Gilead (GILD) Presents Encouraging Interim Data from ATOMIC of GS-7977
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Gilead Sciences, Inc. (Nasdaq: GILD) reports 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 47th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2012) in Barcelona, Spain.
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.
Overall, GS-7977 was well tolerated. The frequency and severity of adverse events were consistent with the historical safety profile of Peg-IFN and RBV and included fatigue, headache, nausea, chills and insomnia.
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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.
Overall, GS-7977 was well tolerated. The frequency and severity of adverse events were consistent with the historical safety profile of Peg-IFN and RBV and included fatigue, headache, nausea, chills and insomnia.
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