Aa
Expect Sofosbuvir end of 2013
Read this press release about Sofosbuvir from Gilead...
http://www.gilead.com/pr_1786260
You'll see at the top of the article (under the heading), it says:
-- Initial Regulatory Filings Planned for Q2 2013 --
They have fast-tracked Sofosbuvir so it should take a maximum of 6 months for FDA approval. It is to be for Genotype 2 Tx in combo with Riba.
I expect the combo of Sofosbuvir + Ledipasvir to go to FDA by end of this year and get approval by mid 2014, but that's speculation only. That will be for Genotype 1.
A new dawn will soon be here for those who suffer from HCV.
http://www.gilead.com/pr_1786260
You'll see at the top of the article (under the heading), it says:
-- Initial Regulatory Filings Planned for Q2 2013 --
They have fast-tracked Sofosbuvir so it should take a maximum of 6 months for FDA approval. It is to be for Genotype 2 Tx in combo with Riba.
I expect the combo of Sofosbuvir + Ledipasvir to go to FDA by end of this year and get approval by mid 2014, but that's speculation only. That will be for Genotype 1.
A new dawn will soon be here for those who suffer from HCV.
@OC, Since Sofosbuvir is fast tracked by the FDA, it will be approved or rejected in 6 months.
@JimmyMose, yes they need to combine Sofosuvir with another DAA to increase effectiveness. Currently, they're combining it with Ledipasvir, a NS5A inhibitor, with quite good results...
@JimmyMose, yes they need to combine Sofosuvir with another DAA to increase effectiveness. Currently, they're combining it with Ledipasvir, a NS5A inhibitor, with quite good results...
More Sofosbuvir news Early 2Q Done
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C 4-8-2013
http://www.gilead.com/news/press-releases/2013/4/gilead-submits-new-drug-application-to-us-fda-for-sofosbuvir-for-the-treatment-of-hepatitis-c
HCV Treatment — No More Room for Interferonologists?
http://www.nejm.org/doi/full/10.1056/NEJMe1303818
What are we to conclude from these studies? The low incidence of side effects, the relatively short duration of treatment, and the pangenotypic properties of the drugs are strong selling points of a sofosbuvir–ribavirin regimen and will probably lower the threshold for HCV treatment for both patients and physicians. The likely next step is to combine sofosbuvir with other direct-acting antivirals to enhance its potency. Is the interferonologist down and out? I do not think so, but it is surely time for reeducation.
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C 4-8-2013
http://www.gilead.com/news/press-releases/2013/4/gilead-submits-new-drug-application-to-us-fda-for-sofosbuvir-for-the-treatment-of-hepatitis-c
HCV Treatment — No More Room for Interferonologists?
http://www.nejm.org/doi/full/10.1056/NEJMe1303818
What are we to conclude from these studies? The low incidence of side effects, the relatively short duration of treatment, and the pangenotypic properties of the drugs are strong selling points of a sofosbuvir–ribavirin regimen and will probably lower the threshold for HCV treatment for both patients and physicians. The likely next step is to combine sofosbuvir with other direct-acting antivirals to enhance its potency. Is the interferonologist down and out? I do not think so, but it is surely time for reeducation.
This is hopeful but past experience tells us to be cautious.
Nobody knows how long it will actually take the FDA to approve anything.
Nobody knows how long it will actually take the FDA to approve anything.
How were you able to get into a trial? Were you treatment naive? Or had you previously failed a treatment with Peg-Ifn? I can't get into a trial because I don't fall into either category. Had prior treatment with just plain interferon and ribavirin. Arghhhh.
That is very good news!!
I'm GT 1a and the Sofosbuvir w/ the triple therapy just Cured me..SVR
~Country
I'm GT 1a and the Sofosbuvir w/ the triple therapy just Cured me..SVR
~Country
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
