Boceprevir Trial Question

[SusieS2010]

This is a question for those of you who follow and understand the trials so well. I can't seem to find the results for Boceprevir patients who were previous null-responders. I can find it for non-responders but not null. Do any of you know if they looked at that cohort of people who never had a 2 log drop and what their results were? Also did they look at stage 4 patients? Thanks.

I am asking because I am trying to figure out if I should go with boceprevir....I am terrified of the telaprevir  rash as I have had rash from other drugs and seem sensitive to drugs in that way.

[SusieS2010]

You guys are great. Thank you both so much. This is very helpful.

[spectda]

This is what was posted on the FDA advisory committee about bocperevir.
Maybe this is what you already read.

What is the stage of your disease? I am sure you posted about it and I apologize that I can't remember. If you do not have advanced disease waiting for a two DAA combo seems to be advised for null responders.
-Dave


http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/drugs/AntiviralDrugsAdvisoryCommittee/ucm252341.pdf

"b. Efficacy in Previous Treatment-Failure Subjects (P05101)
In P5101, chronic hepatitis C subjects (HCV genotype 1) who had previously failed treatment with pegylated interferon and ribavirin were enrolled. This study enrolled subjects who would generally be classified as previous partial responders (≥ 2 log10 decline in viral RNA at Week 12, but never achieving undetectable HCV RNA) and relapsers (undetectable HCV RNA at the end of therapy, but detectable HCV RNA during follow-up). Prior null responders (< 2 log10 decline in HCV RNA at Week 12 of prior therapy) were excluded from the trial. The Applicant’s term, “non-responders” will be referred to as previous partial responders in this document. Relapsers were defined as subjects with HCV RNA undetectable at the end of treatment, with a subsequent detectable HCV RNA during follow-up."

[willing]

there's  a good reason you can't find it : it's not there! Merck did not include null-responders in its phase3 re-tx trials. Nevertheless they applied for FDA approval for nulls based on their other data and received it. The situation is very similar to Vertex asking for approval of 24w for cEVR relapsers though they never tested that. That was also granted.

In both cases approval seems well justified, though it's clearly less desirable than something already measured. The null responder protocol for boce is 44w. From the package insert:

"Response-Guided Therapy was not studied in subjects who had less than a 2-log10 HCV-RNA decline by treatment week 12 during prior therapy with peginterferon alfa and ribavirin. If considered for treatment, these subjects should receive 4 weeks of peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS 800 mg orally three times daily (every 7-9 hours) in combination with peginterferon alfa and ribavirin. In addition, consideration should be given to treating previously untreated patients who are poorly interferon responsive (as determined at TW4) with 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS 800 mg orally three times daily (every 7-9 hours) in combination with peginterferon alfa and ribavirin in order to maximize rates of SVR [see Clinical Studies (14)]."

You posted earlier that you had a 1.9 drop at w12 - that's very close. Some of the ifn-supplementing strategies discussed lately might help that along (you'll know at the end of lead-in). Good luck with your decision - I also got scared off by the rash/hemorrhoids etc. sx.