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225238 tn?1296815986

How is this possible? I was on placebo...

So back in November 2010 i started a trial testing PSI 7977 in conjunction w/SOC.  About a month ago, i found out that by the 3rd day of the study, my viral load had dropped from 4.9 million to 4,700.  At week 4 and ongoing, i have been undetected.  Because of my rapid viral response, prior to being unblinded, my doctor assumed i was getting the actual study drug, and not a placebo.

Yesterday the nurse called me and told me that my doctor was unblinded and found out i'd been getting the placebo.  It was shocking news to me.  In a way, i'm disappointed that i wasn't getting the drug, but i'm still happy the virus has cleared.  I just don't understand how this is possible, as i have Genotype 1A, and all i've been taking (as it turns out) is Interferon and Ribavirin.  I'm also really nervous now that the virus will come back (that i will relapse)

The other drag is that i thought i would be finishing the study at week 24 (end of April), but now i've got to continue w/the SOC treatment until week 48 (October).  Part of me wants to bail out of the study now and i'm conflicted about what i should do.

I don't know, in a way, i guess i'm kind of freaking out a bit, and i'm just trying to figure out what is going on.  Any thoughts, advice, suggestions would be appreciated.  Thanks.

-Chris
Best Answer
Avatar universal
With your rapid response I would stick with the program.  Perhaps you are a CC allele and so that trumps the stats of being a geno 1A.  If this is so, you may want to consider stopping at 24 weeks - talk this over w/ your doc.  The clinic I go to has said that SOC for 1A c/ the CC will soon be 24 weeks.

I know that other w/ even more specific info will chime in here for you.  Sounds to me like you are actually doing quite well.
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87972 tn?1322661239
The AASLD Practice Guidelines states:

“…However, only 15-20% of persons with HCV genotype 1 infection and 66% with HCV genotype 2 and 3 infections achieve RVR [Rapid Viral Response].

http://www.hivandhepatitis.com/hep_c/images/hepatitisc.pdf
(page 1343)

Consider yourself one of the fortunate few, and keep at it until you’re there!

Bill
Helpful - 0
Avatar universal
Many people with geno 1 clear with SOC. Seems like you were one of those lucky people. Please stay the course for the full 48 weeks. This will assure your best chance of an SVR. Good luck and enjoy your undetected status.
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96938 tn?1189799858
4 weeks to undetected is not earth-shattering. It's good news but not a subject for the annals of medical history.
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225238 tn?1296815986
meant to add, this just almost seems too good to be true

i told the nurse that there had to be a mistake or something with my labs, she assured me there wasn't...
Helpful - 0
225238 tn?1296815986
I'm just confused- i thought it was unheard of to clear so quickly on just Intfn/Riba if you are Geno 1A- i thought that was the hardest to treat w/SOC.(??)  I don't know much about the "CC allele" thing, more info would be appreciated.  I'm waiting to hear back from my doc about an appt., i asked to talk to him so hopefully i'll see him at some point next week and i can hit him w/questions...

don't get me wrong, i am GRATEFUL i cleared the virus, i'm just a little nervous and i still don't understand how that is possible- as i had a viral load at the beginning of close to 5 million.  am i just extremely lucky?  i certainly must be in the minority, i would think...

thanks everyone for your answers and good wishes,

cheers,

-Chris
Helpful - 0
901131 tn?1293744553
I would love to be in your shoes. Keep on keepin on!!
Helpful - 0
Avatar universal

  There is nothing to be disappointed about. The fact you are RVR is the best predictor of success.
  You are doing fine and the other positive on this is ,no one knows as of yet what the long term side effects of the P.I."s will be ...something you don"t have to be concerned with.

  Congrats on a great response...

Will
Helpful - 0
96938 tn?1189799858

"The other drag is that i thought i would be finishing the study at week 24 (end of April), but now i've got to continue w/the SOC treatment until week 48 (October)."

- You can end participation in a trial anytime you want.

"Part of me wants to bail out of the study now.."

- You would be crazy if you did.

Helpful - 0
Avatar universal
You were RVR and that trumps everything.  You have an excellent chance of SVR if you continue on with the 48 weeks. Being a genotype 1, if you had a viral load under 400,000 starting and reached RVR at 4 weeks then 24 weeks could be a consideration according to EU studies but do you really want to take that chance?   You had a stellar response to the interferon and ribavirin and there is nothing disappointing about that.

As you go forward keep in mind even with a PI there is always the possibility of relapse.  
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