Aa
Still detectable at weeks 4 and/or 12
Hello, I just finished the incivek 12 weeks, and am waiting for my 12 week bloodwork. I am rather anxious at this point, since I was still detectable at weeks 4 and 8. Before tx, i was 2 million, week 4 I was at 81, week 8 was only slight detectable, however,this means I must continue the ribi + peg for 9 more months.
My question is... have any of you still been detectable like this, (type 1a), and if so, what have been your results?
I canot find any results data on people still detectable after weeks 4 and/or 12 on incivek's site. It just states that they must continue peg/rib for a year total in this case.
My question is... have any of you still been detectable like this, (type 1a), and if so, what have been your results?
I canot find any results data on people still detectable after weeks 4 and/or 12 on incivek's site. It just states that they must continue peg/rib for a year total in this case.
Ah, a sigh of relief!! Relax, pinch thyself! Don't worry, be happy.
And now I'll do a happy dance for you.
Sleep tight,
C
And now I'll do a happy dance for you.
Sleep tight,
C
I had 170 VL @ wk4 and was still detectable @ wk8 by sensitive Qualitative
PCR. Became truly UND @ wk10, only did SOC with no PI and did a total
of 60wks . Today I am SVR , ex geno 4.
b
PCR. Became truly UND @ wk10, only did SOC with no PI and did a total
of 60wks . Today I am SVR , ex geno 4.
b
thanks again for all the support...
I will continue to fight, for myself and my family... all we can do is wait and see!
I will continue to fight, for myself and my family... all we can do is wait and see!
I was <43 but DET at week 4. I was UND at week 8.
I think all of us who were detectable at week 4 were disappointed and anxious about our chances. Every time I had a VL drawn I was on pins and needles until I got the results. I think it is very normal and I think we all understand and empathize.
I also think you are not alone in worrying about your chances at SVR. The reason some of us can post that data so fast is because we have been crunching the numbers right and left trying to ascertain our chances for success. I agree with hrsepwrguy. The numbers don't all add up but I think that is because we don't know exactly how they compiled them.
I am at the beginning of week 37 (of 48). I have been UND since week 8. Like hrsepwrguy, I now focus on the relapse rate and hope I don't relapse.
I cannot do anything about not being eRVR so I have to hope I am in the 64% or so who do attain SVR. The way I look at it is that I have a 64% or so chance at SVR. That percentage is a whole lot better than zero, which is what my chances would be if I did not treat.
This may give you a needed boost. I found the treatment much easier after I finished the Incivek. Hopefully you will also. I think the key is to treat the side effects aggressively (especially nausea and rash) and keep them under control. That makes all the difference in the world (at least for me).
Hang in there and try to focus on getting through treatment. You still have a good chance at attaining SVR.
I think all of us who were detectable at week 4 were disappointed and anxious about our chances. Every time I had a VL drawn I was on pins and needles until I got the results. I think it is very normal and I think we all understand and empathize.
I also think you are not alone in worrying about your chances at SVR. The reason some of us can post that data so fast is because we have been crunching the numbers right and left trying to ascertain our chances for success. I agree with hrsepwrguy. The numbers don't all add up but I think that is because we don't know exactly how they compiled them.
I am at the beginning of week 37 (of 48). I have been UND since week 8. Like hrsepwrguy, I now focus on the relapse rate and hope I don't relapse.
I cannot do anything about not being eRVR so I have to hope I am in the 64% or so who do attain SVR. The way I look at it is that I have a 64% or so chance at SVR. That percentage is a whole lot better than zero, which is what my chances would be if I did not treat.
This may give you a needed boost. I found the treatment much easier after I finished the Incivek. Hopefully you will also. I think the key is to treat the side effects aggressively (especially nausea and rash) and keep them under control. That makes all the difference in the world (at least for me).
Hang in there and try to focus on getting through treatment. You still have a good chance at attaining SVR.
Well I got lucky and didn't get the rash and my bloodwork has held up good enough not to need any intervention, once I got passed the incivek (fire breathing dragon butt and severe nausea) it has been tolerable mostly low grade fever, fatigue, anxiety and general aches and pains, I do have a prescription for a anxiety med but the rest has been controlled with OTC meds.
sounds like it is going well for you at this point... how has the overall tx been for you? meaning side effects....
I have had all of the side effects so far, but within tolerable ranges.The rash is becoming a potential problem, but I can deal with it.
And thanks for the well wishes! same to you!
I have had all of the side effects so far, but within tolerable ranges.The rash is becoming a potential problem, but I can deal with it.
And thanks for the well wishes! same to you!
I was det <43 at wk 4, 5 and 6, no other PCR until wk 12 was UND at wk 12, 16, 20 and 24, currently in wk 41, EOT is 7/24 will have PCR then.
Wishing you all the best with your 12 wk PCR
Wishing you all the best with your 12 wk PCR
thanks...
Relapse is a scary prospect, but I am just hoping to achieve an undetectable reading at this point! I can't look too far down the road or I just get myself all stressed out. If I knew then what I know now... right?
Relapse is a scary prospect, but I am just hoping to achieve an undetectable reading at this point! I can't look too far down the road or I just get myself all stressed out. If I knew then what I know now... right?
If you really want to go through some detailed trial data all the specifics can be found at this link
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562
Look in section 6, it has very detailed info
I was detectable at wk 4 myself and tend to just focus on the relapse rate posted above
Relapse 4% (11/298)
>Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA (Target Not Detected) at the end of treatment.<
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562
Look in section 6, it has very detailed info
I was detectable at wk 4 myself and tend to just focus on the relapse rate posted above
Relapse 4% (11/298)
>Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA (Target Not Detected) at the end of treatment.<
I will post my 12 week results as soon as I get them... should be in the next few days.
64% is what I was looking for! thank you so much for your quick resonse... please see my last entry!
I appreciate all of the information, and so fast! you guys are great!
I know my fears are a little premature, but it was just frustrating trying to find the numbers. Seems that all incivek was concered about was eSVR patients!
I am tx naive, type 1a, stage 3, 45 years old, suspect to have been infected 25 years ago. The three months of incivek have been rather hellish, and I was hoping to be a 6 month finisher, but I am willing to walk to the gates of hell and back to beat this crap!
I am just worried that I may go through all of this, and not beat this... can't get that out of my head, even though I know the odds are with me.
Again, I really appreciate the quick and informative responses....
I know my fears are a little premature, but it was just frustrating trying to find the numbers. Seems that all incivek was concered about was eSVR patients!
I am tx naive, type 1a, stage 3, 45 years old, suspect to have been infected 25 years ago. The three months of incivek have been rather hellish, and I was hoping to be a 6 month finisher, but I am willing to walk to the gates of hell and back to beat this crap!
I am just worried that I may go through all of this, and not beat this... can't get that out of my head, even though I know the odds are with me.
Again, I really appreciate the quick and informative responses....
Oh my....Pooh & HPG have given you great info.
.I really must take that typing course...
Will
.I really must take that typing course...
Will
Hi..
Yes the protocol is to do 12 weeks of Incivek and an additional 36 weeks of just Peg/Riba.in your circumstance as long as you are <1000at week 12 and Und. at week 24.(below)
Hopfully you are UND. this test (week 12)
http://reference.medscape.com/drug/incivek-telaprevir-999658
Treatment-naïve and prior relapse patients
•HCV-RNA levels undetectable at weeks 4 and 12: Administer triple therapy first 12 weeks, then dual therapy an additional 12 weeks
•HCV-RNA levels detectable at weeks 4 and 12 (ie, <1000 IU/mL): Administer triple therapy first 12 weeks, then dual therapy an additional 36
In Incivek trials for naive patients that did not achiece an RVR (UND. at week 4) then the odds of overall success in that group was approx. 60 -65%(below).
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm
However keep in mind these are just statistics and whether one is succesful or not individually depends on many factors( sex,BMI,amt. of fibrosis,age,,just to name a few)
Try not to get to caught up in the numbers and just do your best on treatment..
Good luck..
Will
Yes the protocol is to do 12 weeks of Incivek and an additional 36 weeks of just Peg/Riba.in your circumstance as long as you are <1000at week 12 and Und. at week 24.(below)
Hopfully you are UND. this test (week 12)
http://reference.medscape.com/drug/incivek-telaprevir-999658
Treatment-naïve and prior relapse patients
•HCV-RNA levels undetectable at weeks 4 and 12: Administer triple therapy first 12 weeks, then dual therapy an additional 12 weeks
•HCV-RNA levels detectable at weeks 4 and 12 (ie, <1000 IU/mL): Administer triple therapy first 12 weeks, then dual therapy an additional 36
In Incivek trials for naive patients that did not achiece an RVR (UND. at week 4) then the odds of overall success in that group was approx. 60 -65%(below).
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm
However keep in mind these are just statistics and whether one is succesful or not individually depends on many factors( sex,BMI,amt. of fibrosis,age,,just to name a few)
Try not to get to caught up in the numbers and just do your best on treatment..
Good luck..
Will
Hello and welcome to the forum.
Several of us were detectable at week 4 and we are doing 48 weeks of treatment. From the research that those of us who did not become UND at week 4, we have found that we have about a 64% chance of attaining SVR if we treat for 48 weeks. Of course, there are many factors that may affect the SVR rate for a given individual, but over all, the SVR rate for those of us who did not attain eRVR, is 64%.
The main thing is that as long as your Viral load is below 1000 at week 12, you can continue to treat. At week 24 you must be Undetectable in order to continue treatment.
I have copied the data from the Clinical Care Options site:
"The response-guided therapy strategy with telaprevir is based on the results of 2 phase III trials in treatment-naive patients. Results from the ADVANCE trial strongly suggested that 24 weeks of therapy is sufficient for patients with eRVR.[29] In the T12PR48 arm of this trial, patients with an eRVR received 12 weeks of triple therapy followed by 12 weeks of pegIFN/RBV, whereas patients without an eRVR received 12 weeks of triple therapy followed by 36 weeks of pegIFN/RBV. Among patients who achieved an eRVR and received 24 total weeks of therapy, the SVR rate was 89%, confirming that this strategy results in a very high SVR rate (Figure 11). The robustness of response-guided therapy was confirmed by the ILLUMINATE trial, in which treatment-naive patients with genotype 1 HCV who achieved eRVR after 12 weeks of telaprevir were randomized to receive either 12 weeks or 36 weeks of pegIFN/RBV, for a total therapy duration of 24 or 48 weeks, respectively (Capsule Summary).[30] Among patients with eRVR, 92% achieved SVR with 24 total weeks of therapy vs 88% with 48 total weeks of therapy. Patients who did not achieve eRVR all continued pegIFN/RBV through Week 48, and 64% attained SVR (Figure 12). "
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%204.aspx
Here's hoping that your 12 week VL is Undetectable.
Several of us were detectable at week 4 and we are doing 48 weeks of treatment. From the research that those of us who did not become UND at week 4, we have found that we have about a 64% chance of attaining SVR if we treat for 48 weeks. Of course, there are many factors that may affect the SVR rate for a given individual, but over all, the SVR rate for those of us who did not attain eRVR, is 64%.
The main thing is that as long as your Viral load is below 1000 at week 12, you can continue to treat. At week 24 you must be Undetectable in order to continue treatment.
I have copied the data from the Clinical Care Options site:
"The response-guided therapy strategy with telaprevir is based on the results of 2 phase III trials in treatment-naive patients. Results from the ADVANCE trial strongly suggested that 24 weeks of therapy is sufficient for patients with eRVR.[29] In the T12PR48 arm of this trial, patients with an eRVR received 12 weeks of triple therapy followed by 12 weeks of pegIFN/RBV, whereas patients without an eRVR received 12 weeks of triple therapy followed by 36 weeks of pegIFN/RBV. Among patients who achieved an eRVR and received 24 total weeks of therapy, the SVR rate was 89%, confirming that this strategy results in a very high SVR rate (Figure 11). The robustness of response-guided therapy was confirmed by the ILLUMINATE trial, in which treatment-naive patients with genotype 1 HCV who achieved eRVR after 12 weeks of telaprevir were randomized to receive either 12 weeks or 36 weeks of pegIFN/RBV, for a total therapy duration of 24 or 48 weeks, respectively (Capsule Summary).[30] Among patients with eRVR, 92% achieved SVR with 24 total weeks of therapy vs 88% with 48 total weeks of therapy. Patients who did not achieve eRVR all continued pegIFN/RBV through Week 48, and 64% attained SVR (Figure 12). "
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%204.aspx
Here's hoping that your 12 week VL is Undetectable.
Response Rates: Trial 108
SVR in no eRVR subjects 60% (90/151)
On-treatment virologic failure 7% (26/363)
Relapse 4% (11/298)
Other 11% (41/363)
On-treatment failure includes subjects who met a protocol-defined virologic stopping rule or who had detectable HCV-RNA at the time of their last dose of INCIVEK and subjects who had viral breakthrough on peginterferon alfa/ribavirin.
>Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA (Target Not Detected) at the end of treatment.<
Other includes subjects with detectable HCV-RNA at the time of their last trial drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
I have tried to get the stats to balance and it's impossible so I finally gave up, They only cover eRVR or not, nothing on if one became UND at wk 8 or 10 or 12 get the drift
SVR in no eRVR subjects 60% (90/151)
On-treatment virologic failure 7% (26/363)
Relapse 4% (11/298)
Other 11% (41/363)
On-treatment failure includes subjects who met a protocol-defined virologic stopping rule or who had detectable HCV-RNA at the time of their last dose of INCIVEK and subjects who had viral breakthrough on peginterferon alfa/ribavirin.
>Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA (Target Not Detected) at the end of treatment.<
Other includes subjects with detectable HCV-RNA at the time of their last trial drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
http://pi.vrtx.com/files/uspi_telaprevir.pdf
I have tried to get the stats to balance and it's impossible so I finally gave up, They only cover eRVR or not, nothing on if one became UND at wk 8 or 10 or 12 get the drift
Hey If week eight was only slightly detectable there is still a possibility you will not be detectable in week 12.
Is this your first time treating or are you a relapse patient? Not that it matter but I was wondering what stage of fibrosis you are?
I am trying to slog through the Illuminate, Advance & Realize trials since I am trying to find something else. I know will & a few others can recite these by rote so hopefully one of them will post the odds♥
Is this your first time treating or are you a relapse patient? Not that it matter but I was wondering what stage of fibrosis you are?
I am trying to slog through the Illuminate, Advance & Realize trials since I am trying to find something else. I know will & a few others can recite these by rote so hopefully one of them will post the odds♥
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