Thanks for the clarification!
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
http://pi.vrtx.com/files/uspi_telaprevir.pdf
"Incivek is first 12 weeks with peginterferon and riba and then 12 more weeks of just the latter 2"
That is only if you are UND at wk 4 and 12, if not it is 36 more wks of inf/riba
Incivek is first 12 weeks with peginterferon and riba and then 12 more weeks of just the latter 2
Hey Bill, that's for Victrelis
No lead in with incivek in the vertex protocol.
No. Four week lead in with Victrelis.
I thought there was a four-week lead-in with inf and riba before starting Incivek. Is that not the case?
Welcome to all of you, Trixie, sklyaltr, idyllic and congratulations on starting treatment. This forum has been so awesome and everyone is just so very kind and informative. Hoping your week one goes well for all of you!
Good luck to you! So many of us on the new drugs, some halfway through and several who have finished! Exciting to see.
Welcome to all 3 of you newbies, Trixie, sklyaltr,idyllic
I start triple January 31 too with victrellis (the Merck drug)
Never treated before
I signed up with my stats with frillier, I find it informative to compare myself with others
Genotype 1B
Phenotype TT
Grade 2/ stage 2
Viral load 865,000
Good luck to everyone!
Also got the chills around 8 pm and didn't sleep great - woke up every hour or so. But not too bad. Dragons.... Just finished girl with the dragon tattoo and now am reading second book. Good way to keep my mind off things!
I also just started triPle therapy with pegasus injection yesterday (friday the 13th!) and first incivek and riba last night and agin this am. Ate Brie cheese with pills and so far so good. Am obsessing over fat foods and for now no nausea so I can eat what I feel like. I'd like to share this journey with others. My biggest concern is work but my boss is very supportive of me doing this treatment. For this weekend I have just planned to read my book and watch football! Family will have to take care of themselves for 6 months. Lol! Son is 13 so he should be able to do that.
Congrats to both of you for getting started, may your sx be light, wishing you both the best moving foward.
how did it go? up at 6 am with peanut butter and pills; got the chills last night around midnight; slept in 1 hour segments. Feeling decent for day 2....so far.
Good luck.
Oy, not sure who you are addressing so..: I took my 1st shot of Peg today at the doctor's office. I used the Redipen last time but not this time around. I was unsure I would administer my first shot accurately so I did it with the doctor's PA. I took my first dose of Riba & Incivek at 12 this evening and then starting tomorrow I will take my meds at 6, 2 & 10.
I have pretty much been lurking off and on over the years since I last treated. Don't get me wrong me wrong though, when I am miserable I will more than likely post a question rather than use the search function :)
Best wishes for good results and minimal side effects.
Advocate1955
In case you are interested, frijole keeps spreadsheets on our stats and progress. You can go to her page here:
http://www.medhelp.org/personal_pages/user/223152
and under photos you will see 4 spreadsheets. Click on a spreadsheet and it will enlarge. The names are in alphabetical order. You can see how about 100 of us are doing in terms of stats. (Most of us are now undetected or getting there, depending on when we started treatment.) I find it encouraging to view.
I know frijole would love to have your stats too if you wish to give them to her to be placed on the spreadsheet. She needs:
*Genotype (and subtype if you have it)
*Whether you are treatment naive, partial responder, null responder or relapser
*Viral Load at start of treatment or before treatment
*Which drugs you are treating with
*Biopsy results
*Start date of treatment
*Any serious side effects from treatment
Interferon shot with ribavirin at 6:30 pm; 10 pm will be incivek teleprevir. Appreciate all the support and will be checking back many times. Friday night dart club, I like that.
Idyllic - we'll be able to share a significant period of time in 2012.
Thanks again
Welcome to the Friday night Dart Club! you're on your way! I'm doing week 27 tonight and it seems like yesterday when I did my first one. You're not alone. Sounds like u already have a buddy on the same timeline.
Aim straight!! Lol
Karen :)
flcyclist~Awww, I love dragons. That's why I call HCV the alien virus.
But, yes, Chinese New Year's at the end of the month, year of the dragon coming up.
skiyaltr~ Welcome and best of luck.
SVR in 2012!!!
So did you start your pills this morning and your first shot tonight? Or do you do your shot tonight, then start the pills Saturday morning?
Best of luck and warm welcomes to both of you starting trt. Hope you both nail it this round. This is the year of the dragon - so let's all slay the dragon. Let us know how you're doing and come back to visit often. Good luck.
Congratulations on starting treatment.
I and many others were/are on Incivek so let us know if you need remedies for the side effects.