Aa
Another Relapse
Some had questions about Harvoni relapses and I can tell you I did.After clearing a year ago on sovaldi-olysio I relapsed immediately.This time I did 6 months of Harvoni and finished July 3rd.Just got bloodwork back today that was done on August 18.Just 6 weeks after finishing and it says quantitation 455,000. HCV log10 5.658 They will never give me coverage for another treatment,They know I cant be healed and its just throwing money away.I was starting to believe I beat this and now I'm headed straight back to the nose bleeds,the paralyzing cramps in my legs and the unbearable itching.I don't know what to do.Too tired of being defeated by this disease.
Glen
Glen
Glen,
"JImmy The doc said that the ribavirin would not have made a difference in the 24 week program.He said 24 weeks of Harvoni is all I should need.Obviously it wasn't. "
NOTE THE FOLLOWING IS FROM https://archive.org/web/
A wayback machine snapshot of how the http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
looked on December 21, 2014"
In the absence of data, for patients in whom prior treatment with simeprevir plus sofosbuvir failed, strong consideration should be given to enrolling them in clinical trials. For patients with minimal liver disease, consideration should be given to deferral of retreatment pending the availability of data. In patients who require retreatment more urgently, based on emerging data and the expected pattern of HCV drug resistance, patients in whom simeprevir plus sofosbuvir does not result in a cure may be treated with ledipasvir/sofosbuvir with or without RBV for 24 weeks"
Technically when you started treatment in Jan. 2015 your doctor was following the guidelines. There was no preference for adding RBV to 24 week Harvoni treatment at that time.
"Now the recommendations have changed so unless contraindicated, weight-based RBV should be added.specifically for patients with cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed."
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Accessed September 7, 2015
excerpts from the text below the box
"For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time."
-----------
"Data on the retreatment of patients for whom prior treatment with ledipasvir/sofosbuvir has failed are very limited. In a pilot study, 41 patients with and without cirrhosis who did not achieve an SVR with 8 weeks or 12 weeks of ledipasvir/sofosbuvir were retreated with 24 weeks of ledipasvir/sofosbuvir. SVR12 rates varied according to the presence or absence of NS5A inhibitor RAVs. Among 11 patients for whom NS5A inhibitor RAVs were not detected, SVR occurred in 11 of 11 (100%); in contrast, among 30 patients for whom NS5A inhibitor RAVs were detected, SVR occurred in 18 of 30 (60%). Importantly, NS5B inhibitor RAVs (eg, S282T) known to confer decreased activity of sofosbuvir were observed in 3 of 12 (25%) patients for whom the retreatment regimen was not successful. Similarly, in the OPTIMIST-2 study in which patients with cirrhosis were treated with simeprevir and sofosbuvir, the presence of NS3 RAVs, namely the Q80K polymorphism, led to a decreased SVR rate in patients with HCV genotype 1a infection. SVR occurred in 25 of 34 (74%) patients with HCV genotype 1a and the Q80K RAV and in 35 of 38 (92%) patients with HCV genotype 1a without the Q80K RAV. Based on these data, retreatment for patients for whom an NS5A inhibitor-containing regimen has failed should be considered in the context of retreatment urgency and the presence or absence of RAVs to inhibitors of NS3 and NS5A. Further, based on limited data, RBV is recommended as part of all retreatment regimens for patients in whom prior treatment with NS5A inhibitors has failed. Although no data exist, consideration may also be given to the addition of PEG-IFN to the retreatment regimen in patients who are eligible for this agent; PEG-IFN will have antiviral activity regardless of the RAVs present."
Glen,
1. Have you had or asked for testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors AND .to NS5A inhibitors.
2. Is your cirrhosis currently Class A well compensated?
3. Are any of your blood test out of the normal range like bilirubin, creatinine, albumin, platelets, hemoglobin, AST, ALT, sodium etc.
4. Since you were sadly notified of this treatment failure, have you spoken to your doctor and has he said anything about future treatment and how urgent is the need for it.
"JImmy The doc said that the ribavirin would not have made a difference in the 24 week program.He said 24 weeks of Harvoni is all I should need.Obviously it wasn't. "
NOTE THE FOLLOWING IS FROM https://archive.org/web/
A wayback machine snapshot of how the http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
looked on December 21, 2014"
In the absence of data, for patients in whom prior treatment with simeprevir plus sofosbuvir failed, strong consideration should be given to enrolling them in clinical trials. For patients with minimal liver disease, consideration should be given to deferral of retreatment pending the availability of data. In patients who require retreatment more urgently, based on emerging data and the expected pattern of HCV drug resistance, patients in whom simeprevir plus sofosbuvir does not result in a cure may be treated with ledipasvir/sofosbuvir with or without RBV for 24 weeks"
Technically when you started treatment in Jan. 2015 your doctor was following the guidelines. There was no preference for adding RBV to 24 week Harvoni treatment at that time.
"Now the recommendations have changed so unless contraindicated, weight-based RBV should be added.specifically for patients with cirrhosis, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed."
http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
Accessed September 7, 2015
excerpts from the text below the box
"For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time."
-----------
"Data on the retreatment of patients for whom prior treatment with ledipasvir/sofosbuvir has failed are very limited. In a pilot study, 41 patients with and without cirrhosis who did not achieve an SVR with 8 weeks or 12 weeks of ledipasvir/sofosbuvir were retreated with 24 weeks of ledipasvir/sofosbuvir. SVR12 rates varied according to the presence or absence of NS5A inhibitor RAVs. Among 11 patients for whom NS5A inhibitor RAVs were not detected, SVR occurred in 11 of 11 (100%); in contrast, among 30 patients for whom NS5A inhibitor RAVs were detected, SVR occurred in 18 of 30 (60%). Importantly, NS5B inhibitor RAVs (eg, S282T) known to confer decreased activity of sofosbuvir were observed in 3 of 12 (25%) patients for whom the retreatment regimen was not successful. Similarly, in the OPTIMIST-2 study in which patients with cirrhosis were treated with simeprevir and sofosbuvir, the presence of NS3 RAVs, namely the Q80K polymorphism, led to a decreased SVR rate in patients with HCV genotype 1a infection. SVR occurred in 25 of 34 (74%) patients with HCV genotype 1a and the Q80K RAV and in 35 of 38 (92%) patients with HCV genotype 1a without the Q80K RAV. Based on these data, retreatment for patients for whom an NS5A inhibitor-containing regimen has failed should be considered in the context of retreatment urgency and the presence or absence of RAVs to inhibitors of NS3 and NS5A. Further, based on limited data, RBV is recommended as part of all retreatment regimens for patients in whom prior treatment with NS5A inhibitors has failed. Although no data exist, consideration may also be given to the addition of PEG-IFN to the retreatment regimen in patients who are eligible for this agent; PEG-IFN will have antiviral activity regardless of the RAVs present."
Glen,
1. Have you had or asked for testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors AND .to NS5A inhibitors.
2. Is your cirrhosis currently Class A well compensated?
3. Are any of your blood test out of the normal range like bilirubin, creatinine, albumin, platelets, hemoglobin, AST, ALT, sodium etc.
4. Since you were sadly notified of this treatment failure, have you spoken to your doctor and has he said anything about future treatment and how urgent is the need for it.
Glen, I am so very sorry to read this devastating news. All I can offer is that I have a Merck Ad Board meeting on September 30. If you would like, I can tell them a bit about your history and ask if they believe their treatment (scheduled to be approved in mid-January) would be something you should consider. I can also ask if there are any on-going trials or if they would consider you for their patient access program in case your insurance balks. Aarrgghhh. I wonder if it is that the ribavirin wasn't added? Please send me anything I should know in a private message if you want me to chat with Merck.
Thanks for your reply I
Dr John Santoro has been treating me for hep c since the 80s.He has had me on everything under the sun.I am just a non responder,its always been like this.He told me I didn't need the ribo if I was doing the 24 weeks of harvoni.Studies showed the ribo didn't make a difference in the 24 week treatment.As much as I hate the ribo I now wish it was included.
Glen
Dr John Santoro has been treating me for hep c since the 80s.He has had me on everything under the sun.I am just a non responder,its always been like this.He told me I didn't need the ribo if I was doing the 24 weeks of harvoni.Studies showed the ribo didn't make a difference in the 24 week treatment.As much as I hate the ribo I now wish it was included.
Glen
Thanks Lynn
This was a bigger crusher the the S&O. When you hear 99% cure rate you don't think that your the reason its not 100%. With this coming at the holiday I havnt been able to talk to anyone yet but I don't see myself getting anymore financial help from insurance.As a 2 time loser and with the great expense Ive already put them through I wouldn't blame them for sweeping me under the rug.It sux but I have to face the reality of the situation.I do have an appointment to see my doc at the end of September and I will ask him to help me find a trial.He will probably recommend a new treatment that will be a long time off and then a forever fight with the insurance company that I will surely lose.I cant go that route anymore.Its just too tiresome and frustrating and Ive done it too much,no more.
Thanks for the reply Glen
This was a bigger crusher the the S&O. When you hear 99% cure rate you don't think that your the reason its not 100%. With this coming at the holiday I havnt been able to talk to anyone yet but I don't see myself getting anymore financial help from insurance.As a 2 time loser and with the great expense Ive already put them through I wouldn't blame them for sweeping me under the rug.It sux but I have to face the reality of the situation.I do have an appointment to see my doc at the end of September and I will ask him to help me find a trial.He will probably recommend a new treatment that will be a long time off and then a forever fight with the insurance company that I will surely lose.I cant go that route anymore.Its just too tiresome and frustrating and Ive done it too much,no more.
Thanks for the reply Glen
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