Definition of Treatment-Naive?

[bridget]

My insurer wants to treat me with 8 weeks of Harvoni. They say I am treatment-naive despite my prior treatment with Interferon Alpha in 1994. When I read the Harvoni Prescribing Information, I saw that it does not define treatment-naive. Then when it defines treatment-experienced, it specifies PEG-Interferon.  Because I did not get PEG-Interferon, my insurer says I am treatment-naive. The addition of PEG was done to allow the interferon to stay in the system longer, allowing only one shot a week instead of 3 shots a week, but it is the same underlying drug. I am negotiating with my insurer to approve 12 weeks.  If anyone else is having this issue, I want to share that the ION-3 study, the one that tested the 8 week protocol, required the subjects to have no prior treatment with ANY interferon based treatment. I'm waiting for a response from my insurance company.

[Lynn K]

Hi Bridget

Yeah everone forgets about good old useless 3 shots a week monotherapy. Been there done that myself along with 2 null response tries with interferon and Ribavirin.

I agree you are not really treatment naive but we aren't your insurance provider.

For me I guess the bigger question is how is your liver do you have any scarring or are you F0 or F1?

I am taking Harvoni for 24 weeks and looking to add Ribavirin but being a 3 time null responder to interferon and relapsed after 12 weeks Sovaldi Olysio with cirrhosis for 7 years we are pulling out all the stops.

Anyway let us know what your doctor says

Good luck on treatment
Lynn

[bridget]

Hi Lynn,
You are certainly an over-achiever when it comes to qualifying as treatment-experienced! You must be pretty tough to endure interferon so many times. With your treatment history, it makes sense to add the riba to the 24 weeks of Harvoni - definitely pull out all the stops & blast the virus.
I am only f1-f2.  My concern is that I relapsed after interferon & don't want to relapse again. I called Gilead & was told they considered me treatment-experienced. They advised me to read the ION-3 Inclusion Criteria. I did, & I would have been disqualified from ION-3 because of my prior treatment, so the 8 week protocol is not applicable to me. I am hopeful that I can convince my insurance company.
Best wishes for an SVR New Year!
 

[Lynn K]

Good luck to you as well.

Just wondering if you have Express Scripts / Accredo speciality pharmacy that is who I have and it has been an up hill battle with them first to get Sovaldi Olysio and then to get Harvoni. I am wondering how it will go trying to add Ribavirin but that is still to be seen if they fight me on that o e as well.

I have some contact information if that is your insurance also let me know if you need that.

Good luck hoping for SVR in 2015

[bridget]

Thank you for offering to help with my insurance co. However, it is Kaiser Permanente.
thanks

[Lynn K]

I haven't heard anyone complaining about Kaiser Permanente. Good luck

[mikelhc]

I just posted on the same issure under "length of treatment". I called Gilead, support path said verbally I was probably tx experience with interferon mono-therapy, but nothing in writing. When she suggested I contact Gilead medical, a pharmacist there said they had nothing in writing and just sent me another copy of FDA approve prescribing info.  I note, tho, that it really says "can be" treated for 8 weeks, not "must" be. And AASLD says "with caution".    Maybe someone else in Gilead, docs, researchers, can get more involved. It would seem to be in their own best interest.

Haven't been able to convince my MD yet. Please look at my post and stay in touch...Mike

[bridget]

Mike,
I would be happy to share with you the information that succeeded in persuading my dr. & regional hcv committee to reclassify me as treatment experienced.  This change allows me to be treated for 12 weeks instead of 8 weeks.  I will post it later.  When did you start treatment?

[bridget]

Mike,
The revised AASLD Guidelines now make it clear who qualifies as treatment naive.

http://www.hcvguidelines.org/node/71

"Initial Treatment of HCV Infection includes patients with chronic hepatitis C infection who have not been previously treated with IFN, PEG-IFN, RBV, or any HCV direct-acting antiviral (DAA) agent, whether experimental, investigational, or US Food and Drug Administration (FDA) approved."

The attached letter worked for me, I hope it works for you, too. What is your insurance?
Hmm, I clicked on attachments, but can't seem to attach it. Text of letter below.
==================================================
Dear Dr. XXX

I am very grateful that Kaiser is covering my treatment with Harvoni and for your help in making that happen.  I am writing to ask the Regional Hepatitis C Committee to please reconsider the duration of my treatment. XXX, Clinical Pharmacy Specialist, said that I will be treated for 8 weeks rather than 12 weeks because the Committee considers me to be treatment-naïve despite my prior treatment with Interferon Alpha in 1994. She referred me to the Harvoni Prescribing Information on Page 2, Table 1: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf
HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre¬ treatment HCV RNA less than 6 million IU/mL [see Clinical Studies (14)].
However, the Prescribing Information gives no definition of treatment-naïve.  The 8 week treatment protocol discussed on page 20 of the Prescribing Information under Clinical Studies 14.2 describes the ION-3 Trial. The ION-3 trial tested the 8 week protocol exclusively on treatment-naïve subjects who had never been treated with any interferon. I called Gilead to ask for their definition of treatment-naïve and was told that I would be considered treatment-experienced because of my prior treatment with Interferon Alpha. I was advised to read the Inclusion Criteria for the ION-3 Trial on the New England Journal of Medicine site: http://www.nejm.org/doi/suppl/10.1056/NEJMoa1402355/suppl_file/nejmoa1402355_protocol.pdf  Page 51, 4.2 Inclusion Criteria:
1.   6)  HCV treatment-naïve defined as no prior exposure to any interferon, RBV, or other approved or experimental HCV therapy.
I noted that the physician who managed my treatment with Interferon in 1994 (XXX) was one of the ION-3 Principal Investigators.  I think Dr. XXX would agree that my prior treatment with Interferon puts me in the treatment-experienced category.  In the spring of 2014, I was disqualified from participating in a Trial at the NIH because I was considered to be treatment-experienced. This leads me to think that I would have been disqualified from the ION-3 Trial and therefore, the 8 week treatment protocol tested in ION-3 is not applicable in my situation.
I was treated with Interferon in 1994, before Peginterferon was FDA approved. My understanding is the addition of polyethylene glycol (PEG) allowed the Interferon to stay in the system longer so only one shot per week was needed vs. three per week with regular Interferon, but that the pharmacodynamic profiles are comparable.

The updated Guidelines for Treatment on the AASLD website posted on 12/19/14, says,
“Initial Treatment of HCV Infection includes patients with chronic hepatitis C infection who have not been previously treated with IFN, PEG-IFN, RBV, or any HCV direct-acting antiviral (DAA) agent, whether experimental, investigational, or US Food and Drug Administration (FDA) approved.”

“Shortening treatment to less than 12 weeks should be done with caution and performed at the discretion of the practitioner.”

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

I am extremely grateful that Kaiser is covering my treatment with Harvoni. I am encouraged by the improvement in my lab results but I do not want to risk relapsing again after treatment, as I did after my Interferon treatment. I am very concerned that 8 weeks is not adequate to permanently clear the virus from my system.
Thank you for considering this information.
Sincerely,
-XXX

[Lynn K]

Wow very nice letter :-)

[bridget]

Thanks, I'm lucky it worked.
Hope you are managing the Ribavirin side effects ok. I'm sure you would have preferred not to take it again, but it seems like a smart strategy.

[Lynn K]

I just consider it as you gotta do what you gotta do.

so far ok will have a better idea after I do my 1 week blood tests next Tuesday