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New orals what is considered cure SVR12 or SVR24
With all these new oral trials go on , especially Gilead and Abbvie . What is considered a cure is it SVR12 or SVR24 . Hard to get a accurate answer . I am interested because if it is SVR12 will companies go for FDA approval with SVR12 results ? or will be be SVR24 results ?
Any comments appreciated .
Any comments appreciated .
"So happy to read how successful this treatment was for you."
Guess you don't know but sadly treatment did not work for Hector as he relapsed.......
Guess you don't know but sadly treatment did not work for Hector as he relapsed.......
Glad that Dee brought this thread up again.
So happy to read how successful this treatment was for you. My husband's Hep C viral load (who is post-transplant with billary tree complications) just came back as 1,635,000. His dr is planning to do a biopsy in January to see how the new liver is doing and then decide if he is ready for treatment. He did the triple treatment with Incivik before transplant and only lasted 5 weeks due to severe side effects.
I know it will probably be a while before the FDA approves this treatment you took but I just wanted to know if you think this might be a treatment we can look forward to. Not sure you may want to give your opinion about his care but I guess I just want someone to give us some hope on this.
Thanks
Nan
So happy to read how successful this treatment was for you. My husband's Hep C viral load (who is post-transplant with billary tree complications) just came back as 1,635,000. His dr is planning to do a biopsy in January to see how the new liver is doing and then decide if he is ready for treatment. He did the triple treatment with Incivik before transplant and only lasted 5 weeks due to severe side effects.
I know it will probably be a while before the FDA approves this treatment you took but I just wanted to know if you think this might be a treatment we can look forward to. Not sure you may want to give your opinion about his care but I guess I just want someone to give us some hope on this.
Thanks
Nan
finally got a response back from a clinical trial may be able to get into a gilead trial
Sofosbuvir sounds great your results sound very encouraging as your a null responder to the standard treatment . You have a had tough run , but sounds like you have a strong character , good way to be .
As ION 2 results are coming out within the month and ION 3 phase 3 studies are more than half way through , the single pill sofosbuvir ledipasvir may come out faster than we all think , who knows could be early next year for the submission to FDA especially since svr12 is considered a cure , results will come out a lot faster
As ION 2 results are coming out within the month and ION 3 phase 3 studies are more than half way through , the single pill sofosbuvir ledipasvir may come out faster than we all think , who knows could be early next year for the submission to FDA especially since svr12 is considered a cure , results will come out a lot faster
All my side effects were early in treatment. Within the first 16 weeks or so. Increased fatigue, weakness, dizziness, periodic headaches. In the last many months I only have more fatigue then usual. Comparing this treatment to peg-INF and ribavirin is like comparing night and day in my experience. This treatment has been easily doable with no anemia, no lose of platelet count (in fact platelet count has rise by about 30) no extreme white blood cell drop, no skin issues, hair loss and all of the other things related to interferon treatments. At times I forget I am even treating my HCV.
I was a previous null-responder with peg-INF and Ribavirin yet became undetectable by week 2 of treatment and have been undetectable for 44 weeks so far. I highly recommend treating with Sofosbuvir treatments as it has been a real miracle for me.
"Your mileage may differ".
Hector
I was a previous null-responder with peg-INF and Ribavirin yet became undetectable by week 2 of treatment and have been undetectable for 44 weeks so far. I highly recommend treating with Sofosbuvir treatments as it has been a real miracle for me.
"Your mileage may differ".
Hector
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As far as trial for Gilead trials...there are many different types of patients being treated and treatment can be different based on patient factors such as genotype, cirrhosis, treatment experience vs treatment naive etc. So it depend upon which trial you are speaking of and what group of patients the trial is for as treatment duration and SVR times can vary between trials. Gilead has a number of trials ongoing that treat for 12, 16, 24 and 48 weeks. What duration will work best for different types of patients will being determined by trial data which is one of the reasons for the trials.
As far as Gilead's NDAs (New Drug Applications) for treatments that will be available early in 2014...
FOSTER CITY, Calif.--April 8, 2013--BUSINESS WIRE--"Gilead Sciences today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection." ...
"The sofosbuvir NDA is supported primarily by data from four phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV."
Hope this helps.
Hector