Hi there..Was wondering when we hadn't heard from you for a number of months what had happened.
Were you not in the TMC 435 trial? If so that as you would know is a protease and I am a little surprised you would be doing another protease with the resistance issues still looming?
Sorry if I am incorrect on this...
Have a complete physical to see if you are healthy enough for the new tx.Watch your blood pressure and watch for any anemia or other side effects.I ate a lot of ice cream before bed,bagels and cream cheese,hot dogs and other meats high in fat,nuts,cheese,peanut butter and crackers,eggs,pizza,tuna fish,dark meat poultry,pork,etc.are some of the treats I ate 30 min before on Incevek.With Victrelis just an ordinary meal.Wish you luck in your 3rd attempt.
I was in the TMC 345 research. I am 99% sure I got the placebo. So, I quit the study. I knew that I would just relapse and the study (from Belgium) wanted me to continue on the Rib and Peg for another 6 months. I had already tried that treatment (the first time) for 66 wks and relapsed. The 2nd I was on the study for 6 months. Bloodwork was in the toilet and I knew I would relapse, not getting the real drug. Now, I am thinking on starting the triple therapy. I don't understand the terminology of "protease".
Sorry to hear about the study not working for you,however how do you know you were on the placebo?
Was the study blinded to you on what you rec'd as far as the study drug? Have they unblinded the results yet?
TMC 435 is a "protease inhibitor" the same class of drug as the two that are on the market now (Victrelis & InciveK)
If in fact you possibly were on the protease TMC 435 and failed it would not be protocol to start another protease ,as there could be resistance issues.. ..
Hopefully the new doctor is aware of this.
No, I do not know for certain that I was on the placebo, Yes, the results are hidden. The only reason I know is that, the study told me to stay on the drugs for additional 6 months. The study people that received the placebo were told to stay on the treatment for 48 wks. If I would have received the "real" drug, they would have pulled me off of everything at 24 wks. I could also tell from my AST/ALT counts. The new doctor is fully aware of my previous two failed attempts and what I used. I don't seem to have an issue with getting UND after 4 wks, I have a problem with staying UND after 24 wks or 66 wks.
I will add this information in case you do go ahead and start treatment with Incivek.
If you do start Incivek here is a thread with a huge list of high fat foods (towards the bottom of the thread, 80mecheng's post). Be sure to eat some solids with your fat (not just liquids). I often ate Greek yogurt and buttered toast, something to give it a little more food intake.
I had timers and alarms all over the place so I woul not miss a dose of Incivek or Riba and I was religious about setting them for my next pill time as soon as I took a pill. I had one timer that could be carried from room to room and I brought it with me wherever I went. It ot to be such a habit it was pretty easy to just set the timer for the next 8 hours as soon as it rang. Some people get watches that can be programmed. It is crucial that you take the Incivek on time so whatever system works for you, use it.
I am sure you already know these things but if not, here goes:
*Get your teeth cleaned and any dental work done before starting
*Get a baseline eye exam done by an opthamologist who is aware of the Hep C med problems
*You may wan to get a Shingles vaccine, and if you do not already have Hep A and B vaccines you will want to get them
*You may also want to get a pneumonia vaccine
Best of luck and let us know how things go.
I don"t know the exact parameters of your study,however in the study I was in I was told I had to do another 26 weeks also(48 weeks total) ,not because it was a certainly I was on the placebo ..it was result oriented.
In other words if a patient didn't become UND. at week 4 and stay that way till week 12 the protocol was to do 48 weeks..no matter whether on the placebo or study drug.
Personally I would be very hesitant to try treatment again unless I was a 100% sure of what my previous treatment entailed as far as what I was taking.
This is what has held me up re-treating as the study was just recently unblinded and I will be told soon.
I Also have my suspicions on what it was ,however need to be certain ,because of future resistance issues.
Can you not wait till unbinding? Do you have advanced damage?
I am surprised a doctor would start you on another protease if there was any chance at all you already did one,however if he/she is very knowledgeable about these new meds and says it is ok....well...
Best to you...
I became UND at 4 wks and stayed that way. I quit the study and all the drug treatment at 24 wks. I was still testing UND until about 2 months after ending treatment. Now, I am testing AST 43, ALT 58, HCV 655,432, geno type 1, level 2. My last shot and drugs were Nov 4, 2011. Do you think I should hold off for a couple more months to start treatment? Did you relapse after doing 48 wks and being in the TMC 435 study?
Being that you was und at week 4 the odds are very good you were on the PI, i would strongly agree with will about starting another one this soon... Good luck
Not sure why you had the RVR in your study and then quit early ,however at this point it is really here nor there.
Do you think I should hold off for a couple more months to start treatment?
With the resistance issues still a grey area and the fact that there is a chance you have already taken a "protease " I think it would be prudent to hold off.
You are only stage 2 and that is why I asked about when the unblinding of your trial was?
I would be very reluctant personally to re-treat not knowing 100% what I had taken before...
I was in a different trial ..The BMS and have waited for unblinding....
I would add that you should always take into consideration what your doctor is advising you,,,especially if he/she is knowledgeable and up to date with the protocols of these new meds (ie resistance issues etc.)
I am going to agree right down the line with what will has told you.
It is unclear whether you took a placebo or not. 10-20% of people on SOC will RVR, so you cannot base much on that.
IF you were on TMC435 you were indeed on a protease inhibitor and you will indeed have resistant virii. Nearly 100% of those who treat for a full 12 week triple therapy treatment have strains of HCV virus that are resistant to protease inhibitors.
In other words..... retreating with a different brand name protease inhibitor will net you approximately the same results as simply treating with SOC. The HCV population is not affected much at all by the PI. You know that SOC alone will not cure you, and SOC with another protease inhibitor will net you the same results.
There is a test.......
LabCorp has a new test out called a genosure which you can test your virus population. It should be able to tell you if you have the default "wild type" or the resistant to protease inhibitors strains which would result from 12 weeks of exposure to TMC435.
Obviously you can also just wait for the trial to unblind.
If you have been exposed to a protease inhibitor I would strongly consider waiting several years for your population type to revert back to "wild".
If you have a doctor who is willing to treat you with another PI after (if it turns out to be true you have taken TMC435) a prior 12 week exposure...... I would consider consulting with another doctor or reputable source. Personally, I believe it would be ill advised.