Not a question, just an update/comment

I have been reading through many of the posts and realize so many of us have the same concerns.  It is very helpful to hear other peoples experiences.  I am on my 16th week on the clinical trial using boceprevir.  I have been randomized to the decreased dose of ribavarin.  The virus is undetected even with the decreased dose of ribavarin yet I am hoping that the dose won't have to be decreased any more.  I feel like I did a substantial amount of research prior to deciding to go ahead with the trial and find myself continuing to become more familiar with the trial as different issues come up.  I am wondering if anyone has a good explanation for the 48week protocal vs a shorter (24 wk) protocal.  Have there been any results from a phase three trial with niave genotype 1a, where people cleared the virus and remained clear after 24 weeks.  I know it has been mentioned many times throughout the forum that 48 week treatment gives better security that the virus will remain clear.  I am all for 48 weeks if I can know that the benefits outweigh the risks of being on such toxic drugs.  I am very positive about this trial and don"t want to discourage anyone from my mention/concern about the possible risks of the drugs.  I just need to find an acceptable explanation(48 weeks vs 24) for myself so I am comfortable with my choices.   Good luck to everyone on any of the trials.  

[copyman]

sounds like Boceprevir wants to see if their drug will clear the virus with 24 weeks the way the other new drug Telaprevir does.  They realize that people will opt for a shorter course of treatment and treat with Telaprevir.

Since PI's kill the virus within days or a few weeks at most, treating for 24 weeks has shown to be almost as effective as 48 week treatment. Only about a 2% difference if undetectable by 4 weeks.

best of luck

[lapis]

I was in a phase 3 trial with Telaprevir, randomized into the group that got Tela for 8 wks with SOC, then placebo for 4 wks with SOC, then 12 wks SOC.  My tx was a total of 24 wks and I am clear a year after completing tx.  I was geno 1b with VL of 3.6 M.  What I don't know is how soon I cleared the virus.

Since the trial was blinded and I didn't KNOW what group I was in (though I suspected I knew), I was totally prepared to tx for 48 wks, and stunned when I was told I was finished at 24 wks.  Much of my time on tx drugs included reduced Ribavirin dosage because of my anemia.

I don't know what the SVR rate was for people in my tx arm, haven't seen the data yet, not sure if it's come out.  For me, it worked!  So grateful!

Best wishes to you!

[banarep]

i was on telaprevir as well, but treated for 48 (okay 47) weeks and was on 50% riba from week 17 on.  was und at week 14 and have been since.  do not know before then, except that I had to a a vl of <100 to continue on treatment.

go in for my 24 week eot test next week.  so reduced riba does work.

[portann]

Sorry, wgtb, but I don't have much to offer in answer to your questions. :(

I want to say hi to Lapis, though!

Lapis, I knew you were in a study but I didn't somehow absorb the fact that not only did you do half the treatment time (24 weeks) for Geno-1 but you were on reduced riba most of the time as well. And only added the telaprevir for eight weeks at the front end.

That is so cool!!! And hopefully the way to go for G-1's in future. Shorter time, better results.

How much riba were you on for most of the time?

I remember well how you got that false positive at your twelve-week PCR and we all stressed with you. I think NY (?) had gone through that, too -  it's crazy to live through that topsy-turvy of emotions. And it all worked out, but sheesh...

So nice to see you and big congrats on your one year SVR.  Clinical cure, gal! :)

Susan

[portann]

Sorry, Lapis, I meant to say your twelve-week POST-PCR, three months after you'd completed treatment!!!