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Treatment for Genotype 6
Hello,
My father is infected with HCV genotype 6 treatment and the doctor recommended sovaldi+ribovarin+pegylated interferon. However, it got rejected as the reasoning is that Sovaldi is not an FDA approved treatment for Genotype 6. Is this true? If it is true, is there an alternative route for treament? And is it curable? Or at least suppress the viral load? I'm so worried for my Dad. I love him so much, don't want him to die young. Please help me.. Thanks!
My father is infected with HCV genotype 6 treatment and the doctor recommended sovaldi+ribovarin+pegylated interferon. However, it got rejected as the reasoning is that Sovaldi is not an FDA approved treatment for Genotype 6. Is this true? If it is true, is there an alternative route for treament? And is it curable? Or at least suppress the viral load? I'm so worried for my Dad. I love him so much, don't want him to die young. Please help me.. Thanks!
Ok. So after about more than a month of additional supportive study of my father's liver, he finally received another Denial letter from the Insurance.
The Specialist sent my father to perform liver biopsy and got the results and sent back to the insurance company to ask for Ribavavin treatment, as well as Sovaldi. but once again, the insurance stick to their decision and denied my father (or his Specialist) application for the treatment.
The insurance rationales are as follow:
1) It shows that there's no sign of Cirrhosis development
2) No sign of Fibrosis development.
Now, i'm afraid and wondering, why would they want to approve application based on rationales? I mean, if someone got a cirrhosis, he/she could be close some death. as Cirrhosis is like a last stage of the liver disease. If someone has to wait for this to occur, then I guess there's no high chance of survival or successful treatment?
I really feel bad for my father, but seems like we are hopeless for his Liver. :-(
The doctor seemed to have done his best. But his best wasn't good enough. I am so sad for father. Seems like there's no way the insurance allow this treatment to occur. The insurance is HealthNet. and my Dad's under Covered California. I thought, the Government would approve this kind of treatment?
Please advise. I appreciate it.
The Specialist sent my father to perform liver biopsy and got the results and sent back to the insurance company to ask for Ribavavin treatment, as well as Sovaldi. but once again, the insurance stick to their decision and denied my father (or his Specialist) application for the treatment.
The insurance rationales are as follow:
1) It shows that there's no sign of Cirrhosis development
2) No sign of Fibrosis development.
Now, i'm afraid and wondering, why would they want to approve application based on rationales? I mean, if someone got a cirrhosis, he/she could be close some death. as Cirrhosis is like a last stage of the liver disease. If someone has to wait for this to occur, then I guess there's no high chance of survival or successful treatment?
I really feel bad for my father, but seems like we are hopeless for his Liver. :-(
The doctor seemed to have done his best. But his best wasn't good enough. I am so sad for father. Seems like there's no way the insurance allow this treatment to occur. The insurance is HealthNet. and my Dad's under Covered California. I thought, the Government would approve this kind of treatment?
Please advise. I appreciate it.
Thank you very much for taking the time and effort to advise the best possibility that I could do to help my father get the right treatment. I will definitely inform him about this. Like Hector said, I will make sure the Doctor do his work to have the insurance approve the request to treat my dad's illness with Sovaldi. Again, thank you. And yes, I will follow up on the updates of this issue. I hope that like you all said, there is high possibility that my dad will be approved for treatment.
I am so glad someone with lots of facts, experience and expertise responded to your post. What state are you in? The doctor (Lawitz) Hector quoted in his post is the one who followed me both times I treated my Hepatitis C (in South Texas). There is a lot you can do to advocate on your father's behalf but as a family member you are limited how successful you will be. Your father truly needs a doctor who will help you help your father get the treatment he needs. If your father's doctor will not advocate more effective treatment I strongly encourage you to find a doctor who will.
____________________
As far as one thing you asked in your initial post about 'suppressing his viral load,' Hepatitis C is unlike HIV when it comes to treatment goals.
With Hepatitis C the treatment goal is to eliminate the virus to undetectible levels. Your father's viral load is not necessarily an indicator of the condition his liver is in or how advanced his fibrosis is. This is another reason it helps to have your fathers medical records and copies of his labs. It is the start of building a case for effective treatment for him. Copies of studies and other data will be equally useful. There have been a lot of people on this forum who have been in this very same boat and perseverance is the key
As one who did take Interferon and Ribavirin for 48 weeks (with a Protease Inhibitor) trust me when I say this is not a medication regimen I would wish on anyone ~ especially if there is a chance to take less harsh meds with a shorter treatment duration.
I hope you continue to post how this is all working out
____________________
As far as one thing you asked in your initial post about 'suppressing his viral load,' Hepatitis C is unlike HIV when it comes to treatment goals.
With Hepatitis C the treatment goal is to eliminate the virus to undetectible levels. Your father's viral load is not necessarily an indicator of the condition his liver is in or how advanced his fibrosis is. This is another reason it helps to have your fathers medical records and copies of his labs. It is the start of building a case for effective treatment for him. Copies of studies and other data will be equally useful. There have been a lot of people on this forum who have been in this very same boat and perseverance is the key
As one who did take Interferon and Ribavirin for 48 weeks (with a Protease Inhibitor) trust me when I say this is not a medication regimen I would wish on anyone ~ especially if there is a chance to take less harsh meds with a shorter treatment duration.
I hope you continue to post how this is all working out
" is there a high chance that his insurance will stick to the decision "
No. It is unethical and perhaps illegal to treat someone with inferior treatment. Why would an insurance company want to pay for 48 week of treatment that may be unsuccessful. He may also need "helper drugs" for the possible anemia or neutropenia which can be side effects from this older treatment which can cost additional thousands of dollars. It doesn't even make business sense as your father will need to treat again with another expensive treatment at some point?
Never mind the pain and suffering physically and mentally many people have experienced over the 11 months of treatment. Which would include not being able to work during some parts of treatment.
Only if your father's doctor's office doesn't know how to get approval for treating patients properly. In which case I would change doctors and find someone who is knowledgeable and experienced in treating patients with hepatitis C properly.
As I said it is not usual for a health insurance company to turn down the 1st request for coverage for a provider. There are many example on this forum of people who were initially refused approval for treatment. Especially patient with an individual doctor's request (such as their primary doctor or gastroenterologist) vs a hepatitis clinic at a major hospital for example. Let's be clear, it is the doctor's responsibility to get insurance approval for the best treatment that is available for their patients. What is the point of paying for health insurance when they won't pay for coverage of the treatment you need it? It is not a doctor's job to treat someone with a second best, inferior, treatment that is known to have dangerous side effects that needs to be used 4 times long than current treatment. It doesn't even pass the common sense test. I would not let my father or anyone I know take an inferior treatment with sometimes brutal side effects knowing that more effective and safe treatment is available and is what every other hepatitis C patient is treating with and having it paid for one way or another.
Personally I would have him go to the nearest large teaching hospital that has a liver transplant clinic and a hepatitis clinic. They know how to treat genotype 6 patients and get insurance approval for the latest, proper treatments.
I would NOT let my father have inferior treatment that has less chance of working and can have serious disabling side effects for almost a year.
I know that at our hepatitis clinic here in San Francisco he would not be dealing with this issue. They know how to get people the proper treatment that they need.
The bottom line is his DOCTOR is responsible for getting approval for the best treatment available. It is NOT the patients responsibility to get approval for treatment. IF the doctor's office can do it then I would go elsewhere.
From above..
Alternative regimens for treatment-naive patients with HCV genotype 5 or 6.
Daily weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 48 weeks is an "acceptable" regimen for persons infected with HCV genotype 5 or 6.
Rating: Class IIb, Level A
PEG/RBV for 48 weeks was the previously recommended regimen for patients infected with HCV genotype 5 or 6. Sofosbuvir has activity against genotypes 5 and 6, and when combined with PEG/RBV for 12 weeks led to SVR in the 6 patients in whom it was studied. (Lawitz, 2013b)
************************************************************************************
The addition of sofosbuvir (400 mg daily) to PEG/RBV shortens duration of therapy with no apparent additional adverse effects and likely substantially increases response rates.
*********************************************************************************
The treatment of choice is pretty obvious even to stingy insurance companies.
Get the doctor and insurance company to do their jobs then your father can do his job of taking the proper medicine with the best chance for a cure.
Don't except a no from his insurance company or doctor and have your father suffer through inferior treatment for almost a year when he can treat with more effective and humane treatment in only 3 months just like all of us who infected with hepatitis C. None of us would do peg-interferon + ribavirin for 48 weeks and neither should your father.
If you need particular help. myself or others can tell you how we got approval for our Sovaldi treatments.
Hector
No. It is unethical and perhaps illegal to treat someone with inferior treatment. Why would an insurance company want to pay for 48 week of treatment that may be unsuccessful. He may also need "helper drugs" for the possible anemia or neutropenia which can be side effects from this older treatment which can cost additional thousands of dollars. It doesn't even make business sense as your father will need to treat again with another expensive treatment at some point?
Never mind the pain and suffering physically and mentally many people have experienced over the 11 months of treatment. Which would include not being able to work during some parts of treatment.
Only if your father's doctor's office doesn't know how to get approval for treating patients properly. In which case I would change doctors and find someone who is knowledgeable and experienced in treating patients with hepatitis C properly.
As I said it is not usual for a health insurance company to turn down the 1st request for coverage for a provider. There are many example on this forum of people who were initially refused approval for treatment. Especially patient with an individual doctor's request (such as their primary doctor or gastroenterologist) vs a hepatitis clinic at a major hospital for example. Let's be clear, it is the doctor's responsibility to get insurance approval for the best treatment that is available for their patients. What is the point of paying for health insurance when they won't pay for coverage of the treatment you need it? It is not a doctor's job to treat someone with a second best, inferior, treatment that is known to have dangerous side effects that needs to be used 4 times long than current treatment. It doesn't even pass the common sense test. I would not let my father or anyone I know take an inferior treatment with sometimes brutal side effects knowing that more effective and safe treatment is available and is what every other hepatitis C patient is treating with and having it paid for one way or another.
Personally I would have him go to the nearest large teaching hospital that has a liver transplant clinic and a hepatitis clinic. They know how to treat genotype 6 patients and get insurance approval for the latest, proper treatments.
I would NOT let my father have inferior treatment that has less chance of working and can have serious disabling side effects for almost a year.
I know that at our hepatitis clinic here in San Francisco he would not be dealing with this issue. They know how to get people the proper treatment that they need.
The bottom line is his DOCTOR is responsible for getting approval for the best treatment available. It is NOT the patients responsibility to get approval for treatment. IF the doctor's office can do it then I would go elsewhere.
From above..
Alternative regimens for treatment-naive patients with HCV genotype 5 or 6.
Daily weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 48 weeks is an "acceptable" regimen for persons infected with HCV genotype 5 or 6.
Rating: Class IIb, Level A
PEG/RBV for 48 weeks was the previously recommended regimen for patients infected with HCV genotype 5 or 6. Sofosbuvir has activity against genotypes 5 and 6, and when combined with PEG/RBV for 12 weeks led to SVR in the 6 patients in whom it was studied. (Lawitz, 2013b)
************************************************************************************
The addition of sofosbuvir (400 mg daily) to PEG/RBV shortens duration of therapy with no apparent additional adverse effects and likely substantially increases response rates.
*********************************************************************************
The treatment of choice is pretty obvious even to stingy insurance companies.
Get the doctor and insurance company to do their jobs then your father can do his job of taking the proper medicine with the best chance for a cure.
Don't except a no from his insurance company or doctor and have your father suffer through inferior treatment for almost a year when he can treat with more effective and humane treatment in only 3 months just like all of us who infected with hepatitis C. None of us would do peg-interferon + ribavirin for 48 weeks and neither should your father.
If you need particular help. myself or others can tell you how we got approval for our Sovaldi treatments.
Hector
Thank you to you. I appreciate you effort to inform me. I just have one thought. Even though the recommended treatment for Genotype 6 is from AASLD, is there a high chance that his insurance will stick to the decision saying "Sovaldi+Ribavirin+Pegylated Interferon" is NOT an FDA approved combination treatment? and therefore, will deny the request again? Let's say the request is denied again after resubmission, is there other treatment that the Doctor can consider? and therefore, will be approved by health care insurance?
THanks again.
THanks again.
His doctor is correct. The health insurance company doesn't appear to be well informed about the current recommended treatment or there was a red tape issue unrelated to the actual treatment that caused a denial.
His doctor should resubmit the request for payment for the treatment with documentation indicating that both the AASLD (American Association for the Study of Liver Diseases) and IDSA (Infectious DIseases Society of America) recommend this as the preferred treatment based on clinical trial data (NEUTRINO study) where all 6 genotype 6 patients were cured.
This treatment is only 12 weeks vs 48 weeks for interferon treatment and has a lot less serious side effects that can make treatment debilitating to many people.
Here are the AASLD/IDSA current treatment guidelines for genotype 6 for those who have never treated before.
The latest recommendation can always be found here.
http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment
-----------------------------------------------------------------------------------------------------
INITIAL TREATMENT OF HCV INFECTION IN PATIENTS STARTING TREATMENT
V. Genotype 5 or 6
Few data are available to help guide decision-making in patients infected with HCV genotype 5 or 6. Nonetheless, for those patients for whom immediate treatment is required, the following recommendations have been drawn from available data. No data are available to support the use of a non-PEG containing regimen for patients with HCV genotype 5 or 6 infection.
Recommended regimen for treatment-naive patients with HCV genotype 5 or 6.
*************************************************************************************
Daily sofosbuvir/Sovaldi (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is recommended for IFN-eligible persons with HCV genotype 5 or 6 infection.
Rating: Class IIa, Level B
In the Phase 3 NEUTRINO trial (Lawitz, 2013b), treatment-naive patients with genotypes 1 (n=291), 4 (n=28), 5 (n=1), and 6 (n=6) were treated with sofosbuvir (400 mg daily) plus PEG (2a) (180 µg per week) and weight-based RBV (1000 mg 1200 mg once daily) for 12 weeks. All 6 patients with HCV genotype 6 and the 1 patient with genotype 5 achieved SVR12. The adverse event profile in these patients and in the larger study population was similar to that seen with PEG/RBV therapy.
************************************************************************************
Alternative regimens for treatment-naive patients with HCV genotype 5 or 6.
Daily weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 48 weeks is an "acceptable" regimen for persons infected with HCV genotype 5 or 6.
Rating: Class IIb, Level A
PEG/RBV for 48 weeks was the previously recommended regimen for patients infected with HCV genotype 5 or 6. Sofosbuvir has activity against genotypes 5 and 6, and when combined with PEG/RBV for 12 weeks led to SVR in the 6 patients in whom it was studied. (Lawitz, 2013b) The addition of sofosbuvir (400 mg daily) to PEG/RBV shortens duration of therapy with no apparent additional adverse effects and likely substantially increases response rates.
----------------------------------------------------------------------------------------------------
The following regimens are NOT recommended for treatment-naive patients with genotype 5 or 6 HCV.
Monotherapy with PEG, RBV, or a DAA
Rating: Class III, Level A
Telaprevir- or boceprevir-based regimens
Rating: Class III, Level A
Because of their limited activity in vitro and in vivo against genotypes 5 and 6, boceprevir or telaprevir should not be used as therapy for patients with genotype 5 or 6 HCV infection.
---------------------------------------------------------------------------------------------------
"Sovaldi is not an FDA approved treatment for Genotype 6. Is this true?"
Technically yes, but it is THE recommended treatment because Sovaldi does work on the genotype 6 virus.
Having treatment not covered by insurance companies the first time is not uncommon.
And is it curable?
Yes.
In the NEUTRINO drug trial conducted by Gilead, all 6 genotype 6 patients were cured. (6/6) SVR =100%. The reason genotype 6 treatment is not FDA approved is it is a rare genotype and it hasn't been tested on enough people to have enough data to predict outcomes.
Or at least suppress the viral load?
Yes. All Sovaldi treatments suppress the viral load to undetectable during the time of treatment.
"I'm so worried for my Dad. I love him so much, don't want him to die."
Please be assured that no one dies from being infected with the hep C virus itself. People can die from the liver disease or liver cancer the virus caused by chronic infection after 20-40 years. Your father would have to have advanced End-Stage Liver Disease to be concerned about his mortality. But even then, he could get a liver transplant and live after the virus destroyed his liver. Hepatitis C is more curable every month and new, more effective treatments will be coming soon.Hep C soon will be curable in most pre and post transplant patients. Future deaths from advanced liver disease will soon be a rare occurrence.
Good luck with your dad's treatment!
Hector
His doctor should resubmit the request for payment for the treatment with documentation indicating that both the AASLD (American Association for the Study of Liver Diseases) and IDSA (Infectious DIseases Society of America) recommend this as the preferred treatment based on clinical trial data (NEUTRINO study) where all 6 genotype 6 patients were cured.
This treatment is only 12 weeks vs 48 weeks for interferon treatment and has a lot less serious side effects that can make treatment debilitating to many people.
Here are the AASLD/IDSA current treatment guidelines for genotype 6 for those who have never treated before.
The latest recommendation can always be found here.
http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment
-----------------------------------------------------------------------------------------------------
INITIAL TREATMENT OF HCV INFECTION IN PATIENTS STARTING TREATMENT
V. Genotype 5 or 6
Few data are available to help guide decision-making in patients infected with HCV genotype 5 or 6. Nonetheless, for those patients for whom immediate treatment is required, the following recommendations have been drawn from available data. No data are available to support the use of a non-PEG containing regimen for patients with HCV genotype 5 or 6 infection.
Recommended regimen for treatment-naive patients with HCV genotype 5 or 6.
*************************************************************************************
Daily sofosbuvir/Sovaldi (400 mg) and weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 12 weeks is recommended for IFN-eligible persons with HCV genotype 5 or 6 infection.
Rating: Class IIa, Level B
In the Phase 3 NEUTRINO trial (Lawitz, 2013b), treatment-naive patients with genotypes 1 (n=291), 4 (n=28), 5 (n=1), and 6 (n=6) were treated with sofosbuvir (400 mg daily) plus PEG (2a) (180 µg per week) and weight-based RBV (1000 mg 1200 mg once daily) for 12 weeks. All 6 patients with HCV genotype 6 and the 1 patient with genotype 5 achieved SVR12. The adverse event profile in these patients and in the larger study population was similar to that seen with PEG/RBV therapy.
************************************************************************************
Alternative regimens for treatment-naive patients with HCV genotype 5 or 6.
Daily weight-based RBV (1000 mg [75 kg]) plus weekly PEG for 48 weeks is an "acceptable" regimen for persons infected with HCV genotype 5 or 6.
Rating: Class IIb, Level A
PEG/RBV for 48 weeks was the previously recommended regimen for patients infected with HCV genotype 5 or 6. Sofosbuvir has activity against genotypes 5 and 6, and when combined with PEG/RBV for 12 weeks led to SVR in the 6 patients in whom it was studied. (Lawitz, 2013b) The addition of sofosbuvir (400 mg daily) to PEG/RBV shortens duration of therapy with no apparent additional adverse effects and likely substantially increases response rates.
----------------------------------------------------------------------------------------------------
The following regimens are NOT recommended for treatment-naive patients with genotype 5 or 6 HCV.
Monotherapy with PEG, RBV, or a DAA
Rating: Class III, Level A
Telaprevir- or boceprevir-based regimens
Rating: Class III, Level A
Because of their limited activity in vitro and in vivo against genotypes 5 and 6, boceprevir or telaprevir should not be used as therapy for patients with genotype 5 or 6 HCV infection.
---------------------------------------------------------------------------------------------------
"Sovaldi is not an FDA approved treatment for Genotype 6. Is this true?"
Technically yes, but it is THE recommended treatment because Sovaldi does work on the genotype 6 virus.
Having treatment not covered by insurance companies the first time is not uncommon.
And is it curable?
Yes.
In the NEUTRINO drug trial conducted by Gilead, all 6 genotype 6 patients were cured. (6/6) SVR =100%. The reason genotype 6 treatment is not FDA approved is it is a rare genotype and it hasn't been tested on enough people to have enough data to predict outcomes.
Or at least suppress the viral load?
Yes. All Sovaldi treatments suppress the viral load to undetectable during the time of treatment.
"I'm so worried for my Dad. I love him so much, don't want him to die."
Please be assured that no one dies from being infected with the hep C virus itself. People can die from the liver disease or liver cancer the virus caused by chronic infection after 20-40 years. Your father would have to have advanced End-Stage Liver Disease to be concerned about his mortality. But even then, he could get a liver transplant and live after the virus destroyed his liver. Hepatitis C is more curable every month and new, more effective treatments will be coming soon.Hep C soon will be curable in most pre and post transplant patients. Future deaths from advanced liver disease will soon be a rare occurrence.
Good luck with your dad's treatment!
Hector
I am sorry this is happening. Hopefully others who know more about this will respond to your post. There are a lot of of people on here who can offer all kinds of insight.
Meanwhile just a quick check on the prescribing information for Sovaldi says:
SOVALDI efficacy has been established in subjects with HCV
genotype 1, 2, 3 or 4 infection, including those with hepatocellular
carcinoma meeting Milan criteria (awaiting liver transplantation)
and those with HCV/HIV-1 co-infection.
I see no mention of Genotype 6. Actually as long as I have been on here yours is the first post I have seen related to Genotype 6.
I came across one article on line treating with PEG-IFN plus RBV called, "Response-guided Therapy for Patients With Hepatitis C Virus Genotype 6 Infection" in Medscape.
It is a small study that says:
In this study, we found that the rate of RVR in patients with genotype 6 was slightly lower than that of genotype 3 (74% and 88%, respectively), but was significantly higher than that of genotype 1 (44%).
Has your father treated in the past with Peg and Riba? Also what stage of fibrosis is he? The more detail you provide the better another person can taper a response based on his situation.
It seems like there are lots of posts on here where there is a battle between the system and these new HCV meds.
Best of luck
Meanwhile just a quick check on the prescribing information for Sovaldi says:
SOVALDI efficacy has been established in subjects with HCV
genotype 1, 2, 3 or 4 infection, including those with hepatocellular
carcinoma meeting Milan criteria (awaiting liver transplantation)
and those with HCV/HIV-1 co-infection.
I see no mention of Genotype 6. Actually as long as I have been on here yours is the first post I have seen related to Genotype 6.
I came across one article on line treating with PEG-IFN plus RBV called, "Response-guided Therapy for Patients With Hepatitis C Virus Genotype 6 Infection" in Medscape.
It is a small study that says:
In this study, we found that the rate of RVR in patients with genotype 6 was slightly lower than that of genotype 3 (74% and 88%, respectively), but was significantly higher than that of genotype 1 (44%).
Has your father treated in the past with Peg and Riba? Also what stage of fibrosis is he? The more detail you provide the better another person can taper a response based on his situation.
It seems like there are lots of posts on here where there is a battle between the system and these new HCV meds.
Best of luck
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