Aa
NOT HAPPY WITH LAB REPORT
Today I was told my lab work indicated I was Olysio resistance (Q80K) and that my sovali and Olysio treatment only had about 60% to achieve SVR. I was hoping for different labs results, now I am thinking if I should wait for the new drugs coming around November that I would have a better chance at SVR. My mind is all over the place with should I do the treatment or not. I was infected 40 years ago and getting rid of this virus is something that I need to do. I am open for all your suggestions, thank you.
Not on the same treatment, but on Sol/Riba 24 wks for gt3 - also not the hightest success rater and have been studying up on the new meds coming in the Fall, 'just in case'. When saw me Dr last visit, I asked a question about one of the studies and he asked me why I was interested. I told him that I just wanted to be prepared, since I didn't have as high a chance od success as some other gts on differents combos. He said, basically, it doesn't matter what the percentages of success are, if yor are cured, your percentage is 100%. Sure got my attention because he is right - even IF the success rate was only 60%, if you are in the people who clear and reach SVR then your chance is/ 100%. Also, every minute we give our livers a rest from this dragon, is that much better chance it has of regenerating enough to improve our quality of life.
Go for it, keep a good attitude, stay on here for follow up support and advice and good luck. On to SVR!! Pat
Go for it, keep a good attitude, stay on here for follow up support and advice and good luck. On to SVR!! Pat
Happy birthday!
Just think that by your next birthday, you will have put this 40 year albatross behind you!
Wishing you a happy, worry-free day!
Nan
Just think that by your next birthday, you will have put this 40 year albatross behind you!
Wishing you a happy, worry-free day!
Nan
Good morning, I spoke to the Doc this morning , Pamela you are correct , the Sovaldi and Olysio are over 90 % with F4 and they are having real good results. I have heard couple of negative comments along the way and its really grrreat to get the positive comments from all you. I am almost ready to jump into the pool of S & O and my what if ? is stressing me out. After 40 years of this virus and praying I would reach 50 is really a blessing for me to have these meds now. Today is my B-day and Iam 53, very grateful:)
Fred....on Day 2 of S/O, I felt like a blanket had been lifted from my head and shoulders...my eyes even felt clearer. On Day 7...I had an incredible feeling of....normal....my energy increased, my symptoms of HCV started to decrease if not disappear, I felt a sense of calm. I continued to feel stronger each day. I will swear that I actually felt the virus leaving my body. The first week! Ah! And I finally slept...that was heaven, sleeping enough to actually wake up and feel good.
The photosentivety was real....couldn't stay in sun and even the heat was bothersome. That decreased dramatically after 4 weeks. Water intake was imperative...I could tell when I didn't drink enough. Mouth would get dry, etc plus I think it kept the headaches at bay.
I could tell my skin was sensitive. Tags on shirts bothered me. I kept my body moisturized and cut the tags off. Problem solved!
I can't say enough about this combo...for me it was a miracle. I do know that with a lot of docs, it is now their SOC...standard of care....and insurance is embracing it more especially for F3/F4. Janssen has also submitted for the FDA approval so eventually it will not be 'off label'. Good luck and Blessings!
The photosentivety was real....couldn't stay in sun and even the heat was bothersome. That decreased dramatically after 4 weeks. Water intake was imperative...I could tell when I didn't drink enough. Mouth would get dry, etc plus I think it kept the headaches at bay.
I could tell my skin was sensitive. Tags on shirts bothered me. I kept my body moisturized and cut the tags off. Problem solved!
I can't say enough about this combo...for me it was a miracle. I do know that with a lot of docs, it is now their SOC...standard of care....and insurance is embracing it more especially for F3/F4. Janssen has also submitted for the FDA approval so eventually it will not be 'off label'. Good luck and Blessings!
Go for it Fred , what do you have to lose , but everything to gain , I was the same as Lynn non responder to anything , cirrhosis liver transplant and cirrhosis again I was losing hope until s/o broke thru and the folks that post on this page gave me hope and I wanna give you hope I believe we have the combination to slay this dragon , for the first time I feel free , results just came back UNDETECTED Prayers and best wishes to you Fred
Hi Fred
Like madelefant mentioned maybe they were thinking about Sovaldi with interferon. I dunno
I have (or hopefully had) GT1a for many years treated 3 times null responder with cirrhosis. My doctor did not check me for the Q80K either. Q80K is a problem with Olysio with interferon and ribivirin. Their results with Olysio Ribavirin and interferon for GT 1a Q80k was about 34% which is why that is not a recommended regiem. But Olysio with Solvaldi the Sovaldi appears to offset the lack of effectiveness against the Q80K.
I finished treatment of 12 weeks just Sovaldi and Olysio w/o Ribavirin on 6/10 so still wailing to see if I made SVR I will be tested again in early September.
I had little to no sides altho I was cautious about sun exposure. Also many here have said to make sure you drink enough water which is what is recommended I was very much not good in that department. Just my usual hardly any liquid a day at all small glass of water with my pills and milk in my cereal and a cup of coffee but I would not recommend following my example there.
Anyway good luck
Lynn
Like madelefant mentioned maybe they were thinking about Sovaldi with interferon. I dunno
I have (or hopefully had) GT1a for many years treated 3 times null responder with cirrhosis. My doctor did not check me for the Q80K either. Q80K is a problem with Olysio with interferon and ribivirin. Their results with Olysio Ribavirin and interferon for GT 1a Q80k was about 34% which is why that is not a recommended regiem. But Olysio with Solvaldi the Sovaldi appears to offset the lack of effectiveness against the Q80K.
I finished treatment of 12 weeks just Sovaldi and Olysio w/o Ribavirin on 6/10 so still wailing to see if I made SVR I will be tested again in early September.
I had little to no sides altho I was cautious about sun exposure. Also many here have said to make sure you drink enough water which is what is recommended I was very much not good in that department. Just my usual hardly any liquid a day at all small glass of water with my pills and milk in my cereal and a cup of coffee but I would not recommend following my example there.
Anyway good luck
Lynn
I posted on here how when I looked at the outcomes based on the clinical data my possible rate of SVR was 60 percent (Sovaldi and Ribivirin). Think is, I think that is higher than any rate when the treatment was Interferon and RIbivirin the highest SVR rates depending on your particulars was around 50 percent. So relatively speaking 60 percent is pretty good.
I am going to call my Dr. office tomm and speak to the Doc. I was told by the nurse about the 60%. Pamela, like to know how you did with the sides.
I didn't bother testing for the Q80K or the IL2B test, since my doctor and I weren't going to change what we had decided on together, to do for my treatment. I had exposure to Telaprevir (Incivek) in a clinical trial and did not clear. During that trial, I had a HORRIFIC rash, like I'd put my arms into a vat of boiling water type of rash. So, I was not interested in the protease inhibitor part of the Sovaldi/Olyssio combo. So, I am on Sovaldi, + Peg and Riba. I tested undetected on my first 4 wk blood draw. Now I wait and hope for the best on my future viral load blood draws. Susan400
"95 percent of patients with METAVIR F4 scores, and 96 percent of genotype 1a patients with the Q80K polymorphism at baseline achieved SVR12....." According to cohort 2, final phase for F4 as noted above.
I'm Q80K positive, GT 1a and F4.....finished S/O 6 weeks ago. Docs tested me for it back in January but by March according to HCVguidelines.org..."Q80K testing can be considered but is not strongly recommended."
Have no idea where your doc got the 60%...but regardless, it's outdated.
I'm Q80K positive, GT 1a and F4.....finished S/O 6 weeks ago. Docs tested me for it back in January but by March according to HCVguidelines.org..."Q80K testing can be considered but is not strongly recommended."
Have no idea where your doc got the 60%...but regardless, it's outdated.
I am currently F4 (Fibrosure Test) does this report mean I have at least a 90 % chance of SVR at 12 weeks?
This from the final results of Cosmos (Sovadi/Olysio)....cohort 1 includes those with F0/F2 and cohort 2 is F3/F4....
Final Phase 2 Data from the Interferon-free COSMOS Study
Cohort 21
Final results from cohort 2 of the Phase 2 COSMOS study* found that overall, 94 percent of genotype 1 treatment-naïve and prior null-responder HCV patients, with advanced liver fibrosis (METAVIR F3 or F4 scores) treated with simeprevir in combination with sofosbuvir, with or without RBV, for either 12 or 24 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). In patients treated with simeprevir and sofosbuvir alone, 93 percent and 100 percent of patients achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively. The addition of RBV did not improve SVR rates; 93 percent of patients treated with the ribavirin-containing regimen achieved SVR12 after both 12 weeks and 24 weeks of treatment. Among HCV genotype 1a patients without Q80K, overall 97 percent of patients achieved SVR12 after 12 or 24 weeks of treatment regardless of treatment regimen, respectively. All patients with HCV genotype 1b achieved SVR12, regardless of treatment regimen or duration.
Among patients with baseline characteristics typically considered more difficult to treat, overall 98 percent of patients with the IL28B CT genotype, 95 percent of patients with the IL28B TT genotype, 95 percent of patients with METAVIR F4 scores, and 96 percent of genotype 1a patients with the Q80K polymorphism at baseline achieved SVR12. The most common adverse events reported during the study were fatigue, headache and nausea.
*Excluding non-virologic failures
Cohort 12
An analysis of data from cohort 1 of the COSMOS study* demonstrated that overall 97 percent and 96 percent of genotype 1 HCV patients with METAVIR F0-F1 scores and F2 scores, respectively, treated with simeprevir and sofosbuvir alone achieved SVR12 after both 12 and 24 weeks of treatment. In patients treated with the ribavirin-containing regimen, 100 percent achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively.
Among HCV genotype 1a patients with Q80K, 83 percent and 100 percent of patients treated with simeprevir and sofosbuvir alone achieved SVR12 after 12 or 24 weeks of treatment, respectively, compared to 89 percent of patients treated with simeprevir and sofosbuvir in combination with ribavirin. All patients with HCV genotype 1b achieved SVR12, regardless of treatment regimen or duration. Among patients with baseline characteristics typically considered more difficult to treat, overall 100 percent of patients with the IL28B CT genotype, 83 percent of patients with the IL28B TT genotype, and 100 percent of patients with IL28B CC genotype achieved SVR12. All patients without the Q80K polymorphism achieved SVR12, regardless of treatment regimen or duration. Adverse events (AEs) were mostly Grade 1/2 (77.5%); no serious AEs were reported, two patients discontinued treatment due to AEs.3
“The efficacy seen with the combination of simeprevir and sofosbuvir is very promising, especially considering the inclusion of patients with more advanced liver fibrosis in Cohort 2,” said Dr. Eric Lawitz, M.D., simeprevir clinical trial investigator, CEO at The Texas Liver Institute and Alamo Medical Research and Clinical Professor of Medicine at University of Texas Health Science Center. “I look forward to seeing the combination of simeprevir and sofosbuvir further evaluated in the recently initiated Phase 3 OPTIMIST trial.”
Final Phase 2 Data from the Interferon-free COSMOS Study
Cohort 21
Final results from cohort 2 of the Phase 2 COSMOS study* found that overall, 94 percent of genotype 1 treatment-naïve and prior null-responder HCV patients, with advanced liver fibrosis (METAVIR F3 or F4 scores) treated with simeprevir in combination with sofosbuvir, with or without RBV, for either 12 or 24 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). In patients treated with simeprevir and sofosbuvir alone, 93 percent and 100 percent of patients achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively. The addition of RBV did not improve SVR rates; 93 percent of patients treated with the ribavirin-containing regimen achieved SVR12 after both 12 weeks and 24 weeks of treatment. Among HCV genotype 1a patients without Q80K, overall 97 percent of patients achieved SVR12 after 12 or 24 weeks of treatment regardless of treatment regimen, respectively. All patients with HCV genotype 1b achieved SVR12, regardless of treatment regimen or duration.
Among patients with baseline characteristics typically considered more difficult to treat, overall 98 percent of patients with the IL28B CT genotype, 95 percent of patients with the IL28B TT genotype, 95 percent of patients with METAVIR F4 scores, and 96 percent of genotype 1a patients with the Q80K polymorphism at baseline achieved SVR12. The most common adverse events reported during the study were fatigue, headache and nausea.
*Excluding non-virologic failures
Cohort 12
An analysis of data from cohort 1 of the COSMOS study* demonstrated that overall 97 percent and 96 percent of genotype 1 HCV patients with METAVIR F0-F1 scores and F2 scores, respectively, treated with simeprevir and sofosbuvir alone achieved SVR12 after both 12 and 24 weeks of treatment. In patients treated with the ribavirin-containing regimen, 100 percent achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively.
Among HCV genotype 1a patients with Q80K, 83 percent and 100 percent of patients treated with simeprevir and sofosbuvir alone achieved SVR12 after 12 or 24 weeks of treatment, respectively, compared to 89 percent of patients treated with simeprevir and sofosbuvir in combination with ribavirin. All patients with HCV genotype 1b achieved SVR12, regardless of treatment regimen or duration. Among patients with baseline characteristics typically considered more difficult to treat, overall 100 percent of patients with the IL28B CT genotype, 83 percent of patients with the IL28B TT genotype, and 100 percent of patients with IL28B CC genotype achieved SVR12. All patients without the Q80K polymorphism achieved SVR12, regardless of treatment regimen or duration. Adverse events (AEs) were mostly Grade 1/2 (77.5%); no serious AEs were reported, two patients discontinued treatment due to AEs.3
“The efficacy seen with the combination of simeprevir and sofosbuvir is very promising, especially considering the inclusion of patients with more advanced liver fibrosis in Cohort 2,” said Dr. Eric Lawitz, M.D., simeprevir clinical trial investigator, CEO at The Texas Liver Institute and Alamo Medical Research and Clinical Professor of Medicine at University of Texas Health Science Center. “I look forward to seeing the combination of simeprevir and sofosbuvir further evaluated in the recently initiated Phase 3 OPTIMIST trial.”
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