What is the key drug and condition highlighted in this filing?

The key drug is Gilead's investigational drug sofosbuvir (also known as GS-7977), and the condition is Hepatitis C Virus (HCV) infection, specifically genotype 1.

What were the main results of the study presented?

The study showed that 96% of genotype 1 treatment-naïve HCV patients achieved a sustained viral response four weeks after completing a 12-week treatment course of sofosbuvir combined with daclatasvir (with or without ribavirin). All patients who didn't initially achieve SVR-4 later achieved SVR-12.

Who developed the other drug used in the combination therapy?

The other drug, daclatasvir, is an investigational NS5A inhibitor developed by Bristol-Myers Squibb Company.

What does SVR-4 and SVR-12 mean?

SVR stands for Sustained Viral Response. SVR-4 means the patient achieved sustained viral response four weeks after the completion of treatment, and SVR-12 means sustained viral response twelve weeks after the completion of treatment. These are key indicators of a cure for HCV.

GILD 8-K: Regulation FD

Summary

Gilead Sciences, Inc. (GILD) announced significant positive data from a Phase 2 study presented at the American Association for the Study of Liver Diseases Liver Meeting 2012. The data pertains to the investigational drug sofosbuvir (GS-7977) when used in combination with Bristol-Myers Squibb's daclatasvir, with or without ribavirin, for the treatment of genotype 1 Hepatitis C Virus (HCV) infected patients. The study focused on a 12-week treatment course.

Key Highlights

1Positive Phase 2 study results for sofosbuvir (GS-7977) in combination with daclatasvir were presented.
2The combination therapy, with or without ribavirin, was evaluated for 12 weeks in genotype 1 treatment-naïve HCV patients.
3An impressive 96% of patients (79 out of 82) achieved a sustained viral response four weeks post-treatment (SVR-4).
4All three patients who did not achieve SVR-4 subsequently achieved SVR-12, indicating high overall treatment success.
5This data suggests strong efficacy for Gilead's sofosbuvir in a significant HCV patient population.
6The results were presented at a major liver disease conference, indicating a high level of scientific validation.

GILEAD SCIENCES, INC. 8-K Report, Regulation FD Disclosure (Nov 13, 2012)

Summary

Key Highlights

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