Update on me, bad news for Hubby, I'm very sad but hoping for false test
For those of you that remember me, I just wanted to say I am now 3 months SVR post (Gilead) study treatment. I was in arm 1 and received two study drugs and soc, I was und by wk 2 or 3 and randomized to quit treatment at 16 wks. What wonderful good news for me, however, my husband (in same study, do not know what arm) made the decision to quit all treatment at 23 wks ( he became und at wk 13) due to serious side effects. He has remained und until wk 28 and we just found out today that his viral load is now 355,000. What a blow, he is on his way to be re-tested for possible false positive or contamination of blood test. They stated that they would not tell him what arm he was in or what drugs he was given until study is completed in three years and since he quit one week early he was in non-compliance and they would probably not continue with soc for him. I believe it was the soc that gave him such horrible side effects anyway. Since we don't know what he has already taken, I don't think he would be able to take the new PI's. Does anyone more knowledgable than I have any feedback on this situation????? Words of incouragement would also be nice. He is 60 years old and the pa at the clinic said that he would probably never die of hep C related causes (his liver is stage 2 and his vl was 5,500,000 when we started this journey, probably had hep c for 35 years). What is the progression of the VL does it rise rapidly or increase slowy over a number of years? I know I am grasping at straws here but what are the chances the test was false or contaminated??
Thanks for listening.
Sherry, so sorry to hear of your bad news on hubby but happy for you and your SVR. Do you still have his study drugs? He may have been on placebo. If interested, I could send you the lab I used to test my study drugs. This way you would not have to wait three years. Just a thought.
I'm very sorry but 355,000 is probably not a false positive, false positives are usually like 60 or something like that.
the good news is if he does take good care of his liver he should have time as a stage 2 but you have to make sure to get a biopsy done on him every few years to monitor the damage. I believe that they say that once we are older the damage can progress faster. It is not linear in nature meaning that it could take 30 years to get to stage 2 but then only 5 to get to cirrhosis. So he has to be extremely good to that liver.
Hopefully the newer new drugs will pan out and lead to SVR and he can try them rather than interferon and riba - we don't know yet how well they will lead to SVR but of course as all interferon haters do......we sure hope so.
Congrats on your SVR I am very very sorry that your husbands treatment did not succeed.
Sherry...I was wondering the other day what had become of you folks .seeing as we hadn't heard from you in awhile.
That is great news on you own results. ..being UND 3 months post tx. you will undoubtedly SVR.
Very sorry to hear about hubby..unfortunately the chances of the PCR being a false positive are low ..especially given the fact he was only UND at week 13 and stopped at week 23.
Good advice from sandy and Eyes of Blue ...if you have some study med left and can get it analyzed it would be good info to have to move forward with possible treatment now(if indeed it is placebo)
Failing that or if it is study drug.. then it is best to wait until he knows what he was taking to be able to treat again.
He is in roughly the same position I and a few others are here....a failed trial experiment and waiting for them to unblind in order to move forward.
You say 3 years?..that seem like an unusually long time for this trial...are you sure it is that long from now?
The rapid or slow onset of returning virus will have no bearing on his progression of liver damage (fibrosis) There are many with low loads with significant damage and vice versus.
On a positive note..as you mentioned he only has moderate damage(St2) and this will allow some time to see how things unfold to be able to treat again..
So.1) if you have drugs left ..try to ge analyzed 2) get then to give you the exact date of study completion and 3) he is stage 2 so no matter what there is time(possibly a significant amount)
Sorry for your husbands bad news. Good advice from the others. I just want to add not to worry about the study not letting your husband continue the SOC drugs. They most likely wouldn't work at this point anyway.
I would put all the effort into if your husband got the placebo, and if he did then he should re-treat with one of the new PI's that came out earlier this year.
Best of luck
Am I remembering correctly that the whole study was pulled because of adverse effects some of the participants had? You are fortunate, indeed that you are SVR . Many congrats. I was asked to be in that study but declined. At my stage I could not take a chance with the uncertaincys.
I am sorry for your husband's not clearling-- at least that is as it appears. He still has time, but do make sure he gets a biopsy when it has been 3 years. frijole
I'm so happy for your results. I understand the disappointment that you feel about your husband. From talking to my doctor and study coordinator, nearly anyone that had one or both of the study drugs, had success so chances are he was on a placebo. So even though it did not work this time, he can see what happens with the non-interferon treatments. I've said before that interferon was no friend to me either.
@frijole - the study was not pulled, just one of the drugs - Tegobuvir - for its interaction with interferon. The drug is still being tested in all oral studies and this particular study is still going on with the other study drug as yet unnamed.
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