4 weeks results, headed the wrong direction

[ek_66]

Starting week 7 of tx tomorrow, I am in the Gilead trial NCT01225380. Just got the week 4 results and headed the wrong way. Looks like I will be waiting to see where I end up on week 12. If on placebo and continued poor response, may have a chance at the study drugs.

Starting VL 5460000 log 6.74
Week 1  VL 8980      log 3.95
Week 2  VL 22100     log 4.34
Week 4  VL 173000   log 5.24

My HGB has dropped from 15.5 to 10.5 and ANC from 4420 to 1280

[ek_66]

My coordinator did tell me that at week 12 if I do not have a good response, I will be unblinded, and have the possibililty of restarting with both study drugs, assuming I not already on both study drugs.

Ed

[spectda]

Mary-I misread something in your post and thought the woman was und at week 1 (when was she und by the way?)

Ed-Sorry to Hijack the thread.

-Dave

[Bali05]

VL going up during tx is considered a breakthrough.

[spectda]

Maybe I am misinformed, but I don't think it is common for people with genotype 1 to become und at week 1 or to have a 3 log drop at week 1 as ed did if they are on SOC.

What makes you believe she is probably on SOC? Did she have a very low viral load to begin with? If she truly was on SOC and und at week 1 adding a pi doesn't make a lot of sense to me.

-Dave

[Mary4now]

We had 4 people in our group ( Gilead ) und at week 1,  and 1 person finally went und, but is probably on the SOC, because she is doing well now and und, she cannot roll over into the study drugs.  
Please talk to your coordinator about this,  I do know that as stated above if you are not doing well you do have option of study drugs.  

[Mary4now]

If your not doing well enough, they will give you the option of taking the study drugs, I do believe it is for 48 weeks.   Good luck

[nygirl7]

Is there any way you can stop and regroup and take tela or boce (sorry those names have been said too many times to go away quickly for me). I mean at this 4 week juncture you have way less than a two log drop and are on the rise........that indeed concerns me that you have not gotten to UND and are already breaking through so to speak.

Just ***** all around.

[willbb]

Hi Ed..  sorry to hear about your results being less than stellar. You say that you would qualify for the roll over substudy if  you were on the placebo..if I read your post properly. However most studies don't unblind the arm you were in until the end of the entire study.. so I am not clear how you could carry on with a 12 week lead in when you wouldn"t know what you are taking at the 12 week mark..

Good luck...hopfully your results will improve.

Will

[ek_66]

Dave - there are 3 arms, all have inf and riba. Arm 1 is 2 study drugs, Arm 2 is one study drug and placebo and arm 3 is just SOC and two placebo.
Debra and Dave -  At this point, I am going to keep going to week 12  ( only 6 weeks away)and see what my response is and if I qualify for the open label substudy. I am going to have to think hard if my option at that time is the full 48 weeks. The other consideration is that at the 12 week mark,  I should have word from my insurer if they will be covering Incivek and/or Victrelis.   I would have a 12 week leadin done  :)

Ed

[spectda]

What stage of if any of liver disease do you have? I could be completely wrong about this, but considering your almost 3 log drop at week 1 I think there is a good chance that you are getting the study drug. They may stop you before week 12 if you don't decide this yourself.

Isn't there an arm without either riba or peg or both in this trial?

Talk to your doctor asap and see what there plans for you are.

I am so sorry this is not working for you.
Dave

[researchmonkey326]

I'm so sorry to hear that your results are not what you had hoped.  Have you discussed with your doctor, any options that you may have besides waiting to see which arm that you are in or wait to find out if you qualify for the open label substudy?  There are a few instances in the study where you end up doing 48 weeks of SOC and at this point, I would think that does not even make sense with more successful treatment on the horizon especially as promising as these study drugs have been.  You may even want to talk to a doctor not involved in the study so that you get an objective point of view.  If you are not going to have successful treatment in this study (as they remind us, our success is not the goal of the study), you want to come out of it as strong and healthy as possible so that you can regroup and prepare for the next option.  I wish you luck - hang in there and don't give up.
Debra