Latest Gilead Sofosbuvir Trial data for gt types 2/3
All trial data using Sofosbuvir (GS-7977) + Ribavirin good in genotypes 2/3 except cirrhotics.
NDA 2nd quarter 2013. Expected FDA approval early 2014.
November 27, 2012
Sofosbuvir Effective in Phase 3 POSITRON Study for Hepatitis C
"Gilead announced topline results from the Phase 3 POSITRON study examining a 12-week course of once-daily sofosbuvir plus ribavirin (RBV) in patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who are not candidates to take interferon (IFN). Sofosbuvir is a once-daily nucleotide analog polymerase inhibitor.
In the study, HCV genotype 2 or 3 patients who were interferon intolerant, interferon ineligible or unwilling to take interferon were randomized (3:1) to receive 12 weeks of either sofosbuvir 400mg once daily plus weight-based RBV twice daily (n=207) or matching placebo (n=71).
Of the 207 patients randomized to the sofosbuvir/RBV arm, 15% had compensated cirrhosis (more advanced liver disease) and 53% were infected with genotype 2.
The study found that 78% of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12).
SVR12 rates were 93% in genotype 2 and 61% in genotype 3.
In the small percentage of patients with cirrhosis at baseline who received sofosbuvir/RBV, 61% achieved SVR12.
All patients receiving sofosbuvir/RBV became HCV RNA negative on treatment and relapse accounted for all virologic failures.
No patient in the placebo group achieved an SVR12."
Wish the odds were better for cirrhotics...... As for approval filing? Heard that before from companys... Maybe this time, or more shareholder spin?
None of this means that Vertex shouldn't push the FDA to review telaprevir as soon as possible; and the company has stated it will do just that once the final data from PROVE 3 are in hand in late 2008, early 2009.
If Vertex is successful, telaprevir could be filed with the FDA in mid-2009 with an approval in late 2009. If not, the drug will likely be filed in the second half of 2010 based on data from an ongoing phase III study in treatment-naïve hepatitis C patients.
Vertex shares traded up 2.5% to close at $33.06 Monday
Any thoughts on how insurance companies will be willing to pay the cost for these when studies have shown just as good results with SOC?
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.
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