Thanks for filling me in.
My knowledge is limited to a summary given to me by a geneticist relative involved with HIV.
I do know it takes time and often it's longer than we would hope. That certainly was the case with teleprivir.
We all are hoping the orals are approved sooner rather than later :)
The delay in approval is not primarily with FDA as they have made commitments to give a 6 month review for priority drugs. A lot of time gets eaten up with the sponsor acquiring and auditing data, doing the statistical analysis then getting concurrence from FDA that the data analyses are done the way the Agency wants to see them. Then there is the Agency review and LOTS of negotiation on the labeling. That doesn't even include the manufacturing and analytical portion of the application. It's a very labor intensive process, one that I've lived through a number of times.
Gilead are going to apply for approval in 2013. It will be used for geno 2's with Riba and with IFN for geno 1's. In 2014 they hope to have FDA approval for their 7977+5885 (all orals) for geno 1's.
Well....that's the hope and I don't see why that can't happen.
No offense but the truth is nobody knows because the FDA has to approve the meds. My hepatologist is up on research and goes to the liver conventions.
He guessed that the triple treatment would be available a good two years before it was.
It really isn't up to the doctors.
First there are the various stages of clinical trials then, it is up to the FDA.
And we all know how long things can take with government agencies.
The earliest projection I've heard is 2014.
I have a hepatologist appointment Nov 20 something so I will get the scoop of probably of availability then.
Hector
Very best wishes to you. And thanks to the fabulous life-giving researchers and scientists who created the new drug.
I'll post my results here as I go on.
Good luck to you, and me.
Pete