Gilead Announces Sustained Virologic Response Data For 12-Week Regimen Of GS-7977 Plus Pegylated Interferon And Ribavirin In Genotype 1 Hepatitis C Patients

Gilead Sciences, Inc. (Nasdaq:GILD) today announced interim data from a Phase 2 trial (ATOMIC) examining a 12-week course of treatment with the once-daily nucleotide GS-7977 plus pegylated interferon (Peg-IFN) and ribavirin (RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. The study found that 90 percent of patients (n=47/52, missing data equals failure analysis) achieved a 12-week sustained virologic response (SVR12), defined as maintaining undetectable viral load (HCV RNA <25 IU/mL) 12 weeks after the completion of therapy. These findings will be presented today during an oral session at the 47 th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.

“These data suggest that this GS-7977-based regimen could offer most patients with genotype 1 a simple, short, three-month course of treatment with very high cure rates,” said Kris Kowdley, MD, Director of the Liver Center of Excellence at the Virginia Mason Medical Center in Seattle and the study’s principal investigator. “An all-oral regimen for HCV remains the ultimate treatment goal. In the interim, these results suggest that we may soon be able to end the complex process of response-guided HCV therapy and shorten the duration of treatment, which would be a significant advance for patients and for physicians who manage their care.”

In this study, 52 patients were randomized to the 12-week treatment arm. One patient was lost to follow up during the course of treatment. At the end of treatment, 51/51 patients (100 percent) were HCV RNA undetectable. At the 12-week, post-treatment time period, data were available for 50/51 patients, as one patient was lost to follow up during the post-treatment time period. Of the 50 patients, 47 (94 percent) remained HCV RNA undetectable. Three patients experienced viral relapse after the end of treatment.

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