New Treatment

Was thinking about going back on treatment with new triple combo. Failed in 2009-2010 with SOC. Tryed to get into clinical trials with all orals, but nothing open for people who were previosly treated. I know that curioslady1 is having great success with the new Pharmassett trial. I hate to start over again being that I had a tough time with SOC last time. I feel that if I need to start treatment soon for I am getting a lot of confusion,elevated ammonia and white blood cells,bacterial infections,and sore and red gums. Any suggestions? Which triple therapy might be easier,Incivek or Vitrellis.

[coeric]

hi bob,
i started the incivek (telaprevir) 12 days ago and so far my sides of been mild. the incivek does require you to eat 20 grams of fat immediately before taking each dose of incivek.  incivek users may have problems with sever rash, while victrellis may cause worse hemolytic anemia. the following links will take you to the documents that were presented at the advisory commitees for each drug. they include all the side effects.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252343.pdf

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf

have you spoken to your doc about starting? i hope that you are under the care of a skilled hepatologist.
blessings
eric

[curiouslady1]

Someone mentioned they had introduced a new arm for NCT01278134 at clinicaltrials.gov which is an all oral intended for interferon intolerant people.  The new arm is supposed to consider nulls and nons.  You may want to call the 888 number.  Doesn't hurt to ask.  Other than that, your hepatologist needs to be involved.  I think, not entirely sure, that many or most of these studies go by referral.  Seems that a lot of people contact them who don't qualify and it is costly to run the tests and consult.  Beyond that, being in a trial is not right for everyone, regardless of the trial.  It all depends on liver condition and a good physician's interpretation of that condition and the progression of your disease matched with the right study drug(s).  It can take months for all the assessments to be done, for FDA and IRB reviews to be completed and to get scheduled into some trials.  Further, you have to look carefully to see if the objective of the specific experiment matches your own which ought to be SVR.  That is not the objective of all the experiments I think.  It depends where they are in investigating the drug, its safety and its efficacy.  So, all this to say that the triple may very well be your best bet anyway.  Good luck to you no matter what you and your doctor decide.

[UKgirl55]

Hi curiouslady,

I was wondering if you could tell me whether you have treated before, or were you tx naive when you went on your trial? What were your deciding factors for going ahead with the trial? Do you know if the oral PSI-7977 and TMC-435 have already started? I was a little unclear on that one. Thanx!

[curiouslady1]

Hi UKgirl,  I was treatment naive going into the trial which was a requirement.  The factors I took into consideration were the importance of my work and career and the fact that prolonged periods of being unavailable mentally, emotionally and physically would not be acceptable; the fact that I had little family support; the information given to me that I would be able to treat with other drugs if I failed this particular trial; the fact that I was in reasonably good health and that I had low fibrosis; the willingness of the study staff to accommodate my schedule somewhat and the fact that I had already altered my personal life to accommodate daily visits to the hospital; the interest in the trial and the drugs and what I had read and what was reported to me about findings on its efficacy and safety thus far, the fact that little or no side effects had been reported; the fact that I would probably not be responsive to interferon since I am a 1a; the hospital is practically next door as I moved several years ago with the thought in mind I would be close to a research hospital; the repeated horror stories I was hearing from people on this forum even from those who were not sorry they treated, etc.  All of these issues made it an easy decision.  I don't know about the trial involving TMC 435?  I know that the PSI 7977 and PSI 938 has started and that it is supposed to be worldwide but, like all these things it is very slow because there are many prospective sites who still need approval from their IRBs.  They will be posted little by little as they get approval.  

[orphanedhawk]

My friend just called the number and will most likely be doing the non-interferon trial.
I'm the one who referred her :)

[orphanedhawk]

I hope you're taking lactulose for the elevated ammonia and know to stay away from red meat and reduce salt intake.
If you already have decompensated cirrhosis, that may complicate things.
I think you need a good hepatologist.

Good luck

[UKgirl55]

Thank you for your reply. I think it's a possibility I may be offered the PSI 7977 and 938, what are your thoughts on this one? I've heard a very good report on the TMC and of course we know what the PSI is doing. I'm not sure about the 938 because there doesn't seem to be as much data out there. I believe it's a nuceloside that works differently than the 7977. The drugs you say you will be offered if this doesn't work would be interferon and Riba...right?

[UKgirl55]

Do you know which trial your friend will most likely be doing?

[orphanedhawk]

She said it was an all oral w/o interferon. Its located in San Francisco.
Sorry I don't know more than that right now.

[bob528]

Hi and thanks for the information, will continue to look for clonical trials for all orals. If not then probably have to retreat with triple therapy. I hate to do this because I had such a tough time before and now I don't have the support that I had then.

                                                                                    
                                                                                Bob

[bob528]

  Hi Curiouslady1,

                             I enjoy readig your posts and learning about your experience's and knowledge. After I have some dental work done I will probably go on treatment again with the triple dose of meds. Don't know which one yet.  I had such a tough time at the end with the last time that I'm going to have to figure nsomkething out.

                                                                       Bob

[curiouslady1]

I think both OH and UKgirl are talking about the same trial.  It is called Quantum.  It is actively recruiting but it just opened up and so far only a few places in the western US have gotten their IRB approvals.  These things take time unfortunately.  If I wasn't doing the trial I am in, I would jump for Quantum.  Both PSI 7977 and PSI 938 have been fast tracked with the FDA and they both have gotten good preliminary results.  In the Quantum trial you will see that one arm involves PSI 938 as a monotherapy.  I am told that they usually don't do it like that at Phase II unless they have good prior info that it will work.  Further, they just added an arm today in NZ for PSI 7977 to be used as a monotherapy on 25 GT1a's for only three months!  That takes some guts if you ask me.  It sure gives me some comfort since I am only in week 7 (with 7977 and a BMS drug).  I will feel a sigh of relief now when I make it through 3 months.  Of course, the real goal is SVR 6 m and 12 m but all these little nuggets along the way really help sustain one's optimism.  I suppose we will hear a LOT more in a few weeks at the AASLD conference at the beginning of November.