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When will the new treatment for GENO 2 be out on the market?
We go back to the doctor June 18. I'm trying to get as much info from here as possible before we go so I have a game plan. We really don't want to have to do the RIBO/PEG combo again as he relapsed soon after stopping treatment. I know the last time I checked on here they had approved a new treatment for geno 2, my question is, is it out on the market yet or when will it be?
Thanks all!
Thanks all!
Gilead's Sofosbuvir + ribavirin, without peg-interferon has a 66 percent SVR rate in the 16-week arm.
While the FDA review must be completed by December 8th, doctors will still need to be trained on proper use of the treatment and the treatment will need to be distributed for sale where patients live. All this takes time and varies depending on where you live in the US.So for practical purposes the treatment won't be available until early 2014 for most patients. Whether it is available one month or the next makes no difference medically for patients.
FUSION study, 195 participants who had failed a previous therapy and were infected with either genotype 2 or 3 of the hepatitis C virus (HCV) were randomly divided into two even groups to receive either 12 or 16 weeks of sofosbuvir (400 mg) plus ribavirin (1,000 or 1,200 mg) once a day.
On average, 50 percent of those in the 12-week arm and 73 percent of those in the 16-week arm achieved a sustained virologic response 12 weeks after completing treatment (SVR12, considered a cure).
Eighty-six percent of those with genotype 2 in the 12-week arm achieved SVR12, and
30 percent of the genotype 3 participants achieved SVR12.
Ninety-four percent of those with genotype 2 and
62 percent of those with genotype 3 achieved SVR12 in the 16-week arm.
Thirty-four percent of the participants had compensated cirrhosis at the beginning of the study; 31 percent of them achieved SVR12 in the 12-week arm; and 66 percent did so in the 16-week arm.
There were no discontinuations due to adverse effects. The most common side effects (reported in 15 percent or more of the participants) were fatigue, headache, insomnia and nausea.
"Foster City, Calif. -- June 7, 2013 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options. Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013. (targeted date for completion of FDA review)
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-naive patients with genotype 1, 4, 5 and 6 HCV infection."
Good luck.
Hector
While the FDA review must be completed by December 8th, doctors will still need to be trained on proper use of the treatment and the treatment will need to be distributed for sale where patients live. All this takes time and varies depending on where you live in the US.So for practical purposes the treatment won't be available until early 2014 for most patients. Whether it is available one month or the next makes no difference medically for patients.
FUSION study, 195 participants who had failed a previous therapy and were infected with either genotype 2 or 3 of the hepatitis C virus (HCV) were randomly divided into two even groups to receive either 12 or 16 weeks of sofosbuvir (400 mg) plus ribavirin (1,000 or 1,200 mg) once a day.
On average, 50 percent of those in the 12-week arm and 73 percent of those in the 16-week arm achieved a sustained virologic response 12 weeks after completing treatment (SVR12, considered a cure).
Eighty-six percent of those with genotype 2 in the 12-week arm achieved SVR12, and
30 percent of the genotype 3 participants achieved SVR12.
Ninety-four percent of those with genotype 2 and
62 percent of those with genotype 3 achieved SVR12 in the 16-week arm.
Thirty-four percent of the participants had compensated cirrhosis at the beginning of the study; 31 percent of them achieved SVR12 in the 12-week arm; and 66 percent did so in the 16-week arm.
There were no discontinuations due to adverse effects. The most common side effects (reported in 15 percent or more of the participants) were fatigue, headache, insomnia and nausea.
"Foster City, Calif. -- June 7, 2013 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options. Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013. (targeted date for completion of FDA review)
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-naive patients with genotype 1, 4, 5 and 6 HCV infection."
Good luck.
Hector
Thank you all so much! Our doctor wants to hold off on tx until the beginning of the new year. We go back in September to talk further about our options but the sounds of it he will unfortunetely go back on pegasys/rib combo added with some new drug. We are just very fortunate that we are able to wait as I know some are far too sick to wait. Any new information will always be greatly appreciated :)
Thank you all!
Thank you all!
"The FDA has set a target review date of Dec. 8 under the Prescription Drug User Fee Act. "
What does that mean target review date? Does that mean the day they will decide or does mean they're going to be looking at it for a while and then decide?
-David
What does that mean target review date? Does that mean the day they will decide or does mean they're going to be looking at it for a while and then decide?
-David
From what I'm told from my trial Doctor it WILL be available by the end of THIS year.
Bob
Bob
December 8th is the target date for 2's & 3's
The FDA grants priority review status to drug candidates that may offer major advancements in treatment over existing options. The FDA has set a target review date of Dec. 8 under the Prescription Drug User Fee Act.
Gilead proposes the use of sofosbuvir and ribavirin, or RBV, as an all-oral therapy for genotype 2 and 3 HCV infection
The FDA grants priority review status to drug candidates that may offer major advancements in treatment over existing options. The FDA has set a target review date of Dec. 8 under the Prescription Drug User Fee Act.
Gilead proposes the use of sofosbuvir and ribavirin, or RBV, as an all-oral therapy for genotype 2 and 3 HCV infection
doc told me genotyp2,3 around october genotype1 end of year -early 2014.others onsite have been completely correct w/ saying there are drugs being sent for fda approval right now.so its very soon.
she did say at 1st that the newer drugs would have interferon then on to interferon -free but the time frame of tx will be 12 weeks for even the genotype 1's.
i did watch a quick video from one doc saying the same thing last night.
she did say at 1st that the newer drugs would have interferon then on to interferon -free but the time frame of tx will be 12 weeks for even the genotype 1's.
i did watch a quick video from one doc saying the same thing last night.
Sorry but nothing has been approved but just submitted to the FDA for approval. October would be the earlist for just approval. When they would hit the market nobody knows for sure but I would guess soon after.
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