardia, but nothing too severe, just feel like I drank too much coffee but haven't had any coffee since last March. :) Brain is clearing, food tastes SOOO good again, air is sweet, mucosal sores have cleared up, gaining back some weight, and generally feeling pretty good.

I got a flu shot last week and it hit me pretty hard. I have never had any problem with them before, but it is probably a combination of the meds I've been on plus the addition of the H1N1 vaccine which has been added to the standard shot.

I have to go for my one month post tx blood and check up on Monday, but I'm sure everything is still fine. I will let you all know what I find out when I get my results.

Best wishes to you both,
~Pos.

[almawe]

Thnaks for that info Blondie.  l doubt that l will qualify as l live in australia!.  Got my appointment with the hep doc next thursday, will get my viral load and latest LFT results.  Will discuss what my treatment options are then.  Sort of a bit excited about finally doing something, but nervous too!  

[blondie717]

hit there name, which is in blue. then you will go to their page. from there look for notes, messages. If you hit message, then you have a private line, to the person. I have seen a trial comming up for Soc and Dano?????.....You will find it at www.clinicaltrial.com    I wish I were in it , but it is not in my area...Maybe you can qualify for it...

[almawe]

You have got me intrigued now.  How do l ask a question to someone?

[almawe]

Thankyou all for that feedback.  Really want to do 'treatment' that will give be the best chance of clearing the virus.  Hope l am offered a trial that does includes all three.  Am geno 1a, had it for about 30 years, know my geno type is the hardest to clear.

[orphanedhawk]

There are a number of new meds being tested which don't include interferon or ribavarin. From my understanding, they take a different approach to attacking the virus.
My doctor thinks good alternatives will be appearing in the future but how long, is anyone's guess.

[nygirl7]

That is why they are trials......they are trying to find out if it will work.  To me - the chance of getting an immunity to a PI by taking it without SOC and then finding out it doesn't work....is just not worth the risk.  

I wouldnt do a trial without peg and riba both on board - no way. Just ask Susan400 what can happen if you don't get the riba, let alone the interferon too.

[blondie717]

You might also try looking under www.clinicaltrials.gov   for clinical trials. I hope you get some feed back from people who have tried trials w/o SOC.. I was told by one person they would not do a trial w/o Soc. Good luck and best wishes

[Diane12855]

You're done already? Wow! That really gives perspective on the advantages of the new PIs over SOC alone. You started just after me and I still have 21 weeks to go. How did you do?

All my best!!!
Diane

[almawe]

Thanks for that response.  The site that l was looking at regarding trials was:

http://www.hcvdrugs.com/

Can't really make head nor tail of it!.  Was your treatment successful?

Alison

[positude]

Hello and welcome to the forum. I just finished treating with Pegylated Interferon Alpha 2b, plus Ribavirin, AND Boceprevir. I was in a "Procrit" study to determine the benefits of adding epo as opposed to dose reduction (although I actually had to do both epo and dose reduction due to the anemia). I don't know anything about treatment without Interferon and Riba as those are the gold standard drugs used to treat at this time, but it is an interesting thought.

Maybe someone on here will know more about this subject than I and can offer you more information. Best wishes.

~Pos.