Biotech Values

[DewDiligence]

GILD reports 78% SVR12 in phase-3 trial of Sofosbuvir + ribavirin in treatment-naïve geneotype-2/3:

http://finance.yahoo.com/news/gilead-announces-sustained-virologic-response-133000093.html

Gilead Sciences today 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). The study found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12). The safety profile of sofosbuvir was similar to that observed in previous studies, and there were few treatment discontinuations due to adverse events.

Full data from the study will be submitted for presentation at a future scientific conference.

The SVR12 rate in POSITRON was 93% in genotype-2 and 61% in genotype-3.

The overall phase-3 program for Sofosbuvir:

The Phase 3 clinical trial program for sofosbuvir includes two additional studies evaluating 12 and 16 weeks of therapy with sofosbuvir plus RBV in HCV genotype 2 and 3 infected patients. A fourth Phase 3 clinical trial is evaluating sofosbuvir combined with RBV and peg-IFN among patients with HCV genotypes 1, 4, 5 and 6. Pending the results, these studies will support initial regulatory filings in mid-2013 for an all-oral therapy with sofosbuvir plus RBV among genotype 2/3 treatment-naïve, treatment-experienced and interferon-intolerant patients, and for sofosbuvir in combination with RBV and peg-IFN among treatment-naïve patients with HCV genotypes 1, 4, 5 and 6.