Thank you~ !! Q80K test has been questioned why by my doc. Perhaps, he's smarter than he's let on~ on board with starting tx... He's not sure yet s&o or wait for new combo in fall. So grateful to have gained so much info on forum, I was able to ask questions, armed with info, really for first time! Dr. is now sitting up, taking me seriously, treating me with care & respect & ready to roll with me to achieve SVR. So, thank you all. I'm sure elated to see so many are curing & as Nan said in another post.." How wonderful" - HCV will be stopped! Yes! Stay encouraged all, we journey together.
I guess your insurance company be trippin. I mean really what other viable alternative do you have? Per the Sovadli prescribing info the on label recommended use is Sovaldi, interferon and ribavirin.
And that "SOVALDI in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible."
I cant find results just now but without the interferon it is less effective
Hope your results are good but really Sovaldi / Olysio is your best option or the new stuff when it comes out later this year but as you have cirrhosis that is also not the best choice to wait
Good luck
Lynn
Actually, insurance approved Sovaldi and denied Olysio saying they need the Q80K.
I'm confused. If the results are good whether or not you have it, then why is insurance even tripping on it?
Just as an FYI....
Final phase II data from the interferon-free COSMOS study
Cohort 2
Final results from cohort 2 of the phase II COSMOS study demonstrated that 93 percent of prior null responder and treatment-naïve patients with genotype 1 HCV and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir and sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). The addition of ribavirin did not improve SVR rates and consistent responses for both treatment arms were seen across HCV genotype subgroups after 12 weeks.
Genotype 1a HCV without the Q80K polymorphism - 88%
Genotype 1a HCV with the Q80K polymorphism - 100%
Genotype 1b HCV - 100%
METAVIR F4 - 88%
The most common adverse events reported during the study were fatigue, headache, nausea, anemia, pruritus, dizziness, rash and photosensitivity. One patient discontinued treatment due to adverse events.
Cohort 1
Previously presented data from cohort 1 at AASLD in November 2013, demonstrated that 96 percent and 93 percent of prior null responder patients with METAVIR F0-F2 scores treated with simeprevir and sofosbuvir without or with ribavirin, respectively, for 12 weeks achieved SVR12.
In genotype 1a patients with the Q80K polymorphism at baseline, 83 percent and 89 percent achieved SVR12 after 12 weeks of treatment without and with ribavirin, respectively.
The most common adverse events reported during the study were fatigue, headache, nausea and insomnia. Two patients discontinued treatment due to adverse events.
Rapid virologic response (RVR, defined as undetectable HCV RNA at Week 4 of treatment) was not found to be predictive of achieving SVR. In patients receiving simeprevir and sofosbuvir alone for 12 weeks, 93 percent achieved SVR, while 57 percent achieved RVR.
"A study of an all-oral combination of simeprevir with Gilead's sofosbuvir has shown that the regimen mitigates the effect Q80K has on simeprevir, Gaston Picchio, hepatitis disease area leader at J&J's Janssen unit"
See more at: http://hepatitiscnewdrugresearch.com/olysiosimeprevir-resistant-variant-q80k.html#sthash.x32dwVez.dpuf
My doctor did not as the outcome of the test would have had no bearing on the treatment I would be doing for me this was my only option so it would just have been a moot point.
I also have cirrhosis, meld 7, platelets about 85-90, had varicies banded, and have some edema and ascities.
Solvaldi and Olysio is the first choice for patients like us. The only option to be considered is whether or not to add ribivirin to the mix with the other two.
Good luck hope you hear soon
Lynn