Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from two Phase 2 studies evaluating an all-oral treatment regimen of the investigational once-daily nucleotide analogue sofosbuvir plus ribavirin (RBV) for both the prevention and treatment of recurrent chronic hepatitis C virus (HCV) infection among patients who undergo liver transplantation. The findings will be presented this week at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2013) in Washington, D.C.
HCV infection is the most common cause of liver transplantation in the United States and Europe. Recurrence of HCV infection is universal among patients with active disease at the time of transplantation and up to 50 percent develop cirrhosis of the liver within five years. Suppression of HCV RNA prior to liver transplantation should reduce the risk of re-infection and its serious complications, but currently available treatment options are often ineffective and poorly tolerated. Similarly, in the post-transplant setting, treatment is generally poorly tolerated and complicated by strong drug interactions with immunosuppressive agents used to prevent the body’s rejection of the transplanted liver.
In a study conducted among pre-transplant HCV patients (Study 2025), up to 48 weeks of sofosbuvir/RBV therapy was administered. Among patients with undetectable HCV (<25 IU/mL) at the time of transplantation, 64 percent (n=25/39) achieved undetectable HCV RNA 12 weeks post-transplant (pTVR12). Patients who achieve pTVR12 are considered cured of HCV infection. In a second study conducted among post-transplant HCV patients (Study 0126), patients with established recurrent HCV infection following liver transplantation received 24 weeks of sofosbuvir/RBV therapy. Seventy-seven percent (n=27/35) of patients in this study have achieved a sustained virologic response four weeks post-treatment (SVR4).
“Recurrence of HCV following liver transplantation almost always occurs in clinical practice. These patients are at higher risk for disease progression, the development of cirrhosis, liver graft failure, re-transplantation and increased morbidity and mortality,” said Michael P. Curry, MD, Medical Director, Liver Transplantation at Beth Israel Deaconess Medical Center, Boston, and an investigator for the pre- and post-liver transplant trials. “In these studies, sofosbuvir clearly demonstrated the potential to improve patient outcomes by either preventing or effectively treating recurrent HCV infection following liver transplantation.”
Three percent and five percent of patients discontinued treatment due to adverse events in the pre- and post-transplant studies, respectively. No serious adverse events reported were associated with sofosbuvir. The most common adverse events observed were consistent with the safety profile of RBV, and included fatigue, anemia, headache and nausea in the pre-transplant study, and fatigue, headache, arthralgia (joint pain) and diarrhea in the post-transplant study.
About the Pre-Transplant Study
Study 2025 is an on-going open-label Phase 2 study evaluating the efficacy and safety of sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) for up to 48 weeks or until liver transplantation. Sixty-one patients with HCV infection (Child-Pugh class A or B cirrhosis) and liver cancer, who were either treatment-naïve or treatment-experienced were enrolled.
About the Post-Transplant Study
Study 0126 is an ongoing open-label Phase 2 study evaluating the efficacy and safety of 24 weeks of treatment with sofosbuvir 400 mg once-daily plus RBV (starting at 400 mg/day) among 40 treatment-naïve and treatment-experienced patients with recurrent HCV infection. Patients in the study had received a transplant a median of four years prior to the study, and 40 percent were cirrhotic.
There were no deaths, graft losses or episodes of organ rejection among post-liver transplantation patients in the study.
Additional information about these studies can be found at www.clinicaltrials.gov.
Sofosbuvir is an investigational product and its safety and efficacy have not 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 and South 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 Studies 025 and 126 and other ongoing and subsequent clinical trials involving sofosbuvir, alone or in combination with other products, for the treatment of HCV. In addition, regulatory authorities will not approve sofosbuvir for HCV-related indications and any marketing approval may have substantial limitations on its use. As a result, sofosbuvir may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of sofosbuvir if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, 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.
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