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Gilead sofosbuvir update
Did I missed the discussion of the Gilead announcement of the planned FDA filing for sofosbuvir approval this summer? Which means that it may be available for tx in about a year? It seems like in combo with IFN and Riba for geno 1, and without IFN for geno 2,3,4.
"Four ongoing Phase 3 studies will support Gilead’s initial regulatory filing in mid-2013 for an all-oral therapy with sofosbuvir plus RBV among genotype 2/3 treatment-naïve, treatment-experienced and interferon-intolerant patients, and for sofosbuvir in combination with RBV and peg-IFN among treatment-naïve patients with HCV genotypes 1, 4, 5 and 6.
Topline results from the first Phase 3 study, POSITRON, were announced in November 2012, and results from the remaining three studies (FISSION, FUSION and NEUTRINO) are anticipated in Q1 2013. Results from ION-1, ION-2 and LONESTAR are intended to support a regulatory filing for the fixed-dose combination of sofosbuvir/GS-5885 by mid-2014"
The link to full announcement:
http://tinyurl.com/avr64n6
"Four ongoing Phase 3 studies will support Gilead’s initial regulatory filing in mid-2013 for an all-oral therapy with sofosbuvir plus RBV among genotype 2/3 treatment-naïve, treatment-experienced and interferon-intolerant patients, and for sofosbuvir in combination with RBV and peg-IFN among treatment-naïve patients with HCV genotypes 1, 4, 5 and 6.
Topline results from the first Phase 3 study, POSITRON, were announced in November 2012, and results from the remaining three studies (FISSION, FUSION and NEUTRINO) are anticipated in Q1 2013. Results from ION-1, ION-2 and LONESTAR are intended to support a regulatory filing for the fixed-dose combination of sofosbuvir/GS-5885 by mid-2014"
The link to full announcement:
http://tinyurl.com/avr64n6
Different people have different tolerance and side effects due to IFN, some have less, some more severe. You may have to wait for all orals. Hopefully your liver holds well and the new meds will be available sooner than expected.
Best of luck to you.
Best of luck to you.
In my opinion, having the option of relatively short (12 or 24 weeks) sofosbuvir (GS-7977) with Riba and IFN is very significant. Even without interferon GS-7977 + Riba it has about the same or better success rate as current triple tx.
Gilead says they had about 250 genotype 1 patients in the Neutrino trial and …“among genotype 1 patients, 89 percent achieved SVR12. Among patients with cirrhosis at baseline, 80 percent achieved SVR12”.
It is significantly better than current triple tx and no eating fat, severe rash or anemia.
Short course with IFN should be quite tolerable for many, I survived 72 weeks of IFN and Riba and the severity of side effects (mostly Riba rash) usually increases in the second half of tx. Of course all orals without IFN would be better, but this may be available only in 2 years if all goes well. But experience with vertex and Murphy laws show that it usually does not.
I am very interested in your thoughts about this announcement. I have not discussed it with my doc yet, previously he was talking only about all orals in 2-3 years.
Gilead says they had about 250 genotype 1 patients in the Neutrino trial and …“among genotype 1 patients, 89 percent achieved SVR12. Among patients with cirrhosis at baseline, 80 percent achieved SVR12”.
It is significantly better than current triple tx and no eating fat, severe rash or anemia.
Short course with IFN should be quite tolerable for many, I survived 72 weeks of IFN and Riba and the severity of side effects (mostly Riba rash) usually increases in the second half of tx. Of course all orals without IFN would be better, but this may be available only in 2 years if all goes well. But experience with vertex and Murphy laws show that it usually does not.
I am very interested in your thoughts about this announcement. I have not discussed it with my doc yet, previously he was talking only about all orals in 2-3 years.
Does treating it over n over speed up the damage and disease?
I barely survived 6 mos of interferon, no way in hell can I do that again , dont know how some of you have done tx 3, 4 even 5 times.
I barely survived 6 mos of interferon, no way in hell can I do that again , dont know how some of you have done tx 3, 4 even 5 times.
I think they are aiming for 100% success and the length will be 12 weeks
I can put up with 12 weeks on interferon and Riba
At least one more chance till the non interferon will be ready (another 2-3 years? )
I can put up with 12 weeks on interferon and Riba
At least one more chance till the non interferon will be ready (another 2-3 years? )
No longer the answer then is it, Sofosbuvir? Still the INF for most of us. And no info about lengths of tx? Treatment-experienced?
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