Aa
Approved 8 weeks
Approved for 8 weeks gt 1a tx naive viral load 2million . Will that be enough ?
Yes that is a very good point Thanks for the tip. I will get my game on when we get the call tomorrow. I will let you know
Thank you.
Thank you.
I also don't have any symptoms of hep c I work get up at 5 am go to work till 4:30 walk ten minutes to subway then take a bus then go to gym for an hour get back on bus and come home. Go to bed at 9pm and get up at 5am and start all over. That is 5 days a week. Pretty much the same on weekends except out doing errands and lots of walking.
Thank you I interpreted the results just as you have. It does seem like I would be ok with the 8 weeks I still would feel much better with 12 weeks having that cushion. My insurance pays 80% and Gilead is picking up the 20% Naturally seeing I fit the 8 weeks criteria that is what they want to cover despite the fact that my doctor prescribed 12 weeks. I will let you know what they say tomorrow if they don't agree we will proceed with the 8 weeks and havery the drugs sent to me. Your information is very much appreciated. Goon luck to you as well you will reach svr for sure.
We should be able to edit posts. After studying that info more the 10% relapse rate is for patients starting with a VL over 6 million. That would put you in good shape with only 8 weeks of tx. There is still a lot of good info in the pdf at the end of my previous post. I'd still be more comfortable doing 12 weeks in your position but the data does show a very good response rate for 8 weeks. Sorry for causing confusion but I cannot correct my last response!
Unless I'm reading this chart wrong, it shows a 10% relapse rate with 8 weeks tx vs a 1% relapse rate with 12 weeks tx. That's correlates to 90% SVR vs 99% SVR. The tables don't copy in the original format. I will post the source under the "table." You'll need to copy and paste it into a new window. It has tons of good info. This table is #7 on page 23.
Table 7 Study ION-3: Relapse Rates by Baseline Viral Load after 8 and 12
Weeks of Treatment in Treatment-Naïve Non-Cirrhotic Subjects with
Genotype 1 CHC
HARVONI
8 Weeks
(N=215)
HARVONI
12 Weeks
(N=216)
Number of Responders at End of Treatment 215 216
Baseline HCV RNAa
HCV RNA <6 million IU/mL 2% (2/123) 2% (2/131)
HCV RNA ≥6 million IU/mL 10% (9/92) 1% (1/85)
a
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
Table 7 Study ION-3: Relapse Rates by Baseline Viral Load after 8 and 12
Weeks of Treatment in Treatment-Naïve Non-Cirrhotic Subjects with
Genotype 1 CHC
HARVONI
8 Weeks
(N=215)
HARVONI
12 Weeks
(N=216)
Number of Responders at End of Treatment 215 216
Baseline HCV RNAa
HCV RNA <6 million IU/mL 2% (2/123) 2% (2/131)
HCV RNA ≥6 million IU/mL 10% (9/92) 1% (1/85)
a
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
Good luck with your tx. I am nearing my 4 week point. I fought for, and got, 24 weeks. If I were in your position I would fight for 12 weeks. Tell your dr to report all symptoms you are experiencing such as fatigue, brain fade, etc. You are facing good odds but 12 weeks would get you near 100% SVR rate. They dangled an 80% cure rate in front of me with the old triple therapy. I tried and failed. I'm not buying the 80% cure rate figure.
100% agree Will discuss tomorrow with my insurance company and Gilead. Appreciate all comments. Thank you.
"Thank you that is my concern I know I fit the 8 week tx guidelines however I feel more comfortable with 12 weeks to make sure."
I totally agree with you and your doctor. If your insurance says only 8 weeks then see if your doctor can get you the extra 4 weeks through their care program.
To many times trial results and real world results have been different. Good luck to you.
I totally agree with you and your doctor. If your insurance says only 8 weeks then see if your doctor can get you the extra 4 weeks through their care program.
To many times trial results and real world results have been different. Good luck to you.
Thank you that is my concern I know I fit the 8 week tx guidelines however I feel more comfortable with 12 weeks to make sure. We all want to achieve svr and want to give ourselves the best tx outcome. Monday we will get the answer from my insurance company why they did notime approve the 12 weeks my doctor asked for. I am still approved for 8 weeks my concern is will they extend to 12 weeks if not enough. I am still grateful to have been approved no matter which I do but as everyone here all we wish is to be cleared of this virus and go on to livea hep ffree life. I pray all of us achieve svr.
flyinlynn, "Results for your cohort was 94% or 202 of 215 in the trial"
Only 11 relapsed 5%. I'm guessing 2 were missing from 12th week post tx results. This was for all non-cirrhosis on 8 week tx
Of those with VL under 6M only 2 of 123 relapsed. 98% SVR.
Those with VL over 6M 9 of 92 relapsed 90% SVR.
Printze With VL 1/3 of the 6M cutoff for 8 weeks your in the high 90's% to achieve SVR Best wishes.
Only 11 relapsed 5%. I'm guessing 2 were missing from 12th week post tx results. This was for all non-cirrhosis on 8 week tx
Of those with VL under 6M only 2 of 123 relapsed. 98% SVR.
Those with VL over 6M 9 of 92 relapsed 90% SVR.
Printze With VL 1/3 of the 6M cutoff for 8 weeks your in the high 90's% to achieve SVR Best wishes.
PS-you are very lucky to get it. Could it be that they are now starting on a 2nd wave of treating those who are not very sick? They see how the drugs are working now and 8 weeks for those tx naïve who are no worse than stage 2 and under 6MM virus load. I hope it's the second wave of treatment for those less sick.
Yes according to the 8 week criteria it should be enough for you. I'd still do 12 but 8 weeks is what they are saying for someone like you.
Yes I am very glad my insurance approved I have waited 4 years since my diagnosis. I refused interferon and glad my doctor and I decided to wait for these all oral tx.I was a little concerned the guidelines say 8 weeks tx naive -6million viral load and mild fibrosis.F2 is mmoderate.. I thought there might be others who have treated and achieved Svr with 8 weeks who could chI've in.I appreciate your information.
Still your protocol per the AASLD for you
I am taking 24 weeks of Harvoni and Ribavirin but I have had cirrhosis F4 for 7 years and a3 time null responder to interferon based tx plus relapsed last year after 12 weeks of Sovaldi Olysio but you only need 8 weeks
http://depts.washington.edu/hepstudy/presentations/uploads/122/ion3ledipasvirsofosbuvir.pdf
Results for your cohort was 94% or 202 of 215 in the trial
Consider yourself fortunate
I am taking 24 weeks of Harvoni and Ribavirin but I have had cirrhosis F4 for 7 years and a3 time null responder to interferon based tx plus relapsed last year after 12 weeks of Sovaldi Olysio but you only need 8 weeks
http://depts.washington.edu/hepstudy/presentations/uploads/122/ion3ledipasvirsofosbuvir.pdf
Results for your cohort was 94% or 202 of 215 in the trial
Consider yourself fortunate
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