CONFUSED

Can some please explain this Arm 2 in english...i stiil dont know what they mean by (Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion)


Arm 2: Experimental
Subjects in Arm 2 will be assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.

PEG + RBV (WBD) for 4 weeks followed by boceprevir + PEG + RBV (WBD) for 32 weeks, then:

36-week regimen: Subjects who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
48-week regimen: Subjects who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.

[Rockerforlife]

i understand arm 1 and 3....but arm 2 i just cant wrap my brain around

[Fl_Gator]

If you are UND at week 8 then you discontinue treatment and enter 36 wks post tx follow up

If you aren't UND at week 8 then get an additional 12 wks of  tx followed by 24 wks of post tx follow up....it seems by the last line that the remaining 12 weeks of therapy  is a placebo...hmmm?

[Rockerforlife]

This dont seem fair...if im not clear by week 8...i get 12 weeks of candy?....am i reading this right?....HOLY COW....no way

[kitkat14]

It sounds like they missed out a sentence when they printed the literature.  It should probably say something like -for 50% of those receiving 48 weeks treatment, placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.  Just a guess.

[Bill1028]

That is poorly written.  According to my informed consent:

It is the standard 4 week lead-in and boce will added.  
  
If you are undetectable at week 8, you will continue treating and complete treatment at week 36.  

If you are detectable at week 8, you will continue treating until week 36 and your boce will be switched to a placebo and continue treating to week 48.  

At week 12, if you are undetectable, you will continue your assigned treatment.

At week 12, if detectable, you will be discontinued.

[Rockerforlife]

Now that makes sense Bill...


At week 12, if you are undetectable, you will continue your assigned treatment.

At week 12, if detectable, you will be discontinued.

THANK YOU....i believe by George yu hit the nail on the head


and thanx to you
Kit and Gator



They could have made it a tad simpler to read...