Experimental Phase 3 Study with Telaprevir in combination Pegasys and Ribavirin in Treatemnt-Naive Subject with G1 Hepc

[ouc]

Does anybody currently participate or was a participant in  Experimental Treatment that involved a new drug Telaprevir in combination with Interferon and Rebavirin Has Genotype 1 and was never treated before. Would you share your experience with me. I am very  interested in your outcome ? Did you clear the virus?

[ouc]

I just wonder do you experience any side effect of the drugs?

[Tippyclubb]

I was kidding about stopping.  lol --I am in a no placebo trial so I know I am getting the real deal.  How did I get that lucky ?  There are two groups --one does six months and the other 48 weeks.  We do not know what group we are in until week 24.  

[ouc]

So you were in a good health like me. I was diagnosed in 2001 (found out while donating blood).   I was in perfect health, no symptoms whatsoever. Have no idea how and when I got it. Since 2001  I have progressed from stage 0 to stage 1 and from 500.000 to 1.200.000.   I decided to go on treatment because I wanted to get rid of the "bug" while in good health and still relatively young. 24 weeks of treatment seemed like a bargain comparing to 48 (Old treatment .)
By the way it took me around three weeks to get back to be me again.

[ouc]

Hi Tippyclubb. By no means do no stop now. Of course you do not have a guarantee that  you  would had have  cleared the virus if you have stopped now. Stick to it .
At least you know that Telaprevir works if you are taking Telaprevir. You might be taking
placebo instead  of Telaprevir right? You will not find out in which study group you are until week 72.

[ouc]

That what I want to hear. There are more people like me who dropped the treatment and despite that are SVR. Now let see if all of us Dropouts will stay SVR

[Tippyclubb]

I am in the Telaprevir trial now in the beginning of my 15th week.  Your post is really tempting me to stop now.  Lol !  However, I could never be so lucky to stop and be in that 38% to achieve SVR.  So I will continue on until told to stop.  

Congratulations and good luck

[copyman]

That is great congrats!
I have heard of a few others that had to stop the telaprevir early due to rash, anemia, etc. around 7 or 8 weeks and they acheived SVR. it has to be that telaprevir just kills the dragon super fast !!!

[jacksonblue]

thanks for the posts i treated for 48 weeks got a placebo then rolled over to 12 week triple 12 week double was neg since week 2 go for 4 week post pcr tommorrow congratulations on your svr

[Intrac]

Congratulations OUC !! That is great. The only statistics that I have read concerning people that were on it as short as you were were in the very first trials. Those that stayed on Telaprevir 12 weeks (along with the SOC) inidicated approximately 38% continued to have SVR.

While I know that I was undectable at week 4 and continued through week 24, I continued the full course of treatment. I did not enjoy it whatsoever..LOL. I had rather taken your treatment duration!! However, I pretty much never missed a single dose of the meds while on treatment. I felt a lot of fatigue but never became anemic; by week 24 I was very happy to find out that I was able to stop the meds. I have a lot of respect for anyone who makes it through the full 48 weeks on those meds !!! That would stink.

My viral load before treatment was 3 million. Otherwise, I was in pretty good health. My liver biopsy indicated some slight scarring (stage 1 ??) The first 12 weeks were pretty rough. While it was aggravating having to take the meds 3 times a day (8 hours apart), no one should complain about that.

Do you know how long you had hep C before getting on treatment? Were you in pretty good health? I believe that the Telaprevir medication is on the right track even though some people will have a tough time during treatment. At a minimun, they should give it a try. Who knows, if they make it 6 weeks, they may obtain your same results.

[ouc]

Yes, I participated in Advance study, however, as I mentioned before I have stayed on the Treatment  just 6 weeks.  I dropped off because I developed severe anemia, anxiety, excruciating headaches, muscle pain,  and felt so horrible to the point that I couldn't take it anymore.
At that point I just didn't care about the treatment. I just wanted to get back to old me before  the treatment (and before the Treatment I was just a happy totally asymptomatic  person) Upon my discontinuation my study doctor told me that my Viral Load  will get back soon to previous level or it might be even higher.(by the way my Viral Load  before Tx was 1,200.000) So when I find out that after 10 weeks I was SVR and then after 22 weeks I am still SVR and most likely I will stay that way meaning I have cleared my virus for good I just couldn't believe it. It took only SIX WEEKS. (not 24, not 48) just SIX. Looks like Telaprevir is really working. Getting back to your case I understand that you went through full treatment 24 months, right? I just wonder what was your Viral Load before the treatment and what stage was your liver? If you can elaborate on your experience during the treatment  I would appreciate it very much.

[Intrac]

By the way, Vertex (the maker of telaprevir) is scheduled to release prelimary results of the Phase III "ADVANCE" study sometime during the the EASL (European Associatian for the Study of Liver Disease) conference in Copenhagen, Denmark held April 22-26. I will be watching for these results when they are released.

  Did you participate in the 'ADVANCE' study? It appears to work as indicated.

[Intrac]

I participated in the study. Apparently, I was negative at week 4 and 12 because the study allowed for this group to discontinue treatment at 24 weeks. I have continued to remain undectectable (as of week 12) post treatment. :)  In the phase I and II studies of naive patients, 100% of the patients taking telaprevir who were negative 12 weeks post treatment remained negative through 24 weeks post treatment. I plan on posting my treatment expericence for others to read in the next few days.