Sovaldi/Olysio approval - please help

[TinaD76]

Hi..I am wondering, for all of you on the sovaldi/olysio combo- did you have to meet certain criteria to get this as opposed to having to do the interferon/RIBA / sovaldi? My mom has hep c and has never had treatment .. She is 65 and I'm very worried about her handling the interferon/riba meds. She is genotype 1 and has stage 3-4 liver damage. Also has anyone had any luck with Medicare approving the off label combo? Please let me know! I want to be as informed as possible for the appt next week.
Also, is there some kind of bloodtest for a mutation of some sort that they do before starting treatment and what is it called/for exactly. I seem to remember reading something about that but wasn't sure what it was...
Thanks so much!

[TinaD76]

Thanks so much everyone for all the great info..jimmy, we are seeing a gastro not a hepatologist, but he is very active in hosting clinical trials for many hep c drugs so we are hoping that he will be well informed and up on the most current options because of that. To Nan, she had a liver biopsy about a year ago and no, so far no symptoms. Thank you everyone for the well wishes and wish us luck tomorrow ! Good luck to everyone.

[nan535]

Has she had recent liver biopsy?  You wrote that your mother has "Stage 3/4 liver damage"  please let us know - does your mother have any of these symptoms:  portal hypertension, edema, ascites, esophageal varices, or hepatic encephalopathy. These are symptoms of advanced liver disease and decompensated cirrhosis. An interferon/ribavirin based treatment can be particularly difficult for her and can push her into further decompensation. I know this because it happened to my husband when he tried triple treatment with Incivik, interferon and ribavirin.

The HCV guidelines mentioned in the prior posts will also provide you with suggested treatments for patients with decompensated cirrhosis  (if that is the case).

It is very important to be armed with information when you visit the doctor.

I wish you and your mother  the very best going forward.

Nan

[JimmyMose]

"I want to be as informed as possible for the appt next week."
You are already working on the best first step to help your Mom.
____________________________________________
What do you know about the doctor she is seeing next week? don't provide a specific doctor's name.

The best recommendation is to see s good Hepatologist with Hepatitis C treatment experience knowledge including the latest approved drugs including off label use. For some people it may be real hard to get to see a Hepatologist. If a gastroenterologist is your only option at this time be sure to review and or ask questions about his experience and knowledge about liver disease and new Hepatitis C treatments

FYI
What Is A Hepatologist ? What Is A Gastroenterologist?
http://hepatitiscnewdrugs.blogspot.com/2010/12/what-is-hepatologist-what-is.html

"Occasionally, gastroenterologists who have not completed a fellowship in hepatology nonetheless focus their medical practice primarily on the diagnosis and treatment of people with liver disease. While these physicians do not have a separate diploma in the field of liver disease, they may also be considered hepatologists".
_______________________________________________
My personal non medical opinion
"She is genotype 1 and has stage 3-4 liver damage"
This is quite a general indication of advance fibrosis or even cirrhosis. A lot of factors including symptoms, other conditions, blood and other tests must be evaluated by a experienced doctor as mentioned above to determine whether your mom needs treatment now or if it may be better to wait a little longer.    That doctor/practice should also be experienced about the procedures to try and obtain Medicare Off label pre approval.  
______________________________________________________________
These guidelines linked below are for healthcare professionals. Your knowledge of them will better enable you to determine the doctors knowledge and ask questions. The best scenario is you, your mom and the doctor working together to get her the best tx and get rid of this varmin.
___________________________________________________
To provide healthcare professionals with timely guidance as new therapies are available and integrated into HCV regimens, the Infectious Diseases Society of America (IDSA) and American Association for the Study of Liver Diseases (AASLD) have developed a web-based process for the rapid formulation and dissemination of evidence-based, expert-developed recommendations for hepatitis C management.

http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment

Last updated March 21, 2014
excerpts
Recommended regimen for treatment-naive patients with HCV genotype 1 who are not eligible to receive IFN.
Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [75 kg] for 12 weeks is recommended for IFN-ineligible IFN ineligible is defined as one or more of the below:
• Intolerance to IFN
• Autoimmune hepatitis and other autoimmune disorders
• Hypersensitivity to PEG or any of its components
• Decompensated hepatic disease
• Major uncontrolled depressive illness
• A baseline neutrophil count below 1500/μL, a baseline platelet count below 90,000/μL or baseline hemoglobin below 10 g/dL
• A history of preexisting cardiac disease patients with HCV genotype 1 infection, regardless of subtype.
Rating: Class I, Level B

For patients infected with genotype 1a HCV, baseline resistance testing for the Q80K polymorphism may be considered. However, in contrast to using simeprevir to treat a genotype 1a HCV patient with PEG/RBV when the mutation markedly alters the probability of an SVR, the finding of the Q80K polymorphism does not preclude treatment with simeprevir and sofosbuvir, because the SVR rate was high in patients with genotype 1a/Q80K infection (SVR12 rate for cohort 1 was 86% [24 of 28 patients]; SVR4 rate for cohort 2 was 90% [10 of 11 patients]). To date, virologic failure has not been observed in patients in either cohort infected with HCV genotype 1b and with HCV genotype 1a in the absence of the Q80K polymorphism.  Thus Q80K testing can be considered but is not strongly recommended.

This regimen should be considered only in those patients who require immediate treatment, because it is anticipated that safer and more effective IFN-free regimens will be available by 2015.

NOTICE: Guidance for hepatitis C treatment is changing constantly with the advent of new therapies and other developments. A static version of this guidance, such as printout of this website material, booklet, slides, and other materials, may be outdated by the time you read this. We urge you to review this guidance on this website (www.hcvguidelines.org) for the latest recommendations.
_________________________________________________________
Be sure to go back to hcvguidelines.org to check for changes.  As a minimum just before doctor visits and when treatment decision is made.
_____________________________________________________________
I hope you help your Mom to get the best treatment in the quickest time with a SVR result..

[sljl]

Hi Tina,
Yes, I am on this Sovaldi/Olysio off label and on Medicare.  I am a relapser after 48 weeks of interferon/ribavirin tx in 2010-2011.  I did not do well on interferon.  Besides the physical flu like symptoms, there were mental problems.  I hallucinated and thought I was on a roller coaster when I was driving home.  Needless to say, I stopped driving to and from work.  Yes, I was working the whole time on interferon/ribavirin tx.

My doctor had to write reasons why I could not do interferon again.  That may be how I was approved for this off label combination.  This Sovaldi/Olysio is non interferon and it is so much easier to do for 12 weeks.  I'm already 1/3 the way through.

Hope this helps and best of luck to you.

sljl

[flyinlynn]

Hi Tina

Welcome to the forum

Yes the Q80K polymorphism but it seems to only be important if treating with Olysio Interferon and Ribivirin. In treatment of Sovaldi and Olysio together the Sovaldi seems to make up for Olysio's weakness in that area.

Here is some information you could probably use as far as treatment options available.

AASLD (American Assn for the Study of Liver Disease "Online Expert HCV Advice Now Available  "
"Recommendations for Testing, Managing,and Treating Hepatitis C"

http://www.hcvguidelines.org/sites/default/files/full_report.pdf

I have Hep C probably for better that 37 years and now have progressed to cirrhosis. I am currently treating with Sovaldi Olysio on week 2 of 12.

Good luck to you and your mom
Lynn

[John2891]

Yes there is criteria,,and the mutant is Q80K..there is an all oral off label therapy she can get,,,you need a bright Doctor,,I just was approved ,,,I suggest you come over to our Forum there are over 25,000 members with great knowledge,,you wll be amazed,,do it for Mom

Good Luck John
http://forums.delphiforums.com/n/main.asp?webtag=hepatitiscen&nav=start&prettyurl=%2Fhepatitiscen&gid=2102341544