Incivek protocol/treatment duration/futility rules/PCR testing
2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.
Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.
2.7.2 Duration of Treatment—Previously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
Treatment Futility Rules: All Patients
HCV-RNA Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.
http://pi.vrtx.com/files/uspi_telaprevir.pdf .
As far as 24 vs. 48 weeks, for type 1's, I think it's based on response to treatment and whether a person is cirrhotic or not. If cirrhotic, 48 weeks is the standard treatment. If not cirrhotic, 24 weeks of treatment is done as long as a person is undetected at 4 weeks. If the virus is detected at 4 weeks, treatment is extended to 48 weeks. If a viral load is shown at 12 weeks, I think treatment is discontinued. This is how it was explained to me by my NP (nurse practitioner) and I'm pretty sure this is how I've read people talk about it on the forum.
Our more technically savvy members may give you more info. on this but that's my understanding of how it works.
Welcome to the world of Hepatitis C. Pooh has provided you will excellent information along with everyone else. By your post it looks like you are catching on very fast. Your mother is very lucky she has you in her corner.
This can be a fight to understand, get into treatment and getting your doctor to call you back. When you figure out that last one...I would love to know how you accomplished that feat. FYI - it doesn't have anything to do with having insurance or not. With your help and determination... you can get
your mother where she needs to be.....in treatment for Hepatitis C and the
sooner the better.
Thanks Belle, that's so great and encouraging to hear that you were able to get through it, get cured, and without insurance too! Do u mind me asking what the study meds were and how u got the ball rolling on getting into it?
Thanks so much! My mom was just wondering yesterday if we couldn't just call Gilead directly. Is the study that the three of you are in still recruiting..? I saw one on clinical trials.gov that seemed to be sofosbuvir/5885 with and without ribo that was still recruiting. Is that the one you are in?
Also, is getting in to such a study pretty much a long shot do you think? Either way we will at least try.
And BEST OF LUCK to you on the outcome!
Thanks everyone for your input. I never in a million years realized all that people with Hep C had to go through. My thoughts and prayers are with everyone and good luck in September,Reid..I hope you find out you beat it!
Pooh, We are in southern NJ, close to Philly. When she first got diagnosed last month we made an appt with a gastro/hepatology practice here in south jersey that is also affiliated with jefferson hospital's hepatology dept in Philly . We asked as many questions as we could think of but we didn't even know what her staging was and if treatment was going to be necessary - I figured we would ask more questions at the appt where we learned the results. I am shocked that there WAS no follow up appt- he just called her on the phone and told results and recommended treatment and told her she would be coming in soon to meet with a woman about the financial side. We have so many questions and concerns yet, just getting familiarized with all this. When we called back yesterday and asked to meet with the doc again we were told August was the soonest she could get in! Is this normal?? Also there are about 10 other docs in this practice but they told her she could only meet with her one doc. Does this sound right?I thought if she needed someone she could see anyone. I'm so concerned about this availability issue and also having to ask the doc to call back so we can try to have a phone discussion on speaker or something so I can be present plus u never know when they are going to call. I'm wondering if this is because she is on charity care...she's not even getting free visits just paying a reduced rate.
Unbelievable...She always had health insurance and lost it last year due to job loss- she only had 2 yrs to get through uninsured until medicare and we got this diagnosis by accident !
I keep mentioning the Procrit because I try to think of everything that can possibly go wrong ahead of time. (Thats either a blessing or a curse I guess..i think curse)God forbid we get the treatment itself paid for but then she becomes anemic and needs Procrit during the treatment to save her life, and they just hand us a script for it and we're on our own- that med alone is thousands of dollars. Also, is it possible if u become anemic to remain anemic after treatment has ended? Has anyone heard of this?
Also I was surprised that the doc only said it would be 6 months of treatment. I mean, I'm thrilled for her that it wasn't the 48 weeks but so much of what I read seemed to say that depending on the level of damage, genotype and length of time of infection, and patient age the harder to treat cases would be the 48 weeks - . She is geno 1, at stage 3 , has possibly had this since infancy (blood transfusion)... Does the 24 weeks sound right to everyone? Do docs sometimes tell u 24 then change it to 48 along the way??
So sorry for this long post ! Thank u so much everyone!
give you lists of trials and how to access them. The "discoverHepC.com" site
just appeared on Television. They are looking for participants. It might
be in your area. Also, it sounds like your mother has been referred to a doctor and I would see what kind of assistance she can obtain. You might be surprised at the assistance now being offered. I don't know about the Medicare and I'm sure someone on the forum as that knowledge to confirm if it would be covered or not.
Best to you and your mother