Aa
great news!
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C
http://www.gilead.com/pr_1804362
It came out even sooner than most of us expected.
Hopefully, it is a start of a new era in Hep C treatment!
http://www.gilead.com/pr_1804362
It came out even sooner than most of us expected.
Hopefully, it is a start of a new era in Hep C treatment!
Plus I don't recall to much of telling a relapser not to wait, it's always the naive folks... And these results below are pretty good even with shorter treatment with just SOC for type 2...
In the pilot trial, all patients with RVR were treated for 14 weeks, while in the larger trial participants with RVR were randomized to receive therapy for either 14 or 24 weeks.
In an analysis of all RVR patients treated per protocol, 91% of those who received 14 weeks of therapy achieved SVR, compared with 95% of those treated for 24 weeks. The difference of 4% fell well within the pre-determined 10% margin needed to show inferiority, allowing the researchers to conclude that 14 week treatment was non-inferior to 24 weeks.
The relapse rate was highest among participants older than 40 years, those with genotype 3, and those with a high baseline viral load. However, prolonging treatment from 14 to 24 weeks did not reduce the relapse rate substantially for any of these groups.
http://www.hivandhepatitis.com/hep_c/news/2010/1026_2010_a.html
In the pilot trial, all patients with RVR were treated for 14 weeks, while in the larger trial participants with RVR were randomized to receive therapy for either 14 or 24 weeks.
In an analysis of all RVR patients treated per protocol, 91% of those who received 14 weeks of therapy achieved SVR, compared with 95% of those treated for 24 weeks. The difference of 4% fell well within the pre-determined 10% margin needed to show inferiority, allowing the researchers to conclude that 14 week treatment was non-inferior to 24 weeks.
The relapse rate was highest among participants older than 40 years, those with genotype 3, and those with a high baseline viral load. However, prolonging treatment from 14 to 24 weeks did not reduce the relapse rate substantially for any of these groups.
http://www.hivandhepatitis.com/hep_c/news/2010/1026_2010_a.html
I have always liked this comment..."or unwilling to take interferon" Something tells me a insurance company could care less when it comes to them spending money......... I like brand over generic drugs but my insurance don't seem to give a hoot............
Hi that great news it will be interesting how long it will take NICE the medical board here in Britain to approve it to
Obviously I do not have a crystal ball. I wouldn't be up the proverbial creek if I did. A Gordon Ramsay says "F me!"
The check is in the mail right? Okay, so here is the data for Gilead's therapy for treatment naive genotypes 1, 4, 5 or 6.
If you think 89% SVR for G1s for 12 weeks of treatment is rotten.. feel free.
If you think 80% SVR for cirrhotics for 12 weeks of treatment is rotten.. free free.
As we like to say around here everyone is entitled to their opinions no matter how nonsensical those opinions are. ;-)
I'll let you all duke it out
Attn: This is not my opinion or data. If you don't like the data, feel free to make up your own.
Also please send all complaints, grips, conspiracy theories, bad vibes and death threats to someone who cares. In other words... NOT me!
Maybe write to Gilead Chairman & CEO John Martin who snagged a $3.38 million bonus for 2012 — on top of his $1.5 million base salary. At least he gets paid to deal with the riffraff. I don't. Despite rumors you may have seen here in posts, I do not make anything close to John's $$ myself.
Living on SSDI for many years now has really cut into my former jet set lifestyle of dinners in Paris and mornings on the Riviera with the French and Italian model set.
Anyway..I've got to take a few...mental health days. (Obviously)
Catch you all later.
----------------------------------------------------------------------------------------------------------
In the NEUTRINO study, treatment naïve patients with genotype 1, 4, 5 or 6 HCV infection were treated with a 12-week course of sofosbuvir, RBV and peg-IFN. This study met its primary efficacy endpoint of superiority compared to a predefined historic control SVR rate of 60 percent with 90 percent (295/327) of patients achieving SVR12 after completing therapy (P<0.001).
In the NEUTRINO study the most common adverse events that occurred in ≥20 percent of patients were fatigue, headache, nausea, insomnia and anemia.
In NEUTRINO, 327 treatment-naïve HCV genotype 1, 4, 5 and 6 patients were treated for 12 weeks with sofosbuvir 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week). Seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1. Among genotype 1 patients, 89 percent achieved SVR12. Of the 35 patients with genotypes 4, 5 or 6, 97 percent achieved SVR12. Among patients with cirrhosis at baseline, 80 percent achieved SVR12. All patients in this study became HCV RNA negative on treatment and relapse accounted for all virologic failures.
Five patients (2 percent) receiving Sofosbuvir in combination with peg-IFN and RBV discontinued treatment due to adverse events.
------------------------------------------------------------------------------------------------------
Ciao!
Hector
The check is in the mail right? Okay, so here is the data for Gilead's therapy for treatment naive genotypes 1, 4, 5 or 6.
If you think 89% SVR for G1s for 12 weeks of treatment is rotten.. feel free.
If you think 80% SVR for cirrhotics for 12 weeks of treatment is rotten.. free free.
As we like to say around here everyone is entitled to their opinions no matter how nonsensical those opinions are. ;-)
I'll let you all duke it out
Attn: This is not my opinion or data. If you don't like the data, feel free to make up your own.
Also please send all complaints, grips, conspiracy theories, bad vibes and death threats to someone who cares. In other words... NOT me!
Maybe write to Gilead Chairman & CEO John Martin who snagged a $3.38 million bonus for 2012 — on top of his $1.5 million base salary. At least he gets paid to deal with the riffraff. I don't. Despite rumors you may have seen here in posts, I do not make anything close to John's $$ myself.
Living on SSDI for many years now has really cut into my former jet set lifestyle of dinners in Paris and mornings on the Riviera with the French and Italian model set.
Anyway..I've got to take a few...mental health days. (Obviously)
Catch you all later.
----------------------------------------------------------------------------------------------------------
In the NEUTRINO study, treatment naïve patients with genotype 1, 4, 5 or 6 HCV infection were treated with a 12-week course of sofosbuvir, RBV and peg-IFN. This study met its primary efficacy endpoint of superiority compared to a predefined historic control SVR rate of 60 percent with 90 percent (295/327) of patients achieving SVR12 after completing therapy (P<0.001).
In the NEUTRINO study the most common adverse events that occurred in ≥20 percent of patients were fatigue, headache, nausea, insomnia and anemia.
In NEUTRINO, 327 treatment-naïve HCV genotype 1, 4, 5 and 6 patients were treated for 12 weeks with sofosbuvir 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week). Seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1. Among genotype 1 patients, 89 percent achieved SVR12. Of the 35 patients with genotypes 4, 5 or 6, 97 percent achieved SVR12. Among patients with cirrhosis at baseline, 80 percent achieved SVR12. All patients in this study became HCV RNA negative on treatment and relapse accounted for all virologic failures.
Five patients (2 percent) receiving Sofosbuvir in combination with peg-IFN and RBV discontinued treatment due to adverse events.
------------------------------------------------------------------------------------------------------
Ciao!
Hector
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