Sovaldi by itself?

[Sarah1949]

I got the letters today saying I've been approved for the Sovaldi and denied for the Olysio. We're going to appeal it of course, but I was just wondering if Sovaldi would work by itself for 1a. Does anyone know?

[HectorSF]

Makes sense they would want the Q80k test results. You and your doctor should also want to know the results also.

Sovaldi + Olysio is the best treatment available for someone with cirrhosis and GT1 currently. Having genotype 1a, Olysio is less effective against the virus than genotype 1b according to multiple studies. This is why some doctors will add ribavirin to the two drugs in hopes of overcoming the less effective Olysio.

Paul Kwo, MD  Medical Director of Liver Transplantation and leading researcher in hepatitis C treatments.

"In the COSMOS study, all 3 patients experiencing treatment failure in cohort 1 (those with F0-F2 liver disease) had genotype 1a infection with the Q80K polymorphism, whereas the small number of virologic failures occurring in cohort 2 (F3-F4) included genotype 1a patients with and without Q80K. However, overall SVR rates remained high, and most patients with genotype 1a and the Q80K polymorphism did achieve SVR. "

"I do still treat individuals with genotype 1a and Q80K for 12 weeks, but I add in ribavirin. With genotype 1b, I do not add ribavirin."

Note that ribavirin has no effect on platelet count. Interferon is what lowers platelet count and can cause liver decompensation or liver failure and should NOT be used in someone with cirrhosis and portal hypertension like yourself. Ribavirin does lower RBC (red blood cells) and hemoglobin and this should be monitored during your treatment should you develop anemia.

Having cirrhosis you should not wait for newer treatments. By the time Ledipasvir/Sovaldi is available you can be done with your treatment phase. Even if you relapse your liver will have gotten about a 2 month break from the virus while you are undetectable which is always a plus and then should you relapse you will have better treatment options available at that time.

Good luck.
Hector  

[Sarah1949]

T and Pat, The doctor's said the Olysio denial is due to q80k status being unknown and the letter from Express Scripts said the same. I was tested for the variant last Wednesday. I think if I don't have it they're approve it and if I do all we can do is appeal and appeal and if they continue to deny then I'll try again with the new stuff in a few months. I'm just so tired of the politics.

[Sarah1949]

Hi Susan, In around 40 years of having Hep C I have continually refused Interferon. Well, I wasn't offered it until the 90's but have kept refusing it since with every new doctor. I saw my mother almost die from it and the harsh side effects in friends. Now, I'm Interferon ineligible due to depression and low platelets. My doctor didn't want to add the Ribavirin to the S/O because of my low platelets. Even though I have cirrhosis, if I don't get S/O, I will wait for the brand new stuff coming round the bend. It sounds like it is working well for you though and that's wonderful. Here's to the cure for you! :)

[patra_]

What T said about asking the Ins Co yourself is good advice.  Sometimes it is just one statement that was not made that needs to be.  If the Forum has taught me anything, it is to become your own advocate when things don't go through the first time.  Dr's Ofcs have lots of patients and can sometime miss something that needs to be said or done.  If you are able to find out what, and (nicely) bring this to their attention, it helps.

Good luck on getting you Oly approved.   Pat

[truredhead]

I went through the same thing. Solvaldi was approved but for Olysio they denied. I called them and they said the doctor did not send enough info. They want to know the regimen (dosing schedule) and some reason they rather you did not treat with interferon or ribavarin. If you have ever been treated for high blood pressure, heart problems, depression. The doctor has to take time to fill in every question they ask. It just took a week for us to get it approved with faxing. Now this is just my experience, but worth asking doctor and insurance yourself.

[susan400]

Unless you are opposed to interferon, or for some reason, CAN'T use it, it is completely doable and is only a 12 wk treatment.  There's also Sovaldi and Ribavirin (which is cheaper than Olyssio, because Ribavirin is generic), which you could do for 24 wks and skip the interferon, if you are opposed to the injections.  I've been on Sovaldi and Pegasys (interferon) and Riba since June 18th and I've been undetected on week 4 and week 8 viral loads.  This is after having failed treatment on 10 other treatment attempts.  So, I've been impressed with the Sovaldi.  I do shot 10 on Mon. night.  Of course, I'll be glad to be done with treatment.  But, I did want to let you know that there are other options than the Olyssio if for some reason you can't get the ins. approval.  The Ribavirin is a Pill.

Susan400

[HectorSF]

I don't remember the exact data but I can usually remember where (what document) the info can be found in. I have 100s and probably 1000s of docs on hepatitis C, liver disease, liver cancer and liver transplant.

The info about the use of Sovaldi monotherapy is in the fascinating Gilead NDA (New Drug Application) submission to the FDA for Sovaldi approval last year.

Sofosbuvir
For Treatment of Chronic Hepatitis C Infection
Antiviral Drugs Advisory Committee Meeting
Briefing Document
25 October 2013
NDA 204671:

http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/antiviraldrugsadvisorycommittee/ucm371877.pdf

Take care.
Hector
UCSF liver transplant patient starting Sovaldi, Olysio + RBV August 28th
Second round treating with Sovaldi after failing 48 weeks of Sovaldi + Riba pretransplant. 3rd time is the charm!

[Sarah1949]

Interesting! How do you remember all this stuff Hector? Thank you.

[HectorSF]

Being denied insurance coverage for Sovaldi + Olysio initially is not uncommon. There have been many people here who have experienced the same issue. It is your provider's job to submit the paperwork to your health insurance company that proves that you meet their (insurance company's) requirement for them to pay for the Olysio drug. It is common for the resubmitted modified request to be approved once your doctor addresses the issue(s) as to why you weren't approved the first time.

"I was just wondering if Sovaldi would work by itself for 1a. Does anyone know?"

Yes, is was tried early in the clinical trials (ELECTRON) and found not to be effective. In treatment naive people with genotypes 2 (the easiest to treat patients) and 3 without cirrhosis only 60% achieved SVR. Where all other patients when treated with Sovaldi plus the addition of ribavirin or ribavirin + peg-interferon achieved SVR. 100%. These data from the ELECTRON study provided the support for the selection of the SOF 400 mg plus RBV regimen for the Phase 3 FISSION, POSITRON, and FUSION studies in patients with genotype 2 or 3 HCV infection.

Good luck with your treatment.
Hector

[Sarah1949]

It was a stupid question and I know better, but it was a fleeting thought brought about my feeling of hopelessness and frustration. I need to accept waiting for October 10 that is probably really November 10. :)

[flyinlynn]

Genotype 1

SOVALDI + peg-interferon alfa + ribavirin

12 weeks

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

[flyinlynn]

HOW DO I TAKE SOVALDI?

SOVALDI is taken once a day as part of a combination therapy to treat chronic (lasting a long time) hepatitis C (Hep C) in adults. The table below shows SOVALDI combination therapy regimens based on a patient’s type of Hep C, called genotype. SOVALDI has been shown to work in genotypes 1-4. SOVALDI should not be taken alone.

http://www.sovaldi.com/what-is-sovaldi/how-to-take-sovaldi