Aa
Harvoni + Ribavirin works for previous failed treatment patents?
I have failed treatment for HEPC three times in the past; Interferon, Interferon + Ribavirin, and Interferon+Ribavirin+Tepavier. I also have compensated cirrhosis. I've had HEPC for over 50 years. Currently I'm on week 4 of Havoni + Ribavirin (1200 mg a day + 1 Harvoni). I read that the recommended duration for we hard-to-treat previous non-responders is 24 weeks, but my clinician is insisting 12 weeks will be good enough and there is no difference in the outcomes for 12 weeks vs 24 weeks. Is this correct data?
Congratulations on getting rid of that sneaky little powerful vermin. The VA has really started to treat a lot more vets who have HCV. I was GT2 with cirrhosis and achieved SVR last year SOV/RBV 12 weeks.
The hcvguidlines have been updated see my post.
http://www.medhelp.org/posts/Hepatitis-Social/12-or-24-Weeks/show/2709477#post_13127016
Harvoni GT 1 with cirrhosis. Failed PegInf/Rbv 24 weeks without Rbv or 12 weeks with Rbv.
For your situation Harvoni 24 weeks without Rbv -failed with telaprevir
Cirrhosis
Recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom prior treatment with an HCV nonstructural protein 3 (NS3) protease inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN and RBV or simeprevir plus sofosbuvir has failed (no prior NS5A treatment).
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior treatment with an HCV protease inhibitor plus PEG-IFN and RBV has failed. Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patienta with cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Rating: Class I, Level A
We haven't heard from you since February. Hope you have completed treatment or extended and will or have achieve SVR.
FYI to anyone. Many times members may only be at MedHelp for a short time and for many reasons are not heard from again. If you are able to do so please try in the future to come back at least once if possible to let us know how you are doing and or if treatment was successful.
http://www.medhelp.org/posts/Hepatitis-Social/12-or-24-Weeks/show/2709477#post_13127016
Harvoni GT 1 with cirrhosis. Failed PegInf/Rbv 24 weeks without Rbv or 12 weeks with Rbv.
For your situation Harvoni 24 weeks without Rbv -failed with telaprevir
Cirrhosis
Recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom prior treatment with an HCV nonstructural protein 3 (NS3) protease inhibitor (telaprevir, boceprevir, or simeprevir) plus PEG-IFN and RBV or simeprevir plus sofosbuvir has failed (no prior NS5A treatment).
Daily fixed-dose combination ledipasvir (90 mg)/sofosbuvir (400 mg) for 24 weeks is recommended for retreatment of patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior treatment with an HCV protease inhibitor plus PEG-IFN and RBV has failed. Based on limited data, the addition of weight-based RBV to ledipasvir/sofosbuvir is recommended for patienta with cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed.
Rating: Class I, Level A
We haven't heard from you since February. Hope you have completed treatment or extended and will or have achieve SVR.
FYI to anyone. Many times members may only be at MedHelp for a short time and for many reasons are not heard from again. If you are able to do so please try in the future to come back at least once if possible to let us know how you are doing and or if treatment was successful.
Just completed the 12wk program H+Riba, very easy with limited side effects. Tested neg after only 4wks. Thank you VA!
Thanks for your input. For hard to treat patients, did Ira Jacobson say he was prescribing 24 weeks Harvoni with Riba to ensure SVR12, or 24 weeks Harvoni without Riba? Just to clarify. Thank you.
Good appointment with the doc treating me. Undetectable at the 4 week PCR test and holding my own lab-wise with a slight drop in WBC but RBC is okay. Liver readings are down, except total bili which is up due to the Reba killing off blood cells. We spent some time going over the data I provided and discussing the 12 weeks vs 24 weeks issue. Kaiser is going on the data from the Sirius study for the protocol of 12 weeks treatment with Harvoni + Reba for everyone. I noted the Sirius study was in France and was assured there was not difference between Geno 1a patients in the US vs France. Asked about the future if treatment failed, expressed my concern about an age cutoff and she assured me that would not be the case, that one of her current patients is 88 years old. So for now, all is good.
My non medical opinion is Harvoni 24 weeks as mentioned has quite a bit of data and medical opinion to support very strong recommendation. Harvoni plus RBV 12 weeks so far has less data and less number of medical opinions. But as of now appears to have similar results as Harvoni 24 weeks to merit a decent recommendation. Hopefully in the future it will become 1A
My personal comment mentioning "paid trial" was a bad attempt at humor. No, I do not think you are being used as a human "lab rat"
My heart and thanks do go out to all that have been in trials, especially the ones that failed and or suffered serious long lasting side effects or died over the many years. Without them none of us would have chance at treatment whether these new ones or in earlier years the less effective and more harmful ones.
Harvoni and RBV are off-label. Sovaldi or Viekira Pak with RBV are FDA approved and on label depending on GT and condition. RBV label hasn't been updated for them as far as I know.
Best wishes I believe you have a very high chance of SVR
My personal comment mentioning "paid trial" was a bad attempt at humor. No, I do not think you are being used as a human "lab rat"
My heart and thanks do go out to all that have been in trials, especially the ones that failed and or suffered serious long lasting side effects or died over the many years. Without them none of us would have chance at treatment whether these new ones or in earlier years the less effective and more harmful ones.
Harvoni and RBV are off-label. Sovaldi or Viekira Pak with RBV are FDA approved and on label depending on GT and condition. RBV label hasn't been updated for them as far as I know.
Best wishes I believe you have a very high chance of SVR
Sometimes hate typing on smartphone. Plus MH doesn't have a preview before posting.
. Accessed February 12, 2015 is not part of the link
. Accessed February 12, 2015 is not part of the link
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
AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org. Accessed February 12, 2015
When I quote a copyrighted source I try to limit it to basic info (fair use). I use excerpt and suggest if anyone has further interest to go the the link for the details. Please read first . For example There is a link on that page that will take you Methods Table 2 that explains Classification and Level.
Now after reading the details someone may be in a better possition to disscuss it.
Now after reading the details someone may be in a better possition to disscuss it.
Harvoni 24 weeks Rating: Class I, Level A
Harvoni plus RBV 12 weeks Rating: Class IIa, Level B
What does Class 1, Level A mean compared to Class IIa, Level B?
I'm gathering the Riba, being "off label" treatment, is sort of experimental, as the label does not approve it for use with anything except Interferon?
If that's the case, I don't appreciate being a "lab rat" for Kaiser. At my age time is running out to cure this and avoid liver cancer. I"m already being banded over and over for vericies, every 12 weeks.
I've the "showdown" meeting with the HEPC team tomorrow. They tested for PCR at 4 weeks, so we'll see the results tomorrow. I'll post the results of the meeting. If it's not quite undetectable I'm going to push for finishing the two-week supply I have on hand and then test again. I've a record of being very resistant to drug treatment for whatever comes along, antibiotics take 14-16 days to clear something instead of the protocol 7-10 days.
Harvoni plus RBV 12 weeks Rating: Class IIa, Level B
What does Class 1, Level A mean compared to Class IIa, Level B?
I'm gathering the Riba, being "off label" treatment, is sort of experimental, as the label does not approve it for use with anything except Interferon?
If that's the case, I don't appreciate being a "lab rat" for Kaiser. At my age time is running out to cure this and avoid liver cancer. I"m already being banded over and over for vericies, every 12 weeks.
I've the "showdown" meeting with the HEPC team tomorrow. They tested for PCR at 4 weeks, so we'll see the results tomorrow. I'll post the results of the meeting. If it's not quite undetectable I'm going to push for finishing the two-week supply I have on hand and then test again. I've a record of being very resistant to drug treatment for whatever comes along, antibiotics take 14-16 days to clear something instead of the protocol 7-10 days.
Actually he said if you didn't clear or relapsed, it would matter to you no matter what the statistics said. So he is recommending 24 weeks for all of his hard to treat patients on Harvoni and Ribavirin.
I was at a talk tonight by Ira Jacobson, hepatologist at Cornell. He addressed your question. Statistically there is not a significant difference between the 12 and 24 week arms for Harvoni and Ribavirin. He said many doctors are sticking with the 12 week recommendation. He personally is prescribing 24 weeks as he says if you are one of the few patients (I think he said 3 in one of the trials) that didn't clear with 12 weeks, that is a good enough reason for him to write the script for 24 weeks. Good luck convincing your doc and the insurance company.
If you do not have cirrhosis and failed a previous treatment(s) not containing sovaldi, you are one of the recommended treatment as of today's date.
AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Accessed February 11, 2015
Best wishes for achiving SVR
AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Accessed February 11, 2015
Best wishes for achiving SVR
I am being treated by the best Hepa doctor in the upper Midwest. He prescribed 12 wks of harvoni. I am GT1 and relapsed a couple of times.
12 wks not 24 wks. I sure hope he is correct.
12 wks not 24 wks. I sure hope he is correct.
I'm gt2 have relasped twice once on peg/rib 6 month. Sovaldi/rib 12 weeks. Will be starting sovaldi/rib again for 24 weeks. There is no other option right now for gt2. I believe anyone who's relasped on ant tx should do the max tx time. We talked about it the first time I did sovaldi. I cleared on both tx. Peace
AASLD/IDSA/IAS–USA (link in a previous reply) only mentions SOV/RBV for 24 weeks and SOV/RBV plus INF for 12 weeks GT3 re-treatment. In the initial treatment page there is very limited information about Harvoni with RBV for 12 weeks and daclatasvir and Sovaldi for 12 weeks. You may want to read a current version of those treatment pages.
Since you live in the United Kingdom there may be a difference of which treatment may be available and there could be trials maybe.
May I suggest you start a new question and include basic info on condition, prior treatment(s), dates etc. It probably would be easier to get replies for your situation which is different from this topic.
Best wishes for getting treatment and achieving SVR as in the near future.
Since you live in the United Kingdom there may be a difference of which treatment may be available and there could be trials maybe.
May I suggest you start a new question and include basic info on condition, prior treatment(s), dates etc. It probably would be easier to get replies for your situation which is different from this topic.
Best wishes for getting treatment and achieving SVR as in the near future.
My only question here is ..what about geno 3...
Why aren't they included.
Prob agree with hector.. With ribavirin its got more ummph!
12 weeks with rib...
But 24 weeks with rib would really nail it!!!!
Alico
Why aren't they included.
Prob agree with hector.. With ribavirin its got more ummph!
12 weeks with rib...
But 24 weeks with rib would really nail it!!!!
Alico
My other comment only mentioned the possibility that if confirmed future results indicated that the 12 week Harvoni plus RBV wasn't as good then an update to the guidlines could change. That's also why a date access is asked to be shown. So anyone citing or considering hcvguidlines should revisit site before posting or using that information.
They have been update.
AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Accessed February 11, 2015
See GT1
"Two options with similar efficacy in general are recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed."
abbreviated
Harvoni 24 weeks Rating: Class I, Level A
Harvoni plus RBV 12 weeks Rating: Class IIa, Level B
"Based on data from the SIRIUS study, patients with cirrhosis in whom a prior protease inhibitor containing regimen failed may also receive ledipasvir/sofosbuvir plus weight-based RBV for 12 weeks."
To all
Reminder for quoting hcvguidlines please follow
http://www.hcvguidelines.org/news/how-cite-and-permissions
Accessed February 11, 2015
AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C.
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Accessed February 11, 2015
See GT1
"Two options with similar efficacy in general are recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed."
abbreviated
Harvoni 24 weeks Rating: Class I, Level A
Harvoni plus RBV 12 weeks Rating: Class IIa, Level B
"Based on data from the SIRIUS study, patients with cirrhosis in whom a prior protease inhibitor containing regimen failed may also receive ledipasvir/sofosbuvir plus weight-based RBV for 12 weeks."
To all
Reminder for quoting hcvguidlines please follow
http://www.hcvguidelines.org/news/how-cite-and-permissions
Accessed February 11, 2015
"...my clinician is insisting 12 weeks will be good enough and there is no difference in the outcomes for 12 weeks vs 24 weeks. Is this correct data? "
Below you will find the current data concerning cirrhotics treating with or without Ribavirin for both 12 and 24 weeks.
As others said the current protocol for someone with cirrhosis is 24 weeks as stated in the AASLD/IDSA Hepatitis C guidelines and in the treating label that came with your Harvoni. Both studies data is available online and all hepatologist should be aware of them.
...But there is new data (November 2014) that shows that 12 weeks of Harvoni with the addition of Ribavirin appears to be equivalent to 24 week of Harvoni without Ribavirin.
As will all things each person's liver disease is unique. Your doctor (hepatologist hopefully) should be matching your treatment with the latest data and your unique clinical situation.
Evaluating the following factors...
* Previous treatment failure
* Previous Non responder?
* PI failure?
* Severity of cirrhosis/portal hypertension
* Tolerance for Ribavirin side effects
* Etc.
From the Harvoni label:
-------------------------------------------------------------------------------------
------------------------DOSAGE AND ADMINISTRATION-----------------------
Recommended dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food (2.1)
Recommended treatment duration (2.1):
Treatment-naïve with or without cirrhosis: 12 weeks
Treatment-experienced without cirrhosis: 12 weeks
-Treatment-experienced with cirrhosis: 24 weeks
Study ION-2:
Clinical Trials in Subjects Who Failed Prior Therapy
Previously-Treated Adults with or without Cirrhosis ─ ION-2 (Study 0109)
ION-2 was a randomized, open-label trial that evaluated 12 and 24 weeks of treatment with HARVONI with or without ribavirin in genotype 1 HCV-infected subjects with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Demographics and baseline characteristics were balanced across the treatment groups. Of the 440 treated subjects, the median age was 57 years (range: 24 to 75); 65% of the subjects were male; 81% were White; 18% were Black; 9% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 19 to 50 kg/m2); 89% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 79% had genotype 1a HCV infection; 88% had non-C/C IL28B alleles (CT or TT); and 20% had cirrhosis. Forty-seven percent (47%) of the subjects failed a prior therapy of pegylated interferon and ribavirin. Among these subjects, 49% were relapse/breakthrough and 51% were non-responder. Fifty-three percent (53%) of the subjects failed a prior therapy of pegylated interferon and ribavirin with an HCV protease inhibitor. Among these subjects, 62% were relapse/breakthrough and 38% were non-responder.
--------------------------------------------------------------------------------------
Study ION-2: SVR Rates for Selected Subgroups after 12 and 24 Weeks of Treatment in Subjects with Genotype 1 CHC who Failed Prior Therapy
Cirrhosis
12 weeks SVR=86% (19/22)
24 weeks SVR=100% (22/22)
----------------------------------------------------------------------------------------
If your doctor is a hepatologist they may be referring to recent data from the SIRIUS trial which included people who had previously failed PI-Based Triple Therapy. The data seemed to show that Harvoni + Ribavirin for 12 weeks was equivalent to 24 weeks of treatment.
-------------------------------------------------------------------------------------
=================================================
New data from the SIRIUS trial presented at the November AASLD meeting showed that Harvoni with the addition of Ribavirin for 12 weeks was equivalent to 24 weeks of Harvoni withour Ribavirin..
***We will have to see if the Harvoni treatment guidelines are changed based on this study's data.***
------------------------------------------------------------------------------------
The French SIRIUS trial
Ledipasvir/Sofosbuvir Fixed-Dose Combination Is Safe and Efficacious in Cirrhotic Patients Who Have Previously Failed Protease-Inhibitor Based Triple Therapy SIRIUS Trail
LDV/SOF in Cirrhotic Patients Who Previously Failed PI-Based Triple Therapy: the SIRIUS trial
In this double-blind, placebo-controlled study in cirrhotic GT1 patients who failed PegIFN+RBV or PI+PegIFN+RBV regimens in France (null or partial responders) 154 patients were included into two arms
The mean age was 56 years (range 23-77). The majority were, male (74%), and IL28B non-CC (94%). Twenty-seven (18%) had a platelet count ≤100,000/μL and 20 (13%) had serum albumin <3.5 g/dL. 41 had varices at baseline..
Results:
LDV/SOF+RBV for 12 weeks SVR=96%
LDV/SOF for 24 weeks SVR=97%
Treatment experienced cirrhotics had a similar response to LDV/SOF+RBV for 12 weeks and LDV/SOF for 24 weeks. So again if RBV tolerant the combination of LDV/SOF + RBV appears the most cost-sensitive approach forward in cirrhotic treatment-experienced patients.
-----------------------------------------------------------------------------------------
Good luck with your treatment!
Hector
Below you will find the current data concerning cirrhotics treating with or without Ribavirin for both 12 and 24 weeks.
As others said the current protocol for someone with cirrhosis is 24 weeks as stated in the AASLD/IDSA Hepatitis C guidelines and in the treating label that came with your Harvoni. Both studies data is available online and all hepatologist should be aware of them.
...But there is new data (November 2014) that shows that 12 weeks of Harvoni with the addition of Ribavirin appears to be equivalent to 24 week of Harvoni without Ribavirin.
As will all things each person's liver disease is unique. Your doctor (hepatologist hopefully) should be matching your treatment with the latest data and your unique clinical situation.
Evaluating the following factors...
* Previous treatment failure
* Previous Non responder?
* PI failure?
* Severity of cirrhosis/portal hypertension
* Tolerance for Ribavirin side effects
* Etc.
From the Harvoni label:
-------------------------------------------------------------------------------------
------------------------DOSAGE AND ADMINISTRATION-----------------------
Recommended dosage: One tablet (90 mg of ledipasvir and 400 mg of sofosbuvir) taken orally once daily with or without food (2.1)
Recommended treatment duration (2.1):
Treatment-naïve with or without cirrhosis: 12 weeks
Treatment-experienced without cirrhosis: 12 weeks
-Treatment-experienced with cirrhosis: 24 weeks
Study ION-2:
Clinical Trials in Subjects Who Failed Prior Therapy
Previously-Treated Adults with or without Cirrhosis ─ ION-2 (Study 0109)
ION-2 was a randomized, open-label trial that evaluated 12 and 24 weeks of treatment with HARVONI with or without ribavirin in genotype 1 HCV-infected subjects with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Demographics and baseline characteristics were balanced across the treatment groups. Of the 440 treated subjects, the median age was 57 years (range: 24 to 75); 65% of the subjects were male; 81% were White; 18% were Black; 9% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 19 to 50 kg/m2); 89% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 79% had genotype 1a HCV infection; 88% had non-C/C IL28B alleles (CT or TT); and 20% had cirrhosis. Forty-seven percent (47%) of the subjects failed a prior therapy of pegylated interferon and ribavirin. Among these subjects, 49% were relapse/breakthrough and 51% were non-responder. Fifty-three percent (53%) of the subjects failed a prior therapy of pegylated interferon and ribavirin with an HCV protease inhibitor. Among these subjects, 62% were relapse/breakthrough and 38% were non-responder.
--------------------------------------------------------------------------------------
Study ION-2: SVR Rates for Selected Subgroups after 12 and 24 Weeks of Treatment in Subjects with Genotype 1 CHC who Failed Prior Therapy
Cirrhosis
12 weeks SVR=86% (19/22)
24 weeks SVR=100% (22/22)
----------------------------------------------------------------------------------------
If your doctor is a hepatologist they may be referring to recent data from the SIRIUS trial which included people who had previously failed PI-Based Triple Therapy. The data seemed to show that Harvoni + Ribavirin for 12 weeks was equivalent to 24 weeks of treatment.
-------------------------------------------------------------------------------------
=================================================
New data from the SIRIUS trial presented at the November AASLD meeting showed that Harvoni with the addition of Ribavirin for 12 weeks was equivalent to 24 weeks of Harvoni withour Ribavirin..
***We will have to see if the Harvoni treatment guidelines are changed based on this study's data.***
------------------------------------------------------------------------------------
The French SIRIUS trial
Ledipasvir/Sofosbuvir Fixed-Dose Combination Is Safe and Efficacious in Cirrhotic Patients Who Have Previously Failed Protease-Inhibitor Based Triple Therapy SIRIUS Trail
LDV/SOF in Cirrhotic Patients Who Previously Failed PI-Based Triple Therapy: the SIRIUS trial
In this double-blind, placebo-controlled study in cirrhotic GT1 patients who failed PegIFN+RBV or PI+PegIFN+RBV regimens in France (null or partial responders) 154 patients were included into two arms
The mean age was 56 years (range 23-77). The majority were, male (74%), and IL28B non-CC (94%). Twenty-seven (18%) had a platelet count ≤100,000/μL and 20 (13%) had serum albumin <3.5 g/dL. 41 had varices at baseline..
Results:
LDV/SOF+RBV for 12 weeks SVR=96%
LDV/SOF for 24 weeks SVR=97%
Treatment experienced cirrhotics had a similar response to LDV/SOF+RBV for 12 weeks and LDV/SOF for 24 weeks. So again if RBV tolerant the combination of LDV/SOF + RBV appears the most cost-sensitive approach forward in cirrhotic treatment-experienced patients.
-----------------------------------------------------------------------------------------
Good luck with your treatment!
Hector
I have another thought just personal opinion.
Some members have fought for and were able to get 24 weeks Harvoni.with or without RBV
Since the trials are limited and real world results can be lower and or different.
For those who patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed."
Some insurance coumpanies may approve 24 weeks for the "sweaky wheel" persistent patients and or doctors. Other will just get 12 weeks with RBV.
Subject to new guidlines in the mean time if any. Numbers I used are just. guessing examples and nothing else.
They will observe the results over time and compare. If the SVR results are close say 93 % 12 weeks and 95% 24 weeks. They will continue to push for 12 weeks only and retreat those who fail. Much cheaper. If the 12 tx ends up much lower SVR like closer to 10% or more lower. Then they might be more inclined to treat all for 24 weeks. Call it an unofficial trial paid trial.
Some members have fought for and were able to get 24 weeks Harvoni.with or without RBV
Since the trials are limited and real world results can be lower and or different.
For those who patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed."
Some insurance coumpanies may approve 24 weeks for the "sweaky wheel" persistent patients and or doctors. Other will just get 12 weeks with RBV.
Subject to new guidlines in the mean time if any. Numbers I used are just. guessing examples and nothing else.
They will observe the results over time and compare. If the SVR results are close say 93 % 12 weeks and 95% 24 weeks. They will continue to push for 12 weeks only and retreat those who fail. Much cheaper. If the 12 tx ends up much lower SVR like closer to 10% or more lower. Then they might be more inclined to treat all for 24 weeks. Call it an unofficial trial paid trial.
Gotta agree 100% that you go for 24 weeks with Harvoni and Riba. If I were in your shoes I would insist until they agreed. You must remember that with these clinical trials the participants were "Cherry Picked" so that the best possible outcome would occur. This does not translate to the Real World.
In my opinion your life depends on it! You can not afford to relapse at this stage of the game. Your instincts and observations are spot on. Do not let them deter you from the goal and stand your ground.
My best to you as well
.......Kim
In my opinion your life depends on it! You can not afford to relapse at this stage of the game. Your instincts and observations are spot on. Do not let them deter you from the goal and stand your ground.
My best to you as well
.......Kim
can-do-man and pooh55811 provide some good arguments to try and get treatment extended to 24 weeks.
You can gather as much information as possible to present to doctor and insurance. You can ask your doctor to check with experts for their opinion with your specific situation. Get a second opinion.
Mostly my personal opinion.
First priority is to focus on treatment and not get overwhelmed with worry and anxiety. You can try again if denied maybe there will be more supporting info before you finish tx Hopefully some members can provide links to professional recommendations to help you.
It can take a month, months or even longer before certain guidelines are updated. The review panel has to discuss,review statistics and come to an agreement. Then the recommendations have to published on the website. Some doctors may be privy to new information before published. Great if your doctor knows anyone that unofficially has more info.
Actually since you treated with telaprevir the correct hcvguidlines (link in prior post accessed February 10, 2015)
"Two options with similar efficacy in general are recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed."
abbreviated
Harvoni 24 weeks Rating: Class I, Level A
Harvoni plus RBV 12 weeks Rating: Class IIa, Level B
"Based on data from the SIRIUS study, patients with cirrhosis in whom a prior protease inhibitor containing regimen failed may also receive ledipasvir/sofosbuvir plus weight-based RBV for 12 weeks."
So even if unsuccessful getting tx extended you still have a very good chance of achieving SVR
My best wishes.
You can gather as much information as possible to present to doctor and insurance. You can ask your doctor to check with experts for their opinion with your specific situation. Get a second opinion.
Mostly my personal opinion.
First priority is to focus on treatment and not get overwhelmed with worry and anxiety. You can try again if denied maybe there will be more supporting info before you finish tx Hopefully some members can provide links to professional recommendations to help you.
It can take a month, months or even longer before certain guidelines are updated. The review panel has to discuss,review statistics and come to an agreement. Then the recommendations have to published on the website. Some doctors may be privy to new information before published. Great if your doctor knows anyone that unofficially has more info.
Actually since you treated with telaprevir the correct hcvguidlines (link in prior post accessed February 10, 2015)
"Two options with similar efficacy in general are recommended for patients with cirrhosis who have HCV genotype 1 infection, regardless of subtype, in whom a prior PEG-IFN, RBV, and an HCV protease inhibitor regimen has failed."
abbreviated
Harvoni 24 weeks Rating: Class I, Level A
Harvoni plus RBV 12 weeks Rating: Class IIa, Level B
"Based on data from the SIRIUS study, patients with cirrhosis in whom a prior protease inhibitor containing regimen failed may also receive ledipasvir/sofosbuvir plus weight-based RBV for 12 weeks."
So even if unsuccessful getting tx extended you still have a very good chance of achieving SVR
My best wishes.
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