Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients
Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients
Date(s): 26-Mar-2013 8:30 AM
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-- Enrollment in ION-1 Study Continues Following Planned DSMB Review --
Sofosbuvir/ledipasvir is also being evaluated in a second Phase 3 study, ION-2, initiated in January 2013, which is now fully enrolled. ION-2 is evaluating sofosbuvir/ledipasvir with RBV for 12 weeks, and with and without RBV for 24 weeks, among 400 treatment-experienced genotype 1 HCV patients. Participants in this study failed to respond to past therapy containing pegylated interferon (peg-IFN) or peg-IFN plus a protease inhibitor.
Sofosbuvir, ledipasvir and the sofosbuvir/ledipasvir fixed-dose combination are investigational products and their safety and efficacy have not yet been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable longer-term results from the ION-1 study, the possibility that the proportion of patients who maintain a sustained virologic response with longer follow up will not be as favorable as the SVR4 rates observed in the study, and the possibility of unfavorable results from ION-2 and other ongoing and subsequent clinical trials involving sofosbuvir and the fixed-dose combination of sofosbuvir/ledipasvir. In addition, Gilead may make a strategic decision to discontinue development of sofosbuvir, ledipasvir and/or the fixed-dose combination regimen if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. As a result, these compounds may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
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