Aa
Has anyone cleared with 12 wks Harvoni starting with highj VL?
8 million in my case. 1a. Prior tx with old triple therapy. We are fighting the insurance to get 24 weeks.
I had viral load of 11 million. Prior tx was discontinued because of symptoms. I was 1a genotype. Stage 1 fibrosis. Just finished my 12 wk therapy yesterday (YAY), was undetected at wk 4. Just had blood drawn today for my EOT value. I expect to be udetected once again. I THINK I'M CURED.
Thanks Hector,
I just got the news that my viral load doubled after 8 weeks of Harvoni.
Was 550K initially, then up to 1.7 mill after 7 weeks of Harvoni.
Im 37, Likely infected 15 years ago. I have never been treated before Harvoni, which I started 2 months ago. They prescribed 8 weeks. I took it every day at night... I missed one night and took in morning.
I was worried and couldn't find any information on failing Harvoni tx. I go see the doc in 2 weeks to discuss and get another test.
My doc tried to get a another 4 weeks after the test, but it was denied by insurance.
I don't know where to go from here. You mentioned that Solvadi is another option.... just hoping for any good news right now.. I was so happy when I heard about Harvoni and the results it has.. now I feel like crap and worried about what my future holds for me and my family.
I just got the news that my viral load doubled after 8 weeks of Harvoni.
Was 550K initially, then up to 1.7 mill after 7 weeks of Harvoni.
Im 37, Likely infected 15 years ago. I have never been treated before Harvoni, which I started 2 months ago. They prescribed 8 weeks. I took it every day at night... I missed one night and took in morning.
I was worried and couldn't find any information on failing Harvoni tx. I go see the doc in 2 weeks to discuss and get another test.
My doc tried to get a another 4 weeks after the test, but it was denied by insurance.
I don't know where to go from here. You mentioned that Solvadi is another option.... just hoping for any good news right now.. I was so happy when I heard about Harvoni and the results it has.. now I feel like crap and worried about what my future holds for me and my family.
In my non medical opinion after reading hcvguidlines accessed February 14, 2015 for your condition. As far as I know as of now tbere is no meaningful statistical difference in achiving SVR Harvoni with orr without RBV for 12 or 24 weeks. It would appear that Harvoni for 12 weeks is the best treatment for you with the least possible side effects.
When SVR success rates approach the mid 90's and are only a few points between them, the main consideration is less time, side effects and significant cost savings (more funds and meds to treat more sooner).
My heart goes out to those unlucky few percent who fail tx and hope they get retreated successfully in the near future. The odds are extremely better now for GT1 than the old Inf/Rbv when it was 35 or whatever percentages.
I can understand wby some who have failed treatment can feel like "throw everything at it including the kitchen sink" A very few may have a very specific situation wbere their dotor recommends 24 weeks with RBV.
I believe we have to careful not to cause unnessary worry and anxiety for many that are getting Harvoni treatment as it appears is happening. I know your intentions are good.
My hope and prayers are that everyone achieve SVR with the least amount of side effects, as soon as possible and have better health.
When SVR success rates approach the mid 90's and are only a few points between them, the main consideration is less time, side effects and significant cost savings (more funds and meds to treat more sooner).
My heart goes out to those unlucky few percent who fail tx and hope they get retreated successfully in the near future. The odds are extremely better now for GT1 than the old Inf/Rbv when it was 35 or whatever percentages.
I can understand wby some who have failed treatment can feel like "throw everything at it including the kitchen sink" A very few may have a very specific situation wbere their dotor recommends 24 weeks with RBV.
I believe we have to careful not to cause unnessary worry and anxiety for many that are getting Harvoni treatment as it appears is happening. I know your intentions are good.
My hope and prayers are that everyone achieve SVR with the least amount of side effects, as soon as possible and have better health.
Spend a bit more on a few extra PCR's and check your progress.
AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have
Accessed February 14, 2014
The assessment of HCV viral load at week 4 of therapy is useful to determine initial response to therapy and adherence. In phase III clinical trials, almost all patients who did not have cirrhosis had undetectable HCV RNA level at week 4; those with cirrhosis may require more than 4 weeks of treatment before HCV RNA level is undetectable. There are minimal data on how to use HCV RNA level during treatment to determine when to stop treatment for futility. The current recommendation to repeat quantitative HCV RNA testing at week 4 of treatment and to discontinue treatment if the quantitative HCV RNA level increases by more than 10-fold (>1 log10 IU/mL) is based on expert opinion. There are no data to support stopping treatment based on detectable HCV RNA results at weeks 2, 3, or 4 of treatment, or that detectable HCV RNA level at these time points signifies medication nonadherence. Although HCV RNA testing is recommended at week 4 of treatment, the absence of an HCV RNA level at week 4 is not a reason to discontinue treatment. Quantitative HCV RNA level testing at the end of treatment will help to differentiate viral breakthrough from relapse, if necessary. Some may choose to forego end-of-treatment viral load testing, given the high rates of viral response with the newer regimens, and to focus on the week 12 posttreatment viral load. Virologic relapse is rare at 12 or more weeks after completing treatment. Nevertheless, repeat quantitative HCV RNA testing can be considered at 24 or more weeks after discontinuing treatment for selected patients."
AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have
Accessed February 14, 2014
The assessment of HCV viral load at week 4 of therapy is useful to determine initial response to therapy and adherence. In phase III clinical trials, almost all patients who did not have cirrhosis had undetectable HCV RNA level at week 4; those with cirrhosis may require more than 4 weeks of treatment before HCV RNA level is undetectable. There are minimal data on how to use HCV RNA level during treatment to determine when to stop treatment for futility. The current recommendation to repeat quantitative HCV RNA testing at week 4 of treatment and to discontinue treatment if the quantitative HCV RNA level increases by more than 10-fold (>1 log10 IU/mL) is based on expert opinion. There are no data to support stopping treatment based on detectable HCV RNA results at weeks 2, 3, or 4 of treatment, or that detectable HCV RNA level at these time points signifies medication nonadherence. Although HCV RNA testing is recommended at week 4 of treatment, the absence of an HCV RNA level at week 4 is not a reason to discontinue treatment. Quantitative HCV RNA level testing at the end of treatment will help to differentiate viral breakthrough from relapse, if necessary. Some may choose to forego end-of-treatment viral load testing, given the high rates of viral response with the newer regimens, and to focus on the week 12 posttreatment viral load. Virologic relapse is rare at 12 or more weeks after completing treatment. Nevertheless, repeat quantitative HCV RNA testing can be considered at 24 or more weeks after discontinuing treatment for selected patients."
Jimmy, I had not seen the Hector link and I was rhetorically posing the question (and I think providing the answer).
Thank you for providing Carl and others than proof in this thread by posting the URL to the pertinent thread.
You can seldom go wrong by citing Hector. :)
Carl; I think everybody who has treated with riba has extra ribavirin left over after treatment. : )
I have no proof of that; just strong feelings.
Good luck and godspeed.
Thank you for providing Carl and others than proof in this thread by posting the URL to the pertinent thread.
You can seldom go wrong by citing Hector. :)
Carl; I think everybody who has treated with riba has extra ribavirin left over after treatment. : )
I have no proof of that; just strong feelings.
Good luck and godspeed.
Here is my question; what is the difference in SVR rates of 24 weeks of Harvoni versus 12 weeks of Harvoni and riba?
HectorSF explains it very well see his comment for this question.
http://www.medhelp.org/posts/Hepatitis-C/Harvoni--Ribavirin-works-for-previous-failed-treatment-patents/show/2462909
If you haven't already done so I recommend that anyone interested in hcvguidlines go to the home page and then read. How to cite link. Then Full report. Introduction, methods before going to the recommendations pages.
AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org. Accessed February 12, 2015
HectorSF explains it very well see his comment for this question.
http://www.medhelp.org/posts/Hepatitis-C/Harvoni--Ribavirin-works-for-previous-failed-treatment-patents/show/2462909
If you haven't already done so I recommend that anyone interested in hcvguidlines go to the home page and then read. How to cite link. Then Full report. Introduction, methods before going to the recommendations pages.
AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org. Accessed February 12, 2015
I have a bunch of left over riba that I've kept refrigerated. I will look into that.
Here is what I would add;
I agree that the actual viral load is less relevant. Often what is more relevant is
what particular strains of HCV you have and what regimen you are using to fight it.
We have seen many people with high viral loads clear quickly, and have also seen those with low viral loads which seem to stall and take forever to clear the final hurdle. IMHO.... in those "stalled" situations what you have is all of the easy to kill virii are gone, and those few resistant remaining ones which have selected to survive with somewhat greater resistance to that form of TX you are treating with. It isn't the same viral sub-population makeup as what you started TX with. (I believe this also may pertain to those few which remain and cause a relapse at EOT)
IMHO..... and it is just an opinion and may be partially right, partially wrong.....
The decision to treat without riba was somewhat of a marketing decision. The idea was to sell the perception that Harvoni was so strong that riba wasn't needed.
Here is my question; what is the difference in SVR rates of 24 weeks of Harvoni versus 12 weeks of Harvoni and riba?
I think if you are convinced that you must have 24 weeks, but that you can only get 12 weeks approved, I would start by adding in some relatively cheap generic ribavirin.
Spend a bit more on a few extra PCR's and check your progress. I think w/ riba you will RVR and you can decide at what point (IF) to reduce it, or based on viral response your doctor can sell the idea of extending if your response rate were slow.
It's just an ever so slightly out of the box approach, but may suit you or your doctors or payer.
~W
I agree that the actual viral load is less relevant. Often what is more relevant is
what particular strains of HCV you have and what regimen you are using to fight it.
We have seen many people with high viral loads clear quickly, and have also seen those with low viral loads which seem to stall and take forever to clear the final hurdle. IMHO.... in those "stalled" situations what you have is all of the easy to kill virii are gone, and those few resistant remaining ones which have selected to survive with somewhat greater resistance to that form of TX you are treating with. It isn't the same viral sub-population makeup as what you started TX with. (I believe this also may pertain to those few which remain and cause a relapse at EOT)
IMHO..... and it is just an opinion and may be partially right, partially wrong.....
The decision to treat without riba was somewhat of a marketing decision. The idea was to sell the perception that Harvoni was so strong that riba wasn't needed.
Here is my question; what is the difference in SVR rates of 24 weeks of Harvoni versus 12 weeks of Harvoni and riba?
I think if you are convinced that you must have 24 weeks, but that you can only get 12 weeks approved, I would start by adding in some relatively cheap generic ribavirin.
Spend a bit more on a few extra PCR's and check your progress. I think w/ riba you will RVR and you can decide at what point (IF) to reduce it, or based on viral response your doctor can sell the idea of extending if your response rate were slow.
It's just an ever so slightly out of the box approach, but may suit you or your doctors or payer.
~W
Thanks to everyone. I understand better now. Hector, you don't know me but I've followed your situation and had been concerned about not seeing you here in awhile. I also hope that you are doing better. I think the 24 week appeal has already been put through. I will call the Dr. Tuesday (Mon is a holiday) and see. Then we will put in for the proper 12 week regiment. Everyone goes und? This truly is an amazing drug combination breakthrough then. I think my question has been answered guys. Thank you. Hector, best wishes to you. I love and respect you for still helping people after all you have been through and are still going through. :)
I'll be starting 24 weeks of sol/rid next week. Iv relasped twice. I'm g2b. First tx in 2010 VL was 11.5 million cleared early 6 mo relasped. VL of 250k S/R last year VL 255k cleared early in tx. Relasped with VL of 235k. Look like VL don't matter that much. I'm like you I feel once you relasped next tx should be for 24 weeks regardless. But we don't make those decisions
Hey you're done with treatment, that's awesome. I am done in two weeks, also on the 12 week. Time for some SVR!!
A few basic facts about treating with the newer DAA treatments.
First, a viral load of 8 million is not an unusual viral load at the start of treatment.
Second, initial viral load is irrelevant to the achievement of SVR.
ALL people who treat become undetectable (usually by week 4) and stay undetectable for as long as they remain on treatment. There are no non-responders, slow responders, breakthroughs during treatment. Therefore the only people who fail treatment do so by relapsing after stopping treatment. Usually within 4 weeks after the end of treatment (EOT).
As the Harvoni label says...
"Treatment-experienced without cirrhosis: 12 weeks"
The ION-2 study (which included many people with a viral loads of 8 million and higher) showed that those who treated with Harvoni for 12 weeks and had failed prior therapy had a SVR rate of 95%. So to worry about failing treatment is unwarranted.
Only those who are treatment-experienced AND have Cirrhosis (which always leads to lower SVR rates than those with lesser stages of disease) need to treat for 24 weeks
All of this information is available in the online Harvoni full prescribing label.
There is no resistance to Sovaldi so anyone can retreat with a different Sovaldi based treatment. Some of us have retreated with a newer Sovaldi based treatment and achieved SVR.
Good luck with your treatment!
Hector
First, a viral load of 8 million is not an unusual viral load at the start of treatment.
Second, initial viral load is irrelevant to the achievement of SVR.
ALL people who treat become undetectable (usually by week 4) and stay undetectable for as long as they remain on treatment. There are no non-responders, slow responders, breakthroughs during treatment. Therefore the only people who fail treatment do so by relapsing after stopping treatment. Usually within 4 weeks after the end of treatment (EOT).
As the Harvoni label says...
"Treatment-experienced without cirrhosis: 12 weeks"
The ION-2 study (which included many people with a viral loads of 8 million and higher) showed that those who treated with Harvoni for 12 weeks and had failed prior therapy had a SVR rate of 95%. So to worry about failing treatment is unwarranted.
Only those who are treatment-experienced AND have Cirrhosis (which always leads to lower SVR rates than those with lesser stages of disease) need to treat for 24 weeks
All of this information is available in the online Harvoni full prescribing label.
There is no resistance to Sovaldi so anyone can retreat with a different Sovaldi based treatment. Some of us have retreated with a newer Sovaldi based treatment and achieved SVR.
Good luck with your treatment!
Hector
Yay! Congratulations. That's awesome news. Und at 3 weeks. Wow. I really want to start these pills NOW. Just so nervous about failing but your story is very encouraging. Thank you for sharing it.
I finished my 12 wks of Harvoni. I have relapsed a couple of times. Its been a few years since I was on any treatment. My viral load went up and down, as low as 330,000 and as high as 16 million. I've had biopsies and a fibroscan, little or no cirrhosis. So, my treatment plan is 12 wks. My first bloodtest was at 3 wks of treatment and I was already undetected. I discussed with my specialist, no need to do 24 wks. I will be SVR on May 1st.
Have faith.
Have faith.
I'm sorry. Where are my manners?! Good luck to you too in getting approved and getting well!
No. Drug and alcohol testing was never mentioned. I did find out that all of the blue cross plans and companies are different. Their explanation was that protocol calls for 12 weeks and not 24. Maybe 12 weeks will work but I'm pretty nervous about failing again!
Did you do drug and alcohol testing? That is why I was rejected. So I did that yesterday so have to wait probably another 2 weeks for that appeal.
I wish there was an edit function! I got my insurance rejection letter yesterday and until then did not know why I was rejected for tx. It looks like they may approve me for 12 weeks. I am concerned that if I fail this tx that I will have a built up tolerance for these two drugs in Harvoni and that if I fail that I may not have any further recourse. I want to maximize my chance of clearing and 8 million iu/ml is a whole lot of billions of viruses to kill. IDK what shot it up so high. When I was diagnosed 2 1/2 years ago I was near 4 million. Now I am eating healthier and haven't had a drink in well over a year.
Looking again at those charts the relapse rate for 12 weeks and over 6 million initial VL is very low but I do not see a SVR chart that breaks down response rates by initial VL. It looks promising but this may be my final chance at curing. If I am not und by a certain time period does it mean that I will not respond or is it possible to lengthen the tx period if I am not und by, say, 8 weeks?
We are putting in an appeal for 24 weeks based on the high VL and the fact that I have symptoms of fatigue, achy joints and muscles and brain fog. I don't think that it will fly though. I am scared that 12 weeks won't work. Has anyone here cleared with such a high VL?
Looking again at those charts the relapse rate for 12 weeks and over 6 million initial VL is very low but I do not see a SVR chart that breaks down response rates by initial VL. It looks promising but this may be my final chance at curing. If I am not und by a certain time period does it mean that I will not respond or is it possible to lengthen the tx period if I am not und by, say, 8 weeks?
We are putting in an appeal for 24 weeks based on the high VL and the fact that I have symptoms of fatigue, achy joints and muscles and brain fog. I don't think that it will fly though. I am scared that 12 weeks won't work. Has anyone here cleared with such a high VL?
Yes unfortunately it does. But there are huge differences in percentages on SVR 12 weeks vs 24 weeks for people who treated previously. I honestly don't understand why the insurance co don't make everyone treat 24 weeks. Evidently VL is not an issue.
With the cost of this drug I would find it hard that your ins co would approve 24 weeks unless you had other underlying health issues.
Hang in there Carl...keep fighting them!!! Give em HELL!
With the cost of this drug I would find it hard that your ins co would approve 24 weeks unless you had other underlying health issues.
Hang in there Carl...keep fighting them!!! Give em HELL!
That would put me in the 12 week period as I have no cirrhosis or measurable fibrosis. We are concerned about how long it will take to knock down that high VL though.
Carl look @ Table 7 but it is for tx naïve patients. Seems that most of the information is for tx naïve patients so their percentages look better for SVR. Here is the link. It would not let me copy the table.
jules
http://hepatitiscnewdrugresearch.com/harvoni--svr-ratesdosagedrug-interactionsside-effects.html
jules
http://hepatitiscnewdrugresearch.com/harvoni--svr-ratesdosagedrug-interactionsside-effects.html
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