Just for the record, Linda (the original poster) is in the middle of triple medication treatment with Interferon, Ribavirin, and Victrellis. Linda's original question/concern seems to have been derailed amongst posts about clinical trials, which Linda is not doing. These posts and chit chat about clinical trials have nothing to do with Linda, her situation, or her question. Perhaps those who wish to discuss clinical trials could start a new thread so that the comments responding to Linda's situation are not lost in the discussion concerning clinical trials.
geno 1a (used to be 1b)
stage 2, F4 (cirrhosis next)
ALT 65
AST 55
Hgb 16.1
VL 4,990,000
relapser to Peg-interferon/riba several years ago
just started (first dose 1 MAR 13) arm 2 (sofosbuvir/GS5885 plus riba 24 weeks) of the Gilead ION-2 study.
i am optimistic i will be UND by week 2 or 4..and will be clear all the way to 12 weeks..it may be an option to stop at 12 if that's all one needs to renaming SVR
thank you so much for you wise info, I haven't been undected yet, I have my blood woork done tommorow,week 20, I'm not sure if its for viral load or not tho. I do have blood work every mon. for blood counts, plus I had to use procrit, and now had my riba lowered form 1000 to 800.
Back to linda and her question, from reading poohs post your odds would be very low as not only did you have a somewhat slow response but you were not und at week 12........ Trying a shortcut now would more then likely end in failure. Do the 48 weeks, wishing you the best going forward....
Good luck! The real "nail biters" will be the post Tx labs. Praying we all achieve SVR :)
Yes this is very aggressive but no side effects Thank God my next visit is on march 18
That's great. I was a little discouraged not achieving und by week 2...but was happy when I achieved it by week 4. Lowest I ever got was vl-100 on victrelis/interferon/riba then taken off at month 3 or 4 (can't remember). God help us is correct :) Prayers for all of us. This new combo seems to be very aggressive...I just hope 12 weeks is enough. Gabe at the clinic said Gilead is trying to fine tune the combo to an 8 week treatment regime.
I have 1 week UND 4 weeks UND 8 weeks UND 2 weeks left
God help as
Hi. I did a 1 week draw (vl<25 detectable)...2 week (vl<25 detectable)...4 week UND...8 week UND. I have 2 weeks left of 12 week Tx study. They draw blood on Wednesday and I have the results on Friday. The lab work is performed right there at the study/trial clinic. Thanks
How often have you needed to go in (for blood draws or whatever)? At what dates into treatment have you gotten results, and what's the lag time between the blood draw and your getting the info? Thanks!
BTB
Yes this same all the best to you partner))
I'll bet we are in the same study group. I have 2 weeks left of the 12 week arm with Dr. Lawitz AMR :)
Hello from Austin my wife is my hero with out her i will quit the treatment
Thank you (from San Antonio). I have hope on this new study finally reaching UND. The last 3 yrs with 3 attempts/failures have taken it's toll on me...and my wife (having to deal with me) :)
Yes new medicine is coming im on the 3th attempt in san antonio with Gilead study sofosbuvir GS 5885 + riba I wish you all the best
Just a side point: I did do 48 weeks of Tx (Interferon, Ribavirin, Incivek) because I was DET at week 4. I completed the Tx and I did attain SVR.
"Just wondering, has anyone on here been able to do only 24 weeks with geno 1a and be cured? "
--------------------------------------
The simple answer is that some people with Geno 1, depending on the circumstances, various factors, and the Tx response, can and have attained SVR with 24 weeks of Tx, but that does not give the entire picture. But that does not mean you will attain SVR with 24 weeks of Tx.
Your question does not give us enough information to answer your question accurately as it pertains to you personally. But I went back through your posts and I will try to respond as well as possible.
BOTTOM LINE is, according to protocol, YOU should do 48 weeks of treatment.
You are on Victrellis.
In Nov. 2012, after your 4 week lead in, you said that your VL "dropped from like 20million to 2 million so will be doing 48 weeks." (a 1 log drop, but barely)
On Jan. 15, 2012: you posted: "when I started treatment 14 weeks ago I was in the high millions, 4 weeks later 18200, 8 weeks 118, now the nurse just called to tell me that I can continued treatment because I was under 34, but this isn't condidered undected right?"
On Jan. 22, 2012: you posted that "week 12 viral load dectected<34, I'm now allowed to continue therapy with my insurance. I'm on 2 riba in morning and 3 at night, I weigh around 175..... Should I be taking more riba? is that why I'm having such a hard time getting undected? I'm geno 1a triple therapy victrellis."
So, here is the situation:
You had barely a 1 log drop at 4 weeks after the Peg/Riba lead in
You were detectable at 118 at 8 weeks of Tx
You were detectable at 34 at 12 weeks of Tx
Have you ever reached Undetectable? If you did, I do not see it posted.
However, working with what we do know:
You did not attain an eRVR. In your situation with a borderline 1 log drop after 4 week lead in, and then a DET status at week 8 of Tx, the protocol calls for 48 weeks of treatment. Being DET at 8 weeks would call for 48 weeks of Tx but the barely 1 log drop after lead in would alsol lean towards 48 weeks of Tx. Plus, you were still DET at 12 weeks.
We do not know your liver fibrosis stage. If you are at Stage 4, then you need to do 48 weeks regardless.
Here are some excerpts and the links:
"For early responders (HCV RNA undetectable at Week 8) who maintain undetectable HCV RNA at Week 24, triple therapy can be discontinued at treatment Week 28. For late responders (HCV RNA detectable at Week 8 but undetectable at Week 24), treatment with pegIFN/RBV and boceprevir should be continued through Week 36, then followed with an additional 12 weeks of pegIFN/RBV through treatment Week 48. This recommendation is based on, but somewhat different than, the response-guided therapy arm in SPRINT-2 (Figure 10).[28] Late responders in this arm received an additional 20 weeks of peg/IFN/RBV (after completing the 4-week lead-in phase followed by 24 weeks of boceprevir plus pegIFN/RBV). Across both the nonblack and black cohorts, SVR rates were 75% in the 48-week arms and 66% in the response-guided therapy arm. This was considered a potentially meaningful difference, leading to the recommendation that the boceprevir phase should consist of 32 rather than 24 weeks."
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20New%20Agents/Module/Practical_Guide/Pages/Page%204.aspx
"Previously Untreated Subjects In previously untreated subjects evaluated in SPRINT-2, interferon-responsiveness (defined as greater than or equal to 1-log10 decline in viral load at TW4) was predictive of SVR. VICTRELIS-treated subjects who demonstrated interferon responsiveness at TW4 achieved SVR rates of 81% (203/252) in VICTRELIS-RGT arm and 79% (200/254) in VICTRELIS-PR48 arm, compared to 52% (134/260) in subjects treated with PegIntron/REBETOL. VICTRELIS-treated subjects who demonstrated poor interferon responsiveness (defined as less than 1-log10 decline in viral load at TW4), achieved SVR rates of 28% (27/97) in VICTRELIS-RGT arm and 38% (36/95) in VICTRELIS-PR48 arm, compared to 4% (3/83) in subjects treated with PegIntron/REBETOL. "
http://www.natap.org/2011/HCV/results.htm
I know treatment is difficult. I also know from reading your posts that you have had some bad side effects. But in order for you to have the best chance at SVR the protocol calls for doing 48 weeks of treatment.
I wish you the best.
Yes! With the miracle med "Inceivek" added to the mix, triple therapy actually does in many provide SVR. I had to stop therapy at end of 19 weeks due to side effects, my body had enough. I am Geno 1a,cc and started with over 15 Million. I have been undetected since week 4.
Therapy is brutal, that was my indicator it was working.
Take your meds as instructed, on time and have rescue plans for side effects: These simple steps can increase your chance of SVR. Good Luck!
Absolutely! If I knew 3 yrs ago what I know now...I would have waited. 3 yrs of Tx attempts with interferon were not pleasant and each time the side effects got worse. I went from a stage 2 (of 6 ishak scale) to a stage 5 after these 3 Tx attempts....in only a 3 year period. In my mind I blame it on the interferon...but cannot back it up with any evidence. This time around (sofosbuvir/gs-5885/riba) I have no side effects. Alot of folks are advanced and can't wait the 2 yrs or so for FDA approval of the new drugs...understandable. After my 3rd attempt/failure I concluded to never go on interferon again. I was lucky enough to get the call for the Gilead study. One of the larger research centers (and prominant liver disease Doctors) is 20 minutes from my house although there are different research/study centers throughout the US. I am by no means out of the woods yet...but to finally reach UND after 3 yrs and on my 4th attempt...gives me a glimmer of hope.
LOTS of people get to SVR in only 24 weeks. The current FDA approved drugs are almost always 24 week treatments. That said, a few cases have to go longer like 48 weeks. But there are a ton of advanced studies now where people are getting to SVR in 12 weeks, some with only all-oral meds. You shouldn't be scared. Treatments now are simply getting better and better by the calendar quarter.
Forgot the link :)
http://www.drugs.com/pro/incivek.html
Trial 108 (ADVANCE)
Trial 108 was a randomized, double-blind, parallel-group, placebo-controlled trial conducted in treatment-naïve subjects (had received no prior therapy for HCV, including interferon or pegylated interferon monotherapy). Incivek was given for the first 8 weeks of treatment (T8/PR regimen) or the first 12 weeks of treatment (T12/PR regimen) in combination with Peg-IFN-alfa-2a/RBV for either 24 or 48 weeks. Subjects who had undetectable HCV RNA (Target Not Detected) at weeks 4 and 12 (extended Rapid Virologic Response [eRVR]) received 24 weeks of Peg-IFN-alfa-2a/RBV treatment, and subjects who did not have undetectable HCV RNA at weeks 4 and 12 (no eRVR) received 48 weeks of Peg-IFN-alfa-2a/RBV treatment.
SVR in eRVR subjects (24 wk tx) 92% (195/212)
hi my hubby is geno 1a he doing triple tx with teleprevir(incivek) he is on wk 17 and as been und sice wk 4, so he is on course to finish at wk 24 and hep c doc confident too. Good luck and keep us posted